Subscribe to Legal/Regulatory

The Lead

Bristol-Myers Gets Positive EMA Opinion for Immunotherapy Drug, Opdivo

April 24, 2015 12:36 pm | by Stephanie Guzowski, Editor | Articles | Comments

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Bristol-Myers Squibb’s Opdivo today for the treatment of melanoma. Read more..

FDA Grants Priority Review for AbbVie's Hepatitis C Treatment

April 24, 2015 12:16 pm | News | Comments

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug...

J&J Hikes Quarterly Dividend by 7 Percent

April 24, 2015 12:06 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Johnson & Johnson on Thursday said it's raising its quarterly dividend by 7 percent, marking...

Wellness Advocate, Bestselling Author: I Faked Cancer

April 24, 2015 8:21 am | by Seth Augenstein, Digital Reporter | Articles | Comments

A woman who became a bestselling author and wellness advocate after she claimed she healed...

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

FDA Grants Priority Review for Boehringer Ingelheim's Idarucizumab

April 23, 2015 2:06 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab. Read more...

FDA Accepts Filing of Bayer's MS Treatment

April 23, 2015 2:03 pm | News | Comments

Bayer is pleased to announce today that the U.S. Food and Drug Administration (FDA) has accepted the filing for Bayer's supplemental Biologics License Application (sBLA) for Betaconnect (proposed name), another delivery option for Betaseron (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis. 

Majority of Lung Cancer Treatment Decisions Not Guided by Genetics: Survey

April 23, 2015 1:47 pm | News | Comments

Despite the majority of newly diagnosed advanced non-small cell lung cancer (NSCLC) patients being tested for genetic mutations, a gap still exists for providing a personalized treatment plan for patients based on their cancer type and mutation subtype, according to a new international survey. Read more...


Abbvie Raises Outlook as Humira Again Delivers Earnings Beat

April 23, 2015 1:36 pm | by Matthew Perrone, AP Health Writer | News | Comments

Drugmaker AbbVie is raising its full-year earnings guidance after reporting better-than-expected first quarter adjusted results on continued growth of its blockbuster anti-inflammatory drug Humira. Read more...

Pipeline Advancements, Asset Acquisitions Fueled Mid-Cap Biotech R&D Spend in 2014

April 23, 2015 12:22 pm | by Adam Dion, GlobalData's Senior Industry Analyst | Articles | Comments

The combined spend on research and development (R&D) for the peer group of 35 mid-cap biotech companies increased by nearly $2 billion to reach a total of $9.7 billion in 2014. Read more...

Link Between Serotonin and Depression is a Myth, Says Psychiatrist

April 22, 2015 2:11 pm | by Stephanie Guzowski, Editor | News | Comments

The widely held belief that depression is caused by low levels of serotonin and that certain antidepressants raise the levels of this neurotransmitter, is a myth, according to a psychiatrist in an editorial article in The BMJ this week. Read more...

AACR 2015: Pembrolizumab Comes Out on Top for Melanoma, Lung Cancer

April 22, 2015 10:33 am | by Stephanie Guzowski, Editor | Articles | Comments

At the AACR Annual Meeting 2015, immunotherapies, called PD-1 inhibitors, were front and center stage, due to clinical trial results that led to U.S. Food and Drug Administration (FDA) approvals for treating melanoma and non-small cell lung cancer (NSCLC). Read more..

Regulatory and Clinical Factors Limiting U.S. Non-Vascular Stent Market Growth

April 22, 2015 9:43 am | by Priya Radhakrishnan, Director of Medical Devices, GlobalData | News | Comments

The future growth of the non-vascular stent market by 2021 will be slower in the US than almost every other major market, due in part to an increasingly difficult regulatory process and the medical device excise tax, but primarily as a result of clinical factors and unmet needs still to be addressed, said research and consulting firm GlobalData. Read more...


Teva Offers to Buy Mylan in $40.1B Cash and Stock Deal

April 21, 2015 2:49 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Generic drug giant Teva formally offered to buy fellow drugmaker Mylan about $40.1 billion in cash and stock on Tuesday. Read more...

Mylan Skeptical of Rumored Teva Bid

April 21, 2015 8:42 am | by The Associated Press | News | Comments

Mylan said that it hasn't received an offer and described the idea that Teva might want to buy it as a rumor. Read more...

Global Pandemic of Fake Medicines Poses Urgent Risk

April 20, 2015 4:41 pm | by National Institute of Health | News | Comments

Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis. Read more...

Disney Measles Outbreak that Sparked Vaccination Debate Ends

April 20, 2015 10:22 am | by Alicia Chang, AP Science Writer | News | Comments

An outbreak of measles that popped up at Disneyland in late December soon spread to six other U.S. states, Mexico and Canada. Read more...

Glaxo Recalls Flu Vaccine Due to Potency Problem

April 20, 2015 8:29 am | by Matthew Perrone, AP Business Writer | News | Comments

GlaxoSmithKline is recalling a popular four-in-one flu vaccine because its effectiveness can decline over time. Read more...


Ventana, Astellas to Leverage Diagnostic Tests for Targeted Cancer Treatments

April 15, 2015 11:49 am | News | Comments

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced it has entered into master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop novel automated tissue diagnostics in support of therapeutic compounds in development. Read more...

Adherence to Blood Thinner Best With Pharmacist Management, Researcher Says

April 15, 2015 11:28 am | by Tracie White, Stanford University | News | Comments

Researchers found that adherence to a new-generation anticoagulant, used to prevent stroke in heart disease patients, is best at sites with pharmacist-led management. Read more...

French Legislators OK Health Care Reform Targeting Anorexia

April 15, 2015 8:23 am | by The Associated Press | News | Comments

France's lower house of Parliament approved a draft law Tuesday tackling a range of public health problems, from smoking and drinking to obesity and anorexia. Read more...

Actavis: No Apologies for Seeking Alzheimer's Drug Profits

April 14, 2015 10:38 am | by Larry Neumeister, Associated Press | News | Comments

A lawyer for the Irish manufacturer of an Alzheimer's drug urged a U.S. appeals court on Monday to let it replace a two-pill daily regimen with a single-dose version of the drug even if it cheats generic drugmakers of profits. Read more...

Australia to Withhold Payments from Parents Against Vaccine

April 14, 2015 8:25 am | by Rod Mcguirk, Associated Press | News | Comments

The Australian government has ramped up pressure on parents who oppose vaccination by threatening to withhold child care and other payments from families that fail to immunize their children. Read more...

Hi-Tech Pharmaceuticals To Acquire Advanced Pharmaceuticals, Nutritionals

April 13, 2015 11:58 am | News | Comments

Hi-Tech Pharmaceuticals ("Hi-Tech"), a leading global provider of Dietary Supplements, Contract Manufacturing, Raw Material Sales, and OTC Pharmaceuticals, and Advanced Pharmaceuticals and Nutritionals ("APN"), headquartered in Guadalajara, Mexico, today announced that they have entered into a definitive agreement in which Hi-Tech has agreed to acquire APN for an undisclosed amount. 

California Vaccine Bill Sparks Acidic Debate

April 13, 2015 11:49 am | by Judy Lin, Associated Press | News | Comments

A California bill that would sharply limit vaccination waivers after a measles outbreak at Disneyland has generated such an acidic debate that the proposal's author was under added security this week. Read more...

Cancer Surge in China Prompts Rise of Special Patient Hotels

April 13, 2015 8:27 am | by Jack Chang, Associated Press | News | Comments

With lung, bowel and breast cancer rates surging in China, such hotels have sprouted up in big cities such as Beijing and Shanghai, part of an ad hoc response to what medical experts say is a growing health crisis challenging an unprepared medical system. Read more...

Suit Claims AIDS Foundation Scammed Medicare for $20M

April 10, 2015 10:11 am | by Kelli Kennedy, Associated Press | News | Comments

One of the nation's largest suppliers of HIV and AIDS medical care is accused of bilking Medicare and Medicaid in an elaborate $20 million dollar scam that spanned 12 states. Read more...

NIH Funds Nine Antimicrobial Resistance Diagnostics Projects

April 9, 2015 4:57 pm | by NIH | News | Comments

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded more than $11 million in first-year funding for nine research projects supporting enhanced diagnostics to rapidly detect antimicrobial-resistant bacteria. Read more..

Inovio to Lead $45M Program to Expedite Product Development for Ebola

April 9, 2015 4:43 pm | News | Comments

Inovio Pharmaceuticals, Inc. announced that the company has been selected to receive a grant from the Defense Advanced Research Projects Agency (DARPA) to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola. Read more..

EU Approves Roche’s Avastin Therapy

April 9, 2015 4:25 pm | News | Comments

Roche announced that the European Commission (EU) approved Avastin (bevacizumab) in combination with standard chemotherapy (paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy) for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix. Read more...

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