Veru’s COVID-19 drug comes up empty at FDA committee

Today's Big News

Nov 10, 2022

AstraZeneca discards Moderna-partnered solid tumor prospect, kidney disease asset in pipeline clear-out

Not once, but twice: BrainStorm shares tumble as FDA again knocks back ALS drug

In a squeaker, Veru's COVID-19 drug loses split decision at FDA advisory committee

'The decision is clear': Curis cuts workforce as pending data hint at near-term FDA application

After nearly 20 years, Cyclacel kicks phase 3 leukemia drug back to Daiichi

Nordic Nanovector avoids demise after freezing top asset, acquiring fellow Norwegian biotech APIM

 

Featured

AstraZeneca discards Moderna-partnered solid tumor prospect, kidney disease asset in pipeline clear-out

AstraZeneca has tossed out two early-phase drug development programs in its quarterly review, adding a Moderna-partnered solid tumor candidate and in-house chronic kidney disease treatment to its discard pile.
 

Top Stories

Not once, but twice: BrainStorm shares tumble as FDA again knocks back ALS drug

The FDA was pretty clear a year and a half ago that BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis therapy was not ready for prime time—but perhaps this latest rejection will really send the message home.

In a squeaker, Veru's COVID-19 drug loses split decision at FDA advisory committee

Veru has lost a split decision at its FDA advisory committee, with the experts voting eight to five against the known and potential benefit-risk profile of VERU-111 in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome.

'The decision is clear': Curis cuts workforce as pending data hint at near-term FDA application

In order for Curis’ leukemia drug to survive, resources must be shifted, and, in today’s biotech landscape, that means layoffs and a slimming of other programs.

After nearly 20 years, Cyclacel kicks phase 3 leukemia drug back to Daiichi

Cyclacel once had high hopes for sapacitabine. But, despite making it as far as a phase 3 trial for acute myeloid leukemia as well as midstage studies for other cancers, the biotech has decided to give up and hand the rights back to Daiichi Sankyo.

Nordic Nanovector avoids demise after freezing top asset, acquiring fellow Norwegian biotech APIM

Nordic Nanovector appeared to be on its deathbed after axing its lead asset in July. But the company will live to fight another day after acquiring fellow Norwegian biotech APIM Therapeutics.

Biogen taps Sanofi vet Viehbacher as CEO amid sales slowdown and Alzheimer's launch prep

Biogen’s board has tapped former Sanofi chief Christopher Viehbacher to assume the CEO throne on November 14. Viehbacher will also take over the role of director from Vounatsos, who plans to stick around at the struggling biotech for a “limited period of time” to smooth the CEO switch, Biogen said in a securities filing.

In transition and tumult, Seagen names former Novartis oncology chief Epstein as new CEO

Seven months after Seagen was rocked by the domestic abuse arrest of founder, chairman and CEO Clay Siegall and his subsequent resignation, the powerhouse Seattle biotech has found its new leader, appointing oncology veteran David Epstein as its CEO. Epstein, 59, spent more than 25 years at Novartis, building its oncology business from “initiation to the second largest in the world,” Seagen said in a release.

French CRO Excelya inks deal with Veeva for data platform

Excelya has brought on Veeva Systems’ suite of clinical trial management tools for data cleaning and reporting in clinical trials.

Alimentiv, Summit Clinical partner to improve research on NASH treatments

Alimentiv and Summit Clinical Research are joining forces to improve clinical trials for treatments being developed to address a chronic liver disease. 
 
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‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring.
 

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