Alzheimer’s experts have suggested that future research may involve combination therapies after yet another trial failure involving a drug targeting amyloid – in this case Roche Holding AG’s crenezumab. Originally discovered by Swiss biotech AC Immune SA, of Lausanne, crenezumab failed to slow or prevent cognitive decline in people with a certain mutation that causes early onset in a closely watched trial. Read More
Bioinvent International AB is banking an up-front payment of $25 million as part of an option and license agreement with Exelixis Inc., which aims to discover antibodies acting on new immuno-oncology targets. Further financial details were not disclosed, but the alliance entails the discovery of three novel targets and their associated antibodies, identified through Bioinvent’s F.I.R.S.T. screening platform and its n-Coder antibody library. Read More
In sharp contrast with its up and down rhythm of 2021, the BioWorld Infectious Disease Index (BIDI) is mostly down this year, having fallen 63.4% to date. The index ended last year up by 10.4%, which was its lowest point. In 2020, when the SARS-CoV-2 infection became a global focus, BIDI was up by 144%. Read More
Meta Pharmaceuticals Inc. has raised $15 million in seed and pre-series A rounds in six months for the pipeline and AI platform development. Shenzhen, China-based Meta Pharma plans to use the new funds to support its three candidates to enter clinical trials, as well as the development of its Meta-map platform for pipeline expansion. Read More
From 20 years of research on metabolic change as a result of salt intake, Karen Duggan discovered in 2003 that a naturally occurring molecule in the human body, native vasoactive intestinal peptide (VIP), was capable of reversing fibrosis caused by hypertension and other chronic diseases such as diabetes. From that discovery, Vectus Biosystems Ltd. was founded, and the company has developed a new class of mimetic drug candidates and a drug library based on VIP. Read More
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing. Read More
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles. Read More
In keeping with the 21st Century Cures Act, the U.S. FDA issued a draft guidance describing a standards recognition program for regenerative medicine therapies at the Center for Biologics Evaluation and Research that’s intended to facilitate the development of the therapies and reduce the regulatory burden. Read More
New hires and promotions in the biopharma industry, including: Aerami, Apnimed, Biolinerx, Clearmind, Deciphera, Glycoera, Insilico, Valo, Xilio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aceragen, Astrocyte, Attralus, Biogen, Clovis, Fusion, Halia, Immunic, Kymera, Pfizer, Recordati, Renibus, Scancell. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affini-T, Biogen, Coya, Eurocrine, Karyopharm, Lassen, Leo, Metagenomi, Neoimmunetech, Quoin, Redbiotec, Rxomeg, Scilex, Vipergen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Biontech, Covis, Horizon, Jazz, Kintara, Moderna, Omega, Pfizer, Phanes, Redx. Read More
