India's Glenmark Pharma tapped Gilead Sciences oncology chief Alessandro Riva as CEO of its newly formed wholly owned U.S subsidiary that focuses on innovative medicines. The FDA has found repeated problems at Biocon's plant where it makes biosimilars with Mylan. Shionogi is paying $20 million upfront for rights in Japan and Taiwan to two video game-based digital therapeutics for ADHD and autism. And more.
Just days after Gilead welcomed its new CEO, former Roche executive Daniel O’Day, it said it would lose its EVP of oncology, Alessandro Riva, M.D., who only jumped from Novartis in 2017. Riva will become CEO of Glenmark Pharmaceuticals’ U.S.-based innovation spinoff. The new firm has three R&D centers, around 400 employees and eight assets, half of which are in oncology.
Biocon’s plant in Bangalore, India, where it makes Mylan-partnered biosimilars, was hit with an FDA Form 483. Problems the FDA found at the plant in 2017 delayed approvals of some of the partners’ products. This time, two observations again cited process deficiencies that could cause contamination of sterile drugs.
Shionogi is shelling out $20 million upfront and up to $105 million in milestone payments to exclusively market Aikili Interactive’s two digital medicines in Japan and Taiwan. Delivered through immersive video games, Akili’s lead treatment for children with ADHD is under review at the FDA, and its second potential therapy is under study for cognitive dysfunction in children with autism.
Pfizer is closing a legacy Hospira sterile injectables plant in Irungattukottai, India. But that didn’t stop the FDA from issuing it a warning letter. Last year, Pfizer stopped manufacturing and recalled products from the plant after the FDA found that employees had manipulated testing results. And the citation this time was largely in line with the 32-page Form 483 a year ago.
Following an FDA warning letter just four months ago, Lupin said it had received another letter for its Mandideep Unit 1 plant. An FDA Form 483 shows observations for both the API and finished-dose portions of the plant. The 11 problems in the API part include inadequate environmental monitoring, among others. And customer complaints are piling up for the finished-dose business.
Akebia Therapeutics’ anemia candidate vadadustat has yet to wrap up its global registrational studies, but results from two Japanese phase 3 trials bode well for the drug. Top-line data at 24 weeks showed that vadadustat matched up to Amgen’s Aranesp in both dialysis-dependent and dialysis-free patients in terms of mean hemoglobin levels. Mitsubishi Tanabe will use the data for a Japanese NDA this year.
Fujifilm is paying Biogen up to $890 million for the latter’s facilities in Denmark. The Hillerød site comes with 800 employees and includes a 90,000-L biologics production facility with assembly, labeling and packing capabilities, quality-control laboratories and warehouses.
Sun Pharma just debuted its first TV ad for psoriasis treatment Ilumya. Next-gen psoriasis biologics such as Novartis’ Cosentyx, Eli Lilly’s Taltz and Johnson & Johnson’s Tremfya all launched with big TV campaigns. The Ilumya ad touts its ability to prompt a quick response, saying “a majority of people were clear or almost clear” after two doses.
In a new deal, China’s HitGen will use its DNA-encoded small-molecule design to help Sun Pharma's Advanced Research arm screen for novel leads. HitGen’s capabilities have attracted deals with the likes of Biogen, Sanofi and Pfizer.
Novo Nordisk teamed up with Health2Sync to help promote the latter’s digital diabetes management app in Japan. The app tracks blood sugar trends and treatment effectiveness through an artificial intelligence engine, and it reminds users to adhere to their disease management plans.
The FDA has sent a warning letter to the Jubilant Life Sciences plant in Sikanderpur Bhainswal, India. The agency criticized the solid-dose plant for failing to thoroughly investigate customer complaints and failing to examine every batch of a product when one batch failed testing.
Charles River Labs is buying an exclusive license to Crown Bioscience’s ZDSD rat model and expects commercial distribution to begin by this summer. The model of metabolic disorders can more closely mimic human disease development.