Pharmaceutical News

RSS

Study to identify early warning biomarkers for presence of breast and prostate cancers

Using biological samples taken from patients and state-of-the-art biochemical techniques, a Florida State University researcher is working to identify a variety of "biomarkers" that might provide earlier warnings of the presence of breast and prostate cancers.

11 Jan 2011

Discovery Labs provides update on Surfaxin FDA marketing authorization for RDS in premature infants

Discovery Laboratories, Inc., a biotechnology company developing its novel, synthetic, peptide-containing surfactant, is providing an update regarding its efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization of Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants.

11 Jan 2011

Largest, national long-term study of children's health opens for Cuyahoga County

Residents of Cuyahoga County, and later Lorain County, will soon have the opportunity to contribute to the establishment of a national resource for childhood growth and development. The National Children's Study is the largest, long-term study of children's health ever conducted in the United States. It will follow 100,000 children from pre-birth to 21-years-old. The study will enroll women who are pregnant or planning to become pregnant in the next few years.

11 Jan 2011

Nutriceuticals may restore age-related vision loss

While age-related vision loss of catastrophic proportions is predicted in coming decades, rising from 17 million patients today to 55 million by the year 2050, it's possible this catastrophe could be averted and lost vision even restored using molecular medicine.

11 Jan 2011

Predator microbes may work against antibiotic resistant disease-causing bacteria: Study

There are predators in the bacterial world that consume other bacteria, much as predators attack prey in the animal world. A team led by researchers at the University of Medicine and Dentistry of New Jersey-New Jersey Dental School suggests that some of these predator microbes might be put to work against disease-causing bacteria that have become resistant to antibiotics.

11 Jan 2011

PPD announces joint venture with TBL to develop novel biotherapeutics

PPD, today announced it has established a joint venture with Taijitu Biologics Limited in the area of the discovery of novel biotherapeutics. The joint venture, named BioDuro Biologics, expands PPD's capability to deliver unique, highly differentiated drug discovery services for biopharmaceutical companies across the globe.

10 Jan 2011

IGI Laboratories submits second abbreviated new drug application to FDA

IGI Laboratories, a New Jersey based formulation and manufacturing company, today announced that it has submitted its second abbreviated new drug application to the US FDA.

10 Jan 2011

Obama administration sides with drug companies in pricing lawsuit; Supreme Court agrees to hear case regarding use of prescription drug data

At issue are charges to public hospitals and clinics that treat a large number of poor patients and a Vermont law that restricts prescription drug data.

10 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Neomend receives CE Mark for ProGEL PLATINUM Surgical Sealant

Neomend, Inc., an innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company's ProGEL® PLATINUM Surgical Sealant.

10 Jan 2011

EffRx submits EX101 NDA for osteoporosis treatment to FDA

EffRx Pharmaceuticals SA, a Lausanne, Switzerland based drug delivery company announces the NDA submission of the company's lead project to the US Food and Drug Administration.

10 Jan 2011

Manhattan enters settlement and release agreement with Nordic and H Pharmaceuticals

Manhattan Pharmaceuticals, Inc. announced that on January 4, 2011, the company entered into a settlement and release agreement with Nordic Biotech Fund II K/S and H Pharmaceuticals K/S. Manhattan Pharmaceuticals and Nordic are partners in the H Pharmaceuticals joint venture for the development and commercialization of Hedrin®, a non-pesticide treatment for head lice.

10 Jan 2011

Pennsaid fourth quarter prescriptions increase 20% sequentially

Nuvo Research Inc., a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced it will be meeting with several U.S. investment bankers, analysts and fund managers during J.P. Morgan's 29th annual Healthcare Conference held from January 10th to January 13th, 2011, in San Francisco, California.

10 Jan 2011

New, paid prescriptions for Questcor's Acthar increase 66%

Questcor Pharmaceuticals, Inc. today reported a strong finish to 2010. The Company estimates that 353 new, paid Acthar prescriptions for the treatment of multiple sclerosis (MS) were filled and shipped during the quarter, up 66% from the year ago period and up 9% from the third quarter of 2010.

10 Jan 2011

Watson receives FDA approval for generic Fentora

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ® tablets.

10 Jan 2011

New study finds extending term of exclusive access can lead to higher drug costs in short term

A new study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data — and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

10 Jan 2011

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for its new formulation of OPANA® ER designed to be crush resistant.

10 Jan 2011

FDA warns public about extortion scam

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued international extortion scam.

10 Jan 2011

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc has received approval from the US Food and Drug Administration for Abstral. Abstral is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain.

10 Jan 2011

U.S. District Court grants injunction for Sensipar patents

A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's Sensipar® (cinacalcet) until expiration of the drug's U.S. patents.

10 Jan 2011