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ExonHit Therapeutics includes proprietary lead compounds into collaboration with Allergan

ExonHit Therapeutics today announced the inclusion of proprietary lead compounds, which were derived from one of its internal medicinal chemistry programs, into its productive and long-running strategic collaboration with Allergan.

23 Feb 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., has received notice of allowance from the US Patent Office for its two key patent applications covering methods of use and compositions covering the use of betahistine with olanzapine for the mitigation of the serious weight gain associated as a side effect of the antipsychotic drug.

23 Feb 2010

Study shows CEL-2000 vaccine blocks RA progression in mice

CEL-SCI Corporation and their scientific collaborators announced today that the Company's CEL-2000 vaccine demonstrated that it is able to block the progression of rheumatoid arthritis (RA) in a mouse model.

23 Feb 2010

FDA grants Haemonetics clearance to collect two RBC on Cymbal system

On January 27, 2010 the FDA cleared the Haemonetics 510(k) for its expanded nomogram to collect two Red Blood Cells on the Cymbal® Automated Blood Collection System from female donors who are at least 150 pounds and are 63 inches in height. The Cymbal is a small, portable, battery operated instrument that automates blood collection from volunteer donors, improving process control and helping alleviate blood shortages.

23 Feb 2010

DURECT, Nycomed amend POSIDUR Development and License Agreement

DURECT Corporation announced today that Nycomed and DURECT have amended the Development and License Agreement entered into between the parties in 2006 covering the development and commercialization of POSIDUR™ (also known as SABER™-Bupivacaine or OPTESIA™), an investigational drug for the treatment of post-surgical pain.

23 Feb 2010

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

Star Scientific, Inc. announced that on Friday, February 19 the company filed an application with the Food & Drug Administration for approval to market Ariva-BDL™ as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

23 Feb 2010

Eon Labs to pay $3.5M for resolving False Claims Act allegations concerning Nitroglycerin SR capsules

Eon Labs Inc. has agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company's drug Nitroglycerin Sustained Release (SR) capsules, the Justice Department announced today. Eon Labs is a subsidiary of Sando Inc., which is in turn a subsidiary of Novartis AG.

23 Feb 2010

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

23 Feb 2010

Senate, FDA reports increasing concerns about controversial diabetes drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline."

23 Feb 2010

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

A new guideline from the American Academy of Neurology recommends that the drug quinine, although effective, should be avoided for treatment of routine muscle cramps due to uncommon but serious side effects.

23 Feb 2010

Chiltern International and Charles River Laboratories to study radiolabelled drug products

Chiltern International Limited, a global contract research organization (CRO), announced its latest collaboration with Charles River Laboratories, Inc. As part of this collaboration, Chiltern Early Phase will partner with Charles River to conduct and support early phase radiolabelled studies.

22 Feb 2010

Ritter Pharmaceuticals to discuss lactose intolerance and associated health risks at NIH Conference

Ritter Pharmaceuticals, a company dedicated to helping individuals live a healthier and happier life style through improved digestion, announced today that it will join the leading lactose intolerance experts around the country at the NIH Consensus Development Conference for Lactose Intolerance and Health in Bethesda, Maryland from February 22-24.

22 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.

22 Feb 2010

Genetics associated with DILI and SSR: FDA and SAEC complete third release of data

The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).

22 Feb 2010

Cancer pain patients: European regulations restricting access to opioid-based drugs

Many cancer patients in Europe are being denied access to adequate pain relief because of over-zealous regulations restricting the availability and accessibility of opioid-based drugs such as morphine.

22 Feb 2010

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

U.S. Attorney Thomas Scott Woodward announced today that Cardinal Health Pharmacy Services, LLC, a company engaged in providing hospital pharmacy management services, has agreed to pay a civil penalty in the amount of $1 million for failing to account for large amounts of missing prescription drugs.

20 Feb 2010

News outlets examine HIV vaccine research, cervical cancer screening data presented at conference

Several news outlets examine the latest reports out of this week's Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

20 Feb 2010

Pharmaceutical News

ExonHit Therapeutics includes proprietary lead compounds into collaboration with Allergan

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Study shows CEL-2000 vaccine blocks RA progression in mice

FDA grants Haemonetics clearance to collect two RBC on Cymbal system

DURECT, Nycomed amend POSIDUR Development and License Agreement

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

Eon Labs to pay $3.5M for resolving False Claims Act allegations concerning Nitroglycerin SR capsules

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Senate, FDA reports increasing concerns about controversial diabetes drug

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

Chiltern International and Charles River Laboratories to study radiolabelled drug products

Ritter Pharmaceuticals to discuss lactose intolerance and associated health risks at NIH Conference

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Genetics associated with DILI and SSR: FDA and SAEC complete third release of data

Cancer pain patients: European regulations restricting access to opioid-based drugs

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

News outlets examine HIV vaccine research, cervical cancer screening data presented at conference

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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