Advertisement
Pharma/Biotech News
Subscribe to Pharma/Biotech News

The Lead

Amgen Submits Application in U.S. and Europe for Multiple Myeloma Treatment

January 28, 2015 9:05 am | News | Comments

The drug is an injection that can treat patients with relapsed multiple myeloma who have received at least one prior therapy. Read more...                     

Malvern's New Platform Enhances Analysis of Macromolecules

January 28, 2015 8:57 am | News | Comments

The platform breaks new ground in delivering the high performance, ease of use and productivity...

Mylan Expands Hepatitis C Licensing Agreement with Gilead

January 26, 2015 11:18 am | by Associated Press | News | Comments

 Mylan Inc. announced that its subsidiary Mylan Laboratories Limited is expanding...

Avian Flu Confirmed in Commercial Turkey Flock in California

January 26, 2015 11:07 am | by Associated Press | News | Comments

Federal agriculture officials say they have found avian influenza in a commercial turkey flock...

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

Shire's Hunter Syndrome Treatment Gains FDA Fast Track Designation

January 26, 2015 10:59 am | News | Comments

Shire's drug treats the neurocognitive decline associated with Hunter syndrome. Read more...                           

GSK Expands Portfolio of Asthma/COPD Medicines in U.S.

January 26, 2015 10:55 am | by GSK | News | Comments

GlaxoSmithKline plc announced the simultaneous availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the U.S. Read more...                             

Regeneron, Sanofi: FDA Accepts BLA for Hyperchoestrolemia Drug

January 26, 2015 10:20 am | by Sanofi | News | Comments

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Read more...

Advertisement

FDA Approves Prestalia's Hypertension Treatment

January 26, 2015 10:00 am | by Prestalia | News | Comments

Symplmed Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.           

Meningococcal Vaccine Gets FDA Approval

January 26, 2015 9:44 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Read more..                       

FDA Clears Roche's MRSA/SA Test

January 26, 2015 9:32 am | by Roche | News | Comments

Roche announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens. Read more...

Aprea's Ovarian Cancer Drug Gains Orphan Drug Designation

January 23, 2015 3:47 pm | News | Comments

The drug gained this designation in Europe. Read more...                                  

FDA Recommends Approval of Astellas' Fungal Infection Treatment

January 23, 2015 1:18 pm | News | Comments

The Advisory Committee's recommendation is based on data from the cresemba development program. Read more...                          

Advertisement

A New Way to Test Brain Tumor Drugs

January 23, 2015 12:54 pm | by Marilynn Marchione - AP Chief Medical Writer | News | Comments

An Arizona hospital is testing medicines very early in development and never tried on brain tumors before. Read more....                        

Luoxis Establishes Initial European Distribution Network for Diagnostic System

January 23, 2015 9:15 am | by Luoxis | News | Comments

Luoxis Diagnostics, Inc., a subsidiary of Ampio Pharmaceuticals, Inc.announced it has secured long-term agreements with European distributors Eurobio, Una Health Limited, and THP Medical, to offer Luoxis' RedoxSYS Diagnostic System to prominent academic and pharma-based research centers within their respective territories.  Read more...

Innovent Biologics Completes $100 Million Series C Financing

January 23, 2015 8:54 am | by Innovent Biologics | News | Comments

Innovent Biologics, Inc., a privately held Chinese biopharmaceutical company dedicated to the development and manufacturing of complex, high-end biologics to be marketed in the rapidly growing Chinese market and elsewhere worldwide that meet EMEA and FDA/cGMP standards, has raised$100 million in Series C financing. Legend Capital led the financing. Read more...

President Obama Announces Precision Medicine Initiative

January 22, 2015 11:59 am | by Ryan Bushey, Associate Editor | Articles | Comments

The President mentioned this project during the State of The Union, but did not provide specific details. Read more...                       

FDA Approves Novartis' Psoriasis Drug

January 22, 2015 11:44 am | by Novartis | News | Comments

Novartis announced the US Food and Drug Administration (FDA) has approved Cosentyx™ (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.                           

Advertisement

Why are Generic Drugs Getting Pricy?

January 22, 2015 11:14 am | by The Conversation, Geoffrey Joyce | News | Comments

More than eight out of every 10 prescriptions dispensed in the U.S. is generic. This growth is because of a large number of top-selling drugs going off patent over the past decade, as well as innovations in the retail sector, such as Walmart’s $4 generic program.

BioMérieux, Astute Medical: Global Agreement to Develop, Market AKI Test

January 22, 2015 9:32 am | News | Comments

This is a semi-exclusive agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). Read more...                    

Pharmalink: Open IND Application for IgA Nephropathy

January 21, 2015 9:59 am | by Pharmalink | News | Comments

Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that its IND for Nefecon is now open with the US Food & Drug Administration (FDA). Read more...                                  

Boehringer Ingelheim: Inhalation Spray Available in U.S.

January 21, 2015 9:53 am | by Boehringer Ingelheim | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that Spiriva Respimat(tiotropium bromide) Inhalation Spray is now available by prescription through retail pharmacies across the United States. Read more...                                                         

Bausch + Lomb Introduces New Optical Software

January 21, 2015 9:47 am | by Valeant Pharmaceuticals | News | Comments

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software for its VICTUS Femtosecond Laser Platform that will provide surgeons with a new, redesigned interface. Read more...

Supreme Court Sides With Teva in Drug Dispute

January 20, 2015 4:14 pm | by Sam Hananel - Associated Press | News | Comments

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug. Read more...           

Aetna Picks Gilead Sciences Hepatitis C Drugs Over Abbvie's

January 20, 2015 12:01 pm | by Associated Press | News | Comments

Insurer Aetna has made new hepatitis C drugs from Gilead Sciences Inc. preferred treatments for customers with the liver-destroying virus. Read more...                                    

Eradicating Ebola: What Will It Take?

January 20, 2015 11:23 am | by Ryan Bushey, Associate Editor | Articles | Comments

A lot of work still needs to be done before the Ebola epidemic is finally over. Read more...                             

Richter, Actavis Announce Phase 3 Results for Schizophrenia Drug Study

January 20, 2015 9:55 am | News | Comments

Gedeon Richter and Actavis announced positive results from a Phase 3 trial evaluating the efficacy and safety of cariprazine. Read more...                    

Roche Adds Neuromuscular Disease Research to Portfolio

January 20, 2015 9:18 am | News | Comments

Trophos was working on a drug that could treat spinal muscular atrophy. Read more...                              

AbbVie's New Hepatitis C Treatment Gains European Approval

January 20, 2015 8:44 am | by Linda A. Johnson - AP Business Writer | News | Comments

The company said the European Commission granted marketing authorization for the combination of Viekirax and Exviera. Read more...                      

Mylan Launches Generic Hepatitis B Treatment

January 16, 2015 11:37 am | by Mylan | News | Comments

Mylan Inc. announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's Epivir-HBV. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Read more...

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading