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

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

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

Coronavirus vaccine from BioNTech, Pfizer set to enter testing in Germany

The study will test four versions of BioNTech's mRNA vaccine in 200 healthy volunteers, and is the first to be cleared to begin in Germany. 

By Ned Pagliarulo • April 22, 2020

Trial data help small biotech ready its anti-itch drug for approval

Korsuva, a drug from Cara Therapeutics, has now succeeded in two Phase 3 trials in chronic kidney disease patients, setting the stage for potential approval filings in the U.S. and Europe.

By Jonathan Gardner • April 21, 2020

Positive data keep Bristol Myers and Exelixis in the kidney cancer race

A combination of Opdivo with Exelixis' Cabometyx, if cleared for use, would compete against an approved pairing of Merck's Keytruda and Pfizer's Inlyta.

By Jonathan Gardner • April 20, 2020

Seattle Genetics wins another speedy approval as FDA clears breast cancer drug

The FDA OK for Tukysa comes four months early and gives the biotech, which has seen its share price hit record highs, its third marketed cancer drug.

By Ben Fidler • April 17, 2020

NIH spearheads broad partnership with drugmakers, regulators to speed COVID-19 therapies

The initiative reflects the urgency for drugmakers to work together, rather than independently, to advance promising treatments for the novel coronavirus.

By Ben Fidler • April 17, 2020

US government to back Moderna's coronavirus vaccine with up to $483M

The BARDA grant will allow Moderna to hire 150 more staff and accelerate testing of its vaccine, which entered a Phase 1 study in March and could soon move to a mid-stage trial. 

By Ned Pagliarulo • Updated April 17, 2020

After 'superspreading' event, Biogen to build hub for COVID-19 patient data

The biotech's employees, who were some of the first people in Massachusetts diagnosed with COVID-19, can offer blood samples to a new biobank aimed at better understanding the disease.

By Jacob Bell • April 16, 2020