Subscribe to Legal/Regulatory

The Lead

AbbVie to Buy Pharmacyclics for $21 Billion

March 6, 2015 3:18 pm | by Ryan Bushey, Associate Editor | Articles | Comments

Investors did not seem pleased about this deal.

FDA Approves First Lower-Cost Biotech Drug

March 6, 2015 2:38 pm | by Matthew Perrone and Linda A. Johnson, AP Business Writers | News | Comments

Federal health officials on Friday approved the first lower-cost copy of a biotech drug in the U...

'Superbug' Infections Hit Another Los Angeles Hospital

March 5, 2015 10:12 am | by Alicia Chang, AP Science Writer | News | Comments

The latest cases occurred at Cedars-Sinai Medical Center.

FDA Approves BMS's Lung Cancer Drug

March 4, 2015 3:12 pm | by Associated Press | News | Comments

The Food and Drug Administration on Wednesday expanded approval of an innovative Bristol-Myers...

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

FDA Warning: Men's Testosterone Drugs Overused

March 3, 2015 4:41 pm | by Matthew Perrone, AP Health Writer | News | Comments

The agency says drugmakers must clearly state in their labeling and promotions that the drugs. Read more...                         

New FDA Official Inherits Raft of Projects, Challenges

March 3, 2015 10:58 am | by Matthew Perrone and Michael Felberbaum | News | Comments

One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products. Read more...

Roche Launches Next-Generation HBV Viral Load Assay in Select Markets

March 3, 2015 9:09 am | News | Comments

The new assay offers broad coverage of all known Hepatitis B (HBV) genotypes (A-H) with high sensitivity, across all critical medical decision points. Read more...                


J&J Announces Binding Offer from Cardinal Health to Acquire Cordis

March 2, 2015 12:49 pm | News | Comments

The deal breaks down to an aggregate value of $1.99 billion. Read more...

Preventing the Spread of Cancer with Copper Molecules

March 2, 2015 12:43 pm | by Bielefeld University | News | Comments

Chemists have developed a molecule containing copper that binds specifically with DNA and prevents the spread of cancer. Read more...                     

An Opening for Measles

March 2, 2015 12:36 pm | by Colleen Walsh, Harvard Staff Writer | News | Comments

Anti-vaccination trend is becoming a growing concern. Read more...                                

Survey: Parents Increasingly Ask Doctors to Delay Vaccines

March 2, 2015 12:29 pm | by Lindsey Tanner, AP Medical Writer | News | Comments

Parents have increasingly pressured doctors to delay vaccines for young children, making their kids and others vulnerable to preventable diseases. Read more...                 

Firm Agrees to Refund to Settle Suit Over Weight-Loss Pills

March 2, 2015 12:23 pm | by Associated Press | News | Comments

Salt Lake City-based company has agreed to pay refunds to consumers who purchased its weight-loss tablets to settle a class-action lawsuit. Read more...                  


Mylan Completes Acquisition Of Abbott's Non-U.S. Developed Markets

March 2, 2015 9:58 am | News | Comments

​Mylan N.V. and Mylan Inc. announced the successful completion of the acquisition of Abbott Laboratories' (NYSE: ABT) non-U.S. developed markets specialty and branded generics business. Read more..

Lyric Pharmaceuticals: $20.4M Series A Funding Round

February 27, 2015 1:41 pm | News | Comments

Lyric Pharmaceuticals Inc. today announced the initial closing of a Series A financing round totaling $20.4 million. Read more...                                     

Heat Blamed for Spray Vaccine's Failure Against Swine Flu

February 27, 2015 12:53 pm | by Mike Stobbe, AP Medical Writer - Associated Press | News | Comments

The makers of the nasal spray version of the flu vaccine say now they know why it has failed to protect young U.S. children against swine flu - fragile doses got too warm. Read more...

Takeda's Treatment for Acid-Related Diseases is Now Available in Japan

February 27, 2015 9:10 am | News | Comments

This medicine treats acid-related diseases with a novel mechanism of action called potassium-competitive acid blockers. Read more...                    

Novartis's Lung Cancer Drug Recommended for EU Approval

February 27, 2015 9:03 am | News | Comments

The medication is meant for patients with ALK+ NSCLC previously treated with crizotinib. Read more...                          


Ebola Doctor: Media, Politicians Fueled the Public's Fear

February 27, 2015 8:29 am | by Tom Mcelroy, Associated Press | News | Comments

A doctor who contracted the deadly Ebola virus and rode the subway system and dined out before he developed symptoms said the media and politicians could have done a better job by educating people on the science of it. Read more...     

Nonprescription Diet Pill Alli Back in Stores After Recall

February 27, 2015 8:25 am | by Associated Press | News | Comments

The British drugmaker voluntary recalled the product last March after finding some packages in stores didn't contain real alli, indicating tampering after shipment. Read more...              

Sanofi Gets FDA Approval for New Insulin Drug

February 26, 2015 12:06 pm | by Stephanie Guzowski, Editor | News | Comments

Sanofi announced late Wednesday that it received approval from the U.S. Food and Drug Administration (FDA) to sell its new insulin product Toujeo. The once-daily, long-acting basal insulin will help improve glycemic control in adults with type 1 and type 2 diabetes. Read more..

Turing Pharmaceuticals Launches

February 25, 2015 10:15 am | News | Comments

Turing Pharmaceuticals AG announced its official launch, along with news of three acquisitions for its commercial operations and development pipeline. New York-based Turing will focus on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options.

Meet Sanofi's Newest CEO

February 24, 2015 11:13 am | by Ryan Bushey, Associate Editor | Articles | Comments

It took five months to find a new chief executive. Read more...                                 

NY Attorney General Expands Herbal Supplement Investigation

February 24, 2015 9:00 am | by Mary Esch, Associated Press | News | Comments

New York's attorney general is targeting manufacturers of the popular products. Read more...                            

Shire Acquires Meritage Pharma

February 24, 2015 8:48 am | News | Comments

Shire paid an upfront fee of $70 million and additional contingent payments based on the achievement of development and regulatory milestones. Read more...                 

Merck Grants Free License for Pediatric HIV Drug

February 24, 2015 8:33 am | by Linda A. Johnson, AP Business Writer | News | Comments

The deal lets any generic or brand name drug manufacturer make low-cost pediatric versions of Merck's raltegravir for sale in 92 low- and middle-income countries. Read more...              

BioDelivery Sciences to Receive $10M from Endo Pharmaceuticals

February 23, 2015 10:56 am | News | Comments

BioDelivery Sciences International, Inc. and Endo Pharmaceuticals Inc., a subsidiary of Endo International plc announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Belbuca. Read more..

Fearing Ebola, North Korea Bars Tourists from Capital Marathon

February 23, 2015 8:56 am | by Eric Talmadge, Associated Press | News | Comments

North Korea barred foreigners from one of its most popular tourist events - the annual Pyongyang marathon - because of concerns over the Ebola virus. Read more...                

Valeant Agrees to Buy Salix for About $10 Billion in Cash

February 23, 2015 8:48 am | by Alex Veiga, AP Business Writer | News | Comments

Canadian drugmaker Valeant Pharmaceuticals International Inc. has agreed to buy Salix Pharmaceuticals Ltd. for about $10 billion in cash. Read more...                  

Indian Health Authorities: 700 Died in Flu Outbreak

February 20, 2015 8:53 am | by Associated Press | News | Comments

Health authorities were working to ensure remote hospitals in northern and western India had adequate medical supplies for a flu outbreak that has claimed more than 700 lives in 10 weeks. Read more...          

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