The FDA granted accelerated approval for the small but significant HER2-mutated NSCLC indication, while the arbitrator in Seagen’s arbitration case ruled in Daiichi Sankyo’s favor.

Even as it prepares for competition from an authorized generic, Lupin expects a launch of its generic to Boehringer’s blockbuster Spiriva in the fourth quarter of FY23. It hopes the launch will help its position in the US, where it has exited low margin products amid heightened competition, leading in turn to manufacturing job losses in India

Strides’ biopharma arm Stelis Biopharma has moved closer to approval in the EU and likely the US too for a biosimilar to Eli Lilly’s Forteo in FY23, following GMP certification for its manufacturing units. Meanwhile, merchant bankers have been appointed to evaluate strategic options to raise cash for Stelis.

Myovant and partner Pfizer have expected a slow ramp for Myfembree in uterine fibroids and new indication endometriosis as they build awareness and grow the market for the GnRH antagonist class.

AstraZeneca and partner Daiichi Sankyo obtain the first approval for targeted therapy in HER2-low metastatic breast cancer for Enhertu, about four months ahead of the FDA action date.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Zoryve joins Dermavant's Vtama as a new topical drug with a broad label for plaque psoriasis and offers some points of differentiation, including price.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sales rose significantly for Reblozyl and for Abecma and Breyanzi, despite manufacturing challenges for the two cell therapies. Newly approved Opdualag and Camzyos are off to encouraging starts.

The major has won US priority review for a commercially crucial label expansion of its breast cancer drug Enhertu while Tezspire and Ultomiris attracted positive CHMP opinions across the Atlantic.

The company’s Quviviq launch has fallen short of early expectations, but Idorsia believes a patient approach will pay off for the blockbuster-tipped insomnia treatment.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.