Policy & Regulation News

Fifth approval for Opdivo in 12 months.

Naloxone in nasal spray form provides important new alternative for family members, first responders.

Pending EC approval, Biogen would commercialize Benepali in the EU.

Civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

If approved, avelumab could potentially become the first immunotherapy to treat metastatic MCC.

The projected FDA action date is 16 March 2016.

One of fastest development programs - from start of clinical trials to approval in just over two and a half years to meet unmet patient need.

FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma.

Warning letter relates to the company’s API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, and Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.

The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers — Compliance Policy.

If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype.

Epigenomics adjusts 2015 outlook after FDA response letter.

Describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.

Eyela already approved in the EU for neovasular (wet) age-related macular degeneration.

Utibron Neohaler (formerly QVA149;indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to place...

Cosentyx demonstrated rapid onset of action and long-term sustainability in patients with and without prior treatment using anti-tumour-necrosis-factor (anti-TNF) therapy.

Third generic product approved since the resolution of the warning letter at the Hayward facility.

Company plans to refile lifitegrast submission in the first quarter of 2016.

Topline results from OPUS-3 Trial expected before year-end.

NICE recommends Daklinza (daclatasvir) for use in some patients with the most difficult-to-treat type of chronic hepatitis C.

Three applications are under review for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1.

The company is preparing for commercialization of this product through Impax's generic division.

MHRA signs Memorandum of Understanding with its counterpart body in India.

Sandoz is seeking approval for all indications included in the reference product's label.

The FTC filed its amicus brief in a private antitrust action in which Mylan Phamraceuticals Inc. alleges that Warner Chilcott PLC/Mayne Pharma Group maintained a monopoly in the market for its antibiotic Doryx by suppressing generic competition through...

First New Drug Application for a GLP-1 receptor agonist to include CV outcomes data.

Pending final FDA approval, Basaglar can be launched in the US beginning on 15 December 2016.

Allergan is the first company to receive FDA approval for and launch a generic version of Janssen's Invega.

Lonsurf represents the first FDA-approved product for Taiho Oncology, setting the stage for the company’s oncology pipeline.

Decision by Swiss Health Authority follows FDA approval of Entresto in July, and serves as an important reference approval for multiple other health authorities.

Vraylar is an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

Allergan's ANDA product is a generic version of Impax Laboratories' Rytary.

First generic product approved from Hayward manufacturing facility following recent resolution of Warning Letter