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Amgen/GSK's Prolia will be preferred as second- or third-line therapy for osteoporosis

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed clinicians say they will use Amgen/GlaxoSmithKline's Prolia as either a second- or third-line therapy for osteoporosis if the drug receives regulatory approval for the indication.

4 Dec 2009

Cancer patient “Statement of Principles” brought to the 2009 ASH meeting

A coalition of cancer patient advocacy organizations led by the International Myeloma Foundation (IMF) and the MDS Foundation (MDSF), will bring its cancer patient “Statement of Principles” to the 2009 Meeting of the American Society of Hematology (ASH) in New Orleans December 5th through 8th.

4 Dec 2009

APCER Pharma Solutions' webinar on 2010 FDA drug safety and pharmacovigilance initiatives

APCER Pharma Solutions, Inc.’s webinar on 2010 FDA drug safety and pharmacovigilance initiatives gave more than 250 professionals in the life sciences-related industries the jump start they needed to prepare for important changes next year.

4 Dec 2009

Viral Genetics to develop drug therapies for immune-related disorders and diseases

The University of Colorado and Viral Genetics Inc., recently executed an exclusive license agreement that expands on its previous agreement allowing Viral Genetics to develop treatments for autoimmune diseases, graft rejection, HIV, and cancer based on the work of M. Karen Newell, Ph.D., a professor of biology at the University of Colorado at Colorado Springs.

4 Dec 2009

ISIS-FXIRx and ISIS-SMNRx included in Isis Pharmaceuticals' development pipeline

Isis Pharmaceuticals, Inc. announced today that it has added two new drugs to its development pipeline, ISIS-FXIRx and ISIS-SMNRx.

4 Dec 2009

Two antimicrobial drug developing companies evaluate new approach for treating bacterial infections

Chaperone Technologies, Inc. and MerLion Pharmaceuticals Pte Ltd., both privately-held companies developing new antimicrobial drugs, announced today that they are together evaluating a unique approach for the treatment of resistant and life-threatening bacterial infections.

4 Dec 2009

Data from recent clinical trial for Caldolor Injection to be presented

Cumberland Pharmaceuticals Inc. announced today that data from a recent clinical trial for Caldolor® (ibuprofen) Injection, an intravenous treatment for pain and fever, will be presented at the 44th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Las Vegas, Nevada, in December.

4 Dec 2009

ISTODAX included in the updated NCCN Clinical Practice Guidelines in Oncology

Gloucester Pharmaceuticals announced today that ISTODAX® (romidepsin) has been included in the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology™ as a suggested systemic treatment option for patients with mycosis fungoides and Sézary syndrome—two of the most common types of cutaneous T-cell lymphoma (CTCL).

4 Dec 2009

Wound Management Technologies to market CellerateRx within the U.S.

Wound Management Technologies, Inc., a rapidly growing provider of specialty medical products, announced today an agreement with the Health Industry Representative Association (HIRA) to serve as a non-exclusive independent sales and marketing representative to market the company's core CellerateRx® product within the U.S.

4 Dec 2009

Sulphonylureas, an antidiabetic drug, carries greater risk of heart failure and death compared to metformin

Research: Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: Retrospective cohort study using UK general practice research database

4 Dec 2009

Alkermes licenses Medifusion technology to develop TNF receptor-Fc fusion protein

Alkermes, Inc. and Acceleron Pharma, Inc. today announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion™ technology, which is designed to extend the circulating half-life of proteins and peptides.

4 Dec 2009

WHO investigates Tamiflu resistance, updates antiviral recommendations for H1N1 patients with severely compromised immune systems

Following recent reports of clusters of Tamiflu resistance, the WHO on Wednesday recommended that patients with severely weakened immune systems who become infected with the H1N1 (swine flu) virus receive additional antiviral treatment as needed throughout the duration of their illness, Agence France-Presse reports. "

4 Dec 2009

Update on European commercial launch of MuGard for oral mucositis provided

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

4 Dec 2009

Report on the type 2 diabetes drug market in Brazil

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, forecasts that the type 2 diabetes drug market in Brazil will grow from $417 million in 2008 to $834 million in 2013.

3 Dec 2009

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone.

3 Dec 2009

FDA approves manufacture of Amneal Pharmaceuticals' Nizatidine Oral Solution

Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form and marks Amneal’s fourth liquid approval.

3 Dec 2009

Tripep receives approval to extend ChronVac-C study

Today Tripep (STO:TPEP) received the approval from the Swedish Medical Products Agency and the local ethical committee to give three patients in the highest dose group in the ChronVac-C® study one additional treatment with the therapeutic vaccine.

3 Dec 2009

FAU professor highlights the need for extensive randomized trials to distinguish drug benefits

In a commentary published in the December 2, 2009 issue of the Journal of the American Medical Association, Charles H. Hennekens, M.D., the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science at Florida Atlantic University, said, "To detect the most likely small to moderate benefits or harm of drugs requires randomized trials of sufficient size and duration. Overreliance on small trials, meta-analyses or subgroup analyses can lead to misleading conclusions."

3 Dec 2009

Nonanesthesiologist-administered propofol for GI procedures safe

The worldwide safety experience of endoscopist-administered propofol sedation now exceeds 600,000 patients. The low rate of serious adverse events underscores the safety of nonanesthesiologist-administered propofol (NAAP) for gastrointestinal (GI) procedures, provided that it is administered by a team of individuals who have received training specific to the administration of propofol according to the "Position statement: nonanesthesiologist administration of propofol for GI endoscopy" issued by the four major gastroenterology and hepatology societies.

3 Dec 2009

China's SFDA initiates quality investigation of Simcere Pharmaceutical Group subsidiary's rabies vaccine

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that China's State Food and Drug Administration ("SFDA") has initiated a comprehensive investigation into quality issues regarding human use rabies vaccine (vero cell) manufactured by Simcere's subsidiary Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen").

3 Dec 2009

Pharmaceutical News

Amgen/GSK's Prolia will be preferred as second- or third-line therapy for osteoporosis

Cancer patient “Statement of Principles” brought to the 2009 ASH meeting

APCER Pharma Solutions' webinar on 2010 FDA drug safety and pharmacovigilance initiatives

Viral Genetics to develop drug therapies for immune-related disorders and diseases

ISIS-FXIRx and ISIS-SMNRx included in Isis Pharmaceuticals' development pipeline

Two antimicrobial drug developing companies evaluate new approach for treating bacterial infections

Data from recent clinical trial for Caldolor Injection to be presented

ISTODAX included in the updated NCCN Clinical Practice Guidelines in Oncology

Wound Management Technologies to market CellerateRx within the U.S.

Sulphonylureas, an antidiabetic drug, carries greater risk of heart failure and death compared to metformin

Alkermes licenses Medifusion technology to develop TNF receptor-Fc fusion protein

WHO investigates Tamiflu resistance, updates antiviral recommendations for H1N1 patients with severely compromised immune systems

Update on European commercial launch of MuGard for oral mucositis provided

Report on the type 2 diabetes drug market in Brazil

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

FDA approves manufacture of Amneal Pharmaceuticals' Nizatidine Oral Solution

Tripep receives approval to extend ChronVac-C study

FAU professor highlights the need for extensive randomized trials to distinguish drug benefits

Nonanesthesiologist-administered propofol for GI procedures safe

China's SFDA initiates quality investigation of Simcere Pharmaceutical Group subsidiary's rabies vaccine

How does norepinephrine influence anxiety-related behaviours?

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

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