FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study
Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs and BioNTech that you may have missed. A Food and Drug Administration advisory panel on Wednesday voted unanimously against expanding…
Novo pressures GLP-1 compounders as FDA ban takes hold
Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace period for their products officially ends. The Danish drugmaker on Thursday said it’s launching a “Choose the Real Thing” campaign…
House passes reconciliation bill with massive Medicaid cuts
The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the legislation — which includes the most drastic overhaul to Medicaid since the program was founded — to the Senate for review. It’s a major victory for…
Sanofi gains experimental Alzheimer’s drug through Vigil buyout
Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for Alzheimer’s disease. The newly announced acquisition has Sanofi paying $8 for each share of Vigil Neuroscience it doesn’t already own,…
AI tool could help doctors ID breast cancers vulnerable to Enhertu
For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and pored over slides, hunting for signs the tumor cells they’re studying harbor a protein known as HER2. A positive result meant they could deploy powerful drugs…
Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer
A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat form of lung cancer, according to clinical trial data made public Thursday. The Phase 3 trial enrolled 660 people with…
FDA panel recommends keeping COVID shots targeted to same strain as last year
Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year. The advisory committee convened…
FDA panel backs Darzalex for early stage multiple myeloma
Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer. Members of the Oncologic Drugs Advisory Committee voted…
Reproductive health startup raises $65M for infertility drugs
ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance two drugs it thinks could help address fertility issues in men and women. The Switzerland-based firm plans to use the new funds to run Phase 2…
Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff
Today, a brief rundown of news involving Tourmaline Bio, Schrödinger and Beckley Psytech, as well as updates from CRISPR Therapeutics and Regenxbio that you may have missed. Shares in Tourmaline Bio fell by as much as 18% in Tuesday morning…
FDA sets stricter approval standards for COVID vaccines
The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of the framework it used to quickly clear updated boosters for all adults the past few years. The new guidelines were…
Novavax’s COVID vaccine gets FDA approval, but with limits
Novavax has at last gained full Food and Drug Administration approval for its COVID-19 vaccine, but the OK comes with limitations not specified for other COVID shots available in the U.S. Dubbed Nuvaxovid, the vaccine is cleared for use in…
Prime Medicine claims ‘proof of concept,’ but lays off staff in pivot
Prime Medicine will lay off one-quarter of its workforce and deprioritize its clinical-stage program for a rare genetic disease as part of a restructuring announced Monday. Moving forward, Prime will focus on Wilson’s disease and alpha-1 antitrypsin disease, as well…
Bridging the data gaps that impact retail and specialty-lite success
Retail and specialty-lite brand teams are facing a paradox – they’re drowning in data yet struggling to gain actionable insight. While manufacturers collect vast amounts of information, most are still making critical business decisions based on incomplete data sets that…
FDA delays approval decision for Biohaven rare disease drug
Connecticut-based Biohaven has been developing what it hopes will be the first medicine for a group of rare, nerve-destroying diseases. The company ran a couple late-stage clinical trials, submitted an approval application to the Food and Drug Administration, and expected…
Novo CEO to depart as obesity drugmaker’s challenges rise
Novo Nordisk CEO Lars Fruergaard Jørgensen, who led the Danish drugmaker to new heights through its development of powerful medicines for diabetes and obesity, will step down from his position, the company said Friday. While the runaway success of Novo’s…
BioMarin to buy rare disease drugmaker Inozyme for $270M
BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based drug company with complementary expertise in rare disease research. The all-cash deal, announced Friday, should close sometime between July and the end of September, having already…
Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff
Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Travere Therapeutics, Allogene and Kyverna Therapeutics that you may have missed. A federal jury has found Amgen liable for violating antitrust and tort laws by…
A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases
A group of scientists successfully made a bespoke gene editing medicine for a critically ill baby in just a few months, suggesting CRISPR technology could be used to quickly develop personalized therapies for an array of ultra-rare diseases. Study results…
Sanofi to pour more than $20B into US drug research and manufacturing
Dive Brief: Sanofi plans to invest at least $20 billion in the U.S. over the next five years as the pharmaceutical industry braces for new tariffs from President Trump. The French drugmaker intends to make direct investments in Sanofi sites…
Can I rely on a Sciatilief review before buying it?
Sciatilief review When considering whether to purchase a new supplement for nerve pain, one of the first steps many take is reading a Sciatilief review. These reviews often serve as an important resource for individuals looking to make informed decisions…
Novo to work with Septerna in hunt for oral obesity drugs
Dive Brief: Novo Nordisk on Wednesday said it will collaborate with biotechnology startup Septerna to hunt new obesity drug prospects, agreeing to pay the California drugmaker more than $200 million in upfront and near-term fees. Septerna and Novo will initially…
GSK to buy liver disease drug for $1.2B
Dive Brief: British drugmaker GSK has agreed to pay privately held Boston Pharmaceuticals $1.2 billion upfront and as much as $800 million more to acquire rights to a liver disease treatment poised to enter pivotal testing. Boston obtained the drug…
Women’s health faces growing headwinds, despite jump in venture investment
The women’s health field has a long way to go addressing persistent deficits in research and treatment. Common conditions that affect women like endometriosis and polycystic ovarian syndrome remain misunderstood, while maternal mortality in the U.S. remains higher than in…
iTeos, GSK to shelve TIGIT drug after study setback
Dive Brief: A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression in a Phase 2 trial, leading the companies to end development and terminate the collaboration they formed around the drug…
FDA follows EMA in limiting use of Valneva shot
Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age. The recommendation announced Monday comes days after the…
Trump revives ‘most favored nation’ plan in effort to cut US drug prices
The Trump administration is resurrecting a controversial policy that aims to tamp down some pharmaceutical costs in the U.S. by linking them to prices paid abroad, delivering another jolt to an industry it has already targeted for tariffs. In an…
[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care
Emerging biopharma companies are now taking the lead on drug development, with smaller and more agile firms able to meet aggressive timelines and navigate unique logistical and regulatory challenges. From business development to clinical supply management, various project management duties…
Novo cuts forecasts as compounded GLP-1s weigh on sales
Dive Brief: While revenue and profit rose year-over-year during the first quarter at Novo Nordisk, the Danish drugmaker on Wednesday scaled back its financial forecasts for 2025 due to the impact compounded copies of its popular GLP-1 medicines have had…
Haya banks $65M to scour the ‘dark genome’ for new drugs
Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after all, aren’t translated into proteins, making them appear as bits of genetic material with no biological purpose. They were often referred to as “junk.” Accumulating academic…
Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily, use prescription drugs without sufficient evidence of their benefit and put patients at risk of side effects or other negative outcomes. The Food and Drug Administration…
Eli Lilly extends Purdue alliance; EMA investigates Valneva shot
Today, a brief rundown of news involving Eli Lilly and Valneva, as well as updates from CRISPR Therapeutics, Vivo Capital and Charles River Laboratories that you may have missed. Eli Lilly and Purdue University on Friday said they are expanding…
Viatris’ new form of old pain drug scores in large trials
Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year. The drug is a reformulated version of an old medication, meloxicam,…
4 more biotechs cut staff amid market tumult
Four biotechnology companies are laying off staff in the latest examples of cutbacks in a sector struggling to hold its footing amid financial market turmoil. On Thursday, Vor Bio, Korro Bio, Rallybio and Insitro all revealed plans to cut at…
Gilead, bracing for tariffs, joins peers in US drug production push
Dive Brief: Gilead on Wednesday became the latest U.S. drugmaker to pledge new investments in U.S. manufacturing, as President Trump threatens the worldwide industry with tariffs. The California biotech said it’s now planning an additional $11 billion in capital and…
FDA set to meet this month on COVID vaccines
A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday. The Vaccines and Related Biological Products Advisory…
Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines
Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named Wednesday as the new leader of a main Food and Drug Administration office. FDA Commissioner Martin Makary announced Prasad’s appointment as the new director of the…
Prasad’s FDA appointment pressures cell and gene therapy stocks
Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic of the speedy approval paths their treatments often rely on was named to lead the Food and Drug Administration office…
AI specialist Recursion trims pipeline in latest shakeup
AI drug discovery specialist Recursion Pharmaceuticals is shelving three of its most advanced drug prospects in an effort to cut costs following a merger last year. Alongside its latest quarterly earnings report, the company revealed plans to halt development of…
PTC stock slides on new data for Huntington’s drug
Dive Brief: Shares in PTC Therapeutics fell by double-digits Monday morning as investors parsed new clinical trial results for an important Huntington’s disease drug the biotechnology company has been developing. Results from the study showed PTC’s drug lowered levels of…
Madrigal’s MASH drug sales again top Wall Street projections
Dive Brief: Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million. More than 17,000 patients have now taken the drug, known as…
AstraZeneca quietly exits neuroscience | BioPharma Dive
AstraZeneca on Tuesday confirmed it has closed down its neuroscience research group to direct resources toward more “high value” projects. On an earnings call with investors, Sharon Barr, AstraZeneca’s head of biopharmaceuticals research and development, explained that the decision allows…
Arvinas, Entrada cut staff; Merck builds US hub for Keytruda
Today, a brief rundown of news involving Arvinas and Biogen, as well as updates from Merck & Co., Entrada Therapeutics and Valneva that you may have missed. Arvinas will lay off about a third of its workforce and scrap a…
CVS strikes Wegovy deal with Novo Nordisk
Dive Brief: CVS Health’s pharmacy benefit manager Caremark reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase…
Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma
Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates from Repare Therapeutics, Amicus Therapeutics and Pliant Therapeutics that you may have missed. The Food and Drug Administration has delayed an approval decision on Cytokinetics‘ experimental…
Amgen’s Stelara biosimilar gets off to fast start
Dive Brief: Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotech’s portfolio of copycat biologics. During the company’s first quarter…
Pharma downplays tariff threat, even as risks remains unclear
The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the largest companies indicating they expect to be able to absorb any impact in the short term. Speaking on earnings calls…
Moderna combination flu, COVID shot delayed amid FDA scrutiny
The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership. Alongside…
Siren, a gene therapy startup, tests unconventional alternative to venture funding
Biotechnology startups usually turn to a few tried-and-true options to raise the money they need to develop a new drug. Company founders might get initial financial help from friends, family or an angel investor. Perhaps they’ll apply for grant funding…
Novartis to acquire Regulus in deal for kidney disease drug
Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA. Announced Wednesday, the…
Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs
Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can’t predict the impact of any tariffs or trade policy changes the Trump administration might impose on the pharmaceutical sector. “While we continue to engage and plan…
Acelyrin should liquidate instead of merging with Alumis, investor says
A shareholder of immune drug developer Acelyin believes the company is better off shutting down and returning cash to shareholders rather than pursuing a merger with fellow biotech Alumis. Trium Capital, an England-based investment fund and Acelyrin stockholder, revealed in…
Abeona cell therapy approved by FDA for rare skin condition
The Food and Drug Administration on Tuesday approved a new treatment for a rare skin condition, teeing up a commercial battle between two cell and gene therapy developers. The agency cleared Abeona Therapeutics’ Zevaskyn for a form of epidermolysis bullosa,…
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on…
Top Republican calls for 340B reform in long-awaited investigation
Dive Brief: On Thursday, the chair of the Senate Health, Education, Labor and Pensions Committee released a long-anticipated report calling for Congress to reform 340B drug discounts, citing concerns about transparency and oversight of the program. The report from Sen. Bill…
Sanofi stays on course amid tariff turmoil
Dive Brief: Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty. Sales climbed 9.7% to 9.9 billion euros, or…
Merck takes $200M tariff hit, trimming its gross profits
Dive Brief: Merck & Co. “absorbed” $200 million in addition expenses related to U.S. and overseas tariffs in the first quarter of 2025, increasing its cost of selling products and trimming a half percent from its gross profits, the company…
Halozyme sues Merck; FDA blames cuts for Vanda delay
Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as updates from Sanofi and Novo Holdings that you may have missed. Halozyme Therapeutics has sued Merck & Co., alleging that the pharmaceutical company is infringing on…
Gilead leans on HIV drugs as oncology sales slow
Dive Brief: Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations. Gilead’s oncology portfolio generated $758 million in sales over…
Biohaven stock slides on withdrawal of European marketing application
Biohaven lost close to $400 million in market value Friday on news that the Connecticut-based drug developer had withdrawn an application to get one of its most advanced experimental therapies approved in Europe. The company first asked the European Medicines…
Caribou, in reversal, scraps autoimmune cell therapy and cuts staff
Caribou Biosciences is laying off about a third of its staff and stopping work on an experimental lupus treatment in a gamble on the potential of a pair of cell therapies for cancer. The company on Thursday said it’s cutting…
Bristol Myers says schizophrenia drug launch ‘off to a solid start’
A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its first full quarter on the market, according to both the company and analysts. In its latest earnings report, Bristol Myers recorded $27 million in net sales…
Versant startup Granite debuts with $100M and two immune drugs
Venture capitalists have been scouring the globe in search of better immunology drugs. Biotech startup creator Versant Ventures is among them, having formed and funded several companies in recent years looking to change the way certain inflammatory diseases are treated. …
German antibody maker valued at $1.6B in blank-check merger
Dive Brief: Veraxa Biotech, a cancer therapy developer backed by Swiss incubator Xlife Sciences, will go public through a combination with a blank-check entity in a deal that will value the company at as much as $1.6 billion and leave it…
Bristol Myers’ prized schizophrenia drug stumbles in testing
A brain drug at the center of a recent $14 billion acquisition has failed a large clinical trial, leading some Wall Street analysts to substantially lower their sales forecasts. Bristol Myers Squibb closed a deal to acquire the drug, Cobenfy,…
Roche, answering tariff threat, pledges $50B to US drug production
Dive Brief: Roche is the latest drugmaking planning to expand drug production in the U.S., announcing Tuesday a pledge to spend $50 billion over five years on new and existing manufacturing facilities in several states. The investment promise comes…
The Trump administration is remaking HHS. Track the changes here.
The Trump administration is radically revising the scale and scope of the federal health workforce. Approximately 1 in 4 employees at the Department of Health and Human Services have been laid off, forced out or pushed to take early retirement…
Novo says it’s submitted obesity pill for FDA approval
Dive Brief: Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive. Novo first reported in 2023 that the drug,…
Enhertu combo tops standard drugs in first-line HER2 breast cancer
A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer, the companies said Monday. In a Phase 3 trial, a combination of Enhertu and the targeted therapy pertuzumab held tumors…
FDA cuts outlined in draft HHS budget
A draft budget document shows the Trump administration’s plan to slash funding to the Department of Health and Human Services includes substantial cuts to the Food and Drug Administration. The preliminary budget sets a total of $2.9 billion in requested…
GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech
Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer and Airna that you may have missed. GSK’s Blenrep has been approved in the U.K. to treat people whose multiple…
Makary seeks to limit industry’s role in FDA advisory panels
The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday. Advisory committees, which the FDA typically…
Sanofi, Regeneron win FDA nod for Dupixent in chronic hives
The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent, clearing the medicine to treat a chronic skin condition that causes hives. The agency OK’d Dupixent for chronic spontaneous urticaria,…
An investment fund sets out to free biotech’s ‘trapped capital’
A British investment fund has launched with plans to extract tens of billions of dollars it believes to be “trapped” on the balance sheets of struggling, publicly traded biotechnology companies. Called Alis Biosciences, the fund aims to return to shareholders…
Sanofi licenses immune disease drugs from startup Earendil
Dive Brief: French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs for two drug candidates designed to treat autoimmune and inflammatory bowel diseases. Under the terms of the deal announced Thursday, Earendil may receive as much as…
Lilly’s obesity pill scores in large diabetes trial
Dive Brief: Eli Lilly’s weight loss pill orforglipron succeeded in a Phase 3 clinical trial in diabetes, helping study participants control their blood sugar while hinting at weight loss that might be comparable to injectable obesity medicines. Enrollees in…
A judge blocked the FDA’s plan to regulate lab developed tests. What now?
The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal the March 31 federal court order that set aside…
Bluebird says Ayrmid missed deadline for rival takeover bid
Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three weeks after the company said it would pay $15 million more than SK Capital and Carlyle Group offered for the gene therapy maker. In a Wednesday…
Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents
Today, a brief rundown of news involving Eisai, Sarepta Therapeutics and Sandoz, as well as updates from Mural Oncology, Cyprumed and Spruce Bio that you may have missed. After a long regulatory saga, Eisai and Biogen have secured European market…
J&J keeps forecasts steady as pharma confronts tariff threat
Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this year, announcing Tuesday that it will maintain its financial forecast for the year while raising its sales guidance. J&J, which…
Safety worries spur Pfizer to drop another obesity pill
Dive Brief: Pfizer is scrapping another obesity pill, announcing Monday it will stop testing an experimental therapy called danuglipron after uncovering a case of possible liver damage in one study participant. The announcement marks the second time Pfizer has given…
US launches probe that could set stage for pharma tariffs
The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future. The investigation, which was announced in a federal notice…
Mining the hidden gems in unstructured EMR data
Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured EMR data is the unsung hero of most queries. Whether a manufacturer is struggling to find a niche patient population,…
Medtech industry pressures White House to exempt devices from tariffs
AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt medical devices and critical supplies from the Trump administration’s tariff policies. AdvaMed, one of the largest medical device industry groups, and organizations including the American Dental…
Trump says ‘major’ tariffs coming on pharmaceuticals
Dive Brief: President Trump on Tuesday said he’s planning soon to announce “a major tariff on pharmaceuticals,” which were exempted from the new levies he imposed this month. Trump didn’t offer any details on the scope of the tariffs or…
Tempest seeks strategic alternatives as cash runs out for Phase 3 trial
Dive Brief: Tempest Therapeutics is seeking a buyer or partner, saying Wednesday it has hired financial advisers to “advance its promising clinical stage programs and maximize stockholder value,” as the California-based biotechnology company prepares a liver cancer drug for late-stage…
FDA plans to phase out animal testing for some drugs
Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a plan to reduce, revise or replace such requirements in favor of newer methods that are more “human relevant.” The agency’s…
Amgen says Imdelltra extended survival; Parker Institute adds new leaders
Today, a brief rundown of news involving Amgen and the Parker Institute, as well as updates from J&J, Alzheon and Amylyx Pharmaceuticals that you may have missed. Amgen’s bispecific cancer antibody Imdelltra helped people with previously treated small cell lung…
Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts
Dive Brief: Biotech executives and venture capital investors are banding together to press Congress to act on Food and Drug Administration layoffs they say are already impacting drug development. In a letter to Bill Cassidy, R-La., the head of the…
Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing
Dive Brief: Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend $23 billion over five years to build six new factories, expand three existing ones and add a new research and development hub. The Swiss drugmaker said…
Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division
Today, a brief rundown of news involving Ferring Pharmaceuticals and Solu Therapeutics, as well as updates from the American Society of Hematology, Bristol Myers Squibb, and PureTech Health that you may have missed. In its first full year on the…
Trump pauses most reciprocal tariffs, hikes China’s further
The U.S. is pausing most country-specific tariffs for 90 days while raising duties on imports from China to 125%, President Donald Trump announced Wednesday. All countries besides China will still be subject to a 10% baseline tariff, Treasury Secretary Scott…
Rallybio discontinues lead drug for rare maternal disorder
Dive Brief: The biotechnology company Rallybio is discontinuing its lead candidate for a rare blood disorder in pregnant women after disappointing data from a mid-stage study, sending shares down sharply Tuesday morning. The drug, dubbed RLYB212, was in testing to…
US risks losing biotech edge to China, report warns
The U.S. risks losing a once-decisive edge over China in biotechnology unless the federal government prioritizes the sector’s advancement with new funding and policies, a bipartisan commission warned in a report issued Tuesday. At minimum, the commission wrote, the U.S….
Judge permanently blocks Trump admin plan to cap NIH funding, setting up appeals battle
Dive Brief: Research universities won an extended reprieve Friday when a federal judge permanently barred the National Institutes of Health from capping funding for indirect research costs at a 15% rate, a move that would cost institutions billions a year. …
Tango Therapeutics cuts nearly one-fifth of staff
Oncology drugmaker Tango Therapeutics has cut about 20% of its staff, following a year in which it twice trimmed its pipeline of experimental cancer drugs. The company “made the difficult decision” to reduce spending on preclinical research and lay off…
New genetic medicine CDMO acquires Landmark Bio
Dive Brief: Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions, hospitals and biotech companies founded in 2021 to help turn research ideas into broadly available genetic medicines. Landmark will continue…
Leqembi’s EU review drags on; Sanofi gets a new development head
Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as updates from Opthea, Novartis, and PTC Therapeutics. The saga to get Eisai and Biogen’s newer drug for Alzheimer’s disease approved in Europe continues. On Tuesday, the…
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a major organizational shakeup that has already resulted in the resignation of the nation’s top vaccine regulator. Novavax’s shot in 2022…
Oz confirmed by Senate to lead CMS
Mehmet Oz, a physician and TV personality, was confirmed Thursday by the U.S. Senate to lead the Centers for Medicare and Medicaid Services, which provides health insurance to more than 160 million people. Oz, who was confirmed by a 53-45…
Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved
Today, a brief rundown of news involving Sarepta Therapeutics, Novartis and Allakos, as well as updates from CSL Behring and Roche that you may have missed. A group of independent trial monitors on Friday recommended dosing continue in a trio…
Tariffs send healthcare industry into ‘unchartered waters’
Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping tariff policy Wednesday that could impact global supply chains for everything from needles and catheters to diagnostic tests and glucose sensors. The policy adjustments include a…
M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals
The world’s largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early months of this year, perhaps indicating how a tumultuous U.S. political environment has led would-be buyers to view bigger deals as too risky for the time…
Roche halts testing of Sarepta Duchenne gene therapy in Europe
Dive Brief: Roche has stopped enrolling and treating patients in three studies of the gene therapy Elevidys following the death of a 16-year-old patient with Duchenne muscular dystrophy. The European Medicines Agency asked for the temporary clinical hold until researchers…
Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs
Biotechnology company funding rounds remain larger than they were in 2022 and 2023, in a sign venture firms continue to favor bigger bets rather than parceling their money into smaller, but more numerous, financings. The median funding round involving one…
Trump installs sweeping new tariffs, but pharma appears to dodge blow
The U.S. will implement a universal baseline tariff of 10%, effective April 5, along with increased tariff rates on various countries, President Donald Trump announced at the White House Wednesday. The president said certain trading partners such as China, Japan…
Judge overturns FDA’s lab developed test regulation, siding with industry
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices, handing a victory to the clinical lab industry. Judge Sean Jordan, for the U.S. District Court for the…
HHS begins layoffs in chaotic fashion
Employees across the Department of Health and Human Services began receiving layoff notices Tuesday, following days of anxious waiting to learn who would be included in the Trump administration’s drastic downsizing of the U.S. health department. Emails went out Tuesday…
RNA editing biotech Airna adds $155M in funding
Dive Brief: Airna, a biotechnology startup developing RNA editing treatments, said Tuesday it raised $155 million in a Series B round that will help propel its lead program in alpha-1 antitrypsin deficiency into the clinic later this year. That medicine,…
Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Over the past decade, several dozen cell and gene therapies have reached market in the U.S., bringing with them the promise of long-lasting benefits for serious diseases. Peter Marks’ fingerprints are all over those approvals. As head of the Food…
How discoverable, comparable and explorable is your data?
If you’re a discovery scientist, you’re probably familiar with the fierce competition that dominates the landscape of biomarker identification. As a cornerstone of precision medicine, biomarkers will only become more entrenched in our understanding and treatment of disease. The key…
‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs
Just before 9 a.m. Thursday in Washington, D.C, the Department of Health and Human Services sent out a press release with the subject line: “HHS Announces Transformation to Make America Healthy Again.” The transformation: 10,000 full-time employees will be fired….
FDA broadens use of Novartis’ radiopharma drug Pluvicto
Dive Brief: Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to treat men with a type of metastatic prostate cancer after U.S. regulators on Friday cleared the medicine for use before chemotherapy. Specifically, Pluvicto can now be…
Peter Marks, FDA’s top vaccine official, resigns
Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with Health and Human Services Secretary Robert F. Kennedy Jr. Marks, who helped lead the successful advancement of COVID-19 vaccines during…
Bluebird gets rival takeout offer from Ayrmid
Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid the pioneering gene therapy developer received last month. In a short statement, Bluebird confirmed Ayrmid Ltd., the parent company of cell therapy developer Gamida Cell, has…
FDA approves first-of-its-kind RNA drug for hemophilia
The Food and Drug Administration approved on Friday a new type of medicine for people with the rare bleeding disorder hemophilia. Current hemophilia treatments generally try to replace or spur the production of key blood-clotting proteins that are missing because…
Alcon buys majority stake in IPO-seeking cell therapy startup Aurion
The leading eye-care company Alcon on Wednesday said it has acquired a majority stake in Aurion Biotech, capping months of legal wrangling over the future of the cell therapy developer. As part of the takeover, Aurion’s board appointed Chief Scientific…
Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy
Nkarta is laying off a third of its workforce, and more than half its executive team, in a bid to survive long enough to see if an experimental cell therapy it’s developing will show promise against multiple autoimmune conditions. Nkarta…
Makary confirmed by Senate as FDA commissioner
The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be commissioner of the Food and Drug Administration, giving him authority over an agency that regulates a wide swathe of the U.S. economy that includes food, tobacco,…
First Prader-Willi drug to reduce hunger approved by FDA
The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer. The agency on cleared Vykat XR,…
Epicrispr banks $68M to test epigenetic editing on rare muscle disease
Dive Brief: Epicrispr Biotechnologies has raised $68 million in pursuit of a first-of-its-kind genetic medicine for a rare neuromuscular disorder called facioscapulohumeral muscular dystrophy. EPI-321, the startup’s lead program, uses CRISPR tools to stop errant expression of a gene implicated…
Merck bets $200M on a new type of heart pill
Dive Brief: Merck & Co. has entered a competitive race for a new type of heart drug, announcing Tuesday it will pay China-based Jiangsu Hengrui Pharmaceuticals $200 million upfront to license a pill that blocks a protein particle believed to…
Character Biosciences raises $93M with an eye on vision loss drugs
Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised $93 million in a Series B round. The financing will help Character bring its two most advanced programs into clinical testing. One, dubbed CTX114, is being…
Verve gets FDA green light to expand base editing trial into US
Verve Therapeutics is expanding a gene editing trial for a cholesterol and heart disease treatment into the U.S., the company said Monday after receiving clearance from the Food and Drug Administration. The treatment Verve is testing, dubbed VERVE-102, changes a…
Leveraging clinical and financial data sets to guide investment strategies in 2025’s biopharma market
To say global markets have been choppy in 2025 is an understatement. Unsurprisingly, biopharma remains one of the most dynamic sectors, driven by late-stage clinical developments, regulatory decisions and intensifying competition for novel therapies. By the end of Q2 alone, 64…
J&J boosts US manufacturing as big pharma reshores
Dive Brief: Johnson & Johnson is planning a major U.S. expansion, announcing Friday it will spend $55 billion over the next four years on manufacturing, research and development and technology in its domestic market. The investments will support three advanced…
Alnylam prices heart drug at premium to rivals
Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday. The price of the drug, Amvuttra, was revealed on a Thursday evening conference…
Optum Rx is reforming how it pays pharmacies
Dive Brief: Optum Rx is shifting to a new pharmacy reimbursement model that should result in pharmacies being paid more for brand-name drugs and less for generics. It’s the latest move from a major drug middleman to reform how pharmacies…
AstraZeneca deepens China investment; Editas loses CFO to Dyne
Today, a brief rundown of news involving AstraZeneca and Novartis, as well as updates from Editas, Adaptimmune and Pfizer that you may have missed. AstraZeneca will spend $2.5 billion over the next five years to set up a research and…
Delayed CDC meeting on vaccines is rescheduled to April
A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed. The Advisory Committee on Immunization Practices, or…
Novartis builds case for new SMA gene therapy
On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma. The drug, code-named OAV101, shares the same active…
Alnylam drug gets long-awaited FDA approval in deadly heart disease
The Food and Drug Administration on Thursday approved an Alnylam Pharmaceuticals medicine for a serious heart condition, a decision that should help the biotechnology firm secure its position as one of the sector’s most valuable companies. The agency cleared the…
Immunovant claims study success for immune disease drug but holds off on submission
Dive Brief: Immunovant gave investors a mixed set of news Wednesday, touting late-stage results for an experimental autoimmune disease drug while saying the company doesn’t currently plan to seek regulatory approval. According to Immunovant, the medicine, batoclimab, succeeded in a…
Optum Rx says it will eliminate some prior authorization requirements
Dive Brief: Optum Rx is moving to eliminate prior authorization requirements for dozens of drugs, the UnitedHealth-owned pharmacy benefit manager said Wednesday, easing a key pain point for physicians and patients at a time of widespread discontent with healthcare middlemen….
Stoke CEO exits; Medicare drug price talks advance
Today, a brief rundown of news involving executive changes at Stoke Therapeutics and the Centers of Medicare and Medicaid Services, as well as updates from Incyte, Precision BioSciences and AstraZeneca that you may have missed. Edward Kaye, CEO of genetic…
Prime sets sights on liver, lung disease as next target for its gene editing tech
Dive Brief: Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing on Tuesday plans for a research program in alpha-1 antitrypsin deficiency. The company, which is developing “prime editing” as a…
Arbor raises $74M amid genetic medicine’s funding slump
Arbor Biotechnologies on Tuesday announced a new $74 million fundraise that comes as many of its peers in genetic medicine struggle to secure venture investment. The Series C round led by Arch Venture Partners and TCGX will help Arbor advanced…
Taiho buys Swiss biotech and its ADC tech for $400M
Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerland’s Araris Biotech and its antibody-drug conjugate technology for $400 million upfront. The two companies have worked together since 2023, when they agreed to use Araris’ technology to explore and develop…
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IRA reforms could be on the table. Will Trump and the GOP pursue them?
The Inflation Reduction Act seems to be sticking around under the new Trump administration, but potential reforms could be coming. One target is a provision of the law that subjects small molecules to pricing negotiations earlier than other medicines. Currently,…
Ono pays $280M to license Ionis rare disease drug
Dive Brief: Ionis Pharmaceuticals is licensing out another experimental medicine, entering an agreement with Ono Pharmaceutical that offers $280 million upfront and as much as $660 million more for reaching certain development, regulatory and sales goals. The drug, sapablursen, is…
Makary advances to full senate vote; Acelyrin, Pliant adopt ‘poison pills’
Today, a brief rundown of news involving Martin Makary, as well as updates from Pliant Therapeutics, Acelyrin and Sutro Biopharma that you may have missed. The Senate Health, Education, Labor and Pensions Committee voted 14-9 Thursday to advance President Donald…
FDA sets flu shot recommendations without input of outside advisers
The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus strains to include in next season’s shots. Typically, the agency sets its advice after consulting a committee of outside advisers, a meeting of whom had been…
Mallinckrodt, Endo to combine in $7B deal
Dive Brief: Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will merge in a cash and stock transaction that will leave a combined company valued at $6.7 billion. Shareholders of Mallinckrodt…
MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup
Gene therapy specialist MeiraGTx is spinning some of its experimental medicines for the central nervous system into a startup that hopes to develop them further using artificial intelligence. Aptly named Hologen Neuro AI, the startup is a joint venture between…
A new obesity biotech launches; Gilead plans to quickly advance once-yearly PrEP for HIV
Today, a brief rundown of news involving Harbour BioMed and Gilead Sciences, as well as updates from Geron, Biogen and Genmab that you may have missed. Harbour BioMed on Wednesday launched a new biotechnology company, Élancé Therapeutics, that will develop…
Roche broadens obesity drug plans with $1.65B Zealand deal
Dive Brief: Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial in December, Zealand said Wednesday. Per deal terms, Roche will…
Merck opens $1B vaccine plant in North Carolina
Merck & Co. on Tuesday opened a new vaccine manufacturing plant in Durham, North Carolina, that will boost the company’s domestic production at a time when President Donald Trump has roiled trade relations with tariffs on foreign imports. The $1…
Viking inks CordenPharma deal to boost obesity drug supply
Dive Brief: Viking Therapeutics is secure production capacity for its experimental obesity drug, announcing Tuesday it will prepay contract manufacturer CordenPharma $150 million to produce up to 200 million injectable and 1 billion oral doses of the treatment annually. The deal…
Novo’s Wegovy successor disappoints in second large trial
Dive Brief: Novo Nordisk’s experimental drug CagriSema helped people who are overweight or obese and have diabetes lose about 14% of their body weight over 68 weeks, or 11 percentage points more than those given placebo, the company said Monday….
Beam base editing therapy gets ‘proof of concept’ in rare lung disease
Preliminary results from a small clinical trial suggest that a cutting-edge genetic medicine developed by Beam Therapeutics can repair the damaged DNA that gives rise to a rare liver and lung disorder. The data, from the first nine patients treated…
3 ways to accelerate development and de-risk cell and gene therapy manufacturing
Cell and gene therapy innovators are after “a gene and a dream.” Those are the words of Hugh Murray, Senior Scientist, Upstream Process Development with MilliporeSigma, whose team works with clients to take cell and gene therapy from concept to…
Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting
Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure from Republican and Democratic senators Thursday over a canceled agency meeting on influenza vaccines. Questioned by several lawmakers at a…
Walgreens to be acquired in $10B take-private deal
Dive Brief: Walgreens has entered into a definitive agreement to be acquired by private equity firm Sycamore Partners and leave the public markets, the retail and pharmacy chain said Thursday. The private equity firm will pay $11.45 per share in…
Nimbus swaps CEOs and turns to new leader for ‘next chapter’
Jeb Keiper, the longtime head of Nimbus Therapeutics, is stepping down in a planned transition that will promote the biotechnology startup’s top business executive to chief executive officer. Nimbus on Friday said Abbas Kazimi, its current chief business officer, has…
Roche launches new Boston center; NIH centralizes peer review
This week has brought enough announcements and updates to fill a third news roundup. Today, we’ve got a rundown of news from Roche and AskBio, as well as updates from the NIH and Pfizer. Roche is expanding its presence in…
J&J scraps depression testing for potential blockbuster drug
Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar product. In a statement released Thursday afternoon, J&J said it will stop developing the drug, called aticaprant, as an add-on…
Vertex’s new pain drug gets first coverage nod from major insurer
Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new, much-anticipated pain drug to some of its commercial formularies. Sold as Journavx, the drug received U.S. approval in late January…
Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review
Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of agency staffing if confirmed but didn’t offer any views on the appropriateness of layoffs ordered by the Department of Government…
Bayer braces for ‘difficult’ year before turnaround pays dividends
Dive Brief: Bayer CEO Bill Anderson is asking investors to bear with the German conglomerate through one more challenging year before a turnaround effort starts showing significant results. The company on Wednesday reported a net loss of 2.55 billion euros,…
Jazz expands in oncology with $935M deal for Chimerix
Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix and an experimental medicine under Food and Drug Administration review for treatment of a form of the brain cancer glioma….
Neumora bids farewell to R&D head; Biohaven’s ‘one step forward, one step back’ data
Today, a brief rundown of news involving Acelyrin and Neumora Therapeutics, as well as updates from Biohaven, Lexicon Pharmaceuticals and Pliant Therapeutics you may have missed. Acelyrin on Tuesday rejected an unsolicited bid from Concentra Biosciences and urged shareholders to…
Sofinnova secures €1.2B for new biotech investments
European venture capital firm Sofinnova Partners has raised 1.2 billion euros, or nearly $1.3 billion, in fresh funds to invest in life sciences and healthcare companies, the group announced Tuesday. “With the new funds, we anticipate supporting 50 to 60…
AbbVie gets into obesity with $350M deal for once-weekly shot
Dive Brief: AbbVie is joining the industry’s rush to develop new obesity medicines, announcing Monday a deal with Denmark-based Gubra to license a drug that could compete with experimental therapies being developed by Novo Nordisk, Eli Lilly and Zealand Pharma….
Biotech startup pulls in $187M to make ‘multi-payload’ ADCs
Dive Brief: Callio Therapeutics on Monday launched with $187 million in Series A funding and a license to a technology that can make antibody-drug conjugates, or ADCs, with multiple tumor-killing payloads. The startup’s ADC capabilities come via a deal with…
Eikon raises $351M in one of the year’s largest biotech venture rounds
Eikon Therapeutics, a well-funded drug startup run by Merck & Co.’s former research chief, has raised one of the biggest venture rounds for a biotechnology company so far this year. The company on Wednesday announced nearly $351 million in Series D…
Lilly expands US manufacturing build-out with $50B target
Eli Lilly will invest tens of billions more dollars in U.S. drug manufacturing in a significant enlargement of plans the Indianapolis company had already described as historic. Lilly, which makes the popular obesity medicine Zepbound, previously pledged to spend $23…
Praxis hits trial setback; Bristol Myers lays off staff in New Jersey
Today, a brief rundown of news involving Praxis Medicines and Bristol Myers Squibb, as well as updates from Eli Lilly and Zevra Therapeutics. Shares in Praxis Precision Medicines fell by nearly 40% in Friday morning trading after the biotechnology company…
BridgeBio oncology spinout to go public in blank-check merger
BridgeBio Oncology Therapeutics, a cancer drug startup spun out of biotechnology company BridgeBio Pharma, will go public by merging with a blank-check entity. In a deal announced Friday, BridgeBio Oncology expects to get around $450 million by combining with Helix…
Leqembi, after delay, gets back on track toward EU approval
Dive Brief: European drug reviewers have “reaffirmed” their positive view of Eisai and Biogen’s Alzheimer’s disease drug Leqembi, clearing the way for an approval decision by the European Commission, the companies said Friday. The recommendation from the European Medicines Agency…
Vertex ends gene editing research pact with Verve
Dive Brief: Vertex Pharmaceuticals has pulled out of a planned four-year collaboration with Verve Therapeutics, returning all rights to a preclinical gene editing program for liver disease. Verve announced the end of the partnership on Thursday along with its fourth…
FDA meeting on flu vaccine composition is canceled
A meeting of Food and Drug Administration advisers to determine the composition of flu vaccines for the upcoming season has been canceled, a member of the committee confirmed to BioPharma Dive. Paul Offit, a vaccine expert and professor of pediatrics…
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AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch
Today, a brief rundown of news involving AstraZeneca and Madrigal Pharmaceuticals, as well as updates from Lava Therapeutics, PepGen and Entrada Therapeutics that you might have missed. AstraZeneca said Wednesday that its experimental drug camizestrant delayed tumor progression in a Phase…
Lilly CEO wields manufacturing plans to push pharma-friendly policies
Eight years ago, Eli Lilly CEO David Ricks stood in front of a red banner emblazoned with the words “Invested in America” to tout an $850 million investment his company was making in U.S. manufacturing. He used the moment to…
Regeneron gene therapy helps deaf children hear in small study
Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed by Regeneron Pharmaceuticals. A few of the children can now hear sound at near-normal levels, like conversational speech. One, who…
Saxenda 可以用於糖尿病管理嗎？
可以用於糖尿病管理嗎 Saxenda 是我們香港醫療中心最受歡迎的減肥藥物之一，許多患者選擇它來幫助管理體重並改善健康狀況。然而，許多糖尿病患者會問，Saxenda 是否可以用於糖尿病管理？Saxenda 的主要成分是 liraglutide，它屬於胰高血糖素樣肽-1（GLP-1）受體激動劑，這類藥物的作用機制與調節血糖有關，因此 Saxenda 確實具有一定的血糖控制效果。但需要注意的是，Saxenda 並非專門用於治療 2 型糖尿病的藥物，而是被批准作為體重管理藥物使用。因此，糖尿病患者在考慮使用 Saxenda 時，應先諮詢醫生，以確保該藥物適合自身的健康需求。 GLP-1 受體激動劑能夠刺激胰島素分泌，並抑制升糖素的釋放，這使得 Saxenda 在一定程度上可以幫助降低血糖，特別是對於患有肥胖的 2 型糖尿病患者而言，這種藥物不僅有助於減重，還能在一定程度上穩定血糖水平。然而，與 Ozempic 相比，Saxenda 的降血糖效果相對較弱，因此它通常不被作為糖尿病的一線治療藥物。如果糖尿病患者的主要目標是控制血糖，那麼 Ozempic 或其他專門治療糖尿病的 GLP-1 類藥物可能會更適合。但如果患者同時需要減重，那麼 Saxenda 仍然是一個不錯的選擇，因為肥胖本身就是 2 型糖尿病的主要風險因素之一，而有效的減重可以顯著改善胰島素敏感性，進而幫助血糖控制。 此外，Saxenda 主要適用於體重指數（BMI）≥ 30 的肥胖患者，或 BMI ≥ 27 且有與體重相關的健康問題（如高血壓、高膽固醇或 2 型糖尿病）的患者。因此，對於部分糖尿病患者來說，Saxenda…
Drug compounders sue FDA over declaration ending Wegovy shortage
Dive Brief: Drug compounders are suing the Food and Drug Administration again over obesity and diabetes drugs, claiming in a complaint Monday the agency’s decision to remove Novo Nordisk’s semaglutide from its shortage list will “deprive patients of a vital…
FDA brings back some fired device office staff
Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters rescinded over the weekend, according to the industry group Advamed and three FDA employees who spoke on condition of anonymity. …
Mirum drug for rare genetic disease gains FDA approval
Dive Brief: The Food and Drug Administration on Friday approved a drug from Mirum Pharmaceuticals to treat a rare genetic disorder that causes toxic depositions of fat in different organs of the body. Called Ctexli, the drug is cleared for…
FTC case against PBMs can move forward, judge rules
Dive Brief: Dive Insight: The FTC’s lawsuit against Caremark, Express Scripts and Optum Rx — known as the “big three” for their outsized control of the U.S. PBM market — hinges on allegations the drug middlemen favor more expensive insulin…
Device industry scrambles amid concern FDA layoffs will cause delays
The sudden firing of Food and Drug Administration employees this past week is already affecting medical device companies. The layoffs could delay the time it takes to bring new products to market and add pressure on remaining staff at the…
Bluebird, at risk of default, agrees to take-private deal
Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be acquired and taken private in a deal with investment firms Carlyle Group and SK Capital. Under an agreement announced Friday,…
Pfizer stops selling hemophilia gene therapy, citing weak demand
Dive Brief: Weak demand for Pfizer’s hemophilia gene therapy Beqvez has led the pharmaceutical company to “cease further development and commercialization” of the one-time treatment, a Pfizer spokesperson confirmed to BioPharma Dive. Originally developed by Spark Therapeutics, Beqvez was licensed…
Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair
Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences and PhRMA that you might have missed. The Food and Drug Administration has declared a two-and-a-half year shortage of Novo…
CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed
An upcoming meeting of vaccine advisers to the Centers for Disease Control and Prevention has been postponed, delaying what was set to be the committee’s first gathering after the swearing-in of Robert F. Kennedy Jr. as U.S. health secretary. The…
In FDA job cuts, experts see threat of far-reaching impact
The firing of possibly thousands of people working in U.S. health agencies this past week is likely to ripple across the biomedical ecosystem, affecting basic scientific research and disease tracking to regulatory oversight of new products. Enacted by the Trump…
Sanofi reaches consumer health deal; Supernus antidepressant fails study
Today, a brief rundown of news involving Sanofi and Supernus Pharmaceuticals, as well as updates from Arcus Biosciences, Gilead Sciences and Ultragenyx Pharmaceutical that you might have missed. Sanofi and CD&R reached an agreement to hand the private equity firm…
Advamed CEO warns FDA job cuts put patients, industry at risk
Advamed CEO Scott Whitaker warned the Department of Health and Human Services that job cuts made over the weekend at the Food and Drug Administration could have a “very negative impact” on patient care and threaten the country’s position as…
Solid says early data suggest ‘differentiated’ Duchenne gene therapy
Dive Brief: An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading the biotechnology company to quickly raise funds on the findings. Three months after treatment with Solid’s therapy, SGT-003, the first…
Biogen buys rights to Stoke’s rare epilepsy drug
Dive Brief: Through a new deal, Biogen has bought access to a potentially first-of-its-kind drug that some doctors and analysts see as a promising treatment for a rare form of epilepsy. Biogen on Tuesday agreed to pay $165 million upfront…
Trump orders agencies to plan for ‘large-scale’ job cuts
The Trump administration has directed federal agencies to “undertake plans for large-scale reductions in force” as part of a sweeping plan to shrink the size of the U.S. government. The executive order, signed by President Donald Trump Tuesday, instructs agency…
Biogen inks royalty deal to gain funding for lupus drug R&D
Dive Brief: Biogen is set to receive as much as $250 million in funding to develop a late-stage experimental lupus medication called litifilimab after signing a deal with Royalty Pharma. In exchange, Royalty Pharma will receive unspecified payments if litifilimab…
Judge orders FDA, health agencies to restore removed webpages
A federal judge on Tuesday ordered the Food and Drug Administration and other federal health agencies to restore websites that were removed in response to executive orders from President Donald Trump, writing that the move harmed underprivileged Americans. District Judge…
Sanofi to take $250M charge on study failure for E. coli vaccine
Dive Brief: Sanofi and Johnson & Johnson are ending a Phase 3 study of an experimental E. coli vaccine after it failed to show a significant benefit over placebo in a review by an independent monitoring board. J&J began the…
RFK Jr. confirmed by Senate as health secretary
Robert F. Kennedy Jr., a prominent vaccine critic who President Donald Trump has directed to “go wild” on healthcare, was confirmed Thursday by the U.S. Senate as the country’s top health official. Every Republican senator voted for Kennedy except Sen….
‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public
Drug development is a notoriously expensive business. Discovering, testing and advancing a medicine can cost hundreds of millions of dollars, putting immense pressure on young biotechnology companies to be on constant lookout for new sources of funding. For such a…
A brain biotech launches with Roche’s spare parts
A startup focused on brain drugs officially launched Thursday, backed by $94 million from a group of investors that includes one of the world’s largest banks and the parent company of Ozempic maker Novo Nordisk. Boston-based Newleos Therapeutics hopes to…
Neumora shakes up its C-suite; Biogen cuts early-stage pipeline
Today, a brief rundown of news involving Neumora Therapeutics and Pliant Therapeutics, as well as updates from Biogen, AbbVie and SpringWorks Therapeutics that you might have missed. Neumora Therapeutics CEO Henry Gosebruch is leaving the brain drug developer in a…
Aardvark prices $94M IPO to fund Prader-Willi, obesity drug work
Dive Brief: Aardvark Therapeutics on Wednesday night raised $94 million in an initial public offering that will support development of hunger-suppressing drugs for the rare disease Prader-Willi syndrome and obesity-related conditions. The biotechnology startup sold 5.9 million shares at $16…