The Latest
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Adeline Kon/BioPharma Dive
Deep Dive // Emerging biotechBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
MBX Biosciences, a clinical-stage startup working on drugs for endocrine and metabolic conditions like obesity, has filed plans to go public, joining Bicara and Zenas in the queue.
Updated 20 hours ago -
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Sponsored by Worldwide Clinical TrialsRadiopharmaceutical trials: The critical role of site selection and support
Through effective collaboration, partnerships can accelerate the development of lifesaving therapies and improve patient outcomes.
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Regeneron gains European approval for bispecific lymphoma drug
Regulators in Europe granted approval based on remission rates, while the FDA sought more progress in confirmatory trials when it rejected Ordspono.
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News roundupFDA to convene immunotherapy panel; Tome scales back operations
Agency advisers will discuss whether use of Keytruda and Opdivo should be limited in gastric cancer. Elsewhere, a buzzy genetic drug startup is exploring “strategic options.”
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Courtesy of Novartis
Emerging biotechVersant reimagines its Chinook success with newest startup launch
Borealis Biosciences launches with money from Novartis, which last year bought the biotech’s predecessor for drugs that treat a rare kidney disorder.
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National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Updated COVID shots from Pfizer, Moderna cleared by FDA
Approval of the reformulated mRNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.
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Adeline Kon / BioPharma Dive/BioPharma Dive
Deep Dive // Patent thicketsDrug patents protect pharma profits. Track when they’ll expire.
Patents protecting five of the first 10 drugs Medicare selected for price negotiations are set to expire by 2026 or earlier, although legal settlements may push back the launch of copycat versions.
Updated May 13, 2024 -
Permission granted by Peyton Helbert / AAMI
FDA defends med device chief’s tenure after report raises ethics concerns
The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.
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Courtesy of Eisai
New Alzheimer's drugsUK approves Leqembi, but reimbursement may not follow
Leqembi’s benefits are “too small to justify the significant cost to the NHS,” said the head of a UK agency in charge of determining medicine reimbursement.
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Courtesy of BioMarin Pharmaceutical
BioMarin taps Amgen, Roche vets in executive reshuffle
Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.
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Mario Tama via Getty Images
Employers foresee higher health costs next year due to rising pharmacy spend
Pharmaceuticals like the in-demand GLP-1 drugs for obesity are expected to drive increases in healthcare spending in 2025, per a new employer survey.
Updated Aug. 21, 2024 -
Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is on the upswing. Track the latest deals here.
The recent close of Lilly's Morphic acquisition further cements immunology as one of the industry's most coveted research areas this year.
Updated Aug. 13, 2024 -
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Emerging biotechBridgeBio sends rare disease drugs to new company
Backed by $300 million from investors that include Viking Global Investors and Sequoia Capital, GondolaBio will inherit several BridgeBio drug programs.
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Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues
Company executives had warned investors that a delay was likely due to issues at a facility run by a third-party manufacturer.
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Lilly’s tirzepatide cuts diabetes risk, study data show
Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.
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Mario Tama via Getty Images
J&J drug combo for lung cancer approved by FDA
Approval of Rybrevant and Lazcluze was supported by results from a study that compared the regimen to AstraZeneca’s widely used drug Tagrisso.
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Daniel Tadevosyan via Getty Images
News roundup
Avidity, Kymera raise fresh funds; Walgreens partners with BARDA
Avidity raised $345 million to advance development of RNA medicines designed to combine the advantages of oligonucleotides and antibodies.
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FDA lifts partial hold on study of BioNTech-partnered ADC
Partner MediLink Therapeutics is limiting the drug’s dosing after reports of lowered white blood cell counts and inflammation of the digestive tract.
Updated Aug. 19, 2024 -
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Novo plans new plant as it races to meet drug demand
The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.
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Alex Wong via Getty Images
Medicare drug price cuts could have limited early impact, but grow with time
Some in the industry described the level of price discounts announced by Medicare as a "relief," though they warned of larger implications for drug research in the future.
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Jeenah Moon via Getty Images
Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot
The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.
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Daniel Tadevosyan via Getty Images
News roundup
Zealand, Arrowhead advance obesity drugs; Bluebird narrows guidance
Zealand is using a recent $1 billion equity raise to “accelerate” several would-be weight loss medicines. Meanwhile, Bluebird reworked a loan and Boundless Bio cut jobs only months after an IPO.
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Permission granted by Incyte
Incyte builds out its arsenal of post-transplant drugs
The approval of Niktimvo in graft-versus-host disease hands Incyte another immune system-regulating medicine that analysts see as valuable, especially if use is broadened through additional clearances.
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Makhbubakhon Ismatova via Getty Images
Lykos to cut 75% of staff after FDA rejection of MDMA-based therapy
The layoffs are part of a larger reorganization that will also see the departure of Lykos’ founder, the psychedelics advocate Rick Doblin.
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Scott Olson via Getty Images
Medicare reveals results of drug price negotiations
The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.
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Courtesy of Gilead
FDA clears Gilead drug acquired in $4.3B buyout
Livdelzi, which Gilead inherited through its acquisition of CymaBay, will now compete with medicines for primary biliary cholangitis that are currently marketed by Ipsen and Alfasigma.
