Product Development

Survey says: Companies seek regulatory flexibility as COVID-19 makes clinical disruptions the new norm

COVID-19 is no longer an approaching threat to clinical trials, now the concern for biotechs is how to manage their trials through the crisis. A joint survey from BioCentury and BIO finds on-the-fly protocol amendments...

COVID-19 roundup: Grifols partners with BARDA, FDA on convalescent plasma; plus Vir, Sorrento, Ascletis, BMS and Ipsen

On the heels of FDA guidance for compassionate use of convalescent plasma for COVID-19, Grifols announced on Wednesday a partnership with the U.S. government to develop the therapy. Meanwhile, Vir and Sorrento are advancing their...

Jefferies leading push to raise up to $1B for U.S. drug packaging surge capacity

Jefferies is leading an initiative to raise as much as $1 billion to support HHS’s newly launched public-private partnership to build U.S.-based manufacturing capacity to rapidly produce hundreds of millions of prefilled medical-grade syringes. HHS...

BIO summit outlines what industry needs for COVID-19 response

BIO's virtual summit on biotech's response to the COVID-19 pandemic generated a wish list of resources to support development of therapeutics, vaccines and diagnostics, with appeals to both government agencies and industry peers. The online...

CROs might be the engine that keeps preclinical research moving during COVID-19

Contrary to the situation for in-house preclinical research, preclinical CROs are largely open for business, according to a survey conducted by Science Exchange. The survey, conducted March 17-20, included CROs and academic laboratories that are...

Repurposing candidates for COVID-19 from UCSF, Aldeyra

A UCSF team has keyed in on more than five dozen compounds against nearly as many targets that could be repurposed to target the virus behind COVID-19. Meanwhile, a repurposing screen by Aldeyra could yield...

COVID-19 roundup: Emergency use of Moderna vaccine could come earlier than expected; plus ASCO goes virtual, Galapagos pauses filgotinib trials and more

The overarching news was negative for biopharma Tuesday, with a fresh round of companies announcing trial delays. But Moderna offered a rare ray of light, hinting that its vaccine could be available sooner than many...

Bruker, PerkinElmer begin marketing COVID-19 diagnostics; plus Nuclein speeds development of at-home test

New COVID-19 diagnostics were launched in Europe and the U.S. on Tuesday, while another company is speeding up development of an at-home PCR test. Bruker Corp. (NASDAQ:BRKR) launched in Europe a COVID-19 test from its...

Novavax’s flu data showcase vaccine platform’s potential

Pivotal data for Novavax’s flu vaccine provide validation of its recombinant nanoparticle vaccine platform as the biotech turns its technology towards developing a COVID-19 vaccine. Novavax Inc. (NASDAQ:NVAX) added $2.01 (19%) to $12.77 Tuesday. This...

Positive data for intrathecally delivered Zolgensma could broaden its patient population

The latest data on Novartis’ Zolgensma could help solidify and possibly expand the gene therapy’s position in the SMA market as the company prepares for a potential new entrant in the coming months. During a...

Biopharma execs highlight regulatory collaboration, call for increased manufacturing, data sharing

Executives at biopharmas developing vaccines and therapeutics to treat COVID-19 provided updates on clinical timelines, the positive impact of regulatory collaboration and the need to dramatically expand manufacturing capacity in order to respond more quickly...

March 23 COVID-19 roundup: Gilead looks to expand access to remdesivir, antiviral gains Orphan designation; plus N.Y.’s chloroquine trial, Celltrion and more

As Gilead begins shifting its individual compassionate use authorizations for COVID-19 candidate remdesivir to broader expanded access programs, the antiviral was granted Orphan Drug designation Monday. The day also saw several companies begin work on...

Milestone says trial design trips up etripamil in tachycardia Phase III

Milestone’s at-home paroxysmal supraventricular tachycardia candidate did not meet its primary endpoint in the Phase III NODE-301 study, but the company believes the miss was due to trial design and that the data support efficacy....

March 23 Quick Takes: Venclexta combo hits in AML; plus Jardiance rebuffed, Zolgensma approved in Japan and Zealand-Boehringer

Venclexta combo shows survival benefit in AML  Partners Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) said Venclexta venetoclax plus azacitidine significantly improved overall survival and composite complete remission rate among acute myelogenous leukemia (AML) patients...

Lilly trial slowdown could include Phase III GI candidate; Syncona among others acknowledging delays

Lilly’s decision to delay most clinical trial starts and suspend enrollment in most ongoing trials makes it the latest and largest biopharma to acknowledge a broad impact of the COVID-19 outbreak on its development plans...