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AMCP supports legislation to prohibit financial agreements for delaying marketing of lower-cost generic drugs

The Academy of Managed Care Pharmacy (AMCP) supports the inclusion of legislative language similar to S. 369 — the Preserve Access to Affordable Generics Act — in appropriations legislation now under consideration by the Senate. S. 369 would prohibit financial agreements between brand-name and generic pharmaceutical manufacturers to delay the marketing of lower-cost generic drugs.

14 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

NCCN Oncology Policy Summit focuses on off-label use of drugs and biologics

The National Comprehensive Cancer Network (NCCN) announced today that key policy organizations and thought leaders will convene to discuss the critically important subject of the use of drugs and biologics for indications that are supported by evidence and compendia, but that are beyond the indications listed in the FDA label. This invitation-only Policy Summit will be held on December 17, 2010 at the National Press Club in Washington DC.

14 Sep 2010

$Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report$

Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report

A widely prescribed class of drugs is highly effective in reducing common bone fractures in people with osteoporosis, but an expert panel announced today that these same drugs - when used long term - may be related to unusual but serious fractures of the thigh bone.

14 Sep 2010

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Neoprobe Corporation a diversified developer of innovative oncology surgical and diagnostic products, today announced that Senior Vice President of Pharmaceutical Research and Clinical Development, Dr. Frederick O. Cope, presented information on the Company's lead pipeline initiative, Lymphoseek, at the International Symposium on Technetium and Other Radiometals in Chemistry and Medicine (TERACHEM), held September 8-11, 2010 in Bressanone (Bolzano), Italy.

14 Sep 2010

$Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL$

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it intends to appeal the U.S. Food and Drug Administration's previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL").

14 Sep 2010

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

Pharmaceutical News

AMCP supports legislation to prohibit financial agreements for delaying marketing of lower-cost generic drugs

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

NCCN Oncology Policy Summit focuses on off-label use of drugs and biologics

Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

IGI submits first ANDA to FDA

ADHD medication improves childhood cancer survivors: Research

Sanofi Pasteur files Fluzone Intradermal influenza virus vaccine sBLA with FDA

Complementary medicine to save millions: Report

Counterfeit drugs become growing problem

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

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

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

Forest files response to FDA Complete Response Letter for roflumilast NDA

Tetraphase Pharmaceuticals presents TP-434 drug candidate clinical data

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

Daiichi Sankyo receives marketing approval for Inavir in Japan

Court of Appeals favors Lilly in third-party payor suit

Santarus expands development pipeline, adds two novel biologic drug candidates

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