Strategy
CEO Matt Gline talked to Scrip about preparing for the launch of brepocitinib in dermatomyositis, lessons learned from Vtama, and how smaller biopharmas are delivering launch successes.
The Phase III study’s principal investigator said that if Xpovio doesn’t win approval, NCCN Guidelines could enable off-label use, as has occurred with BMS’s Reblozyl.
Deal snapshot: Preparing for submission and potential approval and launch of its Phase III sleep apnea drug, Apnimed is divesting its half of Shionogi-Apnimed Sleep Science for $100m.
Activist investor and board chair Peter Tang takes on CEO role at Aurinia, while the COO, CMO and CFO also were replaced.
Pfizer, which licensed the candidate from Valneva, said the vaccine demonstrated clinically meaningful efficacy for preventing Lyme disease, even though the study failed to accrue enough cases.
The company announced positive Phase III data and plans to file an sNDA for Arikayce in newly diagnosed patients with MAC lung disease, a potential blockbuster indication.
More than a dozen semaglutide generics hit the Indian market at sharp discounts post LOE for Novo Nordisk’s GLP-1 RA molecule setting the stage for a high-octane battle in the diabetes and obesity segment. Can Novo hold steady amid the avalanche and what are KOLs looking for?
Scrip spoke with Debiopharm’s Luke Piggott about the Swiss biotech’s interest in synthetic lethality and strategy around development and partnering.
The German biotech hopes to start Phase IIb trials soon of the oral complement C5a inhibitor in the extremely competitive hidradenitis suppurativa market.
Natco has announced a 90% difference in the price of its semaglutide generic in multi-dose vials versus originator Novo Nordisk’s Ozempic pen ahead of launch tomorrow as Novo’s patents on the product expire today. Its pen will be 70% cheaper.
For $650m up front, Collegium will pair Azstarys, which provides both immediate and extended onset of action, with Jornay PM, its ADHD drug indicated for bedtime dosing.
The company announced the first Phase III data testing the GIP/GLP-1/glucagon agonist in diabetic patients, showing reductions in blood sugar and superior weight loss to Mounjaro.
Phase II results evaluating the anti-TSLP drug bosakitug are expected in the fourth quarter. Aclaris is pitching the asset as having best-in-class potential in a currently open field.
The guidelines give specific guidance about LDL cholesterol goals, recommending Esperion’s bempedoic acid and PCSK9 inhibitors from Amgen and Regeneron on top of statins in many cases, but evidence review concluded before Repatha’s primary prevention data.
The company licensed worldwide rights to the IBAT inhibitor from GSK just days ahead of the drug’s US FDA approval for cholestatic pruritus associated with primary biliary cholangitis.
Since being taken private by B-FLEXION, Paratek has been building out its commercial portfolio and Radius’s osteoporosis drug Tymlos will advance that strategy.
After creating a new biosimilars unit, Sandoz is now divesting its generics portfolio in Sub-Saharan Africa to the Strides Pharma group. Strides will acquire or license these brands for an initial $12m plus royalty, placing it among the top five firms in the region
Multinationals showed up with open arms for partnering with Chinese developers at the recent BIOCHINA meeting, but there were signs approaches are changing and firms are now looking beyond straight licensing.
The company received a complete response letter from the US FDA for reproxalap for dry eye disease for the third time.
