Biotech

Record numbers of biotechs are going public. Here's how they're performing.

Initial public offerings have fueled biotech's boom. A new database built by BioPharma Dive will help you keep track of them as they happen. 

By Ben Fidler • Oct. 26, 2020

Mirati cancer drug results spark hopes of outperforming Amgen's

The biotech's KRAS-blocking pill trails Amgen's sotorasib in development, but early data suggest it might match the bar set by Amgen.

By Jonathan Gardner • Oct. 26, 2020

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Inside the global race for a coronavirus vaccine

Some 29 vaccine candidates are now in clinical studies. Early results from five leading efforts are encouraging, suggesting researchers are on the right track despite rapid acceleration of testing.

By BioPharma Dive staff

Sarepta, continuing its gene therapy push, helps launch a startup

The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million. 

By Jacob Bell • Oct. 22, 2020

Ex-Medivation team nets $500M to take their new cancer drugmaker to Wall Street

Nuvation Bio, a large oncology startup run by former Medivation executives, is capitalizing on a boom in mergers with so-called special purpose acquisition company, or SPACs.

By Ben Fidler • Oct. 21, 2020

CRISPR Therapeutics reports remissions, one death in cancer cell therapy study

The biotech is one of several attempting to develop "off-the-shelf "CAR-T therapies. While trial results show potential, high-dose treatment was paused following a patient's death.

By Jonathan Gardner • Oct. 21, 2020

Biogen is running out of safety nets

Third quarter earnings underscore just how vital it is that Biogen secure approval of its experimental Alzheimer's drug, given the challenges elsewhere in its business.

By Jacob Bell • Oct. 21, 2020

With approval in sight, Vifor expands deal for partner's anti-itch drug

The company could pay as much as $440 million through a new licensing pact that gives it more commercial rights to a therapy developed by Cara Therapeutics.

By Kristin Jensen • Oct. 20, 2020

Early signs of survival benefit raise optimism around a small biotech's ALS drug

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.

By Jacob Bell • Oct. 16, 2020

Vertex faces first notable setback as it pushes beyond cystic fibrosis

Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency.

By Jacob Bell • UPDATED: Oct. 15, 2020 at 10:10 a.m.

Gossamer plummets as its lead drug fails 2 studies

Despite the setback, the biotech still sees a path forward for its drug in asthma and plans to find a partner to move it into further testing.

By Jacob Bell • Oct. 13, 2020

FDA puts Voyager study on hold in latest gene therapy speed bump

The biotech won't be able to start human testing of an experimental Huntington's disease treatment until regulators see more manufacturing data.

By Jonathan Gardner • Oct. 13, 2020

Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug

While the committee's votes in favor of ALKS 3831 make an approval more likely, the drug's effects on patients also taking opioids could limit its use.

By Ben Fidler • Oct. 12, 2020

Moderna says it won't enforce coronavirus vaccine patents during pandemic

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

By Jonathan Gardner • Oct. 08, 2020

Column

Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.

By Jacob Bell • Oct. 08, 2020

Vir, GSK keep pace with rivals as COVID-19 antibody drugs grab spotlight

The two companies claim their coronavirus-fighting antibody drug — the type of medicine recently used to treat President Trump — is safe enough to move into advanced testing.

By Jonathan Gardner • Oct. 06, 2020

With a sweetened offer, BridgeBio plans to reel in a subsidiary

After an unsuccessful buyout attempt in 2019, BridgeBio aims to acquire the roughly one-third of Eidos Therapeutics that it doesn't already own.

By Jacob Bell • Oct. 05, 2020

Trump treated for COVID-19 with Regeneron, Gilead drugs

The president has received Regeneron's antibody drug, Gilead's Veklury and the steroid dexamethasone, suggesting his case may be more serious. 

By Ben Fidler , Ned Pagliarulo • UPDATED: Oct. 5, 2020 at 10:48 a.m.

Gilead to distribute COVID-19 drug Veklury in US, taking over from federal government

Supplies of the once scarce drug now exceed demand, leading the Trump administration to step back from controlling distribution.

By Ned Pagliarulo • Oct. 02, 2020

After trial failure, Genfit cuts staff and gives up on experimental NASH drug

The French biotech is looking to substantially reduce its cash burn rate as it regroups from a damaging clinical setback.

By Kristin Jensen • Oct. 01, 2020

Biogen's all-important Alzheimer's drug enters the review gauntlet

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.

By Jacob Bell • Sept. 29, 2020

FDA delays testing of Inovio's coronavirus vaccine

The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.  

By Jonathan Gardner • Sept. 28, 2020

After setback in the US, Galapagos' main drug finds success elsewhere

A month after the FDA surprisingly rejected the rheumatoid arthritis drug, called filgotinib, it's been cleared by regulators in Europe and Japan.

By Jacob Bell • Sept. 28, 2020

Novavax starts large-scale coronavirus vaccine trial in UK, as cases surge

The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.

By Ben Fidler • Sept. 25, 2020

Gene therapy company Taysha completes sprint from first funding to IPO

Led by alumni of Zolgensma developer AveXis, the university spinout could have four experimental therapies in the clinic by the end of 2021.

By Jonathan Gardner • UPDATED: Sept. 24, 2020 at 4:23 p.m.

AC Immune drug fails in blow to another Alzheimer's hypothesis

Negative results for the experimental drug semorinemab dents a theory that Alzheimer's disease may be caused by tangles of the protein tau in the brain.

By Jonathan Gardner • Sept. 23, 2020