Pharma News

Aurobindo Pharma Limited a world-leading marketer and manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, announces the signing of a definitive agreement to acquire certain assets from Sandoz Inc., USA ("Sandoz"), a Novartis Division, comprising a market leading dermatology business and a portfolio of oral solid products along with commercial and manufacturing infrastructure in the US. The acquisition will be on debt free and cash free basis and will be made through its wholly owned subsidiary, Aurobindo Pharma USA Inc. Aurobindo and Sandoz will enter into a transitional services agreement to support the ongoing growth plans of the businesses being acquired by Aurobindo.

Pfizer Inc announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.

The U.S. Food and Drug Administration approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

The Union Health Ministry decide  for renaming the country's drug regulator CDSCO in line with its expanded roles. In a public notice issued on 6.9.2018, the Central Drugs Standard Control Organisation(CDSCO) said its name was given keeping its role when it was created, but the present nomenclature was not reflecting its roles and responsibilities.

Advancing better nutrition is one of my top priorities and implementing the update to the iconic Nutrition Facts label — the first overhaul in 20 years — is a key part of that commitment.

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The practice of compounding medicines can provide important public health opportunities. The FDA’s compounding program – including implementation of the compounding provisions of the law – is a priority for the agency.

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

Four new grants will help to move scientific discoveries and technologies out of the lab and into commercial products that improve patient care and enhance human health. Awards for Regional Technology Transfer Accelerator Hubs for Institutional Development Award (IDeA) states will total almost $2 million in the first year and potentially more than $13 million over three years, pending the availability of funds.

The countries of WHO’s Eastern Mediterranean Region signed a UHC2030 Global Compact during the “Ministerial meeting on the road towards universal health coverage” taking place in Salalah, Oman, from 3 to 5 September 2018. Ministers of health and heads of delegations collectively approved the landmark document, making the Region the first among WHO’s 6 regions to do so.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.