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Bloomberg analysis finds 'doughnut hole' deal to cost drugmakers less than 1% of profits

News outlets report how closing the Medicare 'Doughnut Hole' affects drugmakers and seniors.

1 Oct 2010

Merck to pay millions over Mass. allegations of inflated wholesale rate

Bloomberg Businessweek: A Massachusetts court ordered the drug maker Merck to pay $4.6 million in damages for inflating wholesale prices for generic asthma drugs. "Massachusetts claimed the companies reported inflated wholesale acquisition-cost prices for the generics, and that MassHealth, the state component of the Medicaid program, would rely on those prices for reimbursements" (McQuillen, 9/30).

1 Oct 2010

Encorium announces extension of expiration date for pending rights offering

Encorium Group, Inc. , a full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced that it has extended the expiration date for its pending rights offering from September 30, 2010 to October 15, 2010. The subscription rights may now be exercised at any time prior to 5:00 p.m. ET on Friday, October 15, 2010.

1 Oct 2010

Noven acquires global rights to Daytrana from Shire affiliates

Noven Pharmaceuticals, Inc. today announced that it has completed the acquisition of global rights to Daytrana® (methylphenidate transdermal system) from affiliates of Shire plc.

1 Oct 2010

LSUHSC-S receives $3.9M NIDA grant to develop EMB-001 drug for cocaine dependence

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for addiction and obesity, announced today that the Louisiana State University Health Sciences Center (LSUHSC-S) has received a $3.9 million dollar grant from the National Institute on Drug Abuse (NIDA). The grant will support the next stages of development for Embera's drug candidate EMB-001 to treat cocaine dependence, as well as advance EMB-001 into clinical testing.

1 Oct 2010

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo® tablets.

1 Oct 2010

AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

AcelRx Pharmaceuticals, Inc. today announced that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for ARX-02, a proprietary Sufentanil NanoTab™ Breakthrough Pain Management System for the treatment of cancer breakthrough pain in opioid-tolerant patients. FDA reviewed a package based on the previously announced positive Phase 2 clinical study results to date for ARX-02 and provided AcelRx with guidance on the Phase 3 program design and NDA requirements.

1 Oct 2010

Cortex regains global rights to AMPAKINE compounds for treatment of schizophrenia and depression

Cortex Pharmaceuticals, Inc. announced that it has regained worldwide rights to develop and commercialize its AMPAKINE® compounds for the treatment of schizophrenia and depression.

1 Oct 2010

Mylan subsidiary launches Bupropion Hydrochloride Extended-release Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bupropion Hydrochloride Extended-release Tablets USP, (XL), 150 mg and 300 mg (Once-Daily), the generic version of GlaxoSmithKline's antidepressant Wellbutrin XL®.

1 Oct 2010

FDA issues Complete Response Letter for Teva's Neutroval BLA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Application (BLA) for Neutroval™ (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

1 Oct 2010

First nationwide Safe Medication Disposal Program launched

Walgreens has launched the first ongoing, nationwide Safe Medication Disposal Program, a safe and environmentally responsible way to dispose of unused or expired medications.

1 Oct 2010

Achillion initiates ACH-1625 Phase II dosing for HCV infection

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

Antiretroviral therapy does not reduce risk of HIV transmission

For married couples in which one partner is HIV-positive and the other is HIV-negative, antiretroviral therapy (ART) does not reduce the risk of transmitting HIV to the uninfected partner, according to a study from China in the October issue of JAIDS: Journal of Acquired Immune Deficiency Syndromes.

1 Oct 2010

Praesidian Capital invests $6 million in Meta Pharmaceutical Services

Praesidian Capital, a leading provider of mezzanine capital for small and mid-sized companies, has invested $6 million in subordinated debt in Meta Pharmaceutical Services, a leading sales and marketing data services provider. The investment supports the recapitalization of Meta Pharmaceutical Services by DFW Capital Partners and management.

1 Oct 2010

Maven Semantic updates gastroesophageal reflux research database

The new database is now available to marketing, business development, competitor intelligence, KOL, medical affairs and related departments in the life sciences sector.

1 Oct 2010

Prix Galien USA committee honors life saving innovations

The Prix Galien USA committee honored innovations that are saving lives last night during the Prix Galien Awards Gala. The Pro Bono Humanum Award, the Prix Galien USA 2010 and the Prix Galien International were presented and related accomplishments celebrated.

30 Sep 2010

Shire announces tender offer results

Shire plc, the global specialty biopharmaceutical company, announces that shareholders of Movetis NV have tendered 99.18% of the shares of Movetis during the initial acceptance period of the tender offer which closed on September 27, 2010. The shares tendered into the tender offer are expected to be settled on October 12, 2010.

30 Sep 2010

Jiangbo fourth-quarter revenues decrease 5.9% to $29.3M

Jiangbo Pharmaceuticals, Inc., a pharmaceutical company with its principal operations in the People's Republic of China, today announced financial results for its fourth quarter and fiscal year ended June 30, 2010. The Company's annual report on Form 10-K has been filed with the U.S. Securities and Exchange Commission and is available on the Company's website.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010