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

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

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

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