Industry News

Epidemics don’t occur overnight. U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

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.

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.

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.

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.

Reflecting its uncompromising commitment to patient safety, Alcon  announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market.

Adverum Biotechnologies, Inc a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).