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Lawmakers Aim to Curb Skyrocketing Generic Drug Prices

May 22, 2015 By MedNews Leave a Comment

Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay state Medicaid rebates when prices rise faster than inflation. [Read more…]

Filed Under: Drug Industry News

EMA Reviewing Pneumonia Risk With Inhaled Corticosteroids

May 22, 2015 By MedNews Leave a Comment

The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia. [Read more…]

Filed Under: Drug Industry News Tagged With: copd, corticosteroids, European Medicines Agency (EMA), pneumonia

FDA Approves Janssen’s Schizophrenia Injection Invega Trinza

May 22, 2015 By MedNews Leave a Comment

Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval Monday. [Read more…]

Filed Under: Drug Industry News Tagged With: Invega Trinza, Janssen Pharmaceuticals, schizophrenia

Two More Compounders Warned for Poor Sterile Drug Manufacturing

May 22, 2015 By MedNews Leave a Comment

Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. [Read more…]

Filed Under: Drug Industry News Tagged With: Drug Compounding

India Warns Drugmakers Again to Register in Online Database

May 22, 2015 By MedNews Leave a Comment

India’s drug price regulator is again warning drugmakers to immediately register in an online database or face fines and imprisonment. [Read more…]

Filed Under: Drug Industry News Tagged With: India

Supreme Court Denies Last Pending Request for Review in Reglan Preemption Case

May 22, 2015 By MedNews Leave a Comment

The U.S. Supreme Court has rejected the third and final request for review of a Pennsylvania state court ruling that would allow individuals to sue generics makers for failing to update warnings on drug labels. [Read more…]

Filed Under: Drug Industry News Tagged With: Generics, Reglan

FDA Amends Bristol-Myers Squibb’s Daklinza Breakthrough Therapy

May 22, 2015 By MedNews Leave a Comment

The FDA has revised Bristol-Myers Squibb’s breakthrough therapy designation for its daclatasvir/sofosbuvir combination hepatitis C therapy to cover patients with advanced cirrhosis or whose infection recurs after a liver transplant. [Read more…]

Filed Under: Drug Industry News Tagged With: Bristol-Myers Squibb, Cirrhosis, daclatasvir, Hepatitis C, sofosbuvir

J&J Settles Risperdal Suit With Arkansas for $7.75 Million

May 22, 2015 By MedNews Leave a Comment

The Arkansas attorney general agreed to a $7.75 million settlement with Johnson & Johnson over its marketing of the antipsychotic Risperdal, just over a year after the state’s top court reversed a $1.2 billion verdict. [Read more…]

Filed Under: Drug Industry News Tagged With: Johnson & Johnson, Risperdal

FDA to Release Four Draft Guidances on Biosimilars This Year

May 22, 2015 By MedNews Leave a Comment

The FDA is on track to release draft guidance on naming biosimilars this year, an FDA official said Wednesday. [Read more…]

Filed Under: Drug Industry News Tagged With: Biosimilars

Priority Review Voucher Program Takes Hit in Latest 21st Century Cures Draft

May 22, 2015 By MedNews Leave a Comment

The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program. [Read more…]

Filed Under: Drug Industry News Tagged With: 21st Century Cures Act

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