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{ Category Archives: } Biotech (General)

DEA Removes CBD from Controlled Substances Act

On Monday, April 6, GW Pharmaceuticals revealed that the company had received notice from the U.S. Drug Enforcement Administration (“DEA”) stating that its drug Epidiolex was no longer subject to the requirements of the Controlled Substances Act (“CSA”). In a company release announcing the agency decision, GW CEO Justin Gover stated, “This notification from DEA fully establishes…

BrainStorm Awarded $1.5M Non-Dilutive Grant for 2020 by the Israel Innovation Authority

NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant…

Marketing COVID-19 is bad news for new drug launches. Which will suffer most?

The COVID-19 pandemic and the ensuing societal countermeasures are upending operations in many sectors—and biopharma isn’t immune. The current lockdown is not only hurting clinical trial enrollment but also delaying regulatory timelines for drugs nearing a decision. And with tried-and-true, in-person marketing techniques no longer allowed, new launches may also feel the pain—or hold off altogether. Consider Bristol…

Amgen teams up with Adaptive to both treat and prevent COVID-19

After The Wall Street Journal first broke the news this week, Amgen and new partner Adaptive Biotechnologies have confirmed they are the latest pharma-biotech duo joining forces against the pandemic. The pair, which said it will “start work immediately,” will develop fully human neutralizing antibodies targeting the COVID-19-causing virus, SARS-CoV-2, to potentially prevent or treat…

IL-6 to the rescue? Sanofi, Regeneron barrel ahead into another pivotal effort testing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and…

Novartis, life sciences firms collaborate with BMGF to fight against COVID-19 disease

Novartis and a consortium of life sciences companies have collaborated with Bill & Melinda Gates Foundation (BMGF) to advance the development, manufacture and delivery of vaccines, diagnostics and treatments for COVID-19, the disease resulted due to the novel coronavirus SARS-CoV-2. Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Pfizer,…

COVID-19 prompts Pfizer to stop enrollment in most studies

Pfizer has paused enrollment in many new and ongoing clinical trials in response to the COVID-19 pandemic, Reuters reports. The action sees Pfizer join Bristol Myers Squibb and Eli Lilly on the list of Big Pharma companies to revise their R&D plans in light of the novel SARS-CoV-2 coronavirus. Each company has responded slightly differently to…

FDA authorizes CPAP machines and more as emergency ventilator alternatives

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic. This includes modified anesthesia gas hardware and positive-pressure breathing devices as well as home continuous positive airway pressure machines used to treat sleep apnea, portable oxygen generators…

Gilead halts emergency access to COVID-19 contender remdesivir amid ‘overwhelming demand’

Since the early days of the current coronavirus outbreak, Gilead Sciences’ experimental antiviral drug remdesivir has been hailed as a leading hope. That halo has apparently overwhelmed the Big Biotech. Gilead has temporarily stopped granting patients emergency access to remdesivir under compassionate use due to an “exponential increase” in requests over the last few days,…

UPDATED: Biogen staffer fled to China in search of emergency Covid-19 testing, care — and now faces criminal charges

A Biogen employee who has contracted Covid-19 in Massachusetts fled to Beijing alongside her family. And now she faces criminal charges for lying about her condition on the way back. The company confirmed to Endpoints News that the woman, identified by Chinese officials as Ms. Li, works for the company but said she didn’t attend the strategy…