The Latest
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Brian Tucker/BioPharma Dive
Deep DiveCoronavirus vaccines are rolling out quickly. Here's where the pipeline stands.
J&J said a second dose of its vaccine boosted protection, while study results from China's Clover Biopharmaceuticals appeared promising. Novavax, meanwhile, asked for WHO clearance of its protein-based shot.
UPDATED: Sept. 17, 2021 at 11:56 a.m. -
Martin Vleck/Shutterstock.com
Sponsored by NuvoloCalibrate and connect your equipment in the cloud
Calibration is too important to do on spreadsheets or paper. See how you can improve your calibration activities with a cloud-based solution.
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Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug
The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.
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Lisa Maree Williams via Getty Images
AstraZeneca strikes deal with university spinoff to turn RNA into drugs
The British drugmaker is investing in VaxEquity, a biotech founded last year to explore a twist on the mRNA technology that Moderna and BioNTech have made famous.
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Mark Wilson via Getty Images
Lilly, Novartis, other pharmas could face fines for violating 340B law
The U.S. health department asked its inspector general to review the refusals of six drugmakers to offer discounts to safety net hospitals through community pharmacy partnerships.
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Getty / Edited by BioPharma Dive
Bluebird officially asks FDA to approve gene therapy for rare blood disorder
After several delays, Bluebird has completed an application to the agency to get beti-cel cleared as a treatment for beta-thalassemia.
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Adeline Kon/BioPharma Dive
Deep DiveRecord numbers of biotechs are going public. Here's how they're performing.
Pyxis Oncology, Theseus Pharmaceuticals and Aeon Biopharma are the latest biotechs to outline plans to go public, continuing a rebound in IPO activity.
UPDATED: Sept. 20, 2021 at 10:29 a.m. -
Lisa Maree Williams via Getty Images
US buying 500M more doses of Pfizer coronavirus vaccine for donation to world
Under pressure to help other countries access vaccines, Biden is doubling his administration's planned donation to 1 billion doses, although delivery will extend through September of next year.
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Incyte
Incyte eczema drug wins FDA OK, but with safety warning
A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.
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Seagen, Genmab win speedy FDA approval for cervical cancer drug
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.
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Samsung Bioepis
FDA approves first biosimilar of top-selling eye drug Lucentis
The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.
Grifols is acquiring a large stake in Biotest, a developer of plasma-derived therapies, from Tiancheng Pharmaceutical Holdings in a deal worth 1.1 million euros.
UPDATED: Sept. 17, 2021 at 9:53 a.m. -
European Society for Medical Oncology
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
UPDATED: Sept. 21, 2021 at 10:59 p.m. -
Antonio Masiello via Getty Images
Pfizer says coronavirus vaccine is safe and spurs immune response in children
The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
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Lilly's COVID-19 antibody cleared by FDA for post-exposure prevention
The expanded authorization comes amid surging demand for antibody treatments, particularly in states with lower rates of coronavirus vaccination.
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Jens Schlueter via Getty Images
FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.
UPDATED: Sept. 17, 2021 at 6:56 p.m. -
Permission granted by Biogen
Biogen says experimental pain drug helps neuropathy patients in mid-stage trial
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.
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Amgen Inc.
Amgen to advance KRAS drug combination after improved results in colon cancer
Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial.
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Takeda wins FDA approval for targeted lung cancer drug
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.
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Jacob Bell
After talks with FDA, a biotech prepares to submit its closely watched ALS drug
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will soon ask for approval of AMX0035 — a change of plans from earlier this year.
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Permission granted by University of Maryland School of Medicine
New data from Israel, Pfizer show potent effect from third coronavirus shot
The much-anticipated data arrive ahead of an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
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Theravance to lay off 75% of employees alongside larger restructuring
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
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Sarah Silbiger via Getty Images
FDA staff tight-lipped on booster shot views ahead of consequential meeting
In a briefing document, agency reviewers did not appear to take a strong line either for or against the broad authorization of boosters for the general public.
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Courtesy of Eli Lilly
US stocks up on COVID-19 antibody drugs amid shortage concerns
Deals with Regeneron and Eli Lilly will secure nearly 1.8 million additional doses of the companies' respective treatments over the next four months.
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Getty / Edited by BioPharma Dive
Fourth trial volunteer dies in Astellas gene therapy study
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used.
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Getty Images
Biotech funder Lightstone raises another $375M for life sciences investing
The venture firm, which previously invested in LocanaBio, Catamaran Bio and Tizona Therapeutics, said its third fund surpassed its target.
