FDA – Pharmaceutical Consulting Jobs #pharmaceuticals #industry

Posted On Nov 17 2017 by

#pharma consulting jobs # Careers At The Weinberg Group, our people are our greatest asset and the key to our success. Our staff consists of skilled project managers with advanced degrees and experience in pharmacology, toxicology, epidemiology, biostatistics, chemistry, bioengineering, manufacturing and controls, compliance, law, and both global and FDA regulatory affairs. Our highly credentialed professionals offer regulatory, strategic, and technical consulting services to a broad range of commercial organizations and counsel. The Weinberg Group is expanding and is interested in hearing from qualified candidates interested in a career in pharmaceutical consulting and FDA regulatory affairs. Candidates must possess the …


Promius Pharma – Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, % #amylin #pharma

Posted On Nov 13 2017 by

#promius pharma # Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05% February 07, 2016 11:52 PM Eastern Standard Time HYDERABAD, India & PRINCETON, N.J.–( BUSINESS WIRE )–Dr. Reddy’s announced today that its US subsidiary, Promius Pharma TM. LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the …


K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug #catalent #pharma #solutions

Posted On Nov 9 2017 by

#kv pharma # K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug K-V Pharmaceutical Co.’s lawsuit alleging that the U.S. Food and Drug Administration’s actions led to “unlawful competition” involving its Makena drug was dismissed by a federal judge. U.S. District Judge Amy Berman Jackson in Washington today threw out the company’s claims that the FDA caused it “irreparable harm” by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women. “This case is fundamentally an effort to get the court to direct and oversee the FDA’s enforcement activities, …


You Can – t Duct Tape Quality: FDA Issues Consent Decree against Actavis Totowa #pharma #equipment

Posted On Nov 9 2017 by

#actavis pharma manufacturing # Pharma Manufacturing You Can t Duct Tape Quality: FDA Issues Consent Decree against Actavis Totowa Submitted by pharmamanufacturing on Fri, 01/09/2009 – 12:48 In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production. Actavis Totowa—a subsidiary of Iceland-based generics maker Actavis, Inc.—manufactures, packages, and distributes drugs from two sites in Totowa and one in Little Falls, N.J. FDA inspected Totowa’s Riverview Drive facility early in 2008 and found that the …


Promius Pharma – Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, % #bal #pharma

Posted On Sep 25 2017 by

#promius pharma # Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05% February 07, 2016 11:52 PM Eastern Standard Time HYDERABAD, India & PRINCETON, N.J.–( BUSINESS WIRE )–Dr. Reddy’s announced today that its US subsidiary, Promius Pharma TM. LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the …


FDA Adds Three Chinese Pharma Companies to Import Alert Lists #top #5 #pharmaceutical #companies

Posted On Sep 9 2017 by

#chinese pharmaceutical companies # Pharma Manufacturing FDA Adds Three Chinese Pharma Companies to Import Alert Lists More News: Join the discussion Free Subscriptions Most Popular Novartis’ Alcon Penalized $16M for Illegal Exports to Iran 2016 Contract Pharma Trends Ebook FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel Valeant Sued for Alleged Racketeering, Linked to Philidor Novo Nordisk CEO Steps Down 2016 Contract Pharma Trends Ebook Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen Work for this Biotech Startup, Get a Free Tesla Car FDA Warns China API Maker for Hiding Quality Testing Data Innovation …


FDA – Pharmaceutical Consulting Jobs #thompson #pharma

Posted On Sep 1 2017 by

#pharma consulting jobs # Careers At The Weinberg Group, our people are our greatest asset and the key to our success. Our staff consists of skilled project managers with advanced degrees and experience in pharmacology, toxicology, epidemiology, biostatistics, chemistry, bioengineering, manufacturing and controls, compliance, law, and both global and FDA regulatory affairs. Our highly credentialed professionals offer regulatory, strategic, and technical consulting services to a broad range of commercial organizations and counsel. The Weinberg Group is expanding and is interested in hearing from qualified candidates interested in a career in pharmaceutical consulting and FDA regulatory affairs. Candidates must possess the …


FDA Takes Action Against KV Pharmaceutical Company #novartis #pharma #ag

Posted On Aug 30 2017 by

#kv pharma # Media Inquiries:Rita Chappelle, 301-796-4672Consumer Inquiries:888-INFO-FDA FDA Takes Action Against KV Pharmaceutical CompanyCompany Making, Marketing and Distributing Adulterated and Unapproved Drugs The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current …


FDA Adds Three Chinese Pharma Companies to Import Alert Lists #choice #pharma

Posted On Aug 29 2017 by

#chinese pharmaceutical companies # Pharma Manufacturing FDA Adds Three Chinese Pharma Companies to Import Alert Lists More News: Join the discussion Free Subscriptions Most Popular Novartis’ Alcon Penalized $16M for Illegal Exports to Iran 2016 Contract Pharma Trends Ebook FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel Valeant Sued for Alleged Racketeering, Linked to Philidor Novo Nordisk CEO Steps Down 2016 Contract Pharma Trends Ebook Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen Work for this Biotech Startup, Get a Free Tesla Car FDA Warns China API Maker for Hiding Quality Testing Data Innovation …


Tris Pharma Receives FDA Approval of Dyanavel™ XR (amphetamine) CII as Once-Daily Liquid for #purdue #pharmaceuticals

Posted On Aug 25 2017 by

#tris pharma # Tris Pharma Receives FDA Approval of Dyanavel™ XR (amphetamine) CII as Once-Daily Liquid for Treatment of ADHD in Children MONMOUTH JUNCTION, N.J. Oct. 20, 2015 /PRNewswire/ — Tris Pharma, Inc. (“Tris”) announced that the U.S. Food and Drug Administration (“FDA”) has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children. The approval is based on a Phase III randomized, placebo-controlled, laboratory classroom efficacy …