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Mylan settles Vivelle-Dot patent litigation lawsuit with Novartis

Mylan Inc. today announced that it has settled a patent litigation lawsuit with Novartis Pharmaceuticals Corporation related to Vivelle-Dot® (Estradiol Transdermal System USP, Twice-Weekly, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day and 0.075 mg/day and 0.1 mg/day).

21 Nov 2011

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) on November 18, 2011 to remove the pre-treatment biodistribution evaluation requirement using Indium-111 ZEVALIN imaging dose followed by a gamma scan before administering the ZEVALIN therapeutic dose.

21 Nov 2011

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive preliminary results from its Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

21 Nov 2011

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Adeona Pharmaceuticals, Inc., and the Human Therapeutics Division of Intrexon Corporation, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector platform and RheoSwitch Therapeutic System for the treatment of pulmonary arterial hypertension (PAH).

21 Nov 2011

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention.

21 Nov 2011

ShangPharma third quarter net revenues increase 24.7% to $28.8 million

ShangPharma Corporation, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its unaudited financial results for the quarter ended September 30, 2011.

21 Nov 2011

$GE Healthcare, Neste Jacobs enter alliance to increase self-sufficiency in blood plasma fractionation$

GE Healthcare, Neste Jacobs enter alliance to increase self-sufficiency in blood plasma fractionation

GE Healthcare, the healthcare business of GE and Neste Jacobs, a leading global expert in plasma fractionation plant engineering design and construction, announced today that the companies have formed a strategic alliance to assist countries worldwide to become self-sufficient in the manufacture of blood plasma products.

21 Nov 2011

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Tasly Pharmaceuticals for the company's global Phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.

21 Nov 2011

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Convergence Pharmaceuticals Limited, the company focused on the development of novel and high value analgesic medicines, today announces that the multiple ascending dose Phase I study of the novel, first in class calcium channel blocker CNV2197944, for the treatment of chronic pain has been initiated.

21 Nov 2011

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Almac, a leading provider of contract services to the global pharmaceutical and biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

21 Nov 2011

Valeant signs agreement to acquire iNova

Valeant Pharmaceuticals International, Inc. announced today that it has signed an agreement to acquire iNova, a private pharmaceutical group which sells and distributes a range of prescription and over-the-counter (OTC) products in Australia, New Zealand, Southeast Asia and South Africa from Archer Capital, Ironbridge and other minority management shareholders.

21 Nov 2011

GAVI Alliance to fund roll-out of vaccines against cervical cancer, rubella in developing countries

The GAVI Alliance "has agreed to fund the roll-out of vaccines against cervical cancer in developing countries, offering protection against a disease that kills one woman every two minutes," Reuters reports.

19 Nov 2011

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.

19 Nov 2011

Shire, Shionogi enter agreement to co-develop and co-commercialize ADHD medicines in Japan

Shire plc, the global specialty biopharmaceutical company, announces that it has entered into an agreement with Shionogi & Co. Ltd. of Japan to co-develop and co-commercialize certain of Shire's Attention Deficit Hyperactivity Disorder (ADHD) medicines in Japan.

19 Nov 2011

FDA revokes approval of Avastin for breast cancer

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

19 Nov 2011

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

19 Nov 2011

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with erlotinib, a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer.

18 Nov 2011

Regeneron receives FDA approval for Eylea to treat wet AMD

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

18 Nov 2011

Tikcro reports net loss of $1.0 million for third quarter 2011

Tikcro Technologies Ltd. today reported results for the third quarter and nine months ended September 30, 2011.

18 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Pharmaceuticals News and Research

Mylan settles Vivelle-Dot patent litigation lawsuit with Novartis

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

ShangPharma third quarter net revenues increase 24.7% to $28.8 million

GE Healthcare, Neste Jacobs enter alliance to increase self-sufficiency in blood plasma fractionation

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Valeant signs agreement to acquire iNova

GAVI Alliance to fund roll-out of vaccines against cervical cancer, rubella in developing countries

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

Shire, Shionogi enter agreement to co-develop and co-commercialize ADHD medicines in Japan

FDA revokes approval of Avastin for breast cancer

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Regeneron receives FDA approval for Eylea to treat wet AMD

Tikcro reports net loss of $1.0 million for third quarter 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

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