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

Explore the Trendline➔

Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

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

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

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

Moderna and Pfizer, having shown speed with coronavirus vaccines, see opportunity in seasonal flu

Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.

By Ned Pagliarulo • Sept. 17, 2020

Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials

Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.

By Ned Pagliarulo • Updated Sept. 19, 2020

Arrowhead shares soar on liver disease data from four patients

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

By Jonathan Gardner • Sept. 16, 2020

Merck pays Seattle Genetics $1.7B as antibody cancer drugs continue comeback

Merck's deal for Seattle Genetics' antibody-drug conjugate comes as Gilead agreed to acquire rival developer Immunomedics in the biotech industry's largest buyout of 2020.

By Ben Fidler • Sept. 14, 2020

Gilead to buy cancer drugmaker Immunomedics for $21B

The acquisition capped an active year of dealmaking for Gilead, which under CEO Daniel O'Day aims to become as well known for its cancer drugs as its HIV and hepatitis C medicines. 

By Ned Pagliarulo • Updated Sept. 14, 2020

Intra-Cellular roars back on success in bipolar depression

Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.

By Jacob Bell • Sept. 9, 2020

Grail, Illumina's well-funded liquid biopsy spinout, prepares for IPO

The company claims its test may help avert deaths from cancers that would otherwise kill later on, but will have a tough task convincing doctors and payers of its merit.

By Nick Paul Taylor • Sept. 9, 2020

How biotech and pharma companies pay their CEOs, and their workers

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees.

By Ned Pagliarulo • Sept. 9, 2020

Cancer drug approval puts Blueprint up against Lilly

Gavreto is cleared to treat certain lung cancer patients who have so-called RET mutations. Partners Blueprint and Roche will now compete with Eli Lilly and its rival drug Retevmo.

By Jacob Bell , Ben Fidler • Sept. 8, 2020

AbbVie wagers up to $2B on a Chinese biotech's cancer drug

The licensing deal hands AbbVie exclusive rights to a drug targeting CD47, a protein that has caught the attention of drugmakers like Gilead and Celgene.

By Jacob Bell • Sept. 4, 2020

Amarin loses appeal of court ruling on heart drug patents

The federal appeals court decision makes the launch of generic competitors to Amarin's Vascepa more likely, dealing the drugmaker a major blow.

By Ned Pagliarulo • Sept. 3, 2020

Akebia stumbles and clouds the prospects of anemia pills

The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.

By Ben Fidler • Sept. 3, 2020

After a rare win, a biotech details long-awaited results for its ALS drug

Newly published data describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.

By Jacob Bell • Sept. 2, 2020

Intercept, facing long road ahead for NASH drug, lays off quarter of workforce

In late June, the FDA rejected Intercept's obeticholic acid for the liver disease, asking for more data that could take the biotech some time to collect. 

By Ned Pagliarulo • Sept. 2, 2020

Gilead deal reignites optimism in a cancer biotech

A year after Jounce Therapeutics and Celgene ended a wide-ranging alliance, Gilead has teamed up with the Massachusetts biotech.

By Jacob Bell • Sept. 1, 2020

Vir, GSK push coronavirus antibody drug straight into mid-stage tests

The two companies, chasing rival treatments from Eli Lilly, Regeneron and more, aim to produce their first study results by the end of the year.

By Jonathan Gardner • Aug. 31, 2020

Ionis, changing its strategy, reels its spinoff back in

Reversing course on plans to rely on others to sell its drugs, the biotech will spend about half a billion dollars to acquire its own spinoff, Akcea.

By Jacob Bell • Aug. 31, 2020

Top 10 myths about working with the FDA for an oncology drug approval

Debunking myths around working with the FDA for oncology drug approval. 

By Amy McKee, Vice President Regulatory Consulting Services, Parexel • Aug. 31, 2020

CanSino said to seek early authorization of coronavirus vaccine

The reported talks between CanSino and several countries highlight the urgency with which governments are operating to secure supply of experimental coronavirus vaccines.

By Jonathan Gardner • Aug. 28, 2020