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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

HPV vaccine can prevent 90% of genital warts in men: Study

The vaccine for human papillomavirus can prevent 90 percent of genital warts in men when offered before exposure to the four HPV strains covered by the vaccine, according to a new multi-center study led by H. Lee Moffitt Cancer Center and UCSF.

4 Feb 2011

Merck reports GAAP net income of $861 million for 2010

Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88, which excludes purchase accounting adjustments, restructuring costs and merger-related expenses.

4 Feb 2011

Positive results from KYTHERA's ATX-101 Phase IIb study for reduction of submental fat

KYTHERA Biopharmaceuticals, Inc. today announced that it has successfully completed a third Phase II clinical study with ATX-101, a first-in-class adipolytic agent that is under investigation for the reduction of submental ('under-the-chin') fat.

4 Feb 2011

Bayer HealthCare's regorafenib receives orphan drug status for GIST treatment

Bayer HealthCare Pharmaceuticals Inc. announced today that its investigational compound regorafenib has been granted orphan drug status for the treatment of patients with gastrointestinal stromal tumors by the U.S. Food and Drug Administration.

4 Feb 2011

CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds

CardioVascular BioTherapeutics, Inc. today announced it has submitted an application to the U.S. FDA to obtain "fast track" designation for CVBT-141B, its biological therapy to treat ischemic diabetic wounds based on the active ingredient fibroblast growth factor-1 (FGF-1).

4 Feb 2011

Positive results from Derma Sciences' Phase 2 trial with DSC127 in patients with diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced positive results from its Phase 2 clinical trial with DSC127 in patients with diabetic foot ulcers, including meeting the trial's primary endpoint, the proportion of study ulcers healed by 12 weeks as defined by 100% epithelialized with no drainage, as well as all secondary endpoints measured at this time.

3 Feb 2011

Placebo News and Research

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

HPV vaccine can prevent 90% of genital warts in men: Study

Merck reports GAAP net income of $861 million for 2010

Positive results from KYTHERA's ATX-101 Phase IIb study for reduction of submental fat

Bayer HealthCare's regorafenib receives orphan drug status for GIST treatment

CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds

Positive results from Derma Sciences' Phase 2 trial with DSC127 in patients with diabetic foot ulcers

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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