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Impax initiates litigation against Shire over supply of generic Adderall XR

Impax Laboratories, Inc. today announced that it has initiated litigation against Shire LLC and Shire Laboratories, Inc. ("Shire") in order to resolve recent and recurring supply issues of its authorized generic version of Adderall XR®. The Company is seeking to compel Shire to deliver duly ordered amounts of product under the parties' Settlement Agreement and License and Distribution Agreements.

2 Nov 2010

FDA announces partnership agreement with University of Rochester to form ACTION Initiative

The U.S. Food and Drug Administration today announced a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.

2 Nov 2010

Study finds inhaled corticosteroids increase type 2 diabetes risk

Patients taking inhaled corticosteroids are at increased risk of developing type 2 diabetes, and more so with higher doses, say researchers at the Jewish General Hospital's Lady Davis Institute for Medical Research (LDI) In Montreal. The risk is of special concern for patients suffering from chronic obstructive pulmonary disorder (COPD), and much less significant for asthmatics.

2 Nov 2010

Study finds increasing dosage of blood thinners can help cardiovascular disease patients with genetic defect

Cardiovascular disease patients who have a genetic defect that makes them less responsive to blood thinners may be helped with an increased dosage, according to results of an innovative pilot study led by a cardiologist at The University of Texas Health Science Center at Houston (UTHealth).

2 Nov 2010

Boehringer Ingelheim announces availability of PRADAXA in U.S. pharmacies

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that its new oral anticoagulant, Pradaxa® (dabigatran etexilate mesylate) 150mg capsules, will be available starting Wednesday by prescription in pharmacies across the United States, including CVS/pharmacy, Rite Aid, Walmart, Target, Kmart® and The Kroger Co. In addition, leading independents under the Health Mart®, Good Neighbor Pharmacy® and Medicine Shoppe® banners will be stocked.

2 Nov 2010

Access Pharmaceuticals receives $1.5 million in government grants

ACCESS PHARMACEUTICALS, INC. a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has been awarded $1.5 million in government grants.

2 Nov 2010

NICE to lose its power to ban life saving drugs

Ministers have finally clarified that patients would not be denied life-extending drugs just because the NHS rationing body decides they are too expensive. National Institute for Health and Clinical Excellence (NICE) the drug watchdog in the UK will be stripped of its powers to stop drugs being available on the NHS due to price. The arbitrary limit on the cost of new drugs – around £30,000 per year of extended high-quality life – will be scrapped from 2014.

1 Nov 2010

Valeant, Kadmon enter strategic agreement for taribavirin and ribavirin

Valeant Pharmaceuticals International, Inc. and Kadmon Pharmaceuticals LLC have concluded two strategic agreements for the development and commercialization of taribavirin and the commercial marketing of ribavirin in the treatment of viral diseases, including hepatitis C virus (HCV).

1 Nov 2010

FDA approves cancer drug Afinitor for treatment of rare genetic disorder

The U.S. Food and Drug Administration approved the cancer drug Afinitor (everolimus) on Friday to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was for treatments of SEGA that can not be treated with surgery.

1 Nov 2010

Short courses of antibiotics have long-term impact on microbial flora of human gut

Short courses of antibiotics can leave normal gut bacteria harbouring antibiotic resistance genes for up to two years after treatment, say scientists writing in the latest issue of Microbiology, published on 3 November.

1 Nov 2010

FDA grants orphan drug designation to Discovery's KL4 surfactant for CF treatment

Discovery Laboratories, Inc. today announced that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to Discovery's KL4 surfactant for the treatment of cystic fibrosis (CF).

1 Nov 2010

Spectrum submits complete response to FDA's CRL for FUSILEV to treat colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by the U.S. Food and Drug Administration (FDA), regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

1 Nov 2010

BetterRxCard helps McLennan County residents save on prescription drugs

BetterRxCard, the free prescription discount card sponsored by McLennan County, today announced the program has saved $138,562 for McLennan County residents during its initial six months. "Anything we can do to assist in reducing or deferring the costs to our citizens we are glad to participate in," said McLennan County Judge Jim Lewis.

1 Nov 2010

Biodel receives FDA CRL for Linjeta NDA

Biodel Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company's new drug application (NDA) for Linjeta™ (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.

1 Nov 2010

Acorda reports net income of $12.4 million for third quarter 2010

Acorda Therapeutics, Inc. today announced its financial results for the third quarter of 2010.

1 Nov 2010

Cell Therapeutics announces submission of MAA to European Medicines Agency for Pixuvri

Cell Therapeutics, Inc. announced today that it has submitted a Marketing Authorization Application to the European Medicines Agency for Pixuvri (pixantrone dimaleate) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma.

1 Nov 2010

FDA approves Afinitor drug for tuberous sclerosis complex

The Tuberous Sclerosis Alliance (TS Alliance) today announced the first drug approved for a tuberous sclerosis complex (TSC) indication by the Federal Drug Administration (FDA). This drug, manufactured by Novartis Oncology, is called Afinitor and will be used to treat subependymal giant cell astrocytomas (SEGAs) in individuals with TSC.

1 Nov 2010

FDA new approvals, antibiotic and neurological drugs

Two new drugs have gained approval from the US Food and Drug Administration (FDA) – one is an antibiotic from Forest Labs and the other a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals. Another waiting for approval is Biodel's fast-acting insulin Linjeta. On the other hand seven new drugs got rejected including a diabetes drug from Amylin Pharmaceuticals and weight-loss drugs from Arena Pharmaceuticals and Vivus, respectively.

31 Oct 2010

Health Canada approves PRADAX for preventing stroke in AF patients

Health Canada, the Canadian health authority, has approved PRADAX™ (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate, marking the second approval of this new oral anticoagulant following the recent marketing authorisation by the US Food and Drug Administration (FDA).

30 Oct 2010

Rite Aid to host flu shot clinics at nationwide pharmacies

With the holidays getting closer, Rite Aid is reminding people to get a flu shot so that the only thing they are spreading this season is good cheer. According to The Centers for Disease Control and Prevention (CDC), it can take up to two weeks for flu shots to be effective and protect against the flu; those who get their flu shot now can help protect themselves by the time they sit down for Thanksgiving dinner.

30 Oct 2010

Pharmaceutical News

Impax initiates litigation against Shire over supply of generic Adderall XR

FDA announces partnership agreement with University of Rochester to form ACTION Initiative

Study finds inhaled corticosteroids increase type 2 diabetes risk

Study finds increasing dosage of blood thinners can help cardiovascular disease patients with genetic defect

Boehringer Ingelheim announces availability of PRADAXA in U.S. pharmacies

Access Pharmaceuticals receives $1.5 million in government grants

NICE to lose its power to ban life saving drugs

Valeant, Kadmon enter strategic agreement for taribavirin and ribavirin

FDA approves cancer drug Afinitor for treatment of rare genetic disorder

Short courses of antibiotics have long-term impact on microbial flora of human gut

FDA grants orphan drug designation to Discovery's KL4 surfactant for CF treatment

Spectrum submits complete response to FDA's CRL for FUSILEV to treat colorectal cancer

BetterRxCard helps McLennan County residents save on prescription drugs

Biodel receives FDA CRL for Linjeta NDA

Acorda reports net income of $12.4 million for third quarter 2010

Cell Therapeutics announces submission of MAA to European Medicines Agency for Pixuvri

FDA approves Afinitor drug for tuberous sclerosis complex

FDA new approvals, antibiotic and neurological drugs

Health Canada approves PRADAX for preventing stroke in AF patients

Rite Aid to host flu shot clinics at nationwide pharmacies

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