The combination of Padcev and Keytruda delivered a phase 3 win in muscle-invasive bladder cancer. China did not renew the conditional approval for a controversial Alzheimer's disease drug. Fosun Pharma is out-licensing its DPP1 inhibitor for up to $645 million. And more.
1. Pfizer and Astellas' Padcev, plus Keytruda, delivers 'breakthrough' win in new bladder cancer use
After making waves in first-line metastatic bladder cancer, the combination of Pfizer and Astellas’ Padcev and Merck & Co.’s Keytruda has shown it can extend lives when used as a perioperative treatment around surgery for patients with cisplatin-ineligible muscle-invasive bladder cancer, according to a readout from the phase 3 EV-303 study, which is also known as Keynote-905.
2. China did not renew approval of controversial Alzheimer's drug, regulator's records show
China’s drug regulator did not renew the conditional nod for Green Valley Pharmaceuticals’ controversial Alzheimer’s disease med sodium oligomannate (GV-971), according to public records. The move followed a protracted review that stretched past the expiration date of the drug’s existing licensure, triggering a production and marketing halt in May.
3. Expedition inks $645M pact to pocket Fosun's lung disease asset in knapsack
Inflammatory disease startup Expedition Therapeutics is paying $17 million upfront, plus up to $628 million in potential milestones, for ex-China rights to Fosun Pharma’s DPP1 inhibitor XH-S004. The deal was inked right before the FDA approved Insmed’s brensocatib as the first DPP1 inhibitor. The approved indication for Insmed's therapy is non-cystic fibrosis bronchiectasis.
4. Aurobindo acquires US drugmaker Lannett for $250M to bolster 'reshoring' effort
Aurobindo is paying $250 million to buy Lannett, which is known for manufacturing attention-deficit/hyperactivity disorder medicines and generic liquids. “The acquisition strengthens Aurobindo’s ability to serve the U.S. generics space and provides strategic diversification into a specialized, high-value therapeutic category,” the Indian company said in an announcement.
5. HLB taps new Elevar CEO amid liver cancer setbacks, new FDA push (Korea Biomedical Review)
Korea’s HLB has tapped Byan Kim as CEO of Elevar Therapeutics. Kim will continue as co-CEO of HLB Innovation and CEO of another HLB subsidiary, Verismo Therapeutics. The move comes after Elevar and Jiangsu Hengrui Pharmaceuticals’ PD-1/VEGFR combination suffered repeated FDA setbacks in liver cancer and as Elevar prepares to file an approval for lirafugratinib in FGFR2-altered cholangiocarcinoma.
Other News of Note:
6. RemeGen's telitacicept meets the mark in ph. 3 Sjögren's study in China
7. Indian API maker Garonit Pharma plans $46.1M antiseptic product plant in New York
8. Shilpa wins India approval for world's first NAFLD med, company says (Regulatory tracker)