Barely a month after signing a €1 billion-plus deal with Menarini Group for cholesterol-lowering drug obicetrapib, Newamsterdam Pharma BV has struck a $235 million SPAC merger deal that will see the biotech list on Nasdaq in late 2022. The deal will finance phase III development and potential regulatory filings of the drug once dropped by Amgen Inc. as big pharma turned away from the cholesteryl ester transfer protein inhibitor drug class around five years ago. Read More
Eurekare SA, a technology commercialization and investment firm, has opened the doors to the first of a number of biotech “studios” it is setting up to hothouse synthetic biology and microbiome companies formed around intellectual property sourced from universities across Europe. It’s the most recent step forward in Eurekare’s ambition of creating a pan-European network for identifying, selecting and nurturing high quality European science in these two fields, which in the opinion of the firm’s founders, is at the same time of very high quality and seriously under-exploited. Read More
Increased payload capacity for gene therapies, off-the-shelf genome-engineered allogeneic cell therapies, reduced cost of goods and faster bioprocesses, are promised by “big DNA” specialist Replay Holdings LLC. The newco arrived with a $55 million seed round and having assembled a portfolio of technologies for writing and delivering large pieces of DNA. Read More
Ipsen SA’s $247 million buyout of Epizyme Inc., and the recent decision by Nordic Nanovector SA to dump its phase IIb program with CD-37-targeted Betalutin (177Lu lilotomab satetraxetan), served to highlight the hot space of relapsed/refractory follicular lymphoma, where bispecifics have been showing particular promise. Read More
The U.S. Department of Justice has been intensely focused on illicit billings to federal government agencies, so much so that the agency reclaimed more than $500 million in the first half of calendar year 2022 under the False Claims Act. However, 80% of that amount came from companies in the life sciences, a fact which combines with pending federal and state legislation to amplify the risk for these companies in the coming years, according to a new report by the law firm of Gibson Dunn & Crutcher, LLP. Read More
It was bound to happen someday. With more and more prescription drugs coming to the U.S. market, the FDA is running out of unique combinations for the 10-digit national drug code given to each product. Read More
Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU. Read More
Insider trading appears to be the U.S. SEC violation du jour. The agency filed insider trading charges against 10 individuals July 25, including a former FBI trainee and his friend who made about $82,000 and $1.3 million, respectively, from illegally trading ahead of the February 2021 announcement of Merck & Co. Inc.’s $1.85 billion tender offer to acquire Pandion Therapeutics Inc. Read More
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In this multipart special report, BioWorld explores the concept of extending lifespan, which is surprisingly well-validated by basic research. The team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing these potential “Fountain of Youth” candidate drugs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dice, Field Trip, I-Mab, Leo, Medicinova, Neuralis, Neuraptive, Tris, Vertex, Vistagen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ars, Liminal, Silverback, Sosei, Vericel. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Alnylam, Ascentage, Astellas, Aurinia, Bavarian Nordic, Bristol Myers Squibb, Genentech, Genfleet, Gilead, Janssen, Moderna, Rhythm, Roche, Seagen, Zelira. Read More
