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The Lead

FDA Approves Myriad's PARP Inhibitor for Ovarian Cancer

December 19, 2014 2:08 pm | News | Comments

Myriad Genetics, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza (olaparib). Read more...

Combo Drug Therapy Doubles Positive Effect for Women with Breast Cancer

December 19, 2014 1:20 pm | News | Comments

In a groundbreaking study that offers new hope for women with advanced breast cancer, UCLA...

10 Up-and-Coming Healthcare Medical Innovations

December 18, 2014 12:10 pm | by Christina Jakubowski, Managing Editor, Bioscience Technology | Articles | Comments

The Cleveland Clinic recently unveiled their annual Top 10 Medical Innovations for 2015– a list...

Inovio Initiates DNA Immunotherapy Trial for Cancers

December 18, 2014 10:48 am | News | Comments

Inovio Pharmaceuticals, Inc. announced it has initiated a phase 1 trial of its hTERT DNA...

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GSK Shingles Vaccine Hits Goal in Major Study

December 18, 2014 9:02 am | News | Comments

GSK announced that a pivotal phase 3 study to assess the efficacy of HZ/su, an investigational vaccine for the prevention of shingles, has met its primary endpoint. Read more...                                 

FDA Approves First Pathogen Reduction System to Treat Plasma

December 17, 2014 12:02 pm | News | Comments

The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). Read more...

'Darwinian' Test Uncovers an Antidepressant's Hidden Toxicity

December 16, 2014 10:14 am | by University of Utah | News | Comments

Because of undetected toxicity problems, about a third of prescription drugs approved in the U.S. are withdrawn from the market or require added warning labels limiting their use. An exceptionally sensitive toxicity test invented at the University of Utah could make it possible to uncover more of these dangerous side effects early in pharmaceutical development so that fewer patients are given unsafe drugs. Read more...

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Pfizer: Breast Cancer Treatment Results

December 16, 2014 9:17 am | News | Comments

Pfizer Inc. announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology.  Read more...             

Study Shows Potential for Faster Drug Development

December 15, 2014 1:47 pm | News | Comments

A new study demonstrates the ability to conduct robust cardiac safety characterizations several years earlier than current practice. Read more...                    

Ebola Vaccine Trial Suspended After Side Effects

December 11, 2014 9:17 am | by Associated Press | News | Comments

Swiss researchers have suspended the testing of one of the leading Ebola vaccine candidates after some volunteers reported unexpected side effects. Read more...                                

Actavis Launches Generic Version of Celebrex

December 11, 2014 9:09 am | News | Comments

Actavis plc announced that it has launched a generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer, Inc.  Read more...                                   

New HPV Vaccine Strengthens Cancer Protection

December 10, 2014 4:42 pm | by Associated Press | News | Comments

The drugmaker Merck & Co. Inc. has received approval for an updated version of its Gardasil vaccine that protects against an additional five strains of the virus that causes most cases of cervical cancer. Read more..                  

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Mylan Launches Generic Versions of Celebrex Capsules

December 10, 2014 12:51 pm | News | Comments

Mylan Inc. announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's Celebrex Capsules, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Read more...

Combo Treatment Benefits Women with Metastatic Breast Cancer

December 10, 2014 10:07 am | News | Comments

Results of a Phase 2, open-label, dose-confirmation study of eribulin in combination with capecitabine, suggests that this therapy is efficacious in women with metastatic breast cancer (overall response rate 42.9% and clinical benefit rate 57.1%), with a safety and tolerability profile consistent with previous data. Read more...

BioDelivery Sciences: Phase 3 Trial of Diabetic Neuropathy Topical Gel

December 8, 2014 10:52 am | News | Comments

BioDelivery Sciences International, Inc. announced that it has completed the randomization of all patients in BDSI's ongoing initial pivotal Phase 3 clinical trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). Read more...

Amgen, Onyx: Phase 3 Study Results in Myeloma Trial

December 8, 2014 10:26 am | News | Comments

Amgen and its subsidiary Onyx results of the Phase 3 ASPIRE trial, which evaluated Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone (KRd) compared with Revlimid and dexamethasone (Rd) in patients with relapsed multiple myeloma. Read more...

Seattle Genetics, Takeda: Clinical Trial Data in HL Patients

December 8, 2014 10:17 am | News | Comments

Seattle Genetics, Inc. and Takeda reported data demonstrating that Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT) who received Adcetris (brentuximab vedotin) as consolidation therapy immediately after ASCT had significant improvement in progression-free survival (PFS) compared to patients who received placebo (median of 43 months versus 24 months, respectively. Read more...

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Merck's Cancer Therapy Receives Positive Results

December 8, 2014 10:03 am | News | Comments

Merck announced early study findings demonstrating that patients treated with pembrolizumab, the company's investigational anti-PD-1 cancer therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria. Read more...

UCB Announces Phase 3 Data of Epilepsy Drug

December 8, 2014 9:52 am | News | Comments

UCB announced the primary efficacy and safety data from the latest Phase 3 study evaluating brivaracetam (fixed doses of 100 and 200 mg/day with no up-titration) as adjunctive treatment in adult epilepsy patients with partial-onset seizures. Read more...    

Vaximm Receives Positive Data from Oral Cancer Vaccine Trial

December 4, 2014 9:40 am | News | Comments

Vaximm AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced follow-on data from the first clinical trial of its investigational oral T-cell vaccine VXM01. Data of a trial extension of the randomized, placebo-controlled, double-blind Phase 1 dose escalation study show that the safety profile to date is manageable.  Read More...

FDA Approves Amgen's ALL Treatment

December 3, 2014 5:10 pm | News | Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has granted approval of Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Read more...

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...

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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