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GenFit delivers latest NASH drug failure

The negative results for GenFit's elafibranor deal another another blow to the NASH field, which has seen only one drug make it through late-stage testing.

Trump administration: States to decide which hospitals get Gilead's COVID-19 drug

HHS will distribute to states some of the roughly 600,000 vials of remdesivir Gilead is donating to the U.S., but said decisions on which hospitals receive the drug will be made by state health agencies.

Lilly's Loxo buyout bears fruit as FDA clears cancer drug Retevmo

The pharma will launch Retevmo at a time when hospitals and academic centers are stretched thin by the COVID-19 pandemic. 

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.

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.

UPDATED: May 8, 2020 at 10:35 p.m.

Novartis wins approval for niche lung cancer drug

Jumping ahead of competition, the Swiss pharma secured FDA clearance for Tabrecta, the first therapy targeted to certain mutations in a gene called MET.

After trial failure, Enanta narrows its focus to NASH

The biotech's main drug missed its goal in a mid-stage study of patients with a liver disease known as PBC.

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.

Novo's diabetes drug also appears to work in NASH

Results from a Phase 2 study showed three doses of Novo's semaglutide were better than placebo at resolving the liver disease without worsening fibrosis.

Another delay for Bristol Myers cell therapy as FDA extends review

Bristol Myers now expects an approval decision on liso-cel by mid-November, some six weeks before a deadline set by the pharma in its buyout of Celgene.

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. 

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.

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.

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.

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.

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. 

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.

Gilead's remdesivir, shown to hasten COVID-19 recovery, cleared for emergency use by FDA

In a remarkably rapid turn, the FDA authorized the antiviral drug two days after positive results were announced from a closely watched government-run clinical trial.

UPDATED: May 1, 2020 at 5:03 p.m.

Agios drops as COVID-19 takes a toll on drug studies

The biotech listed nine studies in which it expects coronavirus-related effects on patient enrollment or data collection, including two late-stage trials of its closely watched drug mitapivat​​.

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? 

AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine

The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.

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.

'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.

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.

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.

UPDATED: April 29, 2020 at 2:26 p.m.