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The Lead

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 | News | Comments

Transposagen...

Powdered Measles Vaccine Found Safe in Early Clinical Trials

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

A measles vaccine...

Janssen Submits NDA for STS Treatment

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

Janssen Research...

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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...

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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...

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...

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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...

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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...                     

Pharming, Salix Launch HAE Treatment

November 3, 2014 11:16 am | News | Comments

Pharming Group NV and Salix Pharmaceuticals, Ltd. announced the launch of Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg in the United States for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Read more...

Game Changing Migraine Med to be Available November 2014

October 31, 2014 12:54 pm | News | Comments

Migranade Inc announced the new migraine medication will be available to the 36 million U.S. migraine sufferers November 2014. Read more...                    

FDA Approves Generic Alzheimer's Drug

October 30, 2014 12:52 pm | News | Comments

TWi Pharmaceuticals Inc. announced that it has received final approval from the FDA on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.'s Aricept 23mg. Read more...     

AstraZeneca's Diabetes Treatment Gets FDA Approval

October 30, 2014 12:00 pm | News | Comments

AstraZeneca announced that the FDA has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. Read more...                 

Scientists Aim to Simplify Life Saving Drug

October 30, 2014 9:33 am | News | Comments

A research team from the University of British Columbia has set out to make the use of Heparin a lot safer by developing a universal antidote. Read more...                

Pfizer Gains FDA Approval for Meningococcal B Vaccine

October 30, 2014 9:14 am | News | Comments

Pfizer announced that the FDA has granted accelerated approval of a new meningococcal vaccine. Read more...                          

ESMO: Cancer Immunotherapy on the Road

October 29, 2014 12:20 pm | by Neil Canavan | Articles | Comments

Since cancer immunotherapy was declared the Breakthrough of the Year in 2013 by Science magazine the field has been on fire, and its relatively few experts have been on the run– explaining the nascent technology and related data to oncologists at venues from the April meeting of AACR in San Diego, to the June meeting of ASCO in Chicago, to the September meeting of ESMO in Madrid.  Read more...

AstraZeneca's Cancer Drug Gets Positive CHMP Review

October 24, 2014 1:16 pm | News | Comments

AstraZeneca announced that the CHMP of the EMA has adopted a positive opinion recommending the marketing authorisation of Lynparza (olaparib) as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. Read more...

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