Sibeprenlimab

The FDA in 2025 is set to approve its lowest number of new drug and biologic applications since 2022, even as more than a dozen companies await the regulator’s decisions on their new molecular entities before the end of the year. The number of drug approvals isn’t always indicative of the quality of innovation or whether major strides are being made in hard-to-treat diseases. But it does provide an indication of R&D performance year-over-year. It’s also unclear whether losing thousands of FDA staff played a role in slowing down the approval process this year. The FDA has approved 42 new drugs and biologics so far this year, with about 16 decisions to go before 2026, according to an Endpoints News tally . In comparison, the regulator approved 69 new drugs and biologics in 2024, and 80 in 2023. But it was 2022 that had the fewest number of new approvals since 2020, with 51 new drugs and biologics approved. In 2020, the FDA approved 61 new drugs and biologics, and 63 in 2021. An FDA spokesperson told Endpoints News that “drug reviews and approvals are not affected by the Democrat-led shutdown and this work continues.” This year’s approval numbers likely won’t hit historic highs if applications continue to be delayed at the same rate as they have been recently . Back in July, FDA Commissioner Marty Makary told CNBC that the agency “could hit a record number of approvals” in 2025. The FDA spokesperson did not comment on whether that prediction still stands. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. At least 18 companies are still waiting for the FDA to decide whether to approve their new drug or biologic applications this year:

Pfizer CEO’s remarks on the PD-1xVEGF deal, Otsuka’s phase 3 IgAN win and the ongoing Entresto patent fight between Novartis and MSN made headlines this week. Pfizer's CEO discussed the extensive due diligence the company has conducted on the 3SBio PD-1xVEGF deal. Otsuka detailed its phase 3 data in the kidney disease immunoglobulin A nephropathy (IgAN). Novartis is pressing for a speedy ruling in its Entresto patent litigation against MSN Pharmaceuticals.1. Pfizer CEO talks Chinese due diligence, ADC synergies to justify $6B bet on 'fabulous' bispecificPfizer CEO Albert Bourla said the company was “very careful” with due diligence before signing the 3SBio PD-1xVEGF bispecific deal. “We didn't do due diligence in a data room. We sent people on-site. We feel very comfortable. I met the CEO. They are credible guys,” he said. Pfizer sees the med’s potential to displace PD-1/L1 checkpoint inhibitors and combine with its portfolio of antibody-drug conjugates.2. Otsuka's kidney disease drug halves UPCR levels in phase 3 studyOtsuka unveiled detailed data from a phase 3 win in the kidney disease IgAN. Patients who received the company’s sibeprenlimab, an APRIL blocker, reported a 51.2% reduction in proteinuria from baseline when compared to placebo. The effect was measured by patients’ urine protein-to-cretinine ratio levels. The drug has an FDA target action date for IgAN on Nov. 28.3. Novartis presses court for hasty decision in long-running Entresto patent feud with MSNNovartis is still trying to block the launch of MSN Pharmaceuticals’ proposed Entresto generic. In a patent case, the Swiss drugmaker is asking a federal court in Delaware to issue a final decision before July 15, when a pediatric exclusivity period is set to expire. The Indian company is currently barred from launching until July 16.4. GSK offloads shigella vaccine to Bharat ahead of phase 3, vows to support fundraisingGSK has licensed its shigella vaccine candidate, altSonflex1-2-3, to Bharat Biotech before the start of a phase 3 trial. GSK said it will help Bharat design the phase 3 study and support its partner’s search for external funding. The British pharma framed the deal as a way to get the shot to patients in low- and middle-income countries, where the bacteria is responsible for the deaths of tens of thousands of children from diarrhea.5. Growing Astellas looks to reap the rewards of uniting commercial strategy, medical affairs: execClaus Zieler recently picked up the medical affairs officer title in addition to his existing role of chief commercial officer at Astellas. He said the move to unite the two functions was “almost natural” so that a doctor or a medical team can interact with “one Astellas” when needing support or information. Healthcare professionals are engaging with several different digital channels, leaving drugmakers like Astellas to learn how to cater to each in a unique way.Other News of Note: 6. WuXi Biologics breaks ground on microbial production plant in China7. Samsung Biologics inks $75M CDMO deal with European pharma firm (Korea Biomedical Review)8. Samsung Bioepis taps NIPRO to commercialize multiple biosimilars in Japan (release)