Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision. For the biopharma sector, the impact of COVID-19 was wide-ranging, in many cases showing the industry at its best, with the speedy mobilization of scientific efforts that spawned vaccine approvals at record rates and a host of therapeutics making their way through development. But biopharma suffered COVID-19-related setbacks as well, from a negative impact on clinical trials to the increasing politicization of science that could make the industry’s job harder as the world moves hopefully to end the pandemic in 2021. In looking back over the past year, BioWorld has compiled the biggest trends and lessons from the year of COVID-19. Read More
It might be difficult to view the past year through anything other than a COVID-shaped hole. But 2020 brought some remarkable and impactful news for the biopharma sector that had little to do with the novel coronavirus. In this end-of-year recap, BioWorld takes a look at some of achievements and trends affecting the industry that were completely unrelated to – or, in some cases, in spite of – the COVID-19 pandemic. Read More
Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions. Read More
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report. Read More
DUBLIN – A re-evaluation of psychedelic drugs as potential therapies for major depressive disorder, anxiety, post-traumatic stress disorder and other neuropsychiatric conditions has been underway for some time, but this broad effort gained further momentum during 2020, as commercial firms started to raise money at the level needed to enable the field to start moving from small-scale academic studies to the kind of industry-scale trials that will be needed to convince regulators, patients and physicians that these molecules could become viable treatment options. Read More
A new rule intended to give drug manufacturers the flexibility they need to enter into value-based purchasing agreements with state Medicaid programs and commercial payers could end up hurting patients at the pharmacy counter in the U.S. Read More
Biopharmas raising money in public or private financings, including: Enveric, Ensysce, Helix, Hemostemix, Histogen, Immvira, Innocan, Neonmind. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Direct Biologics, Lexicon, Netris, Redhill. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clene, Generex, Global Cancer Technology, Hoth, Moderna, Nugenerex, Tergus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Immunicum. Read More
