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Federal judge enters consent decree against Downing Labs

RegulatorFDA2016-01-12 09:02 Read   185

On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.

The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

RegulatorFDA2016-01-07 13:21 Read   166

The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States.

US Marshals seize dietary supplements containing kratom

RegulatorFDA2016-01-07 10:30 Read   186

The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation

RegulatorStephen M. Ostroff, M.D.2016-01-04 09:59 Read   164

As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner.

Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma

RegulatorBristol-Myers Squibb2015-11-29 22:41 Read   455

Bristol-Myers Squibb Company today announced that the U.S. FDA has issued a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

Novartis biosimilar takes aim at Amgen drug Neulasta

RegulatorReuters2015-11-18 16:02 Read   337

FDA has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights infections in cancer patients, the Swiss group said on Wednesday.

Celltrion Submits Second Biosimilar for Approval to European Regulator

RegulatorBusiness Korea2015-11-18 15:12 Read   413

South Korean biopharmaceutical firm Celltrion announced that it filed a request for European Medicines Agency (EMA) approval of CT-P10 on Nov. 10 (local time)

FDA Advisory Committee recommends the approval of lesinurad for gout patients

RegulatorPipelinereview2015-10-26 14:37 Read   363

October 23, 2015 I AstraZeneca today announced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout.

Global strategic partners bioeq and Formycon initiate pivotal phase III clinical trial with their Lucentis® biosimilar

RegulatorPharmacodia.com2015-10-13 00:00 Read   341

October 7, 2015, Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, today announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis).

KEYTRUDA® (pembrolizumab) Receives New Draft Recommendation from National Institute for Health and Care Excellence (NICE) in U.K. for First-Line Treatment for Advanced Melanoma

RegulatorPharmacodia.com2015-10-12 00:00 Read   369

Merck, known as MSD outside the United States and Canada, announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a draft recommendation, in the form of a Final Appraisal Determination (FAD), recommending KEYTRUDA (pembrolizumab) as a first-line treatment option for adults with advanced melanoma.

Indian court blocks generic of Merck's Januvia

RegulatorPharmacodia.com2015-10-09 00:00 Read   290

India's Supreme Court has prevented Glenmark Pharmaceuticals from making and selling a generic of Merck & Co's diabetes blockbuster Januvia.

FDA awards 18 grants to stimulate product development for rare diseases

RegulatorPharmacodia.com2015-09-22 00:00 Read   342

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.