Advertisement
Legal/Regulatory
Subscribe to Legal/Regulatory

The Lead

FDA Approves Combo Painkiller from OxyContin Maker

July 24, 2014 2:59 pm | News | Comments

The Food and Drug Administration has approved a new combination pain pill from the maker of OxyContin that is designed to discourage abuse by painkiller addicts. Read more...                     

GSK Asks Europe to OK Malaria Shot

July 24, 2014 2:52 pm | News | Comments

Pharma giant GSK said Thursday it is submitting its malaria vaccine for regulatory approval to...

EU Regulator: Morning-After Pill OK for All Women

July 24, 2014 2:48 pm | News | Comments

A commonly used morning-after pill is suitable for use by heavier women, the European Medicines...

BMS, Ono Collaborate on Immuno-Oncology

July 24, 2014 11:13 am | News | Comments

Bristol-Myers Squibb Co. and Ono Pharmaceutical Co. Ltd. have signed a strategic collaboration...

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

Gilead, MPP Partner on Access to HIV, Hep C Drug

July 24, 2014 10:56 am | News | Comments

Gilead Sciences Inc. announced at the 20th International AIDS Conference in Melbourne, Australia, a new agreement with the Medicines Patent Pool to expand access to Gilead's investigational drug tenofovir alafenamide for HIV and hepatitis B, contingent on the medicine's U.S. regulatory approval. Read more...

FDA Approves Malignant Hyperthermia Drug

July 23, 2014 2:57 pm | News | Comments

Eagle Pharmaceuticals Inc. announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. Read more...      

Head of Troubled CDC Anthrax Lab Resigns

July 23, 2014 2:09 pm | News | Comments

The head of the government lab which potentially exposed workers to live anthrax has resigned, an agency spokesman said Wednesday. Michael Farrell was head of the Centers for Disease Control and Prevention lab since 2009. He submitted his resignation Tuesday, the spokesman said. Read more...

Advertisement

FDA Approves Gilead's Zydelig for Three Cancers

July 23, 2014 1:13 pm | News | Comments

The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. Read more...            

Shire to Spend About $225M on Drug Collaboration

July 23, 2014 11:20 am | News | Comments

The drugmaker Shire plans to spend about $225 million in a joint effort with a privately held, U.S. firm to develop a potential treatment for the rare and life-threatening genetic disorder Hunter syndrom, said the British company Wednesday. Read more...

Merck Strengthens Commitment to Chinese Market

July 23, 2014 11:01 am | News | Comments

Merck, a leading company for high-tech products in the pharmaceutical and chemical sectors, reiterated its commitment to investments in the Chinese market, strengthening a major pillar of its emerging markets growth strategy. Read more...   

Galmed Gets IND Clearance for Fatty Liver Treatment

July 22, 2014 2:47 pm | News | Comments

Galmed Pharmaceuticals Ltd. announced that FDA cleared Galmed's Investigational New Drug application, permitting the company to conduct clinical trials of aramchol in the United States for the treatment of fatty liver disorders. Read more...   

Halozyme Resumes Pancreatic Cancer Trial

July 22, 2014 2:37 pm | News | Comments

Halozyme Therapeutics Inc. announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. Read more...               

Advertisement

FDA Fast Tracks New Epilepticus Drug

July 22, 2014 2:26 pm | News | Comments

SAGE Therapeutics announced that the FDA has granted fast track designation to the SAGE-547 development program, which will facilitate the development and expedite the review of the drug candidate. Read more...          

FDA Accepts Avanir's Trial App for Depression Drug

July 21, 2014 3:43 pm | News | Comments

Avanir Pharmaceuticals Inc. announced that the FDA accepted the company's Investigational New Drug (IND) application for a Phase 2 study assessing the safety and efficacy of AVP-786, Avanir's next generation compound. Read more...      

Arena Grants Marketing, Supply Rights for Belviq in Israel

July 21, 2014 3:28 pm | News | Comments

Arena Pharmaceuticals GmbH has entered into an exclusive marketing and supply agreement for Belviq (lorcaserin HCl) with Teva Pharmaceutical Industries Ltd.'s local Israeli subsidiary, Abic Marketing Limited. Read more...         

Allergan to Cut 1,500 Employees in Restructuring

July 21, 2014 11:10 am | by Tom Murphy, AP Business Writer | News | Comments

Botox maker Allergan will cut about 13% of its workforce, or roughly 1,500 employees, as part of a push to become more efficient and productive, and in the takeover battle's latest twist, Valeant said Monday it has complained to regulators that Allergan has been making false statements about its business. Read more...

InterMune Gets Breakthrough Therapy Status for IPF Drug

July 18, 2014 3:24 pm | News | Comments

InterMune, Inc. announced that pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF), has been granted Breakthrough Therapy Designation from the FDA. Read more...           

Advertisement

AstraZeneca Reveals Plans for Cambridge Site

July 18, 2014 11:15 am | News | Comments

AstraZeneca revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters, including designs for the Global Centre, an R&D Enabling Building and an Energy Centre located on the Cambridge Biomedical Campus, Cambridge, UK. Read more...

AbbVie, Shire Agree on Roughly $55B Combination

July 18, 2014 11:05 am | by Tom Murphy, The Associated Press | News | Comments

The drugmaker AbbVie has reached a deal worth roughly $55 billion to combine with British counterpart Shire and become the latest U.S. company to seek an overseas haven from corporate income tax rates back home when the new company is incorporated on the British island of Jersey. Read more...

Nintedanib Gets FDA Breakthrough Therapy Designation for IPF

July 17, 2014 2:16 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals Inc. announced that the FDA has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF). Read more...

FDA Approves Salix-Pharming Angioedema Treatment

July 17, 2014 2:07 pm | News | Comments

Salix Pharmaceuticals Ltd. and Pharming Group NV announced that the FDA has approved Ruconest for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Read more...         

Medicines Patent Pool Speeds Availability of Generic HIV Drugs

July 17, 2014 11:00 am | News | Comments

Three days before the start of the 20th International AIDS Conference in Melbourne, Australia, the Medicines Patent Pool (MPP) announced seven new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG). Read more...

FDA Grants QIDP Designation to Astellas Candidiasis Treatment

July 16, 2014 1:35 pm | News | Comments

Astellas announced that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis. Read more...               

Pfizer to Acquire InnoPharma for $225M

July 16, 2014 1:07 pm | News | Comments

Pfizer Inc. and InnoPharma Inc., a privately held pharmaceutical development company, announced that they have entered into an agreement under which Pfizer will acquire InnoPharma. Read more...                 

Arena Gets U.S. Cannabinoid Receptor Modulator Patent

July 16, 2014 11:14 am | News | Comments

Arena Pharmaceuticals Inc. announced that it was granted U.S. Patent No. 8,778,950, entitled "Cannabinoid Receptor Modulators," by the United States Patent and Trademark Office for APD371, an agonist of the cannabinoid receptor 2 (CB2). Read more...

Lilly, Immunocore Collaborate on Cancer Immunotherapies

July 16, 2014 10:59 am | News | Comments

Eli Lilly and Company and Immunocore Ltd. announced they have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies using Immunocore's Immune Mobilizing Monoclonal T-Cell Receptor Against Cancer technology. Read more...

Avastin Gets Priority Review for Certain Types of Cervical Cancer

July 15, 2014 3:12 pm | News | Comments

Genentech announced that the FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer. Read more...

FDA Grants Priority Review to New Hep C Combo

July 15, 2014 2:51 pm | News | Comments

Medivir AB announced that the FDA has assigned a Priority Review designation to the supplemental New Drug Application for the use of once-daily Olysio, in combination with sofosbuvir, for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C. Read more...

Codexis, GSK Collaborate on Platform Technology

July 15, 2014 11:38 am | News | Comments

Codexis Inc., a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, announced the signing of a platform technology license agreement with GlaxoSmithKline under which Codexis granted GSK a license to use Codexis’ proprietary CodeEvolver protein engineering platform technology in the field of human healthcare. Read more...

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