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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

Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

Teva Pharmaceutical Industries Ltd. announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts.

6 Feb 2010

AMAG Pharmaceuticals releases safety update on Feraheme Injection

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use.

6 Feb 2010

State policy developments: Iowa seeks to extend birth control coverage; Minn. eyes more health care for poor; Miss. drug settlement

BusinessWeek: "Mississippi will receive $18.5 million from drug maker Eli Lilly and Co. as part of a settlement over claims the company promoted the anti-psychotic Zyprexa for ailments it was not federally approved to treat, Attorney General Jim Hood said Thursday" (Byrd, 2/4).

6 Feb 2010

Health bill stall creates uncertainty for drug makers

"With the possible demise of health care legislation, getting back to business as usual may not be the best thing for the nation's drug makers," The New York Times reports. "After all, in return for the prospect of tens of millions of newly insured customers and a large degree of regulatory certainty, the pharmaceutical industry had agreed to pay a relatively small price: $8 billion a year in discounts and fees.

6 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

FDA grants Talecris Biotherapeutics orphan drug designation for Alpha1-Proteinase Inhibitor to treat AAT deficiency

Talecris Biotherapeutics, Inc. announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, especially emphysema, which typically emerges in the fourth decade of life. Currently, there are no approved, inhaled treatments available for the treatment of AAT deficiency.

5 Feb 2010

Pharmaceutical News

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

Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

AMAG Pharmaceuticals releases safety update on Feraheme Injection

State policy developments: Iowa seeks to extend birth control coverage; Minn. eyes more health care for poor; Miss. drug settlement

Health bill stall creates uncertainty for drug makers

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

FDA grants Talecris Biotherapeutics orphan drug designation for Alpha1-Proteinase Inhibitor to treat AAT deficiency

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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