TerSera Therapeutics has acquired US and Canadian rights to AstraZeneca's cancer drug Zoladex, or goserelin acetate implant, in a deal that will likely close by the end of March. AstraZeneca is entitled to receive an upfront payment of $250 million and sales-related milestone fees of up to $70 million, and the company plans to focus on advancing newer oncology medicines.
The FDA warned pet owners not to feed their pets certain Evanger's and Against the Grain dog foods because the agency is still investigating the companies after the euthanasia drug pentobarbital was found in unopened dog food cans and in the stomach contents of one dog that died after consuming the food. The FDA hasn't released an official summary of its ongoing investigation yet, but there is preliminary evidence of other manufacturing and food-sourcing violations.
Researchers in London have successfully treated leukemia in two babies in what they are touting as the world's first treatment of cancer using genetically engineered immune cells from donors. The doctors treated two British infants, 11 and 16 months old, using Cellectis' CAR T-cell product, UCART19, which is an allogeneic CAR T-cell product candidate for the treatment of chronic lymphocytic leukemia and acute lymphoblastic leukemia. London's Great Ormond Street Hospital experiments could be the first step to off-the-shelf cellular therapy using inexpensive supplies of universal cells. Read the story.
AstraZeneca's Lynparza, or olaparib, has met the primary endpoint of a late-stage study in which patients with HER2-negative metastatic breast cancer who have BRCA1 or BRCA2 mutations had significant improvement in progression-free survival, compared with chemotherapy. The company said it plans to work with regulators to make the drug available to this patient population.
Boehringer Ingelheim and Weill Cornell Medicine's Department of Genetic Medicine have entered into a three-year collaboration that aims to identify new treatment approaches that might stop or reverse the progression of chronic obstructive pulmonary disease. The partnership will combine the drugmaker's research and development expertise in respiratory disease treatments with the institution's knowledge of chronic airway diseases and experience researching new treatment approaches.
Gene editing is a promising tool for improving livestock because it alters existing DNA rather than introducing new genes, providing only beneficial genetic changes, says animal genetics and biotechnology expert Alison Van Eenennaam of the University of California at Davis. Van Eenennaam is using gene editing to produce hornless cows, and other geneticists are using the technology to create chickens that produce only female chicks and to improve disease resistance in livestock.
A proposed biofuel facility by NewGreen Technologies worth approximately $140 million has been approved by the provincial government of Newfoundland and Labrador in Canada. The site will use sawmill waste to produce green diesel.
The FDA has granted final approval to Perrigo's hydrocodone bitartrate and homatropine methylbromide oral solution to relieve cough symptoms in adults and children 6 years old and above. The drug will be available in 5 mg/1.5 mg per 5 mL dosage strength.
A late-stage study of Pfizer and Celltrion Healthcare's Inflectra -- a proposed biosimilar to Janssen Biotech's Remicade, or infliximab -- has demonstrated comparable safety and efficacy with the reference drug in patients with moderate to severe Crohn's disease. Evidence of the drug's longer-term safety and efficacy is expected later this year.
A fill-and-finish facility in McPherson, Kan., that is part of Pfizer's contract manufacturing business received a warning letter from the FDA for unspecified problems. The facility does fill and finish work for Glatopa, a generic version of Teva's multiple sclerosis drug Copaxone, which was co-developed by Sandoz and Momenta Pharmaceuticals, and approval of an abbreviated new drug application for a 40-mg dosage of the drug is dependent on the resolution of the issues, Momenta said.
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