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Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.

9 Feb 2010

Merck's asthma drug formoterol/mometasone to garner global peak year sales of more than $250M

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, following its expected launch this year for the treatment of asthma, Merck's formoterol/mometasone will garner peak year sales of more than $250 million in the United States, France, Germany, Italy, Spain and the United Kingdom.

9 Feb 2010

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

Psyadon Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study ecopipam in patients with Lesch-Nyhan Disease (LND). The first center at which the drug will be evaluated is Emory University under the direction of Dr. Hyder A. Jinnah, MD, PhD. The study is designed to evaluate the safety and tolerability of different doses of ecopipam in adults (group 1), adolescents (group 2) and children (group 3) with LND.

9 Feb 2010

Glaucoma medications appear to reduce mortality risk

Glaucoma patients who take medication for the condition appear to have a reduced likelihood of death, according to a report in the February issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

9 Feb 2010

Study indicates pain treatment may vary in Latino and white children post surgery

Differences might exist in the amount of pain medicine given to Latino and white children after surgery, found a new, small study in which Latino children received 30 percent less opioid analgesics (morphine or morphine-like drugs) than white children did.

9 Feb 2010

FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already commenced.

9 Feb 2010

FDA approves Sagent Pharmaceuticals' labetalol HCl injection for severe hypertension

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two vial sizes – 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials.

9 Feb 2010

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

An early stage clinical trial of the experimental drug dimebon (latrepirdine) in people with Huntington's disease appears to be safe and may improve cognition. That is the conclusion of a study published today in the Archives of Neurology.

9 Feb 2010

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.

9 Feb 2010

Hospitals selling uninsured drugs may negatively impact public system

Governments are under increasing pressure to provide access to expensive new drugs. Canadian patients who want access to drugs that are not publicly insured are seeking to pay for these drugs within public hospitals, states an article in CMAJ (Canadian Medical Association Journal) (pre-embargo link only).

8 Feb 2010

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

8 Feb 2010

Repros Therapeutics submits Androxal revised indication statement to the FDA

Repros Therapeutics Inc. today announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA’s Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state.

8 Feb 2010

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced a collaboration and license agreement with Panacor Bioscience Ltd. to develop and commercialize its Nephoxil(R) pharmaceutical product for the treatment of hyperphosphatemia in China.

8 Feb 2010

LPC Pharma Group outsources pharmacovigilance/drug safety operations to APCER Pharma

APCER Pharma announced that LPC Pharma Group is outsourcing its pharmacovigilance/drug safety operations to APCER.

8 Feb 2010

Novavax to discontinue collaboration agreement with ROVI Pharmaceuticals

Novavax, Inc. announced today that the company has decided to discontinue negotiations in its pursuit of the previously announced collaboration with ROVI Pharmaceuticals to develop Novavax's virus-like-particle (VLP)-based vaccines against influenza in the country of Spain.

8 Feb 2010

Researchers find low prevalence of tamoxifen use for prevention of breast cancer among women

Researchers with the National Cancer Institute (NCI) have found that the prevalence of tamoxifen use for the prevention of breast cancer among women without a personal history of breast cancer is very low.

8 Feb 2010

Investigational drug for osteoporosis inhibits serotonin synthesis in the gut

An investigational drug that inhibits serotonin synthesis in the gut, administered orally once daily, effectively cured osteoporosis in mice and rats reports an international team led by researchers from Columbia University Medical Center, in the Feb. 7 issue of Nature Medicine.

7 Feb 2010

URAC seeks public input for Pharmacy Quality Management Accreditation programs

As part of its commitment to a comprehensive review of its standards, URAC, the nation's leading health care accreditation and education organization, today called for public comment on revisions to its suite of Pharmacy Quality Management® Accreditation programs.

6 Feb 2010

Combination of Motrin and Robitussin drugs is safe for adults and children

A viral e-mail currently making the rounds between private accounts and public message boards warning of a danger posed by mixing over-the-counter medications Motrin and Robitussin is unfounded.

6 Feb 2010

HPV vaccination programs may reduce genital diseases

High-coverage human papillomavirus (HPV) vaccinations among adolescents and young women may result in a rapid reduction of genital warts, cervical cell abnormalities, and diagnostic and therapeutic procedures, researchers report in a new study published online February 5 in the Journal of the National Cancer Institute. Some of these genital abnormalities are precursors of cervical, vulvar, and vaginal cancers.

6 Feb 2010

Pharmaceutical News

Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

Merck's asthma drug formoterol/mometasone to garner global peak year sales of more than $250M

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

Glaucoma medications appear to reduce mortality risk

Study indicates pain treatment may vary in Latino and white children post surgery

FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

FDA approves Sagent Pharmaceuticals' labetalol HCl injection for severe hypertension

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Hospitals selling uninsured drugs may negatively impact public system

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Repros Therapeutics submits Androxal revised indication statement to the FDA

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

LPC Pharma Group outsources pharmacovigilance/drug safety operations to APCER Pharma

Novavax to discontinue collaboration agreement with ROVI Pharmaceuticals

Researchers find low prevalence of tamoxifen use for prevention of breast cancer among women

Investigational drug for osteoporosis inhibits serotonin synthesis in the gut

URAC seeks public input for Pharmacy Quality Management Accreditation programs

Combination of Motrin and Robitussin drugs is safe for adults and children

HPV vaccination programs may reduce genital diseases

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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