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Home » Newsletters » BioWorld

BioWorld

July 19, 2023

View Archived Issues
Road and barrier

IRA: An open road for US biosimilars? Or another barrier?

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

Argenx ADS to balance sheet with whopper $1.1B raise

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
Merger-game-pieces.png

US federal agencies propose to limit mergers that would create ‘a clog on competition’

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
Lisa Park, CEO, Prestige Biopharma

Prestige Biopharma aims to become leading cancer drug developer

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
Woman using eyedrops

Santen sells North American ophthalmic portfolio to Visiox, Harrow

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

Appointments and advancements for July 19, 2023

New hires and promotions in the biopharma industry, including: Accession, Akari, Amarin, Carmot, Cour, Coya, IO Biotech, Jnana, Secretome, Velia. Read More

Conference data for July 19, 2023: AAIC

New and updated clinical data presented by biopharma firms at the Alzheimer's Association International Conference, including: Eli Lilly. Read More

Financings for July 19, 2023

Biopharmas raising money in public or private financings, including: Acumen, Apogee, Biophytis, First Wave, Genprex, Harrow, Kayothera. Read More

In the clinic for July 19, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Antengene, Aptevo, Calidi, Camurus, Corcept, ENB, Engrail, Grifols, Irlab, Janssen, Mineralys, Neumora, Ocuterra, Revolo, Xylocor. Read More

Other news to note for July 19, 2023

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 actions for July 19, 2023

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

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