Biotech

Ovid's plan to prove a shelved sleeping pill for a rare disease ends in disappointment

A quest by former Teva and Bristol Myers executive Jeremy Levin to develop an old drug for Angelman's syndrome fell short in a late-stage clinical trial.

By Ben Fidler • Dec. 02, 2020

With anemia data, Agios blood disease drug takes a crucial step forward

Phase 3 results announced Tuesday boost chances that Agios' drug might not just win approval for a rare type of anemia, but also be useful in treating other blood diseases.

By Ben Fidler • Dec. 01, 2020

Explore the Trendline➔

Trendline

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

Moderna, finishing key study, to ask FDA for emergency approval of coronavirus vaccine

New results confirm the shot's strong efficacy against COVID-19 and should raise confidence vaccination can prevent against severe symptoms as well. 

By Ben Fidler • Nov. 30, 2020

Biogen stocks up on Sage's brain drugs in $3B deal

Biogen and Sage each face challenges. While executives from both companies said the deal could provide a boost, investors don't appear to be sold just yet.

By Jacob Bell • UPDATED: Nov. 30, 2020 at 11:13 a.m.

Alnylam wins US approval for its third rare disease drug

The drug, now known as Oxlumo, is the first approved treatment for patients with a potentially life-threatening condition that can cause kidney failure. Like other Alnylam drugs, it comes at a six-figure list price.

By Kristin Jensen • Nov. 24, 2020

Deep Dive

How Gilead finally spent its money

This year, the biotech spent about $27 billion trying to become a leader in cancer research. Executives who spoke to BioPharma Dive said there's still work to be done.

By Jacob Bell • Nov. 24, 2020

Amgen cuts Cytokinetics loose after heart drug disappointment

The smaller biotech vowed to push forward, although the pill's inability to prevent heart failure death may complicate its plans to win approval. 

By Jonathan Gardner • Nov. 23, 2020

Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use

The drug is the second antibody-based treatment to win FDA emergency authorization this month, though supplies of both are very limited.

By Ben Fidler • Nov. 22, 2020

Stem cell therapy for ALS fails a large clinical trial

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.

By Jacob Bell • Nov. 17, 2020

Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots

Multiple effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.

By Ben Fidler • Nov. 16, 2020

Intellia, beginning treatment in CRISPR study, secures Gates Foundation backing

The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology. 

By Kristin Jensen • Nov. 11, 2020

Pfizer invests in Homology, adding to gene therapy ambitions

Along with an equity stake, Pfizer will get right of first refusal on any deal involving Homology's most advanced therapies, which the biotech is developing for a rare metabolic disorder.

By Kristin Jensen • Nov. 10, 2020

Amgen's asthma drug delivers a needed win

A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome."

By Jacob Bell • Nov. 10, 2020

Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug

The regulator approved Lilly's synthetic antibody treatment for emergency use, but short supplies and logistical challenges could limit its initial impact.

By Ben Fidler • Nov. 09, 2020

5 takeaways from the FDA's high-stakes meeting for Biogen's Alzheimer's drug

The expert panel's decidedly negative vote on aducanumab raised questions about the drug's future, as well as the credibility of the FDA.

By Jacob Bell , Ned Pagliarulo , Ben Fidler • Nov. 09, 2020

FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt

In a tense meeting, a group of experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug.

By Jacob Bell , Jonathan Gardner , Ned Pagliarulo • UPDATED: Nov. 7, 2020 at 7:15 p.m.

BioMarin, stung by FDA rejection, pressed on path forward for 2 key drugs

Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.

By Ned Pagliarulo • Nov. 06, 2020

Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval

Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab. 

By Ned Pagliarulo , Jacob Bell • UPDATED: Nov. 4, 2020 at 2:39 p.m.

Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma

Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson. 

By Ben Fidler • Nov. 04, 2020

The meeting that could change Alzheimer's treatment

On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.

By Jacob Bell • Nov. 03, 2020

Chinese biotech partnered with GSK gets funding boost for coronavirus vaccine

Clover Biopharmaceuticals, one of several China-based groups advancing a coronavirus shot, has now received one of the largest investments to date from the vaccine development alliance group CEPI.

By Kristin Jensen • Nov. 03, 2020

Regeneron pauses study of rare disease drug following patient deaths

The company hasn't determined whether its drug played a role in the deaths, but concerns over the treatment's safety could dim its chances for approval.

By Jacob Bell • Nov. 02, 2020

Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients

A study monitoring board flagged a "potential safety signal" in some hospitalized COVID-19 patients who require breathing support, telling the biotech to modify its study protocol.

By Ben Fidler • Oct. 30, 2020

Atea, riding interest in COVID-19 drugs, pulls off one of 2020's top biotech IPOs

The Boston startup's initial public offering is the fourth-largest in biotech this year, according to data compiled by BioPharma Dive.

By Ben Fidler • Oct. 30, 2020

Gilead lifted by fast sales of COVID-19 drug Veklury. Will they last?

Veklury, which was approved by the FDA last week, earned Gilead nearly $900 million in the third quarter, although U.S. sales could slow in the months ahead.

By Ned Pagliarulo • Oct. 29, 2020