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Amylin and Biocon collaborate to develop a peptide therapeutic for treating diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Biocon, Limited (NSE: BIOCON) announced today that they have entered into an exclusive agreement to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Amylin and Biocon will collaborate to develop the therapeutic potential of the compound and share development costs. Research will center on Amylin's "phybrid" technology.

11 Sep 2009

Recession hits some biopharmaceutical companies and CROs

Recession-driven slowdowns in drug development mean problems for some biopharmaceutical companies and, by extension, the contract research organizations (CROs) they employ to test prospective therapies.

11 Sep 2009

Phase 3 trial of ataluren commences

PTC Therapeutics, Inc. (PTC) today announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF).

11 Sep 2009

Drug manufacturers are seeking out needle-free systems

Many of the novel biopharmaceutical drugs developed now can only be delivered by injection, and this has biologic manufacturers seeking out the most patient-friendly options, including needle-free systems.

11 Sep 2009

Neurologists recommend oral cladribine for treating multiple sclerosis

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to its infrequent dosing and positive efficacy, nearly 90 percent of surveyed neurologists indicate they will prescribe Merck Serono/EMD Serono's oral cladribine for the treatment of multiple sclerosis.

11 Sep 2009

Phase II clinical trial of TAK-700 for treating advanced prostate cancer commences

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of the Phase II portion of a Phase I/II clinical trial of TAK-700 in patients with advanced prostate cancer.

11 Sep 2009

Efficacy of Instanyl in management of breakthrough cancer pain demonstrated

New data presented today further demonstrate the efficacy of Instanyl in management of breakthrough cancer pain. The data which were presented at the 6th congress of the European Federation of Chapters of the International Association for the Study of Pain (EFIC) are from a multinational, crossover trial comparing Instanyl with oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in patients with cancer.

11 Sep 2009

Adamis Pharmaceuticals' Epinephrine injection categorized as a generic

Adamis Pharmaceuticals Corporation announced on July 23 that its wholly owned subsidiary, Adamis Labs launched and shipped the first orders of the company’s Epinephrine Injection, USP, 1:1000 (0.3mg prefilled single dose syringe) (“PFS”). Today, Adamis Labs reports that at least two major data base reference companies (Medi-Span® and First DataBank) placed the Company’s PFS in their generic category.

11 Sep 2009

Ascent Therapeutics demonstrates Pepducin efficacy

Ascent Therapeutics announced today that the Company has demonstrated efficacy in preclinical models in two Pepducin projects. One of the projects targets CXCR4, a key regulator of stem cell and inflammatory cell homeostasis. A second project has yielded the first potent Pepducin agonists for an undisclosed cardiovascular target.

11 Sep 2009

Zevalin radioimmunotherapy drug approved for treating non-Hodgkin's lymphoma

SNM applauds the U.S. Food and Drug Administration's (FDA) recent decision to approve the radioimmunotherapy (RIT) drug, Zevalin, as a front-line treatment of non-Hodgkin's lymphoma (NHL).

11 Sep 2009

Abbreviated New Drug Application for nateglinide tablets approved

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets.

11 Sep 2009

Nuvilex and Legacy Biotechnologies to develop natural remedies for flu- type symptoms

Nuvilex, Inc., announces today that it has entered into a Joint Venture Agreement with Legacy Biotechnologies, Inc., a private company based in Tampa, Florida, to develop and market all natural remedies for symptoms of broad spectrum flu viruses.

11 Sep 2009

New Drug Application for trabectedin approved by the FDA

Centocor Ortho Biotech Products, L.P. 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 trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer.

11 Sep 2009

Phase 2b clinical trial results of TC-5214 to be presented at nAChR2009

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics, today confirmed plans to present data from its completed Phase 2b clinical trial of TC-5214 as an augmentation treatment for major depressive disorder at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009) in Lincolnshire, Illinois on October 15, 2009.

10 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

FDA removes clinical hold on HEPLISAV hepatitis B vaccine

Dynavax Technologies Corporation today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease.

10 Sep 2009

Phase Forward's Empirica Suite to be showcased at the 3rd annual conference

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, will participate in the 3rd annual World Drug Safety Congress Europe, to be held September 15-18 at the Bloomsbury Hotel in London, U.K.

10 Sep 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Inspire Pharmaceuticals, Inc. announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

10 Sep 2009

IBM study reveals the need for smart drug manufacturer supply chain systems

Reducing the risk of counterfeit drugs and contaminated medications amidst the complexity of global manufacturing are among the top concerns of the pharmaceutical and life sciences industries today, according to a new IBM (NYSE: IBM) study. More than 50 percent of executives polled say their companies fail to respond quickly enough to pandemics and other emergencies because of lapses in their supply chain.

10 Sep 2009