University of Houston associate professor of pharmacology Bradley McConnell is helping usher in a new age of cardiac pacemakers by using stem cells found in fat, converting them to heart cells, and reprogramming those to act as biologic pacemaker cells. He is reporting his work in the Journal of Molecular and Cellular Cardiology. The new biologic pacemaker-like cell will be useful as an alternative treatment for conduction system disorders, cardiac repair after a heart attack and to bridge the limitations of the electronic pacemaker.
Genentech, a member of the Roche Group announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq® (atezolizumab) to Cotellic ® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf.
Sun Pharma Advanced Research Company Ltd. (SPARC) announced that Abraxis Bioscience LLC. has dismissed the patent infringement complaint filed against SPARC regarding SPARC's New Drug Application for PICS (Paclitaxel Injection Concentrate for Suspension).
The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.
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.
Alembic Pharmaceuticals’s joint venture, Aleor Dermaceuticals Limited, has received US Food and Drug Administration (USFDA) Tentative Approval for Diclofenac Sodium Topical Solution USP, 2% w/w.
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.
Eminence Business Media’s “2nd Annual Pharma Manufacturing & Automation Convention 2019” concluded on October 17th & 18th, 2019 at Hotel Radisson Blu Plaza Banjara Hills, Hyderabad. The theme of the summit was “From Ideation to Innovation: Aligning with trending market demands”. The event was an outstanding success with 150+ delegates attending the conference with Honeywell, Zenith Technologies, Caliber Group, UL & Pharma Mantra partnering the event.
The Committee recommended granting a marketing authorisation for Isturisa* (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. It leads to patients experiencing weight gain, fat build-up on the face and bruising.
The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.