Orchard lays off a quarter of its staff amid major shift

The gene therapy developer has given up on plans to build a new manufacturing facility and is adjusting its clinical resources to focus on more common diseases.

By Kristin Jensen • Updated May 8, 2020

Moderna plans earlier start to late-stage test of coronavirus vaccine

A Phase 3 trial of Moderna's experimental vaccine could begin in early summer, several months sooner than what was already an ambitious target for starting this fall.

By Ned Pagliarulo • May 7, 2020

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

After donation to the U.S., Gilead outlines plans to distribute COVID-19 drug worldwide

Gilead is negotiating licenses for remdesivir with overseas manufacturers and charities, which parallels past efforts with its hepatitis C and HIV drugs.

By Jonathan Gardner • May 6, 2020

Ousted BARDA director claims retaliation for pushing back on unproven coronavirus drugs

In a newly filed whistleblower complaint, Rick Bright alleged his criticism of the Trump administration's response to the coronavirus pandemic led to his removal last month as head of BARDA.

By Ned Pagliarulo • May 5, 2020

Pfizer, BioNTech launch U.S. trial of coronavirus vaccine

Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.

By Jonathan Gardner • May 5, 2020

Alexion, seeking to broaden business, to buy Portola for $1.4B

The acquisition is a bet by Alexion that its commercial strength will help it broaden the market for Portola's top drug, the blood thinning antidote Andexxa. 

By Ned Pagliarulo • May 5, 2020

Akebia, chasing FibroGen, nears FDA review with new anemia pill data

The company is one of several aiming to upend the market for injectable anemia biologics, which generate billions of dollars in yearly sales.

By Ben Fidler • May 5, 2020

A coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.

Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.

By Jonathan Gardner • May 4, 2020

With new estimate, ICER sets terms of debate on pricing Gilead's COVID-19 drug

The influential watchdog group judged Gilead's remdesivir would be cost effective at $4,500 per treatment course, setting the stage for what's likely to be a controversial decision by the company. 

By Ned Pagliarulo • May 4, 2020

After 2 months of work, Alnylam has its top pick for a COVID-19 drug

The company and its partner, Vir Biotechnology, are now trying to speed their inhaled RNA interference drug into human testing.

By Jacob Bell • May 4, 2020

Gilead may have a drug for COVID-19. Wall Street asks whether it will profit

The biotech is donating its current supply of remdesivir. Afterwards, will it make money on the drug, or continue to take losses for the greater good? 

By Ned Pagliarulo • May 1, 2020

Moderna, with government cash, taps Lonza to make 1 billion doses of COVID-19 vaccine

The deal gives Moderna more manufacturing might to make sufficient supplies of its experimental coronavirus vaccine, which it's advancing quickly.

By Ben Fidler • May 1, 2020

Vertex's drug launch hits new heights, but further growth could be harder to find

Though Trikafta blew by Wall Street estimates with almost $900 million in first quarter sales, Vertex cautioned that patient compliance and the coronavirus pandemic could dampen the drug's growth in the coming months.

By Jacob Bell • April 30, 2020

'We really did need a win.' Gilead drug no knockout in COVID-19, but results spur optimism

Doctors interviewed by BioPharma Dive said results from an important clinical trial of remdesivir were encouraging, even if its benefit seemed only modest.

By Ned Pagliarulo • April 30, 2020

Texas university spins out Taysha, a gene therapy startup with 15 programs

The university uses a gene therapy delivery tool that Taysha says can be scaled for both small and large manufacturing needs.

By Jonathan Gardner • April 29, 2020

Gilead drug for COVID-19 clears crucial clinical test

Data from an NIH-led study showed the antiviral therapy helped to speed recovery in patients hospitalized with coronavirus disease.

By Ned Pagliarulo • Updated April 29, 2020

Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. Whether it can truly help people, however, is not yet clear.

By Ben Fidler • April 28, 2020

Repurposed arthritis drug disappoints in closely watched COVID-19 trial

A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.

By Jonathan Gardner • April 27, 2020

Regeneron, Sanofi immunotherapy extends survival in previously untreated lung cancer

In a boost to the companies' come-from-behind immunotherapy bid, their drug Libtayo helped patients live longer than did chemotherapy. Improving on Keytruda, however, will be more challenging.

By Ned Pagliarulo • April 27, 2020

Axsome, beating the odds, finds success treating Alzheimer's agitation

The biotech's drug, which has shown promise in treating depression, pulled off an unusual feat in hitting the main goal of a late-stage Alzheimer's study.

By Jacob Bell • April 27, 2020

Launch for Neurocrine Parkinson's drug put on hold because of coronavirus

CEO Kevin Gorman told BioPharma Dive it's an inappropriate time to be pitching the drug to neurology doctors, many of who are devoting time to hospitals grappling with COVID-19 cases.

By Jacob Bell • Updated April 27, 2020

Why $120M for Affinivax may reflect a new view of vaccine makers

Secured amid the global pandemic, the sizable Series B round bucks historical trends. One backer sees an "explosion" of similar investments coming.

By Ben Fidler • April 23, 2020

Immunomedics wins long-sought FDA approval for breast cancer drug

Trodelvy, the first approved drug of Immunomedics' 38-year corporate history, was cleared by the FDA roughly five weeks ahead of schedule. 

By Ned Pagliarulo • April 22, 2020

Biogen hammered with questions as Alzheimer's drug moves slower than expected

An application for aducanumab was supposed to be filed with the FDA early this year. Now, the biotech says it will finish doing so by the third quarter.

By Jacob Bell • April 22, 2020

Malaria drug's potential against coronavirus dims as data mounts

Hydroxychloroquine drew praise from President Donald Trump and TV doctors, but recent NIH guidelines and preliminary data build a case against its use.

By Jonathan Gardner • April 22, 2020