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Pfizer reports final results from randomized Phase 3 trial of Sutent

Pfizer Inc. today announced final results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic neuroendocrine tumors, a type of cancer which originates in the hormone-producing area of the pancreas.

23 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

Progress in Anadys Pharmaceuticals' Phase II study of ANA598 announced

Anadys Pharmaceuticals, Inc. today announced that ANA598 dosing has been completed in the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients.

22 Jan 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

AlphaRx Inc. announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO), to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuroprotectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

22 Jan 2010

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today announced the formation of a strategic partnership between Ipsen and Inspiration Biopharmaceuticals ("Inspiration") to create a world leading hemophilia franchise, an important milestone for the Celtic Pharma portfolio.

21 Jan 2010

Amgen announces results of two Phase 3 studies evaluating Vectibix for mCRC

Amgen today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME '203' and '181' trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010.

21 Jan 2010

China Pharma Holdings announces completion of clinical trials for Candesartan

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.

21 Jan 2010

Elevation Pharmaceuticals closes $30M tranched Series A financing

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today the closing of a $30 million tranched Series A financing.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Results of two pivotal Phase III clinical trials with oral FTY720 published

Results of the TRANSFORMS and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).

21 Jan 2010

Phase 3 clinical trial results of Inspire Pharmaceuticals' PROLACRIA announced

Inspire Pharmaceuticals, Inc. announced today that its Phase 3 clinical trial (Trial 03-113) of PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease did not meet its primary endpoint (p = 0.526) or its secondary endpoint (p = 0.368).

21 Jan 2010

IMUC’s ICT-107 vaccine product candidate targets cancer stem cells

ImmunoCellular Therapeutics today announced the results of a study in which it was shown that certain specific antigens are highly expressed on cancer stem cells (CSCs). This suggests that IMUC’s lead cancer vaccine product candidate ICT-107, which targets those antigens, may effectively target not only the cells that make up the bulk of certain cancerous tumors, but also the CSCs that are widely believed to give rise to them and cause their recurrence.

21 Jan 2010

EMD Serono announces results from CLARITY Phase III trial in MS patients

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today the online publication of the results from the CLARITY Phase III trial using Cladribine Tablets (EMD Serono's proprietary investigational oral formulation of cladribine) in The New England Journal of Medicine. The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in 1,326 people with relapsing-remitting multiple sclerosis (MS).

21 Jan 2010

Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

4SC AG, a drug discovery and development company, today announced the start of dosing in a First-in-Man Phase I study in healthy volunteers evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular specificity against selected kinases, including FMS-like tyrosine kinase 3 (FLT3), FLT3 mutants and vascular endothelial growth factor receptors (VEGF-R).

21 Jan 2010

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained positive results from a recently completed Phase 2 study of LX4211 in patients with type 2 diabetes mellitus. LX4211 is a once-per-day, orally-delivered, small molecule drug candidate that inhibits the sodium-dependent glucose transporter 2 (SGLT2), lowering the accumulation of glucose in the body and reducing caloric load.

20 Jan 2010

PROLOR Biotech's hGH-CTP Phase I study data to be presented at the BIO CEO & Investor Conference

PROLOR Biotech, Inc., today announced that final data from a randomized, dose-escalating Phase I clinical study of its longer-acting version of human growth hormone (hGH-CTP) will be featured in an oral presentation by PROLOR management at the 12th Annual BIO CEO & Investor Conference to be held at the Waldorf-Astoria Hotel in New York City on February 8-9, 2010.

20 Jan 2010

Telaprevir effective in HCV patients

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that data from recent clinical trials suggest that Vertex/Johnson & Johnson/Mitsubishi Tanabe's telaprevir is efficacious in hepatitis C virus patients who have not responded to previous treatment with peg-IFN/ribavirin. In contrast, the efficacy of Merck's (formerly Schering-Plough) boceprevir in treatment nonresponders has yet to be proven.

20 Jan 2010

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

PTC Therapeutics, Inc. (PTC) today announced the initiation of an additional clinical trial of ataluren (PTC124®) in boys and young men with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD) who have permanently lost the ability to walk independently.

20 Jan 2010

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes.

20 Jan 2010