Pharmaceutical News

RSS

IGI submits first ANDA to FDA

IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application (ANDA) to the US FDA. IGI President and CEO Charlie Moore commented "This is a significant step forward in validating IGI's commitment to pharmaceutical product development.

14 Sep 2010

ADHD medication improves childhood cancer survivors: Research

A medicine widely used to treat attention-deficit/hyperactivity disorder (ADHD) also provides long-term relief from the attention and behavior changes that affect many childhood cancer survivors, according to a multicenter trial led by St. Jude Children's Research Hospital investigators.

14 Sep 2010

Sanofi Pasteur files Fluzone Intradermal influenza virus vaccine sBLA with FDA

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal (Influenza Virus Vaccine). The file has been accepted by the FDA and an action date is anticipated in the first half of 2011.

From BD (Becton, Dickinson and Company) 14 Sep 2010

Complementary medicine to save millions: Report

According to a new report substituting pharmaceutical antidepressants with St John’s Wort could save the health system $50 million a year. This research was conducted by Access Economics for the National Institute of Complementary Medicine (NICM) at the University of Western Sydney. It showed that cost effectiveness of complementary and alternative therapies have the potential to cut costs without compromising patient outcomes.

13 Sep 2010

Counterfeit drugs become growing problem

"Last year, nearly 1,700 incidents of counterfeit drugs were reported worldwide, triple the number in 2004, says the Pharmaceutical Security Institute (PSI), a group funded by drugmakers," USA Today reports. "Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year. The market is likely much bigger because many cases are hard to detect.

13 Sep 2010

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Shire, the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

13 Sep 2010

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

AB SCIEX, a global leader in life science analytical technologies, and the University of Melbourne today announced a joint technology development project to improve drug metabolism studies of biopharmaceuticals.

13 Sep 2010

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

InterMune, Inc. today announced that four oral presentations related to the company's development program for pirfenidone and idiopathic pulmonary fibrosis will be presented at the Annual Congress of the European Respiratory Society, to be held September 18-22 in Barcelona, Spain.

13 Sep 2010

Forest files response to FDA Complete Response Letter for roflumilast NDA

Forest Laboratories, Inc. today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast. Forest licenses roflumilast from Nycomed, which submitted the original NDA.

13 Sep 2010

Tetraphase Pharmaceuticals presents TP-434 drug candidate clinical data

Tetraphase Pharmaceuticals, Inc., yesterday presented new clinical and preclinical data for its lead drug candidate, TP-434, which demonstrated the novel antibiotic as a once daily intravenous (I.V.) monotherapy capable of treating multidrug-resistant gram-negative pathogens while also having potency and broad spectrum coverage of other serious and multidrug resistant gram-positive pathogens.

13 Sep 2010

Scientists to present preclinical pharmacology data on TRV120027 at Heart Failure Society of America Meeting

Trevena Inc., the leader in the discovery and development of G-protein coupled receptor biased ligands, today announced that its scientists are presenting two posters featuring compelling preclinical pharmacology data on TRV120027 at the 14th Annual Heart Failure Society of America Meeting being held September 12-15, 2010 in San Diego.

13 Sep 2010

Daiichi Sankyo receives marketing approval for Inavir in Japan

Biota Holdings Limited today announced that Daiichi Sankyo has received approval to manufacture and market Inavir® in Japan. Inavir® is Daiichi Sankyo's brand of laninamivir octanoate and also previously known as CS-8958. The approved indication is for the treatment of influenza in adults and children.

13 Sep 2010

Court of Appeals favors Lilly in third-party payor suit

Eli Lilly and Company today announced that the U.S. Court of Appeals for the Second Circuit has agreed with Lilly's position that a class should not have been certified in a pending third-party payor suit, in which unions and insurers who act as third-party payors alleged that they overpaid for Zyprexa prescriptions. The court also agreed with Lilly that plaintiffs' overpricing claims should not go forward.

13 Sep 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

Santarus, Inc., a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.

13 Sep 2010

Debiopharm, Aurigene commence IND enabling studies for Debio 0617 inhibitor

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and Aurigene Discovery Technologies Ltd., a Bangalore based fully integrated, global biotech focused on small molecule and peptide drug discovery and development from target identification and validation to pre IND drug candidates, today announced the successful nomination of a development candidate, Debio 0617, a novel inhibitor of an undisclosed oncology pathway.

13 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Rib-X Pharmaceuticals presents preclinical data of radezolid drug at ICAAC Conference

Rib-X Pharmaceuticals, Inc., a development-stage antibiotics company with a broad product pipeline based on its innovative discovery platform, today announced the presentation of positive preclinical data for radezolid at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference.

13 Sep 2010

CRT agrees with AstraZeneca for AZD-3965 clinical trial

Cancer Research UK and Cancer Research Technology the charity's development and commercialisation arm have reached an agreement with AstraZeneca to take compound AZD-3965 a first-of-its-kind experimental drug to potentially treat a range of cancers into clinical trial.

13 Sep 2010

Covidien supports FDA labeling changes for gadolinium-based contrast agents

Covidien, a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

13 Sep 2010

FDA approves CorMatrix ECM for Pericardial Closure

CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.

13 Sep 2010