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Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes.

9 Feb 2011

Clinical Data reports $2.0 million revenue for third quarter 2011

Clinical Data, Inc. today announced operational and financial results for the third fiscal quarter ended December 31, 2010. The Company received approval from the U.S. Food and Drug Administration (FDA) of Viibryd™ for the treatment of adults with major depressive disorder (MDD) on January 21, 2011.

9 Feb 2011

Repligen third quarter total revenue increases 26% to $7,068,000

Repligen Corporation today reported results for the third quarter of fiscal year 2011, ended December 31, 2010. Total revenue for the quarter was $7,068,000 compared to total revenue of $5,617,000 for the third quarter of fiscal year 2010 ended December 31, 2009, an increase of $1,451,000 or 26%.

9 Feb 2011

QLT's Phase II olopatadine punctal plug delivery system trial demonstrates safety in allergic conjunctivitis patients

QLT Inc. today announced results from a Phase II proof-of-concept clinical trial for the olopatadine punctal plug delivery system (O‑PPDS).

9 Feb 2011

R-Tech commences RK-023 Phase I study for treatment of eyelash hypotrichosis

R-Tech Ueno is pleased to announce the initiation of a Phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes.

9 Feb 2011

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

Gentium S.p.A. today announced that ongoing preclinical and clinical studies on Defibrotide have been completed and confirmed its plan to file for regulatory approval of Defibrotide with the US Food and Drug Administration and the European Medicines Agency by the end of the second quarter of 2011.

9 Feb 2011

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced it has received Food and Drug Administration ("FDA") clearance for its phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States.

9 Feb 2011

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

9 Feb 2011

ASBP concerned over FDA rejection of Contrave drug

The American Society of Bariatric Physicians is concerned that the FDA recently rejected the weight-loss drug Contrave, contradicting the FDA advisory panel's recommendation for approval. The rejection of Contrave marks the third weight-loss drug to be rejected by the FDA in the past six months.

8 Feb 2011

Avandia label revised as per FDA directive

Following the 2010 FDA directive, pharmaceutical manufacturer Glaxo-SmithKline announced this Monday that they have modified the label for diabetes drug rosiglitazone (Avandia). The new label restricts its use to patients already taking it or to those who have failed other antiglycemic drugs.

8 Feb 2011

Elan 2010 total revenue increases 5% to $1,169.7 million

Elan Corporation, plc today reported its fourth quarter and full-year 2010 financial results and provided financial guidance for 2011.

8 Feb 2011

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

8 Feb 2011

Almac opens analytical facility at new 240,000 sq. ft. North American Headquarters

Almac's new 240,000 sq. ft. North American Headquarters, built on 40 acres in Souderton, PA, north of Philadelphia is part of the Almac Group's integrated services solutions strategy. The new facility delivers full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients.

8 Feb 2011

Transition reports second quarter 2011 net income of $24.28M vs. $6.05M net loss for second quarter 2010

Transition Therapeutics Inc., a product-focused biopharmaceutical company developing therapeutics for disease indications with large markets, today announced its financial results for the quarter ended December 31, 2010.

8 Feb 2011

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

AstraZeneca and Targacept, Inc. today announced initiation of a Phase 2b clinical trial of TC-5214, a nicotinic channel blocker, as a "switch" monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies' Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD.

7 Feb 2011

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide).

7 Feb 2011

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced publication of the BLISS-52 study of BENLYSTA in autoantibody-positive patients with active systemic lupus erythematosus in The Lancet.

7 Feb 2011

Positive results from EpiCept NP-1 Phase IIb trial in patients with CPN

EpiCept Corporation today announced positive results from a Phase IIb trial evaluating the efficacy and safety of EpiCept NP-1 in chemotherapy-induced peripheral neuropathy. EpiCept NP-1 is a topical analgesic cream containing two FDA-approved drugs, amitriptyline and ketamine, in development for the relief of pain from various peripheral neuropathies.

7 Feb 2011

Pediatric physicians present 12 research abstracts, posters at Cardiology 2011

Pediatric cardiology researchers and clinicians gather this week in Scottsdale, Ariz. for Cardiology 2011, the 15th Annual Update on Pediatric and Congenital Cardiovascular Disease, sponsored by The Children's Hospital of Philadelphia. Original research from more than 30 cardiac programs in the U.S. and abroad is being presented throughout the meeting.

7 Feb 2011

Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA

Amgen and Pfizer Inc. today announced results from a new trial that demonstrated Enbrel significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology meeting in New Orleans, La.

5 Feb 2011

Placebo News and Research

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Clinical Data reports $2.0 million revenue for third quarter 2011

Repligen third quarter total revenue increases 26% to $7,068,000

QLT's Phase II olopatadine punctal plug delivery system trial demonstrates safety in allergic conjunctivitis patients

R-Tech commences RK-023 Phase I study for treatment of eyelash hypotrichosis

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

ASBP concerned over FDA rejection of Contrave drug

Avandia label revised as per FDA directive

Elan 2010 total revenue increases 5% to $1,169.7 million

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Almac opens analytical facility at new 240,000 sq. ft. North American Headquarters

Transition reports second quarter 2011 net income of $24.28M vs. $6.05M net loss for second quarter 2010

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Positive results from EpiCept NP-1 Phase IIb trial in patients with CPN

Pediatric physicians present 12 research abstracts, posters at Cardiology 2011

Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA

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