Monthly Archives: November 2008

Cosmeceuticals Presents a Huge Opportunity for the Pharma Industry

November 28th, 2008|

Drug maker Dr Reddy's Laboratories recently entered into licensing and distribution agree ment with a US-based dermatology and aesthetic medicine company…[English] 

Watson Pharmaceuticals receives USFDA approval for Wellbutrin XL

November 28th, 2008|

Watson Pharmaceuticals, a leading specialty pharmaceutical company, announced that its subsidiary, Watson Laboratories has received final approval from the Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. 

Teva into agreement on Generic Pulmicort Respules(R) Patent Challenge

November 28th, 2008|

Teva Pharmaceutical Industries Ltd. announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva's U.S. generic version of AstraZeneca's Pulmicort (Budesonide) Respules® including all claims for patent infringement and damages. 

Nplate(TM) (Romiplostim) Receives Positive Opinion For Marketing Authorisation In The European Union

November 28th, 2008|

Amgen  announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate(TM) (romiplostim) in the European Union (EU). 

Vanda Pharma’s resubmission for iloperidone

November 26th, 2008|

Vanda Pharmaceuticals Inc, a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA). 

Sun Pharma acquires Chattem Chemicals

November 26th, 2008|

Sun Pharmaceutical Industries Ltd announced that its fully-owned US subsidiary, Sun Pharmaceutical Industries, Inc, has acquired cent per cent ownership of Chattem Chemicals, Inc (Chattem) from Elcat, Inc. 

NPPA hikes prices of vitamin C by over 50 percentage

November 26th, 2008|

The National Pharmaceutical Pricing Authority (NPPA) has revised the prices of vitamin C bulk drugs, hiking them upto 50 percent. The pricing authority revised prices of seven bulk drugs including vitamin C, ibuprofen and analgin. 

Roche wins EU positive opinion for RoActemra RAs drug

November 25th, 2008|

Roche has announced that the European Committee on Human Medicinal Products has given a positive recommendation for RoActemra, in combination with methotrexate, for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) 

Ipsogen launches new tumor test in Europe

November 25th, 2008|

Ipsogen, a cancer profiler that markets molecular diagnostic assays for leukemia and breast cancer, has launched the MapQuant Dx HER2 test in Europe. 

US FDA Approves J & J’s New Drug Tapentadol hydrochloride

November 25th, 2008|

Johnson & Johnson Pharmaceutical R&D, a wholly owned subsidiary of Johnson & Johnson, has announced that the FDA approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older. Tapentadol hydrochloride is an immediate-release oral tablet for the relief of moderate to severe acute pain. 

Dyax’s BLA DX-88 wins USFDA priority review

November 25th, 2008|

Dyax, a clinical stage biotechnology company, has announced that the FDA has accepted for filing the company's biologics license application for DX-88 for the treatment of acute attacks of hereditary angioedema and has designated the application for priority review. 

Dr Reddy launches ‘Imitrex’ migraine tablets in US Market

November 25th, 2008|

India-headquartered pharma major, Dr Reddy’s Laboratories has launched the authorized generic version of GlaxoSmithKline’s (GSK) ‘Imitrex’ in the US. 

Sunshine Heart’s C-Pulse gets US FDA approval

November 25th, 2008|

Sunshine Heart, a medical devices company based in Australia has received full approval from the United States Food and Drug Administration (FDA) to begin its first US clinical trial for ‘C-Pulse’.  

Valdoxan(R) receives EU CHMP Positive Opinion for Major Depressive Disorder

November 23rd, 2008|

The first melatonergic antidepressant – Valdoxan®/Thymanax® (agomelatine) – has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD). Upon approval by the European Commission in early 2009, Valdoxan is expected to be

JANUVIA Significantly Reduces Blood Sugar Levels

November 23rd, 2008|

New data presented at the 61st Annual Scientific Meeting of the Gerontological Society of America showed JANUVIA™ (sitagliptin), a diabetes medicine from Merck & Co., Inc., significantly reduced blood sugar levels in elderly patients with type 2 diabetes and was not associated with hypoglycemia (low blood sugar).

US FDA Approves Promacta(R) (Eltrombopag) to Increase Platelet Production

November 23rd, 2008|

GlaxoSmithKline announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA® (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

European regulator rejects Bristol-Myers breast cancer drug

November 23rd, 2008|

The European Medicines Agency on Friday said it rejected a marketing application for Bristol-Myers Squibb  drug Ixempra, with the regulator worried that damage to nerve cells didn't outweigh the "very small increase" in survival from breast cancer.

CHMP Recommends approval of New Indication for Enbrel(R) to treat severe Psoriasis

November 23rd, 2008|

The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis. If approved by the European Commission, following the Committee's recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents.

Abbott Labs announces $184 million in settlements

November 23rd, 2008|

Pharmaceutical and medical products maker Abbott Laboratories Inc. has announced settlements totaling about $184 million for a federal court case involving class action claims over its popular cholesterol medication TriCor.

USFDA Advisory Committee gives positive response on Oritavancin

November 20th, 2008|

Targanta Therapeutics Corporation announced that oritavancin, the Company’s investigational antibiotic therapy for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive pathogens, including methicillin resistant Staphylococcus aureus (MRSA), received a mixed review from the United States Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee.