By a News Reporter-Staff News Editor at Marketing Business Weekly Actavis plc, a leading global specialty pharmaceutical company, announced the launch of a leading portfolio of generic specialty injectable medications to be marketed to hospitals across the United States. Actavis also has an industry leading specialty injectable pipeline, with...
By a News Reporter-Staff News Editor at Marketing Weekly News Actavis plc, a leading global specialty pharmaceutical company, announced the launch of a leading portfolio of generic specialty injectable medications to be marketed to hospitals across the United States. Actavis also has an industry leading specialty injectable pipeline, with...
A new regulatory pathway has paved the way for the introduction of increasingly complex biosimilars in the United States, which has generated a great deal of excitement among pharmaceutical contract manufacturing organizations about possible new business opportunities. Making extensive use of data, PharmSource researchers conducted an analysis of..
By a News Reporter-Staff News Editor at Marketing Weekly News Prasco Laboratories, Takeda Pharmaceutical Company Limited, and Takeda's wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. announced that Prasco and TPUSA have entered into a distribution and supply agreement for the rights to distribute Colchicine Tablets, USP, the Authoriz
The US Federal Trade Commission has approved Sun Pharmaceutical' s plan to buy Ranbaxy on the condition that it divests one antibiotic product- generic minocycline tablets- to avoid anti-competitive impact in the US market. Torrent Pharma will acquire Ranbaxy's minocycline business in the US. Ranbaxy is currently one of three suppliers of the produ
Tenders are invited for supply of generic drugs/ pharmaceutical products/ Delay Spray to HLL Stores/ depot Major organization: HLL LIFECARE LIMITED Address: HLL Bhawan Poojappura Thiruvananthapuram Kerala Country: India Url: www.lifecarehll.com Tender notice number: HLL/ MKTG/ SD/2014-15/08HLL/ MKTG/ SD/2014-15/09 Notice type: Tender Notice Open da
The US market for Etodolac 300 mg capsules totals $9 million on a trailing 12 month basis, per IMS Health. Arthur S. Przybyl, President and Chief Executive Officer said, "We are pleased to announce the launch of our second product from the portfolio of approved generic products we acquired from Teva in January 2014." ANI Pharmaceuticals, Inc. is an
The FDA continues to struggle to catch up on ANDA approvals. Discover the three biggest areas of application deficiencies that trigger RTR decisions bioequivalence; chemistry, manufacturing and controls (CMC) quality; and organization and formatting and learn which problems trigger FDA alarm-bells. Plus, see how to avoid other areas that can le
NEW YORK Sun Pharmaceuticals will sell the rights to one generic drug as part of its purchase of competitor Ranbaxy Laboratories, U.S. antitrust regulators said Friday. The Federal Trade Commission said the companies will sell Ranbaxy's interests in generic minocycline, an antibiotic used to treat several types of infections. Torrent Pharmaceuti
Ireland- based Actavis Pharmaceuticals has acquired generic drug maker Auden Mckenzie in a deal worth 306 m. Before it announced the Allergan deal in November, the company acquired rival Forest Laboratories for $25 bn in February and infectious disease expert Durata for $675 m in October. Actavis said the acquisition of Auden Mckenzie will make i
AAPS is the American Association of Pharmaceutical Scientists. x0D;. This meant that large, expensive trials with clinical endpoints were required; the U.S. Food and Drug Administration has acknowledged that this is the least accurate, sensitive, and reproducible approach for demonstrating equivalence. x0D;. In order to promote the development
Company revenue from sales of Acellbia?, exceeded $155 million in 2014, representing more than 80% of global sales of non-originator rituximab biologicals. Most of BIOCAD's rituximab sales were in Russia, where the company won a series of federal government contracts to supply programs that provide high-value, life-saving drugs to patients for wh
The sampling exercise started by Drug Controller General of India in States like Jammu and Kashmir, Himachal Pradesh, Maharashtra, Tamil Nadu, Maharashtra, Rajasthan and Chhatisgarh last year will now also be taken up in North Eastern states to assess the quality of drugs in the coming months. Against the backdrop of the fact that several drug manu
Last year Ranbaxy Laboratories managed to report a one-quarter profit by getting the FDA to allow it to launch its exclusive of generic Diovan from its plant in New Jersey. Ranbaxy had a first-to-file exclusive on the drug but was in the midst of dealing with FDA quality concerns when it went off patent in September 2012. The FDA worked with the co
NEW DELHI: Ranbaxy Laboratories has lost the opportunity to exclusively market in the United States for six months the first generic version of Anglo Swedish drug innovator Astra Zeneca's heartburn drug Nexium, the Delhi- based company said in a filing to the stock exchange on Tuesday. The company, which is in the process of getting acquired by riv
For the most part, there is no difference chemical or otherwise between generic drugs and their more expensive, brand-name counterparts. "Patients' expectations play an important role in the effectiveness of their treatments, and the placebo effect has been well documented, especially in people with Parkinson's disease," explained lead study a
WHEN: Tuesday 3rd of March 2015- Thursday 5th of March 2015. WHERE: Novotel London Greenwich Hotel 173-185, Greenwich High Rd, London, SE10 8 JA. According to market research report,' PharmaSphere: Global Biosimilars Strategy- Regulatory Landscape, Key Drivers, Markets and Trends in 2013' published by GlobalData, the global biosimilars market is ex
AAPS is the American Association of Pharmaceutical Scientists. This meant that large, expensive trials with clinical endpoints were required; the U.S. Food and Drug Administration has acknowledged that this is the least accurate, sensitive, and reproducible approach for demonstrating equivalence. In order to promote the development of generic versi
Actavis, a leading global specialty pharmaceutical company, and the owners of Auden Mckenzie Holdings Limited, a dynamic and fast growing company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK, announced that they have reached a definitive agreement, under which Actavis will acquire A
NEW DELHI: Leading US health groups including AVAC, Oxfam America, amfAR, Health Global Access Project, TAG and others have written to Barack Obama urging him to support India in providing "high-quality, low-cost generic medicines essential for health care around the world". There are concerns that US is pressuring India to push for liberal policie
Ranbaxy Laboratories has lost the 180- day exclusivity period for launching its generic version of the heartburn drug Nexium 20 milligrams and 40 mg capsules in US. The sales would have added $170 million to Ranbaxy's revenue. The US Food and Drug Administration has permitted Teva Pharmaceuticals of Israel to launch its generic version of Nexium.
In a filing on BSE, Ranbaxy said, "We have now received a communication from US FDA that they have determined that Ranbaxy has forfeited its 180- day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg." While Ranbaxy said it is disappointed with the result and is pursuing all available legal options to preserve its right
In support of the concept of Essential Medicines, a model list of essential drugs, which included about 200 generic drugs and vaccines, was prepared by the World Health Organisation in 1977.. Most WHO member states welcomed the new approach to medicines and Malaysia is no exception. The concept of essential medicines had been adopted in Malaysia's
Under the Paperwork Reduction Act of 1995, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. Submit written comments on the collectio
Jan. 27 Teva Pharmaceutical Industries Ltd. has announced that it has received Food and Drug Administration approval for the first generic equivalent to Nexium Delayed-Release Capsules in the United States. Teva says that it is preparing to launch the product in the near future. Nexium Delayed-Release Capsules, marketed by AstraZeneca, had annual