Pharma News

AstraZeneca and MSD Inc., Kenilworth, N.J., US announced that the companies have received marketing authorisation from China’s National Medical Products Administration (NMPA) for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.

Safeguarding human health from climate change impacts is more urgent than ever, yet most countries are not acting fully on their own plans to achieve this, according to the first global snapshot of progress on climate change and health. The new report draws on data from 101countries surveyed by the World Health Organization (WHO) and reported in the 2018 WHO Health and Climate Change Survey Report.

This guidance provides FDA’s current thinking on drug master files (DMFs), which are  submissions to FDA that may be used to provide confidential, detailed information about  facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology  information, shared system REMS (risk evaluation and mitigation strategy).

The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.

There are three treatment options commonly used by doctors in the emergency room to treat patients with refractory status epilepticus, severe seizures that continue even after benzodiazepine medications, which are effective in controlling seizures in more than two-thirds of patients. New findings published in the New England Journal of Medicine reveal that the three drugs, levetiracetam, fosphenytoin, and valproate, are equally safe and effective in treating patients with this condition. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

The investigational therapeutics mAb114 and REGN-EB3 offer patients a greater chance of surviving Ebola virus disease (EVD) compared to the investigational treatment ZMapp, according to published results from a clinical trial conducted in the Democratic Republic of the Congo (DRC). The new report also shows that early diagnosis and treatment are associated with an increased likelihood of survival from EVD.

Sun Pharma along with its wholly owned subsidiaries is a defendant in a multi-district litigation brought by various classes of plaintiffs, in the US District Court (District of Massachusetts), alleging a delay in the market entry for three generic drugs which are Valganciclovir, Valsartan and Esomeprazole.