Acceleron Pharma's midstage ACE-083 was granted orphan drug designation by the FDA. The drug is being developed as a treatment for patients with facioscapulohumeral muscular dystrophy.
GlaxoSmithKline's tafenoquine tablets received a positive opinion from the FDA's Antimicrobial Drugs Advisory Committee, thus recommending tafenoquine for approval. The drug was developed as a radical cure and preventive medication for relapse of malaria caused by Plasmodium vivax.
A supplemental new drug application was filed with the FDA by AbbVie for Venclexta, or venetoclax tablets, in combination with low-dose cytarabine or a hypomethylating agent as a treatment for patients newly diagnosed with acute myeloid leukemia, who cannot receive intensive chemotherapy. The drug was previously approved for patients with small lymphocytic lymphoma or chronic lymphocytic leukemia.
Abbott has obtained approval from the FDA for the third generation of its MitraClip system for use in transcatheter-based mitral valve repair. The new generation of the system, which includes the MitraClip NTR device and the MitraClip XTR device, facilitates use of the clip in difficult anatomies by providing navigation, steering and positioning capabilities.
The FDA found that Kellogg's Honey Smacks cereal, which was recalled last month from more than 30 states because it was linked to a salmonella outbreak that sickened over 60 individuals, is still being sold at retail outlets. The agency warned consumers not to buy the cereal and will follow up with retailers to prevent further sales.
The National Institute for Health and Care Excellence recommended against the use of Janssen's Darzalex, or daratumumab, plus bortezomib and dexamethasone as a second-line treatment in adult patients with previously treated multiple myeloma. The cost regulator ruled that the long-term benefit of the combo drug is unclear.
Esther Wojcicki raised her three daughters -- YouTube CEO Susan, 23andMe founder Anne and medical anthropologist Janet -- on the campus of Stanford University, where her husband worked as a physicist. Wojcicki, herself an internationally known education expert, promoted independence and critical thinking skills in her daughters, encouraged them to explore subjects that excited them and taught them to be self-sufficient and happy and to be positive forces in the world.
In her new role as senior vice president of science and business development at the North Carolina Biotech Center, Mary Beth Thomas will be in charge of emerging-company development, science and technology development and IT and life science intelligence programs. "Mary Beth's experience with industry and academia, along with the role she has created and driven in the sector development space, have well prepared her to take on new challenges and pursue the many opportunities in the ever-changing life science field," says CEO Doug Edgeton.
Gilead is filling out its management team ahead of its upcoming push into the CAR T cancer treatment market. The company tapped Michael Amoroso to serve as senior vice president of its Kite unit, and he will report directly to Gilead CEO John Milligan and act as head of global commercial cell therapy efforts.
Several changes to protocols have been reported by Celgene with regard to its midstage trial to test the efficacy of its chimeric antigen receptor T-cell therapy bb2121 to treat patients with relapsed or refractory multiple myeloma. Amended protocols include raising the dosage to be administered and increasing the number of participants to 140.
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