SUMMARY: The Food and Drug Administration is proposing a regulation to designate official names and proper names for certain biological products. Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is...
WASHINGTON, Aug. 28 The Department of Health& Human Services published the following proposed rule in the Federal Register from the Food& Drug Administration:. A Proposed Rule by the Food and Drug Administration on 08/28/2015. Agencies: Department of Health and Human Services.
Deal Type: Asset Transaction Deal Country: United States of America Deal Status: Announced Deal Value: 0.0000 USD. Alvogen, Inc., a generic pharmaceutical company, has agreed to acquire a portfolio of four pharmaceutical products from Pfizer Inc., a pharmaceutical company. The portfolio includes four products that are being divested by Pfizer as a
ALEXANDRIA, Va., Aug. 27, 2015/ PRNewswire-USNewswire/ The Academy of Managed Care Pharmacy is disappointed in the Food and Drug Administration's draft guidance and proposed rule that calls for biologics, including reference products and biosimilars, to bear a nonproprietary name with an FDA- designated suffix. For several years, AMCP has been se
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of
Unique perspectives will be provided on: The impact of Biosimilars and Orphan Drugs on the the market with case studies from MSD and Quintiles Tiered pricing options with a case study from GSK Case studies in Reforms with Sanofi sharing their recent experience New models for European reimbursement Health Technology Assessment policies Changes in UK
Reddy s Laboratories today announced the following senior level changes in their global management structure. Umang Vohra is moving out of the organization and has consequently stepped down from the position of Executive Vice President& Head North America Generics. Reddy s Laboratories Ltd. is an integrated pharmaceutical company, committed t
For decades, they have not faced generic competition because the FDA lacked a system to approve cheaper versions until 2012. Earlier this year the agency approved the first so-called "biosimilar." Next week, Novartis is scheduled to launch its biosimilar version of Neupogen, a blockbuster Amgen drug used to boost blood cells in certain cancer patie
But representatives for the generic drug industry warned that the FDA's proposal could curb those savings by making the drugs more difficult to prescribe. For decades, they have not faced generic competition because the FDA lacked a system to approve cheaper versions until 2012. Earlier this year the agency approved the first "biosimilar."
WASHINGTON, Aug. 27 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to
Biopharmaceuticals are medicinal drugs which are produced through biotechnology methods such as recombinant DNA techniques, fermentation, hybridoma techniques, and purification processes. However, high costs of biopharmaceuticals, entry of low-cost biosimilars, and risk of side-effects posed by biopharmaceuticals act as restraints for the...
The following discussion and analysis describes material changes in the financial condition and results of operations, as well as liquidity and capital resources of Lannett Company, Inc.. Company Overview Lannett Company, Inc. and subsidiaries develop, manufacture, package, market, and distribute solid oral, extended release, topical, nasal, and or
SMi's 6th annual Biosimilars and Biobetters conference will provide the ideal platform to engage in scientific discussions and debate the best practices and solutions to improve industry performance through technical case studies and practical advice from leading biosimilar and regulatory players from organisations including Harvest Moon...
-Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd., announced Health Canada's approval of its application for the generic version of Pr Vesicare for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urinary urgency and urinary frequency. Teva Canada is the sole generic supplier of th
NEW YORK CITY- Privately-held pharmaceutical company Alvogen said Wednesday that it has agreed to acquire from Pfizer Inc. a portfolio of four pharmaceutical products in the U.S., noting that the acquisition will further diversify and strengthen its commercial platform in the U.S. market. The company has commercial operations in 35 countries with 2
These changes will allow Australian pharmaceutical manufacturers to apply to the Federal Court of Australia for a compulsory licence to manufacture generic versions of patented medicines to supply to developing countries in need. Another legislative change will extend the jurisdiction of the Federal Circuit Court to include plant breeders rights...
Various factors have contributed to the rise in demand for biopharmaceutical products such as biologics and biosimilars. The global biosimilars market is estimated to be worth $2.29 billion in 2015, and is poised to grow at a CAGR of 22.1% during the forecast period. This report studies and analyzes the biosimilars market by product and applicati
Shares of Eli Lilly rose Wednesday in premarket trading a day after the drugmaker said a federal court upheld a patent protecting one of its top-selling drugs, the cancer treatment Alimta. The Indianapolis company said Tuesday after markets closed that the U.S. District Court for the Southern District of Indiana ruled in Lilly's favor regarding
WASHINGTON, Aug. 26 The Federal Trade Commission published the following notice in the Federal Register:. Par Pharmaceutical, Inc. and Concordia Pharmaceuticals, Inc.; Analysis of Proposed Consent Orders to Aid Public Comment. A Notice by the Federal Trade Commission on 08/26/2015.
Write " Concordia Pharmaceuticals, Inc., et alConsent Agreements; File No. 151-0030" on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/concordiaparconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write "Concordia Pharmaceuticals, Inc., et al.Consent...
Aug. 26 Mylan and Perrigo Co. are taking their last swings at each other in the final days before Mylan shareholders vote on whether the generic drug maker should make a formal tender offer for Perrigo, an Irish over-the-counter drug specialist that opposes the hostile bid. "Perrigo continues to make misleading comments with regard to Mylan's of
Our news editors obtained a quote from the research from Tufts University, "At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. To inform the FDA and the global drug development community, th
CSPC Pharmaceutical Group Limited, a leading pharmaceutical company in China, is pleased to announce its interim results for the six months ended 30 June 2015. During the Period, the Group recorded sales revenue of approximately HK $5,730 million, representing an increase of 7.3% over the same period of last year. Profit attributable to sharehold
Table of Contents Office of the Federal Register Agriculture Department SeeFood Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Development of Nutrition Education Messages and Products for the General Public, 51531-51532 Antitrust Division NOTICES...
HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2015/ PRNewswire/ Mylan N.V. today announced that the U.S. In August 2014, the U.S. Food and Drug Administration accepted Mylan's abbreviated new drug application filing for a three times per week Glatiramer Acetate Injection 40 mg/mL, the generic version of Copaxone 40 mg/mL Mylan believes it is on