Gilead commits to in-house development of coronavirus treatment hopeful

The biotech launched two global, Phase 3 studies of remdesivir, an experimental antiviral already being studied in trials run by Chinese researchers and the NIH.

By Ned Pagliarulo • Feb. 27, 2020

Takeda's small celiac disease bet turns into acquisition

Phase 1 data triggered a takeout of PvP Biologics worth up to $330 million, giving Takeda access to a drug invented by a University of Washington team.

By Jonathan Gardner • Feb. 26, 2020

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

BioMarin inches closer to a gene therapy first

A decision by the FDA on whether to approve valrox, potentially the first gene therapy for hemophilia, should come by late August. 

By Jacob Bell • Feb. 21, 2020

GSK taps Immatics' cell therapy science in research deal

For $50 million upfront, the British pharma will gain access to two T cell therapies Immatics is developing to treat solid tumors. 

By Ned Pagliarulo • Feb. 20, 2020

Tocagen restructuring leads to reverse merger with Forte

After a Phase 3 brain cancer study missed its goal last fall, Tocagen laid off two-thirds of its workforce and began evaluating its options.

By Ned Pagliarulo • Feb. 20, 2020

Bluebird's gene therapy hits another delay, this time in the US

The disclosure of a longer timeline until the biotech fully submits LentiGlobin for U.S. approval sent shares sliding and spurred one analyst to downgrade the stock.

By Jacob Bell • Feb. 19, 2020

The cancer genes Wall Street is flooding with cash

Revolution Medicines, a biotech working on cancer drugs that target what are known as RAS genes, announced Wednesday it's raising $238 million through a public offering — more than double its initial goal.

By Jacob Bell • Feb. 13, 2020

Exelixis prostate cancer data could help stave off competitive threats

As Pfizer makes inroads against Cabometyx in kidney cancer, Exelixis said it will ask the FDA next year for approval in prostate disease.

By Jonathan Gardner • Feb. 11, 2020

Moderna, raising cash, quickly advances coronavirus candidate

A initial batch of the biotech's mRNA vaccine could soon be sent to the NIH for use in a Phase 1 study, which would mark a rapid scale-up to clinical testing. 

By Ned Pagliarulo • Feb. 11, 2020

Biogen dips as Alzheimer's drugs from Lilly, Roche fail again

Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.

By Jacob Bell • Feb. 10, 2020

Biohaven misses a chance to prove it's more than migraine

One of Biohaven's late-stage drugs proved no better than placebo in a type of severe anxiety — a lost opportunity for the company to showcase a pipeline beyond its lead migraine therapy.

By Ned Pagliarulo • Feb. 10, 2020

Kite isn't flying with investors, and Gilead knows it

On Tuesday, Gilead acknowledged the cell therapy developer is worth less than it once thought, cutting the accounting value for research assets it acquired by $800 million. 

By Ned Pagliarulo • Feb. 5, 2020

Nestlé boosts investment as Aimmune preps launch of peanut allergy drug

With $200 million more in the bank, the biotech also in-licensed an experimental next-generation food allergy therapy from Xencor. 

By Jonathan Gardner • Updated Feb. 5, 2020

Regeneron partners with US government to develop coronavirus treatment

The biotech hopes to replicate its past success in quickly advancing a treatment for Ebola. But, as that experience showed, proving a new antiviral isn't easy.

By Ned Pagliarulo • Updated Feb. 4, 2020

January price increases confirm slowing drug inflation

Pfizer, GlaxoSmithKline and Allergan were the most active, collectively raising list prices on some 450 drugs, according to one Wall Street analyst.

By Jonathan Gardner • Feb. 4, 2020

Bristol-Myers launches biotech targeting fibrosis, inflammation

Anteros Pharmaceuticals is the first company made via a partnership between Bristol-Myers and biotech accelerator BioMotiv. Its initial targets are liver and lung fibrosis, with one specific focus being IPF.

By Jacob Bell • Feb. 4, 2020

Commercial and regulatory strategy considerations for biotech

Discover ideas and insights for getting innovations in the biotech pipeline to patients sooner. 

By Alberto Grignolo, Corporate Vice President, Parexel; Sheela Hegde, Partner and Managing Director in Parexel’s Health Advances subsidiary; and Leslie DeVos, VP, Regulatory Consulting, Parexel • Feb. 3, 2020

FDA approves Aimmune drug as first treatment for peanut allergy

Aimmune's next challenge will be securing insurance coverage as people allergic to peanuts still have to avoid exposure to the food.

By Jonathan Gardner • Jan. 31, 2020

Biotech lacking diverse leadership, top trade group admits

Too few women and people of color are in executive positions or on the boards of biotech companies, according to a new report from BIO. 

By Ned Pagliarulo • Jan. 31, 2020

Vertex impresses with strong Trikafta launch

With $420 million in fourth quarter revenues, Vertex's cystic fibrosis drug Trikafta performed five times better than expected — and capped off an eight-year growth story for the biotech's CEO.

By Jacob Bell , Ned Pagliarulo • Updated Jan. 31, 2020

With no Alzheimer's update, attention turns to Biogen's troubles

Spinraza competitors and Tecfidera patent challenges were in the spotlight as Biogen provided few details about its planned filing for aducanumab.

By Jacob Bell • Jan. 30, 2020

Big pharma backed away from brain drugs. Is a return in sight?

Biotech executives see a new era of neuroscience breakthroughs on the horizon. But in a historically challenging space, it's hard to pinpoint what would cause big pharma to dive back in — and what ripples that would create.​

By Jacob Bell • Jan. 29, 2020

Decibel CEO steps down as company pares workforce

The Third Rock-backed company put an acting executive in place as it repositions for development in gene therapy and regenerative medicine.

By Jonathan Gardner • Jan. 29, 2020

Pfizer lays out gene therapy aspirations

With more Phase 3 trials on the near horizon, the big pharma plans to add one new gene therapy project per year to its pipeline.

By Jonathan Gardner • Jan. 28, 2020

FDA decision nears on Aimmune's contested peanut allergy drug

Palforzia is one of two products under review by the FDA that are aimed at desensitizing people highly allergic to peanuts.

By Jonathan Gardner • Jan. 24, 2020