Citing what it calls a “significant” study design flaw underlying Astrazeneca plc’s sNDA for the PARP inhibitor Lynparza (olaparib) in a combination therapy for treating prostate cancer, the U.S. FDA has its doubts about expanding the drug’s label. The agency said it is concerned that efficacy and safety have not been demonstrated outside of a small population of patients with tumor BRCA mutations and that combining olaparib with abiraterone may harm patients who are definitively negative for tumor BRCA mutations. The U.S. FDA’s Oncologic Drugs Advisory Committee will be asked today if the indication should be restricted to only patients whose tumors have a BRCA mutation. The FDA is not obligated to follow the committee’s guidance but often does.

BMS’s heart drug, two biologics among latest EU approval recommendations

A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.

Vitalli Bio launches with $477M licensing deal with Daewoong for phase I-ready autoimmune disease candidate 

Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million. Under the agreement, Daewoong, of Seoul, South Korea, grants exclusive rights to Vitalli Bio, of Oakland, Calif., to develop and commercialize DWP-213388 globally, excluding certain Asian countries (including Korea). In exchange, Daewoong will receive more than $10 million in up-front commitments, and the deal is worth up to $477 million. Vitalli Bio also will be granted an option to license earlier-stage dual-target inhibitors being developed by Daewoong.

Interim phase I/II data look good with 4D’s gene therapy for wet AMD

4D Molecular Therapeutics Inc. unveiled positive interim data from the phase I dose-exploration stage (three doses, n=15) of the phase I/II study called Prism for wet age-related macular degeneration (AMD) with 4D-150. The compound, a one-shot genetic medicine that uses 4D’s customized R100 vector for intravitreal delivery to the retina, proved well-tolerated with all doses turning up clinical activity in AMD, including a reduction in anti-VEGF injection burden, stable or improved retinal edema and thickness, and stable visual acuity. Development continues in Prism, with phase II enrollment expected to finish in the third quarter of this year, when a phase II effort called Spectra in diabetic macular edema is expected to start as well. Shares of the Emeryville, Calif.-based firm (NASDAQ:FDMT) took a hit after the Prism data were disclosed at the Association for Research in Vision and Ophthalmology annual meeting April 27 in New Orleans, but showed some recovery and were trading midday at $17.12, up 63 cents.

In Zoonomia project, evolutionary lens hones search for functional genomic variants

A base-by-base comparison of the genome sequences of 240 species of mammals has pinpointed sites in the human genome where mutations are likely to cause disease.

The BioWorld Insider Podcast: Better times ahead for the biopharma sector? Could be, the new numbers say

It used to be a lot easier to find partners. After two years of strong dealmaking, the volume and value of partnerships slid in the first quarter of 2023. M&As also are down compared to prior years. But there are some reasons to be cheerful. Looking at first quarter numbers and surveying the big picture on this BioWorld Insider podcast are Karen Carey, BioWorld’s managing editor and senior data analyst, along with Tim Shannon, a general partner at Canaan. Carey just wrote about biopharma deals and completed M&As in the first quarter. Shannon, who’s been with Canaan since 2009, has a new fund sporting $850 million in new capital, including an oversubscribed $650 million fund for seed and series A financings. They both offer their insights into the first quarter’s numbers and what may lie ahead.

Also in the news

Adagene, Alligator, Alnylam, Amgen, Amicus, Amphera, Antiva, Avacta, Biocryst, Bionomics, Bristol Myers Squibb, Cel-Sci, Celularity, Cinrx, Clearside, Editas, Eli Lilly, Elicio, Galapagos, Gameto, Gensight, GSK, Hillstream, Ideaya, Intelgenx, Junshi, Maia, Minoryx, Navidea, Nestlé Health, Nexcella, Novartis, Ocugen, Opgen, Palatin, Provention, Regeneron, Roche, SAB, Sanofi, Seres, Skye, Sutro, Taiho, Takeda, Tavros, Tryp