Generic Drug News and Research

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Generic Drugs are official nonbrand names by which medicines are known. Generic names usually refer to the chemical name of the drug.

Indian drugmaker seeks to make, sell generic version of Pfizer's HIV drug

The Indian drugmaker Natco Pharma "said Wednesday it has informed Pfizer Inc. that it wants to make and sell a low-cost generic version of the U.S. company's [drug] maraviroc for treating the HIV infection under a so-called 'compulsory license'," Dow Jones Newswires/Smart Money reports.

6 Jan 2011

Teva acquires Théramex

Teva Pharmaceutical Industries Ltd. announced today that it has completed the acquisition of Théramex, Merck KGaA's European-based women's health business.

5 Jan 2011

Indian government rejects Abbott's patent application for second-line ARV

India's patent office "has rejected American drug maker Abbott Laboratories' patent application for an HIV combination drug, allowing low-cost local drug makers to make and sell their generic versions in India and other countries where the medicine is not patented," Economic Times reports (1/4).

5 Jan 2011

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

24 Dec 2010

Walgreen first quarter sales increase 6.0% to record $17.3 billion

Walgreens announced record earnings and sales for the first quarter of fiscal year 2011.

22 Dec 2010

The Citizen examines potential impact of EU-India free trade agreement on HIV/AIDS patients in developing countries

The Citizen examines the potential impact a free-trade agreement between the EU and India currently under negotiation could have on patients living with HIV/AIDS in developing countries.

22 Dec 2010

Genmed obtains marketing authorization license for paracetamol in Europe

Genmed Holding Corp. is announcing its entry into the European generic drug market with the receipt of its first marketing and distribution license for paracetamol. Also known as acetaminophen, paracetamol is an over-the-counter drug used to treat mild to moderate pain from headaches, backaches, osteoarthritis, and to reduce fever.

22 Dec 2010

PharmaNet launches Initiator and PKS technology platforms to improve clinical study timelines

PharmaNet Development Group, Inc., a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, is pleased to announce that it is launching two technology platforms – Initiator™ and PKS™ - that will provide dramatic improvements in clinical study timelines by accelerating data acquisition and the processing of final client reports in its Phase I clinics. By providing clients with real time data faster, sponsors can make informed decisions about their products earlier in the process.

15 Dec 2010

EU, India talks end with resolution on drug seizures, little progress on free trade agreement

"The European Union and India resolved a dispute over generic drugs on Friday which should remove obstacles to Indian drugs manufacturers exporting products to the developing world, officials said," Reuters reports in an article that describes the customs regulations previously in place that led "to numerous seizures of generic drugs shipments in transit from India to countries in South America via Europe."

14 Dec 2010

Reuters: Supreme Court to decide generic drug labeling issue

The Supreme Court said on Friday that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects (Vicini, 12/11).

13 Dec 2010

Teva, Active Biotech report positive initial results from laquinimod Phase III study in multiple sclerosis

Teva Pharmaceutical Industries Ltd. and Active Biotech announced today initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting multiple sclerosis (MS) patients treated with 0.6 mg daily oral laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved.

9 Dec 2010

People enrolled in CDHP plan reaches 22 million in 2010: EBRI report

The ranks of people enrolled in either a consumer-driven health plan (CDHP) or a high-deductible health plan (HDHP) reached 22 million in 2010, according to a report released today by the nonpartisan Employee Benefit Research Institute (EBRI). Participation in these account-based health care plans is low, but continues to grow, EBRI finds in its sixth annual Consumer Engagement in Health Care Survey.

3 Dec 2010

Teva comments on Lovenox’s patent infringement lawsuit

Teva Pharmaceutical Industries Ltd. commented today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc.

3 Dec 2010

Teva board authorizes $1 billion share repurchase program

Teva Pharmaceutical Industries Ltd. announced today that its Board of Directors has authorized the Company to repurchase (including through one or more subsidiaries) up to an aggregate of $1 billion of its ordinary shares/ADRs over the next 12 months.

1 Dec 2010

To reduce spread of HIV/AIDS, IFRC calls for more focus on IDU programs

Ahead of World AIDS Day, the International Federation of the Red Cross on Friday released a report (.pdf) calling for governments around the world to do more to help stop the spread of HIV/AIDS among populations of injecting drug users (IDUs), the Associated Press reports (Heilprin, 11/25).

30 Nov 2010

Pharma enhances its focus on Asia-Pacific partnerships

While the Japanese market still dominates deal activities in the Asia-Pacific (APAC) region, companies and research institutes in emerging APAC countries have recently been attracting high calibre collaborators, according to the latest analysis by Datamonitor.

28 Nov 2010

Cardinal Health announces plan to acquire Kinray

Cardinal Health today announced plans to acquire Kinray, Inc., a leading pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in an all-cash transaction that will significantly expand its ability to serve retail independent pharmacies in the northeastern United States.

19 Nov 2010

FDA grants Impax final approval for generic Allegra-D ANDA

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Allegra-D® (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

16 Nov 2010

Teva presents QNAZE Phase III study results for SAR at ACAAI Meeting

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo.

15 Nov 2010

Drug industry: Pharmaceutical companies find ways to cope as patents expire; FDA criticized for consulting contracts

There is a simple explanation for most of the mergers and acquisitions in the pharmaceutical world these days the so called Patent Cliff. Simply put, many of the drug industry's biggest earners blockbuster medications that have paid the bills for the last decade are about to lose their patent protections.

15 Nov 2010