The board of rare disease specialist Swedish Orphan Biovitrum AB has accepted a takeover bid from the U.S. private equity firm Advent International and Aurora Investment, an affiliate of capital markets group GIC, valuing it at about SEK69.4 billion (US$8 billion). Read More
Disc Medicine Inc. closed a $90 million series B round to move its two lead assets into clinical trials in patients next year. Bitopertin, an oral inhibitor of glycine transporter 1 (GlyT1), is entering a phase II trial in patients with erythropoietic porphyrias (EPPs), a set of rare genetic disorders caused by mutations that disrupt heme synthesis. Disc-0974, an antibody directed against hemojuvelin, will enter a phase II trial in myelofibrosis patients with transfusion-dependent anemia. The molecule, which Disc Medicine in-licensed from North Chicago-based Abbvie Inc., is currently undergoing a phase I trial in healthy volunteers. Read More
After seeing elevated alanine transaminase (ALT) levels consistent with drug-induced hepatotoxicity in its phase II study of ABI-H2158, Assembly Biosciences Inc. decided to discontinue development of the chronic hepatitis B virus (HBV) infection therapy. Read More
Swiss biotech Polyphor AG, left hindered by failures in advanced clinical programs it had pursued in breast cancer and bacterial pneumonia, has found a path forward in a planned merger with Enbiotix Inc. The combination would put Enbiotix Chairman and CEO Jeff Wager in charge of a publicly listed company advancing a combined portfolio of programs for rare disease and cancer, including Polyphor’s inhaled antibiotic, murepavadin, for infections in people with cystic fibrosis. Read More
In studies that give new insights into both developmental biology and the origins of melanoma, investigators at Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College have identified the activity of chromatin remodeling protein ATAD2 as necessary for cells with the oncogenic mutation V600E to give rise to melanomas. Read More
For the last few years, Hong Kong has been the preferred financial hub for many Chinese health care companies to go public and raise money from global investors. “Biotechnology is today the fastest-growing IPO market segment,” said Nicolas Aguzin, CEO of HKEX, during the Hong Kong Exchanges and Clearing Ltd. (HKEX) Biotech Summit 2021. Read More
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs. Read More
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17. Read More
Now that the U.S. judge overseeing Purdue Pharma LP’s bankruptcy proceedings has conditionally signed off on a $10 billion settlement intended to resolve 3,000 opioid lawsuits filed by states, tribes and local governments, the privately owned drugmaker can take the first steps to transform itself into a public service company owned mostly by the National Opioid Abatement Trust and governed by a new independent board. Read More
In a precedential opinion, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s conclusion that Belcher Pharmaceuticals LLC’s chief science officer engaged in inequitable conduct by withholding material information from the U.S. Patent and Trademark Office during prosecution of Belcher’s 9,283,197 patent. Read More
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices. Read More
New hires and promotions in the biopharma industry, including: Acadia, Avacta, Chemomab, Crinetics, Curative, Cyxone, Insilico, Lantern, Oncternal, Seelos, Sumitomo Dainippon, Zealand. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Autolus, Bavarian Nordic, Code, Exevir, Immutep, Lumen, Merck, Pfizer, Revance, Ridgeback, Rigel, Tevogen, Xeris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Bellicum, Biocorrx, Biocryst, Brickell, Eagle, Endo, Hansa, Scandion, Sesen, Stellate, Voronoi, Zentalis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Entos, Harbour, Innovative Cellular, Janssen, Junshi, Medincell, Merck, Neuren, Teva. Read More
