The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) was approved to be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval is, according to Jazz, the first combination therapy for first-line maintenance treatment for the indication and is based on the phase III Imforte study that demonstrated a reduced risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab alone. The approval arrived ahead of the sNDA’s Oct. 7 PDUFA date.

Evita’s new abortion pill generic wins nod

The U.S. FDA has approved a new generic version of the medical abortion pill mifepristone. In a letter Sept. 30, the agency green-lighted Evita Solutions LLC’s ANDA, declaring the 200-mg cortisol receptor blocker bioequivalent to Mifeprex, the drug from Danco Laboratories Inc., which was cleared by U.S. regulators in 2000. The drug was first given the go-ahead in France.

Nanyang Biologics looks to Nasdaq via $1.5B SPAC

Nanyang Biologics Pte. Ltd. has entered a $1.5 billion business combination agreement with RF Acquisition Corp II, a Nasdaq-listed special purpose acquisition company. Nanyang Biologics (NYB) is building a hybrid platform to revolutionize drug discovery by combining machine learning with natural compound libraries, and NYB claims it is developing one of the world’s largest AI-curated collections of bioactive compounds. “AI-driven drug discovery is breaking through barriers, reducing R&D time and costs while opening new opportunities for longevity,” said Roland Ong, NYB chairman and co-founder of the joint laboratory established at Nanyang Technological University in Singapore. Ong and Li Hoi Yeung, lead principal investigator of the joint lab, founded the lab together five years ago.

September biopharma financings jump 54% to $7.12B

Biopharma financings from January through September 2025 totaled $47.1 billion, a sharp decline from 2024’s $86.7 billion during the same period and well below the highs of 2020 and 2021. The slowdown was driven largely by weaker follow-on activity, which brought in $12.9 billion compared to more than $40 billion last year. IPOs fell to $2.1 billion, the lowest level in BioWorld’s records. By contrast, private financings and other public offerings are holding steadier, raising $14.4 billion and $17.7 billion, respectively. September financings totaled $7.12 billion, up 54% from $4.62 billion in August.

Don’t forget about type 1 diabetes; plenty of drug developers haven’t

Although type 2 diabetes tends to get more airtime, type 1 diabetes also had drawn a number of the developers to the table. Recently winning the attention of Wall Street is SAB Biotherapeutics Inc., which offered data during the European Association for the Study of Diabetes annual meeting. Vertex Pharmaceuticals Inc. and Biomea Fusion Inc. are among the other players.

Also in the news

Aavantgarde, Amgen, Aminex, Anavex, Artelo, Bolt, Calico, Cartography, Defence, Eg 427, Galapagos, Kalvista, Kazia, Nacuity, Nanobiotix, Nicox, Oncoc4, Prothena, Repairon, Silo, Taysha Gene Therapies, Vanda, Vanqua, Vector Science & Therapeutics