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FDA approves Impax's ANDA for generic OPANA ER 30mg tablet

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.

23 Jul 2010

Researchers share nanotechnology knowledge

InForm, a AU$2.7 million EU-funded project involving world-leading research institutionsincluding the University of Sydney,hosted its first conference, 'NanoFormulation2010', in June at Stockholm University.

22 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.

22 Jul 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Mylan enters settlement agreement with Forest Laboratories, Merz Pharmaceuticals for Namenda

Mylan Inc. today announced that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Namenda® Tablets, 5 mg and 10 mg, known generically as Memantine Hydrochloride (HCl) Tablets.

22 Jul 2010

Dr. Reddy reports $257 million revenue from global generics in first-quarter fiscal 2011

Dr. Reddy's Laboratories Ltd. today announced its unaudited financial results for the quarter ended June 30, 2010 under International Financial Reporting Standards (IFRS).

22 Jul 2010

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today that the first patient has received an initial dose in a Phase 2 randomized double blind clinical study combining MM-121 with exemestane (Aromasin®) in breast cancer patients.

22 Jul 2010

Medco second-quarter GAAP diluted EPS increases 20.3% to $0.77

Medco Health Solutions, Inc. today reported second-quarter 2010 GAAP diluted EPS of $0.77, up 20.3 percent compared to $0.64 for the second quarter of 2009. Adjusting for the amortization of intangible assets that existed when Medco became a publicly traded company in 2003, second-quarter 2010 diluted earnings per share increased 20.3 percent to $0.83, from $0.69 in the second quarter of 2009.

22 Jul 2010

Alexion second-quarter non-GAAP net income increases 56% to $36.9 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2010.

22 Jul 2010

Euthymics Bioscience completes $24 million Series A financing

Euthymics Bioscience, Inc., a clinical-stage company developing next-generation antidepressants, today announced the completion of a Series A financing -- led by Novartis Venture Funds and Venture Investors - for a total investment commitment of $24 million in milestone-conditioned tranches. Hambrecht & Quist Capital Management, LLC, GBS Venture Partners and the State of Wisconsin Investment Board also participated in the financing.

22 Jul 2010

New understanding on insulin resistance, action of diabetes drugs may lead to safer medication

A new understanding of insulin resistance and the action of diabetes drugs such as Avandia and Actos could pave the way for improved medications that are more selective and safer, say scientists from Dana-Farber Cancer Institute and The Scripps Research Institute.Our findings strongly suggest that good and bad effects of these drugs can be separated by designing second-generation drugs that focus on the newly uncovered mechanism, said Bruce Spiegelman, PhD, of Dana-Farber, senior author on a report appearing in the July 22 issue of Nature.

22 Jul 2010

Study investigates abusive use of drugs on children

Child abuse is a serious problem that affects nearly one million children a year in the United States alone. The American Academy of Pediatrics and the US Department of Health and Human Services classify child abuse into four categories including neglect, physical abuse, sexual abuse, and emotional abuse. None of these categories, however, clearly includes the abusive use of drugs on children. A study soon to be published in the Journal of Pediatrics investigates the malicious use of pharmaceuticals and attempts to shed light on this under-recognized problem.

22 Jul 2010

AstraZeneca provides medicines to patients at Grace Hill Neighborhood Health Centers

AstraZeneca announced today that it is providing medicines at no cost to qualifying patients at Grace Hill Neighborhood Health Centers, Inc. in St. Louis.

22 Jul 2010

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.

22 Jul 2010

Fera acquires investigational new drug for treatment of fungal otitis externa

Fera Pharmaceuticals announces the acquisition of an investigational new drug to treat fungal otitis externa (FOE).

22 Jul 2010

Elan total revenue increases 10% to $579.4 million for first half of 2010

Elan Corporation, plc today reported its second quarter and first half 2010 financial results.

22 Jul 2010

LBL signs strategic partnership agreement with Proliant

Lampire Biological Laboratories announced today that it signed an agreement with Proliant Health and Biologicals, manufacturer of the worlds most trusted, high quality Bovine Serum Albumin, to do contract filling & provide BSA to customers requiring less than Proliant's standard 10 kilogram packaging. Lampire will also offer made-to-order aqueous blends in buffers and package sizes to customer specifications.

22 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010

Pharmaceuticals News and Research

FDA approves Impax's ANDA for generic OPANA ER 30mg tablet

Researchers share nanotechnology knowledge

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Mylan enters settlement agreement with Forest Laboratories, Merz Pharmaceuticals for Namenda

Dr. Reddy reports $257 million revenue from global generics in first-quarter fiscal 2011

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Medco second-quarter GAAP diluted EPS increases 20.3% to $0.77

Alexion second-quarter non-GAAP net income increases 56% to $36.9 million

Euthymics Bioscience completes $24 million Series A financing

New understanding on insulin resistance, action of diabetes drugs may lead to safer medication

Study investigates abusive use of drugs on children

AstraZeneca provides medicines to patients at Grace Hill Neighborhood Health Centers

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Fera acquires investigational new drug for treatment of fungal otitis externa

Elan total revenue increases 10% to $579.4 million for first half of 2010

LBL signs strategic partnership agreement with Proliant

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

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