Pharma News

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). This new MDV presentation was developed to help maximize efficiency for health care workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg. This product is to be launched in Q1 FY16-17.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte® of Hoffman-La Roche Inc.

Gilead Sciences, Inc. and Nimbus Therapeutics, LLC announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

Pfizer Inc. announced that the Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen. The SPIRE-AI trial is the second study completed of the six SPIRE Phase 3 lipid-lowering studies, and we expect it will be part of the potential regulatory filing for bococizumab.

A new study by an international team of scientists has revealed conditions under which a body produces more superoxidea dangerous form of oxygen with the capability to destruct DNA.

With Diabetes being the theme for World Health Day this year, health experts have said that only 10 percent of Indians were aware that diabetes in its later stages damages blood vessels of the eyes, heart, nerves, feet and kidneys.

The Supreme Court was told on Tuesday that one report of a test on Maggi noodles by the government research institute has shown that the lead content was within permissible limits but monosodium glutamate (MSG) was on the higher side.

An injectable drug widely used for the treatment of type 2 diabetes along with controlled diet and proper exercise plan is likely to lead to major health improvements, suggests a new research.