Biotech: Page 2

Vir shares tumble after apparent setback for COVID-19 drug

The NIH stopped enrolling patients hospitalized with coronavirus disease into a study of Vir's antibody drug after data monitors questioned its effectiveness.

By Jonathan Gardner • March 03, 2021

Takeda takes full control of drug for rare epilepsies

A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases.

By Jacob Bell • March 03, 2021

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Trendline

The BioPharma Dive Outlook on 2021

M&A appears to be ticking higher after a slow 2020, while a series of setbacks has renewed questions around gene therapy. Several key clinical trial readouts also loom. Here's what to watch in biotech and pharma this year.

By BioPharma Dive staff

FibroGen shares sink as FDA meeting decision suggests another delay for top drug

The biotech expected the FDA to rule on approval of its anemia drug by March 20. But a newly announced advisory committee meeting seems to make a decision by then unlikely. 

By Ned Pagliarulo • March 02, 2021

A closely watched schizophrenia drug fails key test

Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.

By Jacob Bell • March 02, 2021

Sarepta wins FDA approval of another drug for rare muscular dystrophy

Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.

By Jacob Bell • Feb. 25, 2021

Top Moderna executive to leave company later this year

Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.

By Ned Pagliarulo • Feb. 25, 2021

Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda

The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.

By Ben Fidler • Feb. 22, 2021

After FDA feedback, a biotech's ALS therapy faces murky path forward

Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.

By Jacob Bell • Feb. 22, 2021

Sponsored by SGS

Analytical quality by design: Development of cell-based bioassays

Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust.

By Alex Perieteanu, Ph.D. and Aanchal Mehra, M.Sc • Feb. 22, 2021

Novavax broadens reach of global coronavirus vaccine alliance with new deal

As more transmissible variants spread across the globe, there's growing urgency to equitably allocate vaccine supplies. A deal between Novavax and COVAX will significantly bolster that effort.

By Ben Fidler • Feb. 19, 2021

Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.

By Jonathan Gardner • Feb. 19, 2021

Investment firm raises $300M to fund medical research for overlooked diseases

Adjuvant Capital's first fund drew interest from Merck and Novartis as well as philanthropies and other investment firms.

By Kristin Jensen • Feb. 18, 2021

GSK returns to Vir with expanded deal to develop drugs for flu, other viruses

The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares.

By Kristin Jensen • Feb. 17, 2021

Bluebird stops studies of sickle cell gene therapy after new cancer cases

The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.

By Ben Fidler , Ned Pagliarulo • UPDATED: Feb. 16, 2021 at 10:24 a.m.

10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model

The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.

By Ned Pagliarulo • Feb. 16, 2021

A gene therapy pipeline takes shape for a cluster of rare diseases

Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots.

By Ned Pagliarulo • Feb. 12, 2021

Gilead, Galapagos halt development of experimental drug, denting research alliance

Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.

By Kristin Jensen • Feb. 11, 2021

A new startup gets Takeda's backing to take complex genetic medicines 'off the shelf'

Ensoma debuts with a lucrative alliance with the Japanese pharma and an unusual way to deliver genetic medicines into the body.

By Ben Fidler • Feb. 11, 2021

AbbVie exploring how CRISPR gene editing can improve cell therapies

Using technology from Caribou Biosciences, AbbVie hopes to engineer "off-the-shelf" CAR-T cells that can better withstand attacks from the immune system.

By Jacob Bell • Feb. 10, 2021

Small biotech gets big win on treatment for rare swelling disorder

An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.

By Jonathan Gardner • Feb. 09, 2021

Editas names new CEO in latest executive shakeup

James Mullen, chair of Editas' board and a former Biogen CEO, will replace Cynthia Collins in a critical year for the gene editing biotech.

By Ned Pagliarulo • Feb. 08, 2021

PTC aims again for FDA review of Duchenne drug despite latest miss

The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.   

By Jonathan Gardner • Feb. 05, 2021

Gilead sales propped up by COVID-19 drug Veklury

Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.

By Ned Pagliarulo • Feb. 05, 2021

With $588M IPO, Sana leads wave of new biotechs going public

Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in recent history. 

By Ben Fidler • Feb. 03, 2021

Biogen laser-focused on Alzheimer's drug as rest of business falters

While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.

By Jacob Bell • Feb. 03, 2021