The Latest
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Brian Tucker/BioPharma Dive
Deep DiveThe coronavirus vaccine frontrunners are advancing quickly. Here's where they stand.
J&J and CureVac expect to share their first clinical results in the coming weeks, while Merck & Co. has said a trial of one of its vaccines could begin this month.
UPDATED: Sept. 10, 2020 at 5:29 p.m. -
Lydia Polimeni, National Institutes of Health
NIH starts broad set of studies testing blood thinners against COVID-19
The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow evidence of blood clotting in COVID-19 patients.
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Sanofi's hemophilia drug comes into focus as delays hit a key competitor
With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ.
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FDA wants more details on Sarepta gene therapy, potentially delaying final test
A new request from the regulator could tighten the race between Sarepta and Pfizer to prove out a gene therapy for Duchenne muscular dystrophy.
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GSK inhaler locks down a coveted approval in asthma
The approval helps differentiate Trelegy Ellipta, a three-drug treatment for COPD and, now, asthma, in the crowded respiratory drug market.
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Catalent to invest $130M in gene therapy plant near Baltimore airport
The contract manufacturer is riding a boom in demand for both its gene therapy and vaccine manufacturing services.
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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.
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Jacob Bell / BioPharma Dive
Merck takes aim at Pfizer with pneumonia vaccine data
Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product.
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Nasdaq
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.
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Studies of AstraZeneca coronavirus vaccine put on hold for safety review
A participant in a clinical trial of the experimental shot suffered an unexplained illness, triggering an investigation and a global pause in vaccinations.
UPDATED: Sept. 9, 2020 at 10:13 a.m. -
Pfizer, BioNTech in final talks to supply EU with coronavirus vaccine
The companies, which are among the furthest along in testing, would deliver up to 300 million doses of their shot to EU countries under a proposed deal.
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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.
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Coronavirus vaccine makers vow to wait for data before seeking approval
In an unusual letter, the heads of nine top vaccine developers pledged to "stand with science" and only move forward with approval applications if warranted by clinical results.
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Jacob Bell / BioPharma Dive
Merck details cough drug data, raising questions about its potential
Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use.
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Researchers publish first data on coronavirus vaccine approved by Russia
While the shot appeared less potent than those being advanced by U.S. and U.K. companies, the Russian vaccine could be used broadly because it doesn't need to be kept frozen.
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Dollar Photo Club
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.
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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.
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GlaxoSmithKline
Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine
The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing.
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Amarin
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.
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FDA scolds Mylan for 'repeated' manufacturing problems
Though it once had a glimmering manufacturing record, Mylan now finds itself in the crosshairs of the FDA. The agency is advising the company to quickly and comprehensively assess its global operations.
UPDATED: Sept. 4, 2020 at 11:30 a.m. -
AbbVie
House committee to subpoena AbbVie over drug pricing
Democratic lawmakers have been unhappy with AbbVie's response to an ongoing drug pricing probe, and are now demanding the drugmaker turn over more information.
UPDATED: Sept. 3, 2020 at 8:04 p.m. -
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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.
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Lydia Polimeni, National Institutes of Health
NIH panel says data doesn't support plasma use for COVID-19
The expert advisers' determination appears to conflict with a decision by the FDA last week to clear the blood-derived treatment for emergency use.
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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.
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Sanofi ends research of arthritis drug as coronavirus treatment
Kevzara failed to shorten hospital stays among patients severely sick with COVID-19, study results showed, further dimming hopes that drugs similar to it could help combat the disease.
