Biotech

JPM22: Aftershocks for Lilly, CRISPR versus CRISPR and Bluebird's crucial year

A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology. 

By Ned Pagliarulo , Ben Fidler • Jan. 12, 2022

Amgen partners with Arrakis to develop drugs aimed at RNA

Arrakis, a specialist in designing oral drugs that target RNA, will receive $75 million under the deal, which could be worth "several billion dollars" more. 

By Ned Pagliarulo • Jan. 11, 2022

Explore the Trendline➔

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

5 questions facing the FDA in 2022

If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.

By Jonathan Gardner • Jan. 11, 2022

JPM22: Pfizer's big bet on mRNA, Biogen 'proven wrong' on Aduhelm price and the next cell therapies

The healthcare conference's first day brought a trio of mRNA deals from Pfizer, a rare admission from Biogen's CEO and new focus on what's next in cell therapy.

By Ned Pagliarulo , Jonathan Gardner , Jacob Bell • Jan. 10, 2022

AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

Neurimmune, which will license to AstraZeneca an early-stage treatment for a rare form of cardiomyopathy, is probably best known for its invention of the antibody that became Biogen's Alzheimer's drug Aduhelm. 

By Ned Pagliarulo • Jan. 7, 2022

As three biotechs head to Wall Street, a battered sector braces for a pullback

Amylyx, CinCor and Vigil raised about $480 million combined, a sign of continued investor interest in biotech IPOs. But industry analysts expect fewer and smaller offerings in 2022 due to investor fatigue from high valuations.

By Ben Fidler • Jan. 7, 2022

Novartis turns to Alnylam in research deal aimed at liver failure

The Swiss pharma is familiar with Alnylam's RNA-based technology, which underpins Novartis' newly approved cholesterol drug Leqvio.

By Ned Pagliarulo • Updated Jan. 6, 2022

Pfizer, BioNTech bet mRNA can make a better shingles vaccine

The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech.

By Ned Pagliarulo • Jan. 5, 2022

Avrobio stops work on rare disease gene therapy after unexpected study results

The biotech's gene therapy was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for drug developers.

By Ned Pagliarulo • Jan. 4, 2022

US pauses distribution of Regeneron, Lilly antibodies over omicron concerns

The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.

By Ben Fidler • Updated Jan. 4, 2022

Allakos shares plunge as company's top drug falls short in studies

The drug's effect in tissue did not appear to translate to a benefit in reducing symptoms, surprising executives at the biotech as well as its investors.

By Kristin Jensen • Dec. 22, 2021

Moderna vaccine weaker against omicron, but third shot boosts protection

As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.

By Jonathan Gardner • Dec. 20, 2021

FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.

By Ned Pagliarulo • Dec. 20, 2021

European regulators say no to Aduhelm, but Biogen is pushing back

The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks."

By Jacob Bell • Dec. 17, 2021

Spark expands in Philadelphia, with new facility meant to be Roche's gene therapy hub

The Luxturna developer, now owned by Roche, will invest $575 million to build a huge research and development center on Drexel University's campus.

By Ned Pagliarulo • Dec. 17, 2021

Adagio, after bold promises, says antibody drug won't work well against omicron

Shares in the biotech, which raised nearly $500 million to develop a treatment able to neutralize a wide range of coronavirus variants, plummeted on news of the disappointing laboratory test results.

By Kristin Jensen • Dec. 15, 2021

Moderna reveals first study results for seasonal flu vaccine

Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.

By Ned Pagliarulo • Dec. 10, 2021

Lilly deepens research ties in China with biotech deal

The collaboration with Regor Therapeutics is another example of large pharma companies' interest in partnering with emerging biotechs from China.

By Ned Pagliarulo • Dec. 10, 2021

FDA panel turns down Reata kidney disease drug in unanimous vote

The company said it will keep working with the FDA ahead of a Feb. 25 decision date, but the committee's verdict greatly diminishes the drug's chances of an approval.

By Kristin Jensen • Dec. 9, 2021

Intercept, awaiting needed trial data, pulls its NASH drug application in Europe

The biotech has lost much of its market value amid delays and regulatory questions for obeticholic acid. But the failures of other drugmakers still leave the company with a chance to rebound.

By Ben Fidler • Dec. 9, 2021

Omicron cuts Pfizer vaccine's potency, but data show booster may restore protection

Preliminary laboratory testing by Pfizer and partner BioNTech indicated three doses may protect against omicron as well as two doses versus the original coronavirus strain.

By Ned Pagliarulo , Ben Fidler • Dec. 8, 2021

Acadia shares rise on study success for Rett syndrome drug

The biotech claims the results are enough to pursue an approval, but high rates of side effects and modest efficacy could raise questions about the treatment.

By Ned Pagliarulo • Dec. 7, 2021

AstraZeneca wagers $200M on Ionis' next chance at a rare disease drug

The alliance follows AstraZeneca's buyout of Alexion last year and puts the British drugmaker in competition with Alnylam, Bridgebio and several others.

By Ben Fidler • Dec. 7, 2021

A serial biotech entrepreneur launches his next startup with high-dollar backing

Founded and led by Gary Glick, Odyssey Therapeutics has raised $218 million in Series A funding for its cancer and inflammatory disease drug research.

By Ned Pagliarulo • Dec. 7, 2021

Biohaven to seek FDA approval for second migraine drug after study success

The biotech's drug, called zavegepant, is delivered intranasally and could offer a similar convenience advantage as its first, the fast-selling Nurtec ODT.

By Ned Pagliarulo • Dec. 6, 2021