Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.” Read More
Legochem Biosciences Inc. signed a $1.7 billion licensing deal with Janssen Biotech Inc. for its Trop2-directed antibody-drug conjugate (ADC), closing the biggest technology transfer deal in Korean biotech history after Chong Kun Dang Pharmaceuticals Corp. Read More
Cytokinetics Inc. received a slightly last minute Christmas gift in the form of positive top-line data from the pivotal phase III study of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy. Read More
Lianbio Co. Ltd. is out-licensing NBTXR-3 to Janssen Pharmaceutical NV to develop and commercialize the radioenhancer in China, South Korea, Singapore and Thailand. Earlier this month, Tang Capital’s Concentra Biosciences LLC lodged a proposal to acquire Lianbio for $465 million, which the company’s shareholders rejected. Read More
As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation. Read More
The long, strange and nowhere-near-concluded trip taken by psychedelic drugs as a therapeutic modality continued in 2023, with regulators in the U.S. and Europe – and, perhaps in greater numbers, investors – warming to prospects in a space that once drew only laughter. Read More
The U.S. Federal Trade Commission (FTC) and the Department of Justice (DOJ) have issued the final version of their updated merger guidelines for corporations, concluding a process that took a scant six months to complete following the issuance of the draft. Read More
Drug guidances are still pouring forth from the U.S. FDA as 2023 winds to an end. The latest batch deals with issues as varied as the reformulation of drug products that use carbomers manufactured with benzene, potency assurance for cellular and gene therapies, the quality of topical eye treatments, and the development of drugs and biologics for rare diseases. Read More
The U.S. FDA issued a complete response letter for Zealand Pharma A/S’s NDA seeking approval of dasiglucagon for the prevention of treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism, citing deficiencies identified during an inspection at a third-party contract manufacturing facility. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, CSL, Galecto, Immunicum, Mineralys. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atreca, Biocytogen, Biovaxys, Ctm, Codexis, Eli Lilly, First Wave, Immunome, Innovent, Point Biopharma Theseus, Vyant. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cellusion, Cidara, Daiichi, Ionis, Kite, Olix, Sarepta, Senti, Takeda, Zealand. Read More
