Generics Industry News Search
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March 2007 News Archive |
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JERUSALEM--(BUSINESS WIRE)--Mar 1, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. ...
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REYKJAVIK, Iceland, March 1, 2007 /PRNewswire/ -- Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceuticals company Actavis Group (ICEX: ACT), today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market Ranitidine Oral Solution USP. Due to Actavis's first-to-file status, the FDA has granted Actavis a 180-day marketing exclusivity that will commence with the distribution of the product in the coming weeks.
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BELLEVUE, Wash.--(BUSINESS WIRE)--Mar 1, 2007 - SCOLR Pharma, Inc. (Amex: DDD) announced today that its contract manufacturing partner, Cardinal Healthcare, has produced batches of SCOLR's 12 hour CDT-based pseudoephedrine tablets needed for the completion of its Abbreviated New Drug Application (ANDA) scheduled for submission later this year. ...
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PRAGUE and LONDON, March 01, 2007 /PRNewswire-FirstCall/ --Zentiva N.V. announces today that it has entered the Hungarian pharmaceutical market via the acquisition of certain generic products, personnel and other operating assets from sanofi-aventis. The move into the Hungarian market is in line with Zentiva's strategy of extending its geographic reach in the region, as it moves towards its target of becoming the leading pharmaceutical company in Central and Eastern Europe (CEE). Financial terms of the deal were not disclosed....
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PHOENIX, AZ, Mar. 2, 2007 -- The The Generic Pharmaceutical Association (GPhA) today kicked off its 2007 Annual Meeting by calling on Congress to move forward with legislation to bring safe and effective biogenerics to patients in need and remove barriers that delay consumer access to affordable generic medicines....
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CRANFORD, N.J., March 02, 2007 /PRNewswire/ -- Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group (ICEX: ACT), announced that it has received approval from the U.S. Food & Drug Administration to market Hydrochlorothiazide Tablets USP, 12.5 mg. Distribution of the product will begin immediately. ...
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LONDON, 2 March 2007 – Hikma Pharmaceuticals PLC, the multinational pharmaceuticals group, announces that it has agreed to acquire the entire issued share capital of Ribosepharm GmbH, a German oncology sales and marketing company, from Ratiopharm GmbH for a cash consideration of $45.0 million (€34.7 million)....
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HAYWARD, Calif.--(BUSINESS WIRE)--March 5, 2007--IMPAX Laboratories, Inc. announced today that it has settled its patent litigation suit with Biovail Laboratories International SRL related to IMPAX's version of Bupropion Hydrochloride Extended-Release Tablets, generic of Wellbutrin(R) XL, 150 mg and 300 mg. The settlement was made pursuant to an agreement among the Company, Biovail, a subsidiary of Teva Pharmaceutical Industries Ltd., and Anchen Pharmaceuticals....
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TORONTO--(BUSINESS WIRE)--Mar 5, 2007 - Biovail Corporation (NYSE, TSX: BVF) today announced, following a review by the Federal Trade Commission (FTC) that was requested by the parties, a comprehensive settlement with Anchen Pharmaceuticals LLP, Impax Laboratories, Inc., Watson Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd., related to Wellbutrin XL(R)....
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JERUSALEM--(BUSINESS WIRE)--Mar 5, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has reached an agreement with Biovail Corporation regarding Bupropion Hydrochloride Extended-Release Tablets ("Bupropion HCl ER tablets"), the generic version of the antidepressant Wellbutrin XL(R) Tablets, for the United States market....
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Apotex and its CEO, Bernard (Barry) C. Sherman, were ordered by a federal district court last week to pay Eon Labs $3.1 million in attorney fees and expenses in a patent case they pursued for years before admitting that their patent was invalid. In a Memorandum and Order granting Eon's motion for fees, Judge Avern Cohn of the U.S. District Court for the Eastern District of New York described the case as a "debacle" and the manner in which it was litigated as "reflect[ing] all that is bad in patent litigation."...
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Melbourne, Australia 05 March, 2007 -- Generic Health Pty Ltd, an Australian owned and operated pharmaceutical company headquartered in Melbourne, Australia, has today announced that it has entered into agreement to acquire pharmaceutical company Bellwether Pharma Limited....
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HERSHOLM, Sweden, March 06, 2007 /PRNewswire/ -- LifeCycle Pharma A/S announced today that within the 45-day period under the Hatch-Waxman Act the company has not received notice of any patent infringement lawsuits regarding the company's Paragraph IV certification for LCP-FenoChol filed with the Food and Drug Administration (FDA) and sent to relevant Orange Book patentees and NDA holders....
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ST. LOUIS, March 06, 2007 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company today reported that a Minneapolis Federal District Court jury found in favor of ETHEX/KV on all claims made against KV and its ETHEX generic drug subsidiary by the branded pharmaceutical maker Solvay Pharmaceuticals, Inc. The jury's verdict came after a trial that spanned a seven-week period....
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Toronto, Ontario CANADA, March 06, 2007 /FSC/ - Orbus Pharma Inc. today announced that patent applications for its extended release formulation of the drug fluvastatin has been published by the United States Patent and Trade-mark Office and the World Intellectual Property Office...
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ALLEGAN, Mich., March 06, 2007 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that it has entered into a purchase agreement to acquire nine generic prescription dermatological products and four pipeline products from Glades Pharmaceuticals, Inc. for $56 million in cash plus other consideration for future R&D; collaborations. Glades is a subsidiary of Stiefel Laboratories, Inc., a privately owned company that specializes in the branded dermatology market. The transaction is expected to close by the end of March. The acquisition is expected to add more than $20 million in net sales annually and be accretive immediately....
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JERUSALEM--(BUSINESS WIRE)--Mar 6, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it will continue to sell its generic version of OxyContin tablets at least through the end of 2007....
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IRVINE, California, March 7, 2007 - Teva Pharmaceuticals is pleased to announce the introduction and availability of Azithromycin for Injection. Azithromycin for Injection is available in 500 mg/vial, Single Dose Vials and 2.5 gm/vial Pharmacy Bulk Pack....
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ROCKVILLE, Md., March 7, 2007--The Food and Drug Administration granted tentative approval on March 2, 2007 for a fixed dose tablet containing lamivudine/zidovudine (150 mg/300 mg) tablets, co-packaged with Nevirapine (200 mg tablets) for the treatment of HIV-1 infection, manufactured by Strides Arcolab Ltd., Bangalore, India....
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EXETER, N.H.--(BUSINESS WIRE)--Mar 7, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced that its subsidiaries, Laboratorios Belmac and Laboratorios Davur, have received product approvals of bicalutamide from the Spanish Ministry of Health....
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Wilmington, MA - March 7, 2007 - DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) announced today that the United States District Court in Newark, N.J. lifted the preliminary injunction against River's Edge Pharmaceuticals LLC which had prevented it from selling its generic version of Nicomide®, a patented product of DUSA's. The injunction had been in effect since May, 2006 following the filing of DUSA's complaint alleging that River's Edge's product infringes DUSA's patent. Nicomide® is one of the key products acquired by DUSA when it merged with Sirius Laboratories, Inc. in March of 2006....
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Teva receives approval for generic Dostinex® tablets
Jerusalem, Israel, March 8, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Cabergoline Tablets, 0.5 mg.
Shipment of the product will begin immediately....
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(Washington, DC)— The Pharmaceutical Care Management Association (PCMA) applauds Chairman Kennedy and Ranking Member Enzi for holding today's Senate Health, Education, Labor and Pensions Committee hearing to explore new ways to improve access and affordability for biologic products. Americans currently spend $35 billion annually on biologics, which are more expensive than necessary because they lack generic competition....
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WASHINGTON, March 8 /PRNewswire-USNewswire/ -- The Coalition for a Competitive Pharmaceutical Market (CCPM) applauded Chairman Kennedy and Senator Enzi for holding today's Health, Education, Labor, and Pensions Committee hearing on biogenerics and called upon Congress to "Unlock a Miracle" and pass the "Access to Life-Saving Medicine Act."...
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(Washington, DC) –America's Health Insurance Plans' (AHIP) Board of Directors released a policy statement on improving the availability and affordability of generic biopharmaceuticals for patients. Karen Ignagni, President and CEO of AHIP, issued the following statement on the policy outlined by the AHIP Board of Directors:...
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Statement from Kathleen Jaeger, President and CEO of GPhA on Senate Health, Education, Labor and Pensions Committee Hearing on Biogenerics
"Biogenerics hold great promise for millions of Americans, but that promise will not be fulfilled without Congressional action. The FDA says it needs Congressional authority to create a clear, efficient abbreviated approval pathway to bring safe and effective biogenerics to consumers. The Access to Life-Saving Medicine Act will give FDA this authority and also provide it with the flexibility to let sound science drive the process to ensure safety. Safety must and will always be our number one priority....
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On March 8, 2007, FDA granted approval for generic didanosine for oral solution (Pediatric Powder), 10 mg/mL, packaged in 2 gram and 4 gram containers, manufactured by Aurobindo Pharma Limited, of Hyderabad, India, allowing marketing in United States.
This is a generic version of the already FDA approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured by Bristol Myers Squibb....
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Jerusalem, Israel, March 11, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Moexipril HCl and Hydrochlorothiazide Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg and 15 mg/25 mg. Shipment of these products will begin immediately. ...
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PITTSBURGH, March 14 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Extended-release (ER) Tablets, 250mg and 500mg strengths....
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BANGALORE, India: 14th Mar 07--Strides Arcolab today announced that it has received tentative approvals from the United States - Food and Drug Administration for two new drug applications [NDA] for fixed dose combination of:
* Lamivudine/Stavudine 150 mg/40 mg Tablets
* Lamivudine/stavudine150/40mg tablets Co-packaged with Nevirapine 200 mg Tablets...
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/PLoS One/ 14 March 2007 -- Significant quantities of antiretroviral drugs (ARVs) to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs.
An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies.
Click here to read full article (www.plosone.org)...
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By ANDREW BRIDGES - The Associated Press
Thursday, March 15, 2007; 6:44 PM
WASHINGTON -- Copycat versions of pricey biotech drugs may be relegated to a status below that of generic versions of traditional chemical drugs, the head of the Food and Drug Administration suggested Thursday....
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LEVERKUSEN, Germany, March 15 (Reuters) - Germany's Bayer (BAYG.DE: Quote, Profile , Research) supported Abbott Laboratories' (ABT.N: Quote, Profile , Research) decision to stop launching new drugs in Thailand in protest at the army-backed government's move to override international drug patents....
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PHOENIX--(BUSINESS WIRE)--Synovics Pharmaceuticals, Inc. (OTCBB: SYVC), a specialty pharmaceutical company, today announced that it has entered into a binding letter of intent for exclusive, world-wide rights to the development and commercialization of the PharmPro Division of Fluid Air Inc.’s proprietary over-the-counter (OTC) version of omeprazole OTC....
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Gurgaon (Haryana), India, March 16, 2007
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg....
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Celgene, a Ritalin manufacturer, and Novartis, its distributor, have sued generic production company Abrika for patent infringement....
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news.independent.co.uk - Danny Fortson - 18 March 2007 - Nearly a quarter of the turnover of AstraZeneca, the FTSE 100 drugs giant, could be wiped out by legal challenges to the protection on its best-selling drugs. The company is fighting lawsuits brought in the US and Europe by makers of cheap generic drugs which are challenging the patents of drugs that represent at least $7.2bn (£3.7bn) in annual sales, according to SG Cowen, an American investment bank. That is equivalent to 27 per cent of the company's $26.4bn annual turnover....
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Thailand's health minister has threatened to expand the country's generic drug programme to include cancer and more AIDS medications, unless pharmaceutical companies sharply cut their prices....
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NORWALK, CONN., March 8, 2007 -- IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today reported that U.S. prescription drug sales grew 8.3 percent to $274.9 billion in 2006. Growth was fueled by the Medicare Part D prescription benefit, the increased utilization of generics within new therapy classes, and the launch of new drugs targeted to specific diseases such as cancer and diabetes. ...
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March 2007 - Survey of Consumer Attitudes Toward Generic Drugs (PDF). More than 2,000 adult residents in upstate New York were surveyed from Jan. 31 to Feb. 27, 2007 to determine their perceptions about and use of generic prescription drugs....
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NEW DELHI: The Philippines, which needs drugs worth $2 billion every year, is opening up its government procurement to generic drugs from India. At present, the country does not allow imported generics to participate in government procurement....
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Since Congress passed the Hatch-Waxman Act, large pharmaceutical companies that pioneer major drugs and small labs that seek to market cheaper generic versions of those blockbuster products have frequently worked out what they describe as a mutually beneficial arrangement, in which the "pioneer" manufacturer pays the smaller lab to refrain from bringing the generic version to market. But now, in a dispute that may soon reach the Supreme Court, several groups are asking the Court to end such relationships once and for all....
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Mar 19, 2007 - In an order today, the Supreme Court asked the US Solicitor General for the Gov'ts views on Joblove v. Barr Labs. This case, also known as Tamoxifen Citrate Antitrust Litigation, questions the antitrust viability of reverse-payment settlements....
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By Peter Kaplan - WASHINGTON, March 19 (Reuters) - The U.S. Supreme Court asked the Bush administration on Monday to give its opinion on whether the court should review a case challenging patent settlements between major drugmakers and their generic rivals. The high court made no decision about whether it ultimately would hear the appeal, instead, the justices asked Solicitor General Paul Clement of the Justice Department to file a brief outlining the administration's position....
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By Theresa Agovino - Associated Press - Mar. 19, 2007
NEW YORK - Pfizer Inc.'s Lipitor, which has been steadily losing market share, faces more pressure as health plans unleash a new wave of programs promoting the use of generic cholesterol drugs....
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March 19, 2007 - Language in newly signed free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of U.S. lawmakers contends....
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WOODCLIFF LAKE, N.J., March 20 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Otsuka Pharmaceutical Co., Ltd in connection with its ABILIFY(R) (aripiprazole) tablets, 2mg, 5mg, 10mg, 15mg, 20mg & 30mg....
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ROCKVILLE, Md., March 20, 2007--FDA granted tentative approval on March 19, 2007 for a generic formulation of lamivudine tablets (150 mg), manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR). Final approval cannot be granted at this time because the reference drug product, Epivir Tablets, a product of GlaxoSmithKline, is currently subject to patent protection....
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NEW YORK--(BUSINESS WIRE)--Pfizer Inc announced today that a federal court in the District of New Jersey (Newark) has upheld the three main U.S. patents covering Celebrex, the company’s selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. The patents had been challenged by generic manufacturer Teva Pharmaceuticals USA....
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By Khomba Singh - March 20, 2007 - NEW DELHI: India’s largest drug-maker Ranbaxy has locked horns with the US-based world’s largest drug-maker Pfizer in 17 countries over infringement of patent of the latter’s blockbuster cholesterol lowering drug Lipitor. The company’s launch of the atorvastatin (the generic drug of Lipitor) is crucial in its plan to generate nearly $2 billion in sales over the next five-six years.The countries where Ranbaxy is into litigations with Pfizer for atorvastatin include the US, the UK, Norway, Austria, Denmark, Finland, Australia....
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On the home page of Novartis, there is a link that takes you to 'Information Center - India Glivec patent case.' The company, as you may be aware, is challenging the Indian patent law following the patent office's decision to decline a patent for Glivec / Gleevec, a cancer treatment. "We also are challenging the establishment of additional hurdles to patentability in India that discourage the development of better medicines," declares Novartis.
For starters, here are some inputs from Ms Srividhya Ragavan, Associate Professor of Law, University of Oklahoma College of Law (www.law.ou.edu), US....
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PHOENIX--(BUSINESS WIRE)--Mar 21, 2007 - Synovics Pharmaceuticals, Inc. (OTCBB:SYVC), a specialty pharmaceutical company, today announced that its wholly owned subsidiary ANDAPharm LLC, has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for approval of its formulation of a 10mg dose of hydroxyzine HCL. Hydroxyzine HCL is sold under the brand names of Atarax(R). The U.S. market for 10mg hydroxyzine HCL is $40 million....
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March 20, 2007 - In a 201-page opinion released today, Judge John C. Lifland of the U.S. District Court for the District of New Jersey found all three of Pfizer's patents on Celebrex (celecoxib) valid, enforceable, and infringed by Teva, who had sought to market a generic version of Celebrex before the patents expire in 2015....
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JERUSALEM--(BUSINESS WIRE)--Mar 21, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. District Court for the District of New Jersey has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's Celebrex(R) (Celecoxib) Capsules, 100 mg, 200 mg, and 400 mg, holding the three patents at issue valid and enforceable. Teva plans to appeal this decision....
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BRUSSELS, Mar 20 (IPS) - The leading pharmaceuticals firm Novartis is seeking to prevent the EU's political bodies from supporting an Indian law allowing access to cheap medicines in developing countries.
The Swiss firm has contacted all 785 members of the European Parliament over the past few weeks, urging them not to sign a written declaration opposing the Novartis stance on India's 2005 patents law. Novartis is taking legal action against the law, which provides for patents on medicines to be refused on public health grounds....
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20 March 2007 - Mumbai: Ranbaxy Laboratories. has opted out its bid for the generic drug unit of German pharmaceutical company Merck KGaA, as it found it to be overvalued, reports quoting sources close to the deal said....
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By Scott Gottlieb, M.D. - Tuesday, March 20, 2007 - On Capitol Hill, debate about creating a legal pathway for approving copies of biologic drugs after their patents are up has focused on how much clinical testing should be required for the so-called "generic" proteins, whether the copies can be safely used interchangeably with their branded counterparts, and how much savings is really offered by follow on biologics or FOBs as they are being called.
Nobody has asked what financial and scientific burdens new legislation will place on the Food and Drug Administration. It's time people start....
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March 20, 2007 - SOUTH PORTLAND, Maine --Maine's largest health insurer announced Tuesday an incentive program intended to encourage the use of generic drugs in place of their more expensive brand-name counterparts....
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BANGKOK, March 20 (Reuters) - Thailand will continue talks with global pharmaceutical firms on a drug pricing dispute after its decisions to issue compulsory licences for some medicines, an executive of the U.S. Chamber of Commerce said on Tuesday....
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BANGKOK, Mar 21 (IPS) - A broad coalition of Thai non-governmental organisations (NGOs) is threatening to tap the spirit of nationalism, which runs deep and wide here, in a showdown with a Chicago-based pharmaceutical giant. The need for access to cheaper life-saving drugs has sparked this row....
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CHESTER, N.J., March 21 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. (Nasdaq: ARxT) today announced that it has entered into a settlement agreement with Mutual Pharmaceutical Co. and United Research Laboratories, Inc., both wholly owned subsidiaries of Pharmaceutical Holdings Corp. (collectively Mutual). The lawsuit was in response to Mutual's notification that it filed an ANDA seeking approval for generic versions of Adams' 600 and 1200 mg single-ingredient guaifenesin extended-release tablets prior to the expiration of the '252 patent....
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EXETER, N.H.--(BUSINESS WIRE)--Mar 22, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced that its subsidiaries, Laboratorios Davur and Laboratorios Rimafar, have received product approval for tamulosin from the Spanish Ministry of Health. Bentley's subsidiary, Laboratorios Belmac, also received approval for a branded generic equivalent of tamulosin under the trade name Vetevel(TM)....
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TITUSVILLE, N.J., March 22, 2007 /PRNewswire/ -- A U.S. District Court has upheld the validity and enforceability of the TOPAMAX(R) patent, and today issued a permanent injunction against Mylan Laboratories, Inc. The injunction prohibits Mylan from selling generic topiramate tablets and capsules in the U.S. until the Ortho-McNeil Neurologics compound patent on TOPAMAX(R) expires in 2008....
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NEW YORK, Mar 22, 2007 (PR Newswire Europe via COMTEX News Network) -- Eli Lilly and Company (NYSE: LLY) today announced plans to invest an additional US$50 million in an innovative, global partnership to fight Multi- Drug Resistant Tuberculosis (MDR-TB). The announcement is being made in conjunction with World TB Day activities....
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NEW YORK, March 21 (Reuters) - A U.S. judge on Wednesday ordered Mylan Laboratories Inc. (MYL.N: Quote, Profile, Research) and another generic drug maker to pay a combined $16.8 million in legal fees to Takeda Pharmaceutical Co Ltd. (4502.T: Quote, Profile, Research), which won a patent dispute against the companies last year....
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March 21, 2007 - By Mike Simon
A lawsuit filed by The Prescription Access Litigation Project, a consumer action group, alleges that Mylan Laboratories, Inc. accepted money from Cephalon, one of its competitors, to delay marketing of a generic version of the drug Provigil....
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Wednesday, March 21, 2007 - Further to the Supreme Court's request to the Solicitor General for briefing in the Tamoxifen Citrate Antitrust Litigation, recall the paper by Lawrence T. Kass entitled "FTC Takes Drug-Patent 'Reverse Payments' to High Court," which appeared in the Oct. 3, 2005 issue of the NYLJ....
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Wed Mar 21, 2007 1:40 PM EDT - By Scott Anderson
TORONTO (Reuters) - Sales for Canada's pharmaceutical industry will grow at an annual rate of 7.5 percent over the next few years, an industry report said on Wednesday, swelling to a value of C$23.4 billion ($20.2 billion) by 2010. Generic drug manufacturing is also seen booming over the next few years as manufacturers take advantage of patent expirations....
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NEW YORK (CNNMoney.com) -- March 21 2007 - By Aaron Smith
Drugmakers hunt for new patents on old blockbusters to try and postpone the inevitable: generic competition.
As Big Pharma faces patent expirations on some of its most lucrative drugs, the industry is trying to reinvigorate sales by finding creative ways to land new patents - but on the same old drugs....
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The global ambitions of Indian companies, underpinned by unprecedented overseas acquisitions, are now playing out in the pharmaceutical industry, says Bundeep Singh Rangar, chairman of the UK-based IndusView Advisors....
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TORONTO, March 21 /CNW/ - Canadians could save $700-million on the cost of prescription medicines in the first year alone if the use of generic drugs increased to levels in the United States, the Canadian Generic Pharmaceutical Association (CGPA) said today following the release of 2006 Canadian prescription drug sales information by IMS Health Canada....
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March 22, 2007 - The decision by US-based Abbott Laboratories to withhold new medicines from Thailand certainly strikes at the heart of the government's efforts to secure life-saving medicine for all Thais. But the Ministry of Public Health must stand firm. Backing down now would send the wrong message to other pharmaceutical manufacturers, and deprive citizens of Thailand's rights under the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property (TRIPS)....
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Colleen V. Chien - A.Professor, Santa Clara Law School - Significant quantities of antiretroviral drugs (ARVs) to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs....
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Pfizer Inc. said Thursday that the U.S. Court of Appeals for the Federal Circuit reversed a lower court ruling upholding the company's patent on blood pressure medication Norvasc, which analysts said might pave the way for a generic version of the drug six months ahead of schedule....
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21 Mar 2007 - Basingstoke, UK and Philadelphia, US – March 21, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Maryland against Colony Pharmaceuticals, Inc., Actavis, Inc., and Actavis Group hf (collectively “Colony”) for infringement of Shire’s U.S. Patent Nos. 6,322,819, 6,605,300 and 6,913,768 covering ADDERALL XR...
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LOS ANGELES (Reuters) -- Mylan Laboratories Inc. said Friday it launched generic versions of Pfizer Inc.'s blockbuster Norvasc blood-pressure drug, a day after a federal court ruled a Pfizer patent was invalid.
In response, Pfizer said its plans were to launch its own generic version of the drug, which had U.S. sales of about $2.7 billion last year and is Pfizer's second-biggest selling product.
Click here to read full story (External news site)...
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ZURICH (MarketWatch) -- Swiss drugmaker Novartis AG (NVS) Monday said it is selling the production facilities for the manufacturing of multiple sclerosis drug Betaseron to Germany's Bayer AG (BAY) for $200 million, and plans to introduce its own version of the medicine in 2009.
Click here to read full story (External news site)...
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AMITYVILLE, N.Y.--(BUSINESS WIRE)--March 23, 2007--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Calcipotriene topical solution, 0.005%....
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PITTSBURGH, March 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today launched Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base)....
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PITTSBURGH, March 26 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced its latest first to market generic product with the launch of Ciprofloxacin Extended-release (ER) Tablets in 500mg and 1000mg strengths....
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NEW YORK--(BUSINESS WIRE)--In response to an announcement today by Mylan Laboratories that it has launched a generic competitor to Norvasc, Pfizer said it is making available its own generic amlodipine besylate product immediately through the company’s Greenstone subsidiary....
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WASHINGTON, DC – Congress needs to introduce competition into the biopharmaceutical marketplace by giving the Food and Drug Administration (FDA) authority to approve safe biogenerics, a trustee of the nation’s third largest health care purchaser urged today....
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New York, NY -- March 26, 2007 -- The Public Patent Foundation (PUBPAT) announced today that it has filed formal requests with the United States Patent and Trademark Office challenging four key HIV/AIDS drug patents held by Gilead Sciences, Inc. (NASDAQ: GILD)....
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AP -- Eli Lilly and Co. has fended off patent challenges from generic drug makers who want to copy star seller Zyprexa. But now rivals want a piece of No. 2 seller Gemzar. The Indianapolis drug maker has filed three lawsuits against companies that want to make generic versions of Gemzar, an injectible chemotherapy that treats several forms of cancer and rang up $1.4 billion in sales last year.
Click here to read full story (External news site)...
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Patent Baristas -- Some readers have asked why there is a pediatric exclusivity add-on for FDA approvals. These exclusivity extensions are provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), which permits certain new drug applications to obtain an additional six months of exclusivity if the drug manufacturer submits certain FDA-requested information relating to the use of the active moiety in a pediatric population....
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Patent Baristas -- The CAFC finally shot down Pfizer’s Norvasc® patent after it filed suit against Apotex alleging infringement stemming from Apotex’s filing an Abbreviated New Drug Application (”ANDA”) seeking approval to commercially sell amlodipine besylate tablets before the expiration of the term of U.S. Patent No. 4,879,303....
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On Friday, March 16, KEI organized a briefing in the U.S. Capitol on Thailand’s recent compulsory licenses on three drugs; two for HIV/AIDS (Merck’s efavirenz (Stocrin) and Abbott’s lopinavir + ritonavir (Kaletra)) and one for heart disease (Sanofi’s clopidogrel (Plavix)). The briefing was sponsored by Senator Sherrod Brown and Congressman Tom Allen. Rep. Allen’s legislative assistant Todd Stein moderated a panel that included James Love of KEI, Robert Weissman of Essential Action, Dr. Buddhima Lokuge of MSF/Doctors Without Borders, Richard Kjeldgaard of PhRMA, and Ronald Cass, the President of Cass & Associates. Three members of the Thai embassy to the United States were also in attendance, and Minister-Counsellor Songsak Saicheua was also given the opportunity to make a statement....
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Philadelphia Business Journal - March 22, 2007 - Independence Blue Cross is extending its "no-pay copay" generic pharmaceuticals program for the entire year.
The program, launched for a three-month trial run at the start of the year, encourages IBC subscribes to use generic medicines by waiving copayment requirements.
Click here to read full story (External news site)...
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© 2007 Rediff.com India Limited | March 23, 2007 | 02:37 IST
Multinational drug major Astra Zeneca's attempts to have a patent protection for its branded lung cancer drug Iressa (geftinib) in the country have been challenged by two Indian companies.
The Delhi patent office will hear pleas of Hyderabad-based Natco Pharma and Mumbai-based GM Pharma as part of the patent pre-grant opposition process...
Click here to read full story (External news site)...
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Seeking Alpha -- Shlomo Greenberg submits: Six months ago, I received two interesting articles on developments in the generics sector. Not the one with which we are all familiar from the activity of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), but the generic biotechnology sector which many view as the medical industry's new, mega niche.
One of the articles I received was taken from CNN Money.com entitled "Missing the 20 billion Bio-generic boom," and was written by its staff writer Aaron Smith. The other was taken from the "Boston Globe." The CNN article opened with the sentence, " A huge new industry - biogenerics - is waiting to be born," and then went on to say that the companies leading the entry into this field are Barr Pharmaceuticals Inc. (NYSE: BRL), and Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA).
Click here to read full story (External news site)...
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As discussed in our 2006 Financial Report, we have filed suit against multiple generic companies that have filed Abbreviated New Drug Applications (ANDA) seeking the U.S. Food and Drug Administration (FDA) approval to market generic 37.5 mg, 75 mg and 150 mg venlafaxine HCl extended release capsules. Venlafaxine HCl is the active ingredient used in EFFEXOR XR....
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OrangeBookBlog -- Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate). Mylan's generic launch follows the Federal Circuit's decision yesterday, invalidating Pfizer's patent on Norvasc. The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity....
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AP -- A UBS analyst made optimistic predictions about the futures of generic drug makers Barr Pharmaceuticals Inc. and Teva Pharmaceutical Friday, and but said prospects were not as clear for Mylan Laboratories Inc. Analyst Ricky Goldwasser started coverage of Barr and Teva with "Buy," ratings, expecting both stocks will rise more than 20 percent in the next year.
Click here to read full story (External news site)...
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NEW YORK (AP) - Drug developer Cephalon Inc. said Friday it received a subpoena from the Federal Trade Commission seeking information about patent infringement settlements over narcolepsy treatment Provigil.
Click here to read full story (External news site)...
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MUMBAI (AFX) - India's mid-sized drug maker Aurobindo Pharma Ltd, has tied up with private equity fund CVC Capital Partners (Deutschland) GmbH to bid for Merck KGaA's global generics business, reported the daily Mint, citing people familiar with the bids.
Click here to read full story (External news site)...
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/PRNewswire-FirstCall/ -- Mylan Laboratories Inc. was notified yesterday that the U.S. District Court for the District of Columbia has enjoined the U.S. Food and Drug Administration (FDA) from approving any additional Abbreviated New Drug Applications (ANDAs) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base) from April 11, 2007 until at least April 13, 2007....
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WALTHAM, Mass., March 27, 2007 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, although Sanofi-Aventis's Taxotere will remain the market leader through 2010, generic erosion of Taxotere will reduce the overall value of the taxane market between 2010 and 2015....
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HAWTHORNE, N.Y., March 27, 2007 – Taro Pharmaceutical Industries Ltd. (“Taro,” Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Ciclopirox Topical Solution, 8% (Nail Lacquer) (“ciclopirox nail lacquer”)....
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AP - March 27, 2007 - 8:20AM - A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs in the way the agency approves knockoffs of traditional drugs. Food and Drug Administration deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen Inc. and Genentech Inc., which have never faced generic competition in the U.S. for their products, some of the most complex and expensive on the market.
Click here to read full story (External news site)...
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WASHINGTON (Reuters) - Cheaper, generic versions of more complex protein-based drugs will need more data than simpler compounds to prove their safety and effectiveness, a U.S. Food and Drug Administration official said on Monday.
Click here to read full story (External news site)...
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/PRNewswire-FirstCall/ -- KV Pharmaceutical Company today updated its timing on its pending first-to-file application with the Food and Drug Administration for metoprolol succinate (Toprol(R) XL, marketed by AstraZeneca)....
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VALLEY FORGE, Pa.--(BUSINESS WIRE)--AmerisourceBergen Corporation (NYSE:ABC - News) today announced that it has signed a definitive agreement to purchase Bellco Health, a privately held distributor of branded and generic pharmaceuticals, for a purchase price of approximately $235 million in cash....
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