Clinical Trials
16
15 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
15
93.8%
Completed
1
6.3%
No approval data available
- Halozyme Therapeutics has elected Dannielle Appelhans to its Board of Directors, bringing more than 20 years of executive leadership across biotechnology and pharmaceuticals. - Ms. Appelhans brings deep expertise in operations, manufacturing, and supply chain management, aligning with Halozyme's growth strategy for its ENHANZE, Hypercon, and Surf Bio platforms. - She currently serves as President and CEO of COUR Pharmaceuticals, where she executed a strategic collaboration with Genentech valued at up to $1 billion. - Her prior leadership includes roles at Novartis Gene Therapies, where she oversaw development, manufacturing, and supply chain for the approved therapy Zolgensma.
- The Small Business & Entrepreneurship Council (SBE Council) formally opposed CMS's proposed IPAY 2029 modification that would change how "qualifying single source drugs" are identified under Medicare Drug Price Negotiation. - The proposal would group separately FDA-approved medicines into a single product for negotiation, shortening the window for innovators to recoup investment and discouraging follow-on innovation. - SBE Council argues the change would make biotech startups less attractive to investors, citing data that emerging biopharma companies accounted for 46% of novel U.S. drug launches from 2020 to 2024. - The organization urges CMS to withdraw the modification, warning that expanded price controls would deter the investment needed for the next generation of medical breakthroughs.
- The UK Patents Court dismissed MSD's application seeking further experimental disclosure from Halozyme in a patent infringement case concerning modified human PH20 hyaluronidase enzymes, in a judgment handed down on 20 July 2026. - The dispute centers on whether MSD's subcutaneous Keytruda formulation, containing berahyaluronidase alfa, infringes Halozyme's European Patent EP(UK) 3 130 347. - Mr Justice Mellor applied a restrictive approach to the waiver of privilege, ruling that the scope must be assessed by reference to the specific experiment relied upon rather than the broader pleaded case. - The judge found MSD's inferences unsupported, confirming that Halozyme had conducted no experiments with alternative comparator polypeptides beyond the Creative Biomart reference enzyme.
