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Combination treatment extends lives of women with metastatic breast cancer

Changing the order in which two drugs are taken significantly extended the lives of women with metastatic breast cancer, a study has found.

8 Dec 2011

Positive results from Genentech's pertuzumab plus Herceptin Phase III study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced results from CLEOPATRA, the first randomized Phase III study of the investigational HER2-targeted medicine pertuzumab.

8 Dec 2011

Updated data from Novartis Afinitor plus everolimus Phase III study on advanced breast cancer

Updated results of a Phase III study of Afinitor (everolimus) tablets plus exemestane, a hormonal therapy, show everolimus provided additional time women with advanced breast cancer lived without their disease progressing.

8 Dec 2011

Positive results from Pearl Therapeutics' PT001 Phase 2b trial on COPD

Pearl Therapeutics Inc. today announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist (LAMA) delivered twice a day (BID) via metered-dose inhaler in patients with moderate-to-severe COPD.

8 Dec 2011

ZIOPHARM receives European patent allowance for palifosfamide to treat cancer

ZIOPHARM Oncology, Inc. announced today that it has received an allowance from the European Patent Office for Patent Application No. 05 821 125.1, entitled "Salts of Isophosphoramide mustard and analogs thereof as anti-tumor agents" with claims directed to pharmaceutical compositions of a novel DNA cross-linker, including palifosfamide and their use in treating cancer.

7 Dec 2011

FDA modifies requirements of Amgen's Nplate REMS Program

Amgen today announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate (romiplostim) Risk Evaluation and Mitigation Strategy (REMS) Program.

7 Dec 2011

Positive final results from BioLineRx BL-1021 Phase Ia study for neuropathic pain

BioLineRx announced today the final results of the Phase Ia study of BL-1021, an orally available small molecule for neuropathic pain.

6 Dec 2011

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

6 Dec 2011

Study reveals mechanism of action of laquinimod in patients with RRMS

Laquinimod is an orally available synthetic compound that has been successfully evaluated in phase II/III clinical studies for the treatment of relapsing-remitting multiple sclerosis (RRMS).

6 Dec 2011

Top-line primary endpoint data from Pfizer's Toviaz trial on overactive bladder

Pfizer Inc. announced today the top-line primary endpoint result for Toviaz (fesoterodine fumarate) Study A0221049 - Efficacy and Safety of Fesoterodine Flexible Dose Regimen in Vulnerable Elderly Patients with Overactive Bladder.

6 Dec 2011

EnVivo presents positive EVP-6124 Phase 2b trial data on schizophrenia at 50th ACNP meeting

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it is presenting the comprehensive analysis of a recently completed Phase 2b clinical trial of EVP-6124, a novel, orally bioavailable nicotinic alpha-7 agonist, in schizophrenia at the American College of Neuropsychopharmacology 50th Anniversary Annual Meeting.

5 Dec 2011

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

XenoPort, Inc. announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet (immediate-release levodopa/carbidopa) or XP21279 co-formulated with carbidopa (279/CD) in advanced Parkinson's disease patients with motor fluctuations.

5 Dec 2011

Unigene acquires exclusive worldwide rights to oral PTH program from GSK

Unigene Laboratories, Inc. today announced that the Company terminated its amended and restated exclusive worldwide license agreement and related development services and clinical supply agreement with GlaxoSmithKline (GSK) pertaining to an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women.

5 Dec 2011

NanoViricides submits pre-IND Meeting Request for FluCide to FDA

NanoViricides, Inc. announced today that it has submitted a pre-IND Meeting Request to the US FDA. The Company has requested an initial meeting with the US FDA to review the Company's proposed strategy and plan for conducting safety/toxicology studies and human clinical trials required for approval of its anti-influenza clinical drug candidate, FluCide™ (i.e. NV-INF-1).

5 Dec 2011

Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant.

5 Dec 2011

Zalicus commences Z160 Phase 1 clinical trial for pain

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker.

5 Dec 2011

Post-baseline vision data from Lundbeck's Sabril patient registry presented at AES meeting

Post-baseline vision data from Lundbeck's Sabril patient registry is available for the first time today as a late-breaking poster presentation at the annual meeting of the American Epilepsy Society.

5 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Today, at the occasion of the 4th DNDi Partners' Meeting in Rio de Janeiro, Brazil, Dr Carlos Gadelha, Secretary of Science, Technology and Strategic Products, Brazilian Ministry of Health, announced that Brazil's National Health Surveillance Agency (ANVISA) granted registration of a new paediatric dosage form of benznidazole, developed through a partnership between the Pernambuco State Pharmaceutical Laboratory (LAFEPE) of Brazil and the Drugs for Neglected Diseases initiative (DNDi).

3 Dec 2011

Progesterone can benefit women with catamenial seizures: Study

Seizures in women of childbearing age commonly show patterns of exacerbation that involve hormones as a factor. Investigators today reported the favorable outcome of a multicenter randomized, double-blinded, placebo-controlled phase III clinical trial of progesterone therapy in reducing these perimenstrually exacerbated (catamenial) seizures.

3 Dec 2011

Drug Trial News

Combination treatment extends lives of women with metastatic breast cancer

Positive results from Genentech's pertuzumab plus Herceptin Phase III study on HER2-positive mBC

Updated data from Novartis Afinitor plus everolimus Phase III study on advanced breast cancer

Positive results from Pearl Therapeutics' PT001 Phase 2b trial on COPD

ZIOPHARM receives European patent allowance for palifosfamide to treat cancer

FDA modifies requirements of Amgen's Nplate REMS Program

Positive final results from BioLineRx BL-1021 Phase Ia study for neuropathic pain

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Study reveals mechanism of action of laquinimod in patients with RRMS

Top-line primary endpoint data from Pfizer's Toviaz trial on overactive bladder

EnVivo presents positive EVP-6124 Phase 2b trial data on schizophrenia at 50th ACNP meeting

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

Unigene acquires exclusive worldwide rights to oral PTH program from GSK

NanoViricides submits pre-IND Meeting Request for FluCide to FDA

Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Zalicus commences Z160 Phase 1 clinical trial for pain

Post-baseline vision data from Lundbeck's Sabril patient registry presented at AES meeting

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Progesterone can benefit women with catamenial seizures: Study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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