Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription drug price negotiation mandate withstands numerous constitutional challenges. Read More
The picture keeps getting brighter for Argenx SE which, having targeted $750 million in a financing after positive phase II data, priced a global public offering of $1.1 billion, one of history’s larger rounds. Amsterdam-based Argenx capitalized on positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy. Read More
The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago. Read More
Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization. Read More
Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld. Read More
New hires and promotions in the biopharma industry, including: Accession, Akari, Amarin, Carmot, Cour, Coya, IO Biotech, Jnana, Secretome, Velia. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Biocryst, Biophytis, Catalyst, Er-Kim, Harrow, Novaliq, Panbella, Santhera, Sqens, Riparin, Synaptogenix, US Worldmeds. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Aridis, Astrazeneca, Biocorrx, Karyopharm, Sanofi. Read More
