Alnylam Pharmaceutical Inc. hopes to tap into Roche Holding AG’s global footprint with its early-stage hypertension RNAi therapeutic, zilebesiran, selling development and commercialization rights to the pharma giant for up to $2.8 billion with a view to extending the drug’s future reach beyond the U.S market. Read More
Unexpected cataract cases in top-line data from two of three phase III trials for eye diseases is leading Kodiak Sciences Inc. to quit work with tarcocimab tedromer, an antibody biopolymer conjugate also known as KSI-301. Read More
Fourth time’s a charm for Verrica Pharmaceuticals Inc. as the U.S. FDA has approved Ycanth (cantharidin) to treat molluscum contagiosum in those ages 2 and older. Three complete response letters (CRL) have stood in the treatment’s way for the past three years, blocking approval of the U.S.’s first approved treatment. Read More
The HIV journey is a roller coaster of highs and lows for the patients living with HIV and their families and loved ones but also for the community of researchers and clinicians who pour their hearts and souls into the work they do, said speakers at the International AIDS Society (IAS) 2023 conference in Brisbane, Australia. Read More
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Elucida Oncology, Promontory, Tonix, Triastek. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeon, Alvotech, Apogee, Erydel, Exelixis, Heron, Immunobiochem, Immunogen, Infinity, Mei, Priveterra, Qrons, Quince, Redhill, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Beigene, BMS, Daiichi Sankyo, Emergent Biosolutions, GC, Genentech, Hansoh, Ipsen, Janssen, Jazz, Menarini, Merck, Mirati, Pfizer, Scynexis, SN, Stemline. Read More
