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Ethical Alternative Products launches the OmniFlex joint support formula

Ethical Alternative Products has launched OmniFlex, a unique joint support formula combining five highly researched ingredients shown specifically to positively impact joint structure and function in easy-to-swallow soft-gel capsules.

3 Sep 2009

SAFLUTAN launched in United Kingdom and Spain

Merck Sharp & Dohme (MSD) has launched SAFLUTAN (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today.

3 Sep 2009

Sheller, P.C helps to settle the largest whistleblower complaint

Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal and state taxpayers by marketing Zyvox off-label, according to a qui tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and other documents unsealed with today's $2.3 billion Pfizer settlement.

3 Sep 2009

Ten of ChemBridge's screening libraries available through CDD database

ChemBridge Corporation, a leading discovery chemistry company offering an extensive portfolio of discovery chemistry products and contract research services, has now made ten of their most popular screening libraries available to researchers via the Collaborative Drug Discovery (CDD) Public Access database.

3 Sep 2009

Celgene to collaborate with PTC on advancing drug discovery efforts

PTC Therapeutics, Inc. (PTC) today announced that Celgene Corporation has exercised its option to collaborate on advancing drug discovery efforts on an oncology target addressed through the application of PTC's GEMS(TM) (Gene Expression Modulation by Small-molecules) technology.

3 Sep 2009

Pfizer finalizes settlement agreement with U.S. DOJ regarding past promotional practices

Pfizer Inc today announced that it has finalized a previously reported agreement in principle with the U.S. Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005.

3 Sep 2009

P2Y2 to be included in the intellectual property sale auction

Joseph F. Finn, Jr., C.P.A. ("Finn"), announced today that the P2Y2 Gastrointestinal Early Development Candidate Program will be part of the intellectual property offered for sale at the September 30, 2009 auction.

3 Sep 2009

Pfizer pleads guilty of defrauding Medicare, Medicaid and other government-funded health care programs

Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

3 Sep 2009

Two 2008 drug approval reports highlight Ceplene benefits

EpiCept Corporation today announced that Ceplene (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union.

3 Sep 2009

ODAC calls for randomized study of Vion's Onrigin injection for treatment of the elderly AML patients

VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the results of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for its lead oncology therapeutic Onrigin(TM)(laromustine) Injection were presented for the indication of remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).

3 Sep 2009

New Marketing Authorization Application for Rhucin submitted to the EMEA by Pharming

Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of Hereditary Angioedema (HAE) to the European Medicines Agency (EMEA).

3 Sep 2009

FDA extends review period for Endo Pharmaceuticals' testosterone undecanoate

Endo Pharmaceuticals announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the agency has extended its review period for its long-acting testosterone undecanoate injection for men diagnosed with hypogonadism, from Sept. 2, 2009 to Dec. 2, 2009.

3 Sep 2009

Merck's SAFLUTAN launched in the UK and Spain

Merck & Co., Inc. has launched SAFLUTAN® (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today. SAFLUTAN is a preservative free, synthetic analogue of the prostaglandin F2α for the reduction of elevated intraocular pressure (IOP) in appropriate patients with primary open-angle glaucoma and ocular hypertension.

3 Sep 2009

MIPI to sub-license the Onalta brand 90-Y edotreotide radiotherapeutic

Molecular Insight Pharmaceuticals, Inc. today announced that it has completed an agreement to sub-license its Onalta™ brand 90-Y edotreotide radiotherapeutic in certain countries in Europe, the Middle East, North Africa, Russia and Turkey to BioMedica Life Sciences, S.A., Athens, Greece.

3 Sep 2009

Gloucester’s romidepsin recommended for approval by the FDA Oncologic Drug Advisory Committee

Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL). CTCL is a type of non-Hodgkin's lymphoma, which is a cancer of the immune system.

3 Sep 2009

Sinovac Biotech signs marketing agreement with Boryung Pharmaceutical Company

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has signed an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac's H1N1 vaccine.

3 Sep 2009

Clinical trial results of sumatriptan published in a journal

NovaDel Pharma Inc. announced that an article titled “Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine” was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

Pfizer to pay $301 million as setlement for illegal off-label promotion of Geodon

Blank Rome LLP represented three whistleblowers in two of nine lawsuits being settled today with Pfizer for $2.3 billion. The Blank Rome suits allege that Pfizer Inc. illegally off-label promoted the drugs Lyrica® and Geodon®. The cases are two among a group of nine similar suits, all alleging illegal drug promotion activities, that the United States Department of Justice is announcing today are being settled.

3 Sep 2009

FDA's Oncologic Drugs Advisory Committee votes in favor of FOLOTYN NDA

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

3 Sep 2009