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Engrail’s precision psychiatry drugs get more buy in from venture investors
The San Diego-based startup added $157 million in new funding to back a drug for generalized anxiety order that’s now in human testing.
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Orchard follows buyout with FDA approval of rare disease gene therapy
The U.S. clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.
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Bluebird, short on cash, takes on $175M in debt financing
The funding could extend the cash-strapped gene therapy maker’s financial runway to 2026, but only if the company successfully hits certain milestones.
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Contineum, a startup born from a Roche buyout, files for IPO
The biotech, formed as a successor to a company Roche acquired in 2018, has two drugs in clinical testing for neurological and immune diseases.
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FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma
A majority of experts believed the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.
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Madrigal, FDA approval in hand, outlines plan to sell MASH drug
The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.
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Bristol Myers cell therapy wins first-of-its-kind approval
Sold as Breyanzi, the therapy is now cleared for use in certain adults with hard-to-treat forms of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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AstraZeneca adds another rare disease drug in $800M buyout of startup Amolyt
The deal gives AstraZeneca a prospect in late-stage testing for parathyroidism and bolsters a rare disease portfolio that mainly consists of drugs from Alexion.
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Madrigal wins FDA approval of first drug for MASH
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
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BIO changes stance, backs bill to limit China’s role in US biotech
Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with WuXi-AppTec, a major contract manufacturer to the biopharmaceutical industry.
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J&J, Novo support Asgard’s push to make ‘in vivo’ cell therapies
The Swedish biotech will use the investment to advance a personalized cancer therapy that reprograms tumor cells inside the body.
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German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing
The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.
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FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma
Briefing documents posted ahead of Friday’s advisory panel zeroed in on increased rates of early death in tests of cell therapies from Bristol Myers Squibb and Johnson & Johnson.
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Emerging biotech
IFM, an unorthodox biotech startup, scores third buyout with Novartis deal
With a decision by the Swiss pharma to acquire another one of its subsidiaries, IFM Therapeutics has now sold three spin-offs for a total of $700 million upfront and the potential for billions more in future payments.
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Merck reveals plans to develop newer HPV shots
The pharma intends to test a single-dose regimen as well as a shot that may provide broader protection than the current versions of Gardasil that regularly generate billions in annual sales.
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ALS drug development
After surprise trial failure, ALS doctors brace for one less treatment option
Physicians are preparing for tough conversations with patients on Amylyx Pharmaceuticals’ drug, Relyvrio, while holding out hope it still may help some with the disease.
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Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease
The partnership is designed to help the company stand out in what’s quickly become one of the industry’s hottest areas of drug research.
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Acadia drug fails schizophrenia trial, setting back company’s expansion plans
The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects.
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Biotech stock fundings headed for best quarter in 3 years, Jefferies says
Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.
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Roche, following setbacks, turns to its next Alzheimer’s drug
Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.
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Q&A
Amylyx CEOs look for a path forward following major setback
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
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Boehringer, Sosei Heptares team up in schizophrenia drug deal
Sosei Heptares could receive more than 700 million euros in a deal to develop medicines aimed at the protein GPR52, an emerging drug target in multiple neurological diseases.
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J&J’s growing rare disease focus brings a potential multi-use treatment to the table
The head of J&J’s autoantibody programs believes nipocalimab is unique among potential rare disease drugs because it can harness a common thread among them.
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FDA delays decision on Lilly’s closely watched Alzheimer’s drug
The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.
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Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
Updated March 8, 2024