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Bioniche receives fast track for bladder cancer therapy

Bioniche Life Sciences Inc. has announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its therapy for first-line non-muscle-invasive bladder cancer meets the criteria for Fast Track designation.

6 Mar 2008

Warning of psychiatric side effects with flu drug Tamiflu

Warnings are being issued concerning the drug Tamiflu by both the drug company Roche and the Food and Drug Administration (FDA) in the U.S.

5 Mar 2008

FDA approves Aloxi injection for prevention of postoperative nausea and vomiting

Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

4 Mar 2008

1 in 3 women has pelvic floor disorder

A new study by Kaiser Permanente found that one-third of women suffer from one or more pelvic floor disorders, which include symptoms such as the frequent urge to urinate, dropped pelvic organs, and incontinence.

3 Mar 2008

FDA grants priority review for ACIPHEX (rabeprazole sodium) sNDA for treatment of GERD in adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., has announced that the Food and Drug Administration (FDA) has accepted an ACIPHEX supplemental New Drug Application (sNDA) for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in patients ages 12-16.

3 Mar 2008

FDA approves PRISTIQ for the treatment of adult patients with major depressive disorder

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD).

3 Mar 2008

FzioMed's Oxiplex gel for spine surgery approved in Canada

FzioMed, Inc. (www.fziomed.com) has announced that Health Canada has approved the company's Oxiplex gel for use in lumbar spine surgery.

1 Mar 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

Abilify (aripiprazole) approved for acute treatment of bipolar I disorder in adolescents

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old).

1 Mar 2008

Lilly knocked back by FDA on Zyprexa for schizophrenia treatment

Eli Lilly and Company has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced.

28 Feb 2008

FDA approves Nexium for gastroesophageal reflux disease in children

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD).

28 Feb 2008

Forest Laboratories to develop and distribute the novel beta blocker Bystolic (nebivolol)

Mylan Inc. has announced that it and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. have amended their January 2006 agreement to commercialize, develop and distribute the novel beta blocker Bystolic (nebivolol), which is currently approved in the United States for the treatment of hypertension.

28 Feb 2008

FDA approves Arcalyst for treatment of rare inflammatory syndromes

The U.S. Food and Drug Administration has approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases.

28 Feb 2008

Nasal vaccine for smallpox protects animals against 77 times the potentially lethal dose of smallpox

Scientists at NanoBio Corporation and the University of Michigan have demonstrated their nasally delivered vaccinia vaccine can protect animals against 77 times the potentially lethal dose of smallpox, and without the safety risks of current vaccines for smallpox.

27 Feb 2008

Galderma to acquire CollaGenex Pharmaceuticals

Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, and CollaGenex Pharmaceuticals, Inc. has announced a definitive agreement pursuant to which Galderma's U.S. holding company, Galderma Laboratories, Inc., will acquire all of the outstanding shares of CollaGenex at a price of $16.60 per share in cash, representing approximately $420 million for the equity of CollaGenex.

27 Feb 2008

PolyTherics and Celtic Pharma sign agreement to explore technologies for improved drug performance

PolyTherics Limited, a biopharmaceutical spin-out company from Imperial College London and the London School of Pharmacy, and Celtic Pharma Development Services Bermuda Ltd, a subsidiary of Celtic Pharmaceutical Holdings LP, a global private equity investment fund focused on the biopharma industry, today announced that they have entered into a broad research collaboration agreement.

26 Feb 2008

Mail order pharmacies growing more popular

Of Americans who buy prescription drugs, the proportion who purchase them from mail order pharmacies rose from just under 9 percent in 2000 to just over 13 percent in 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

26 Feb 2008

Questions over use of antibiotics in 'end of life' care

Antibiotics appear to be frequently prescribed to individuals with advanced dementia in nursing homes, especially in the two weeks before death, according to a report in the February 25 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

26 Feb 2008

Abbott receives approval for HUMIRA (Adalimumab) for polyarticular juvenile idiopathic arthritis

Abbott has announced that it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older.

26 Feb 2008

XYNTHA approved for teatment of hemophilia A by FDA

Wyeth Pharmaceuticals, a division of Wyeth ( NYSE:WYE) , announced today that it has received approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis.

22 Feb 2008

Pharmaceutical News

Bioniche receives fast track for bladder cancer therapy

Warning of psychiatric side effects with flu drug Tamiflu

FDA approves Aloxi injection for prevention of postoperative nausea and vomiting

1 in 3 women has pelvic floor disorder

FDA grants priority review for ACIPHEX (rabeprazole sodium) sNDA for treatment of GERD in adolescents

FDA approves PRISTIQ for the treatment of adult patients with major depressive disorder

FzioMed's Oxiplex gel for spine surgery approved in Canada

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

Abilify (aripiprazole) approved for acute treatment of bipolar I disorder in adolescents

Lilly knocked back by FDA on Zyprexa for schizophrenia treatment

FDA approves Nexium for gastroesophageal reflux disease in children

Forest Laboratories to develop and distribute the novel beta blocker Bystolic (nebivolol)

FDA approves Arcalyst for treatment of rare inflammatory syndromes

Nasal vaccine for smallpox protects animals against 77 times the potentially lethal dose of smallpox

Galderma to acquire CollaGenex Pharmaceuticals

PolyTherics and Celtic Pharma sign agreement to explore technologies for improved drug performance

Mail order pharmacies growing more popular

Questions over use of antibiotics in 'end of life' care

Abbott receives approval for HUMIRA (Adalimumab) for polyarticular juvenile idiopathic arthritis

XYNTHA approved for teatment of hemophilia A by FDA

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