One hepatitis delta virus player (HDV) has dropped out after Eiger Biopharmaceuticals Inc.’s phase III effort with peginterferon lambda turned up safety issues, while others remain busy in a space highlighted during last November’s meeting of the American Association for the Study of Liver Diseases. Shares of Palo Alto, Calif.-based Eiger (NASDAQ:EIGR) closed Sept. 13 at 41 cents, down 28 cents, or 40.6%, on word that the company is stopping the Limt-2 study in patients with chronic HDV. Read More

The question of third-party litigation funding has been front and center for life science companies in recent years, with one of the key considerations a lack of transparency as to the source of the funding behind much of this litigation. That lack of transparency was front and center in the Sept. 13 hearing in the U.S. House of Representatives, but the tenor of the hearing made clear that some members of Congress will stand in opposition to any reforms even though the lack of transparency is widely seen as enabling meritless litigation.

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To streamline the development of biosimilars and align it with current analytical science, regulators across the globe are reevaluating a routine requirement for comparative clinical efficacy studies for biosimilar candidates. Read More

The combination of new U.S. FDA phase II study guidance and a $175 million underwritten public offering sent gene therapy developer Rocket Pharmaceuticals Inc.’s stock soaring on Sept 13. Shares (NASADQ:RCKT) closed 38.8% upward to $21.23 each on Sept. 13. Read More

Hasten Biopharmaceutical Co. Ltd. has licensed greater China rights to Lib Therapeutics Inc.’s next-generation PCSK9 inhibitor lerodalcibep in a deal worth up to $325 million. Read More

The Samsung Life Science Fund made its fourth equity investment into a South Korean antibody-drug conjugate (ADC) developer, Aimedbio Inc., to round out its investment portfolio padded with three other firms, including Jaguar Gene Therapy LLC, Senda Biosciences Inc. and Araris Biotech AG. Read More

The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures. Read More

Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Read More

New hires and promotions in the biopharma industry, including: 4D Molecular, Hervolution, Hookipa, Jazz, Myricx, Neurotech, Northwest, Oviva, Protalix, Renagade, Sensorium, Triana, Uvax. Read More

Biopharmas raising money in public or private financings, including: Adlai Nortye, Brim, Crinetics, Dalcor, Mironid, Recce, Vaxess. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Acelyrin, Aerami, Aim, Algo, Altimmune, Anokion, Artiva, Arrowhead, Astrazeneca, Avalyn, Curevac, Day One, Dianthus, Foresee, GSK, Humacyte, Hutchmed, IO Biotech, Lisata, Lyra, Mindmed, Myeloid, Neurocrine, Nextcure, Nuvectis, Ose, Replicate, RS Oncology, Sorrento, Sparrow, Valbiotis, Vistagen. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aayam, Abcellera, Abl, Astellas, Axolotl Bavarian Nordic, Calidi, Carmell, Dignify, First Light, Incyte, Menarini, Scilex, Sorrento, Synaffix. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Arcutis, Biontech, Cygenica, Eikon, Gain, Hoth, Moderna, Pfizer. Read More