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Daily news and top headlines for drug research professionals

Actinium 's AML Drug Receives Orphan-Drug Designation

December 1, 2014 12:23 pm | News | Comments

Actinium announced that the FDA has granted orphan-drug designation for Actimab-A, an alpha radiolabeled antibody being developed for newly diagnosed AML in patients over the age of 60. Actimab-A is currently in a multicenter Phase 1/2 trial clinical trial. Read more...

Abivax Completes First-In-Man Study of HIV Treatment

December 1, 2014 10:55 am | News | Comments

Abivax, a leading clinical stage biotech company developing and commercialising anti-viral compounds and human vaccines, announced the successful completion of its Phase 1 first-in-man study of ABX464, which has been designed to potentially deliver a number of important clinical benefits when treating patients with HIV. Read more...

Mylan, Gilead to Enhance Access to TAF-based HIV Treatments in Developing Countries

December 1, 2014 9:38 am | News | Comments

Mylan Inc. announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs.  Read more...

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Eli Lilly, AstraZeneca Launch Patient Trial for Alzheimer's Treatment

December 1, 2014 9:17 am | News | Comments

Eli Lilly and Company and AstraZeneca announced enrollment of the first patient into Amaranth, a Phase 2/3 study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer's disease. Read more...

First-in-Human Study of Antibody for AML Kicks Off

November 26, 2014 12:00 pm | News | Comments

Oxford BioTherapeutics and Berlin Chemie/Menarini Biotech/Menarini Ricerche announced that they have initiated the first-in-human clinical study of OBT357 (MEN1112), a novel enhanced antibody for the treatment of acute myeloid leukemia (AML). Read more...

Transposagen, Janssen to Collaborate on CAR-T Therapies

November 25, 2014 1:46 pm | by Drug Discovery & Development Staff | News | Comments

Transposagen Biopharmaceuticals, Inc., a private biotechnology company headquartered in Lexington, KY, announced they have entered into a research collaboration and worldwide license agreement with Janssen Biotech, Inc. to develop allogeneic Chimeric Antigen Receptor T-cells (CAR-T). Read more...

Powdered Measles Vaccine Found Safe in Early Clinical Trials

November 25, 2014 12:51 pm | News | Comments

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective. Read more...                             

Janssen Submits NDA for STS Treatment

November 25, 2014 12:29 pm | News | Comments

Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for Yondelis (trabectedin) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. Read more...

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BioMarin Pharma Offers About $680M for Prosensa

November 24, 2014 12:41 pm | News | Comments

The company also said it will make two approximately $80 million milestone payments to Prosensa shareholders. Read more...                       

EU Approves Novartis' Signifor Drug for Rare Hormonal Disorder

November 24, 2014 10:38 am | News | Comments

Novartis announced today that the European Commission has approved Signifor (pasireotide) as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).  Read more...

Neurotrope: Last Patient Dosed in Phase 2a Alzheimer's Study

November 21, 2014 11:41 am | News | Comments

Neurotrope, Inc. announced that the last patient has been dosed in its Phase 2a clinical trial of Bryostatin-1 for the treatment of patients with Alzheimer's disease (AD). The trial is being conducted under an Investigational New Drug (IND) application filed by the Company's licensor, the Blanchette Rockefeller Neuroscience Institute (BRNI). Read more...

FDA Approves New, Hard-to-Abuse Hydrocodone Pill

November 21, 2014 11:27 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

Federal health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards. Read more...

Regeneron, Sanofi: New Positive Results for Cholesterol-Lowering Drug

November 20, 2014 9:06 am | News | Comments

Regeneron Pharmaceuticals, Inc. and Sanofi announced new detailed positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol). Read more...

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Pfizer's Meningococcal Group B Vaccine Is Now Available

November 18, 2014 1:58 pm | News | Comments

Pfizer Inc. announced that Trumenba (Meningococcal Group B Vaccine) is now available for order by healthcare providers in the United States. Read more...

Merck's Cholesterol-Lowering Drug Reduces Heart Problems

November 18, 2014 10:22 am | News | Comments

Merck, known as MSD outside the United States and Canada, announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints.  Read more...

Novartis' Drug Could Change Course of Heart Failure for Patients

November 18, 2014 9:57 am | News | Comments

New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients. Read more...

FDA Accepts Janssen's Schizoaffective Disorder Drug sNDA

November 14, 2014 12:11 pm | News | Comments

Janssen Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Read more...

WHO Sees Few Promising Ebola Drugs in Pipeline

November 14, 2014 9:17 am | News | Comments

WHO scientists have proposed lots of experimental interventions but none has been thoroughly evaluated yet.                          

Gilead's Hep C Drug Gets Positive Results

November 11, 2014 10:09 am | News | Comments

Gilead Sciences Inc. announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options. Read more...

Lilly's Injectable Diabetes Drug is Now Available in US Pharmacies

November 10, 2014 1:18 pm | News | Comments

Eli Lilly's new type 2 diabetes drug arrives in US pharmacies today. Read more...                              

FDA Approves Lilly's Gastric Cancer Drug

November 7, 2014 12:46 pm | News | Comments

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Cryamza (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach). Read more...

Mylan Launches Generic Loestrin 24 Fe

November 7, 2014 12:41 pm | News | Comments

Mylan Inc. announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe. Read more...

Gilead Submits Application for New HIV Pill to FDA

November 6, 2014 1:38 pm | News | Comments

Gilead submitted a new drug application that focuses on an experimental HIV pill. Read more...                                

FDA Approves Janssen's Hep C Drug

November 6, 2014 9:26 am | News | Comments

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio(simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients. Read more...

Astellas' Fungal Treatment Gets Orphan Drug Designation

November 5, 2014 10:43 am | News | Comments

Astellas announced that the FDA granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis. Read more...                     

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