AstraZeneca, J&J cleared to restart major coronavirus vaccine studies

The U.S. trial of AstraZeneca's shot has been paused over safety concerns since early September, while J&J's was halted in mid-October. 

By Ned Pagliarulo • Updated Oct. 24, 2020

At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials

An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.

By Ned Pagliarulo • Oct. 23, 2020

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Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Moderna enrolls final volunteers into key coronavirus vaccine study

Recruiting 30,000 participants for the late-stage trial took Moderna just three months, even after the company slowed enrollment to boost participation of people of color. 

By Ned Pagliarulo • Oct. 22, 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

Merck, with more study data, builds case for pneumonia vaccine successor

Results from two Phase 3 studies showed Merck's candidate to be similarly immunogenic as Pfizer's Prevnar 13, lending additional strength to Merck's plans to ask for U.S. approval.

By Ned Pagliarulo • Oct. 20, 2020

Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

By Ben Fidler • 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

Gilead's COVID-19 drug doesn't prevent deaths, large WHO study finds

The results could weaken the case for widely using Veklury, also known as remdesivir, just as the company is asking for full approval from the FDA. 

By Ned Pagliarulo • Oct. 16, 2020

Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says

An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election. 

By Ben Fidler • Oct. 16, 2020

5 questions ahead of this week's FDA meeting on coronavirus vaccines

Normally staid affairs, this Thursday's advisory committee meeting will be closely watched and could set expectations for how the FDA will approach any future vaccine approval. 

By Jonathan Gardner • 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

NIH study of Lilly COVID-19 antibody drug paused for safety review

Eli Lilly recently asked the FDA for emergency clearance of the drug, which is similar to the treatment from Regeneron that President Donald Trump received earlier this month.

By Ned Pagliarulo , Ben Fidler • Updated Oct. 14, 2020

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

J&J halts studies of coronavirus vaccine due to participant's illness

The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review. 

By Ned Pagliarulo • Updated Oct. 13, 2020

There is value to patients when independent sites offer clinical trials

We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes.

By Steve Smith, President Patient Advocacy, WCG, and Lindsay McCarthy, VP, WCG PharmaSeek • Oct. 13, 2020

US backs AstraZeneca COVID-19 antibody drug with $486M in funding

Days after President Donald Trump was treated with a similar antibody therapy from Regeneron, his administration is backing another candidate being tested by British drugmaker AstraZeneca. 

By Ned Pagliarulo • Oct. 9, 2020

Pfizer stumbles again in early breast cancer study, clearing path for Eli Lilly

The latest setback for Pfizer's top-selling Ibrance leaves Lilly's Verzenio, for now, as the only drug in its class to be proven to stave off breast cancer recurrence after surgery.

By Ben Fidler • Oct. 9, 2020

Key trial test begins for plasma-based COVID-19 therapy from Takeda, CSL

The medicine, a concentrated infusion of blood antibodies, is different than the convalescent plasma that was recently cleared for emergency use by the FDA. 

By Ned Pagliarulo • Oct. 9, 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. 8, 2020

Amgen and Cytokinetics claim heart drug success, but results widely disappoint

A weaker-than-expected benefit for omecamtiv mecarbil, a key drug the companies are developing for heart failure, raised doubts about the medicine's potential role.

By Ned Pagliarulo • Oct. 8, 2020

Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination.

By Ben Fidler • Updated Oct. 7, 2020

Pfizer and Sangamo, after rival's setback, kick off late-stage gene therapy trial

The FDA's recent rejection of a hemophilia gene therapy from BioMarin sets a high standard for approval. Will Pfizer fare any better?

By Jonathan Gardner • Oct. 7, 2020

FDA releases coronavirus vaccine guidelines that White House resisted

The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely. 

By Ned Pagliarulo , Jonathan Gardner • Oct. 6, 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. 6, 2020

FDA told coronavirus vaccine makers of stricter standards for early approval

Blocked by the White House from issuing new vaccine guidelines, the FDA made its criteria for an emergency authorization clear anyway, publishing requirements it had previously communicated to drugmakers. 

By Ned Pagliarulo • Updated Oct. 6, 2020