Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic. Read More
It’s all hands on deck as government agencies, researchers, startups, biopharma giants, health care workers and payers combine their resources to develop proven COVID-19 therapies that can be ready for market by fall when the pandemic is expected to pick up steam again in the U.S. and other northern reaches of the world. Read More
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible. Read More
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted. Read More
Positive top-line results from the first of two pivotal phase III studies of daridorexant, a dual orexin receptor antagonist (DORA) for treating insomnia from Idorsia Ltd., of Allschwil, Switzerland, showed significantly improved sleep onset, sleep maintenance and improved subjective total sleep time in 930 adult and elderly patients. Read More
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma. Read More
DUBLIN – Genespire Srl, a Milan-based startup led by gene therapy pioneer Luigi Naldini, is the third company to receive funding from Sofinnova Partners’ Italian €108 million (US$117.5 million) gene therapy fund, the Sofinnova Telethon Fund. Read More
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ascendis, BMS, Idorsia, Incyte, Karyopharm, Novartis, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Futura, Genentech, Mustang, Precigen. Read More
