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FDA issues complete response letter for Bristol-Myers Squibb's belatacept

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.

3 May 2010

DHA supplements during lactation increases DHA status in preterm infants

Docosahexaenoic acid (DHA), an omega-3 fatty acid, is essential for the growth and development of infants' brains. Very premature infants may be deficient in DHA because they miss out on the third trimester in utero when the fatty acid accumulates in tissues. In addition, their gastrointestinal system is immature, and health problems often increase the risk of malnutrition.

3 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

Vitamin E effective in treating NASH: Study

Vitamin E has been shown effective in treating nonalcoholic steatohepatitis, an obesity-associated chronic liver disease that can lead to cirrhosis, liver cancer, and death. NASH also is related to or a part of type 2 diabetes, lipid disorders and cardiovascular disease.

3 May 2010

Codeine containing preparations lose their OTC status

It will get more difficult to procure Codeine based pain killers, cough syrups etc. from the local pharmacists from now on. There have been new restrictions over codeine based drugs like Nurofen Plus, Panadeine and Mersyndol which were initially sold over the counter but lost this OTC status with effect from May 1st 2010. The National Drugs and Poisons Schedule Committee formulated the changes during meetings in June and October last year.

2 May 2010

Seasonal flu vaccine ups the risk of getting H1N1 flu

Initial reports linking seasonal flu vaccine and getting swine flu or H1N1 flu emerged September 2009 in Canada. In spring 2009 many people who acquired pandemic H1N1 flu had been initially vaccinated with seasonal flu vaccine. This triggered four additional studies in Canada to explore the link further. The studies included 2,700 patients with or without H1N1. The first of the studies showed a surprising 68 percent rise of risk of development of H1N1 flu in those vaccinated with seasonal flu shot. The other 3 studies showed increase of risk of H1N1 flu by 1.4 to 1.5 times with the original flu shot.

2 May 2010

Inergetics signs three-year exclusive distributor agreement with Windmill Health Products

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has agreed in principle with Windmill Health Products to a three year exclusive distributor relationship to sell and market its Surgex sports supplement across multiple classes of trade worldwide.

30 Apr 2010

Update on BioSante cancer vaccine portfolio to be presented at BIO International Convention

BioSante Pharmaceuticals, Inc. will present a BioSante cancer vaccine portfolio update at the BIO International Convention, which will take place May 3-6 in Chicago, Illinois.

30 Apr 2010

NovaBay to present data on Aganocide compounds at ARVO annual meeting

NovaBay Pharmaceuticals, Inc. announced today that the latest public data on its Aganocide® compounds, a new class of broad-spectrum antimicrobials, will be presented during three poster sessions at the Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida.

30 Apr 2010

NeurogesX announces $40 million royalty financing agreement with Cowen Royalty

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that that it has entered into a $40 million royalty financing agreement with Cowen Healthcare Royalty Partners, L.P. ("Cowen Royalty").

30 Apr 2010

MannKind reports first-quarter net loss of $44.7 million applicable to common stockholders

MannKind Corporation today reported financial results for the first quarter ended March 31, 2010.

30 Apr 2010

Repligen granted Notice of Allowance covering use of uridine for treatment of bipolar disorder

Repligen Corporation announced today that the United States Patent and Trademark Office has granted a Notice of Allowance of a patent covering the use of uridine in the treatment of patients with bipolar disorder. The patent, which upon issue will remain in force until 2025 prior to any patent term extensions, covers the use of an effective dose of a uridine composition to improve one or more of the symptoms of bipolar disorder including depression, mania, mixed episodes, hypomania and anxiety.

30 Apr 2010

ISTA Pharmaceuticals first-quarter net revenues up 39%

ISTA Pharmaceuticals, Inc., today reported financial results for the quarter ended March 31, 2010. First quarter 2010 net revenues were $28.3 million, an increase of 39% from the first quarter of 2009. Net income for the first quarter ended March 31, 2010, was $0.5 million, or $0.01 per share, compared to a net loss of $19.6 million, or $0.59 per share, for the first quarter ended March 31, 2009.

30 Apr 2010

Repros Therapeutics receives FDA guidance for lifting clinical hold status of Proellex

Repros Therapeutics Inc. today announced that a teleconference was held with the FDA to review the clinical hold status of Proellex®. Previously clinical studies were stopped due to findings of changes in liver enzymes at higher doses of the oral drug resulting in serious adverse events. Proellex is being studied as a treatment for uterine fibroids and endometriosis.

30 Apr 2010

New PCA-Rx therapy provides natural toxin removal treatment to Alzheimer's patients

According to the Alzheimer's Association, over 5 million Americans are afflicted with Alzheimer's disease. While its cause is controversial, many people believe a correlation exists with toxin accumulation. Until recently, chelation, an invasive, drug-based toxin removal therapy, has been patients' primary option.

30 Apr 2010

Acorda Therapeutics reports AMPYRA gross sales of $3.4 million for first-quarter 2010

Acorda Therapeutics, Inc. today announced its financial results for the first quarter of 2010.

30 Apr 2010

CDC report shows increase in seasonal flu vaccinations, greatest increase among children

More Americans were vaccinated against seasonal flu during the 2009-10 season (40 percent of eligible population) than during the previous flu season (33 percent of eligible population), according to a report by the Centers for Disease Control and Prevention.

30 Apr 2010

Approval of Provenge marks beginning of new era in cancer treatment: Dana-Farber Cancer Institute

Today's announcement that the U.S. Food and Drug Administration has approved Provengeâ, a new form of therapy for some prostate cancer patients, marks the beginning of an era in which patients' own immune systems become part of the standard therapeutic arsenal against cancer, say Dana-Farber Cancer Institute investigators who led a study of the treatment's effectiveness in patients.

30 Apr 2010

UNICEF, WHO release new publication on medicines formulated for children

A new publication that lists medicines formulated for children is being made available online by UNICEF and the World Health Organization, to help doctors and organizations obtain some of the 240 essential medicines that can save the lives of children.

30 Apr 2010

CDC presents clinical trial results of Biojector 2000 at 13th Annual Conference on Vaccine Research

Bioject Medical Technologies Inc., a leading developer of needle-free injection therapy systems (NFITS), today announced that the Centers for Disease Control and Prevention (CDC) and its collaborating institutions presented the latest results of its clinical trial of the Biojector® 2000 at the 13th Annual Conference on Vaccine Research, sponsored by the National Foundation for Infectious Diseases and held in Bethesda, Maryland April 26 - 28, 2010.

30 Apr 2010

Pharmaceutical News

FDA issues complete response letter for Bristol-Myers Squibb's belatacept

DHA supplements during lactation increases DHA status in preterm infants

VIMOVO delayed-release tablets receive FDA approval

Vitamin E effective in treating NASH: Study

Codeine containing preparations lose their OTC status

Seasonal flu vaccine ups the risk of getting H1N1 flu

Inergetics signs three-year exclusive distributor agreement with Windmill Health Products

Update on BioSante cancer vaccine portfolio to be presented at BIO International Convention

NovaBay to present data on Aganocide compounds at ARVO annual meeting

NeurogesX announces $40 million royalty financing agreement with Cowen Royalty

MannKind reports first-quarter net loss of $44.7 million applicable to common stockholders

Repligen granted Notice of Allowance covering use of uridine for treatment of bipolar disorder

ISTA Pharmaceuticals first-quarter net revenues up 39%

Repros Therapeutics receives FDA guidance for lifting clinical hold status of Proellex

New PCA-Rx therapy provides natural toxin removal treatment to Alzheimer's patients

Acorda Therapeutics reports AMPYRA gross sales of $3.4 million for first-quarter 2010

CDC report shows increase in seasonal flu vaccinations, greatest increase among children

Approval of Provenge marks beginning of new era in cancer treatment: Dana-Farber Cancer Institute

UNICEF, WHO release new publication on medicines formulated for children

CDC presents clinical trial results of Biojector 2000 at 13th Annual Conference on Vaccine Research

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