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FDA approves Mylan's ANDA for generic Solodyn ER tablets for acne treatment

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan Pharmaceuticals Inc. commenced immediate shipment of the product after approval.

23 Jul 2010

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

New HIV drug on the block

Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.

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

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

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

New era of scientific innovation to drive novel ways of treating, preventing HIV

The unwillingness of the global AIDS community to accept the status quo is fuelling a new era of scientific innovation to drive novel ways of treating and preventing HIV, organizers of the XVIII International AIDS Conference taking place in Vienna, Austria said today. And, with millions of lives dependent on expanding access to antiretroviral treatment to all those clinically in need, researchers and clinicians are partnering in new ways to find the most effective and efficient methods to deliver treatment and strengthen health systems.

22 Jul 2010

Onconase, Amphinase 2 show positive results for SARS virus: Tamir Biotechnology

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases confirmed that testing of two (2) of the company's compounds Onconase (Ranpirnase), and recombinant Amphinase 2 showed positive in vitro results for Severe Acute Respiratory Syndrome, also known as (SARS) virus.

22 Jul 2010

Eli Lilly CEO says U.S. drugmakers' biggest challenge is sustaining innovation

USA Today/Indianapolis Star: Drugmakers are facing an array of challenges, like lawsuits and patent losses, but also new opportunities including global growth and an expected surge in the number of U.S. residents with health insurance. Eli Lilly CEO John Lechleiter comments in a Q&A: "The biggest challenge facing the industry is to be able to sustain the flow of innovative medicines from our pipelines that can effectively compete against the generic versions of our own products" (Chu, 7/21).

22 Jul 2010

Medicare drug benefit appears to help more seniors with heart failure

The Medicare drug benefit may be helping more older Americans with heart failure get the medications recommended for controlling the disease, a new study finds. The study, of nearly 7,000 older heart failure patients in one large insurance plan, found that the number of filled prescriptions for standard heart failure medications increased after the Medicare drug benefit kicked in in 2006. The biggest increase was seen among seniors who had previously lacked any form of drug coverage.

22 Jul 2010

Caraco Pharmaceutical Laboratories begins marketing bupropion hydrochloride extended release tablets

Caraco Pharmaceutical Laboratories, Ltd. has started shipping bupropion hydrochloride extended release tablets. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA). These bupropion hydrochloride extended release tablets, 100 mg, 150 mg, and 200 mg, are therapeutically equivalent to GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

22 Jul 2010

AIDS 2010 opinions: U.S. AIDS funding; Human rights and HIV; Invest in primary care; Microbicide gel's possibilities

"Having met President [Barack] Obama, I'm confident that he's a man of conscience who shares my commitment to bringing hope and care to the world's poor. But I am saddened by his decision to spend less than he promised to treat AIDS patients in Africa," Desmond Tutu, archbishop emeritus of Cape Town and honorary chairman of the Global AIDS Alliance, writes in a New York Times opinion piece.

22 Jul 2010

IQPC presents summit for better implementation of PAT & QbD initiatives

IQPC presents the 4th PAT Summit: Implementing PAT & QbD for Improved Quality and Cost Savings, taking place September 13 - 15 in Philadelphia. In today's marketplace manufacturers are challenged to improve quality while simultaneously reducing development and production cost.

From IQPC Ltd 22 Jul 2010

Actavis Group receives FDA approval to market Bupropion HCl SR tablets

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion HCl Extended-Release tablets 100mg and 200mg. Distribution of the product will commence immediately.

22 Jul 2010

Avastin – breast cancer drug, fails to pass the FDA advisory panel vote on efficacy

According to a Food and Drug Administration (FDA) advisory committee’s (The Oncology Drugs Advisory Committee, or ODAC) recommendation this Tuesday, the marketing approval of the popular breast cancer drug, Avastin or Bevacizumab should be withdrawn.

21 Jul 2010

Genzyme second-quarter revenue decreases to $1.08 billion

Genzyme Corp. today reported that second-quarter revenue was $1.08 billion, compared with $1.23 billion in the same period last year, reflecting limited shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) due to product supply constraints in 2010. The company expects to be able to increase shipments of Cerezyme and Fabrazyme during the second half of the year.

21 Jul 2010

Genmab reports Arzerra net sales of DKK 73 million during second-quarter 2010

Genmab A/S announced today that the net sales for Arzerra® (ofatumumab) during the second quarter of 2010 were approximately DKK 73 million (approximately USD 12 million). Arzerra second quarter net sales in the U.S. and the rest of the world were approximately DKK 64 million (approximately USD 10.5 million) and approximately DKK 9 million (approximately USD 1.5 million) respectively.

21 Jul 2010

Health Canada grants Osiris Priority Review for Prochymal NDS

Osiris Therapeutics, Inc. announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company's New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days.

21 Jul 2010