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

Explore the Trendline➔

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

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

From no drugs to 3: Patients with spinal muscular atrophy now face hard choices

The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position.

By Jonathan Gardner • Oct. 5, 2020

AstraZeneca restarts another coronavirus vaccine trial, but US delay lingers

The company is now cleared to resume testing of its experimental shot in multiple countries, but a Phase 3 trial in the U.S. remains halted as an FDA investigation reportedly widens.

By Ben Fidler • Oct. 2, 2020

Solid gets all-clear from FDA to restart gene therapy trial

Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.

By Jonathan Gardner • Oct. 1, 2020

Regeneron says antibody drug may speed recovery of patients with mild COVID-19

Early data suggested the therapy could help people whose bodies aren't already fighting infection, a finding that led to emergency clearance in the U.S.

By Ben Fidler • Updated Sept. 30, 2020

Ironwood lays off one-third of staff after heartburn drug falls short in study

The company will halt further work on its only fully owned drug and focus instead on expanding sales of its marketed product Linzess.

By Jonathan Gardner • Updated 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

J&J, beginning final test, shares first data on coronavirus vaccine

The early study results were used to support the drugmaker's recent decision to start a large Phase 3 study that, unlike other large tests underway, will evaluate a one-shot regimen.  

By Ned Pagliarulo • Sept. 25, 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

J&J begins largest Phase 3 study of a coronavirus vaccine

The trial, which launched Wednesday in the U.S., South Africa and several South American countries, will enroll as many as 60,000 participants.

By Ned Pagliarulo • Sept. 23, 2020

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

FDA sets back Novartis plans to expand use of SMA gene therapy

The agency has asked the company to run a new study of the Zolgensma formulation that it aims to bring to older patients with spinal muscular atrophy.

By Ben Fidler • Sept. 23, 2020

Regeneron forges ahead in lung cancer, but will need more to unseat Merck

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

By Ben Fidler • Sept. 22, 2020

Blueprint's bet on itself pays off with rare disease drug data

Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

By Ned Pagliarulo • Sept. 22, 2020

Merck matches Roche in search for next cancer immunotherapy

The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

By Ned Pagliarulo • Sept. 21, 2020

With Eli Lilly data, another drug emerges to stop breast cancers from returning

The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

By Ben Fidler • Sept. 20, 2020

Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

By Ned Pagliarulo • Sept. 20, 2020

Seattle Genetics stays step ahead of rivals with bladder cancer data

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

By Jonathan Gardner • Sept. 18, 2020

In unexpected finding, Roche claims arthritis drug may have role in treating COVID-19

Previous study findings from Roche and others had indicated the Swiss drugmaker's Actemra, and other drugs like it, weren't helping patients hospitalized with coronavirus disease. 

By Ben Fidler • Sept. 18, 2020