Pharma News

Using a medication prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and post-traumatic stress disorder during the first trimester of pregnancy may increase newborns' risk of heart defects, says a study.

Increased sugar levels in blood change the behaviour of blood vessels making them contract more strongly than normal which could result in higher blood pressure and increase the risk of heart attack complications, a study says.

A gene that is known to suppress the growth and spread of many types of cancer has the opposite effect in some forms of colorectal cancer, says a study led by an Indian-origin scientist.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, announced a broad strategic immuno-oncology collaboration.

The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

Hikma Pharmaceuticals PLC (“Hikma”) ,  the fast growing multinational pharmaceutical group, announces that its Abbreviated New Drug Application (“ANDA”) for Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration (“FDA”)  and that it has launched this product in the US market.

Teva Pharmaceutical Industries Ltd.  and Active Biotech  announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.

While genes may influence our likelihood of being overweight or obese, a new study has found that a physically active lifestyle can blunt the effects of inherited obesity genes.

Animal health products and knowledge services firm Elanco on Tuesday announced it had finalised its acquisition Novartis Animal Health India.

Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). Orphan drug status provides Addex with a number of benefits including reduced development costs and seven years US market exclusivity from launch. Dipraglurant is a novel small molecule inhibitor of the metabotropic glutamate receptor 5 (mGluR5) that has successfully completed Phase II proof-of-concept testing in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID), an indication that has no approved treatment options. Addex is currently conducting an mGlu5 receptor occupancy clinical trial and is preparing to start a Phase III pivotal trial in PD-LID.