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Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

September 29, 2014 3:23 pm | News | Comments

Insys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioma. Read more...             

Amag Pharma to Acquire Lumara Health for $675M

September 29, 2014 3:09 pm | News | Comments

Shares of anemia treatment maker Amag...

Janssen's Rezolsta Receives Positive Opinion from CHMP

September 29, 2014 10:49 am | News | Comments

Janssen announced that the CHMP of the European...

EMA Validates Marketing Authorization Application for Nivoluma

September 29, 2014 10:31 am | News | Comments

Bristol-Myers Squibb announced that the European...

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Daiichi Sankyo to Acquire Ambit Bioscience

September 29, 2014 10:09 am | News | Comments

Daiichi Sankyo Co. Ltd. and Ambit Biosciences jointly announced that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for approximately $315 million on a fully diluted basis. Read more...

Pfizer Completes Acquisition of InnoPharma

September 25, 2014 3:03 pm | News | Comments

Pfizer Inc.announced that it has completed its acquisition of the pharmaceutical development company, InnoPharma Inc., following receipt of United States (U.S.) regulatory approval from all government authorities required by the agreement and other closing conditions. Read more...

Pacira Shares Drop as FDA Warns on Misleading Ads

September 25, 2014 2:13 pm | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading. Read more...           

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Shire to Pay $56.5M Over False Drug Claims

September 25, 2014 8:30 am | News | Comments

The U.S. Department of Justice said Wednesday that Irish drugmaker Shire will pay $56.5 million to settle allegations it broke the law in promoting five different drugs, including its attention deficit disorder drugs Adderall XR and Vyvanse. Read more...

FDA Approves New Indication for Celgene's Otezla

September 24, 2014 3:29 pm | News | Comments

Celgene Corp. announced that the FDA has approved Otezla for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Read more...                

Acorda to Buy Developer of Parkinson's Treatment

September 24, 2014 3:07 pm | News | Comments

Acorda Therapeutics Inc. plans to buy privately-held Civitas Therapeutics for $525 million in cash as the drugmaker seeks to expand into treatments for Parkinson's disease. Read more…

Gilead Submits Fixed-Dose Hep C Combo NDA in Japan

September 24, 2014 11:09 am | News | Comments

Gilead announced that the company has submitted a NDA to Japan’s PMDA for approval of an investigational once-daily fixed-dose combination  for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults. Read more...    

Abraxane Approved in Switzerland for Pancreatic, Breast Cancers

September 24, 2014 11:00 am | News | Comments

Celgene International Sàrl announced that Swissmedic, the regulatory authority for Switzerland, has granted approval for Abraxane as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer. Read more...

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FDA Warns Doctors to Beware Fake Drug Distributors

September 23, 2014 2:44 pm | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health regulators are trying to help doctors spot counterfeit and unapproved drugs by raising awareness of illegal operations that peddle bogus drugs to health professionals. Read more...                 

Clampdown on Tax Maneuver Leaves its Mark on Pharma

September 23, 2014 1:46 pm | News | Comments

A handful of big companies pursuing overseas mergers to lower their tax bills - including pharmaceutical company AbbVie - came under pressure Tuesday after the U.S. unveiled rules to discourage them. Read more...           

FDA Fast Tracks MedImmune’s Pneumonia Drug

September 23, 2014 11:07 am | News | Comments

AstraZeneca announced that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody MEDI3902 for the prevention of nosocomial pneumonia. Read more...

Ebola Drug Trials to be Fast-Tracked in West Africa

September 23, 2014 10:48 am | News | Comments

Potential new treatments for Ebola are to be tested in West Africa for the first time as part of an international initiative to fast-track trials of the most promising drugs against the disease that has already led to over 2,600 deaths. Read more...

Amgen Submits BLA for Investigational Cancer Immunotherapy

September 22, 2014 3:54 pm | News | Comments

Amgen announced submission of a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...                

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Japan Approves Bayer's Eylea for Myopic Choroidal Neovascularization

September 22, 2014 9:58 am | News | Comments

Bayer HealthCare has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of myopic choroidal neovascularization (myopic CNV). Read more...     

Auxilium Rejects Endo's Takeover Offer

September 22, 2014 8:40 am | News | Comments

Auxilium Pharmaceuticals Inc.'s board has rejected an approximately $1.4 billion unsolicited takeover offer from Ireland's Endo International PLC. Read more...                          

Germany's Merck to Buy Sigma Aldrich for $17B

September 22, 2014 7:40 am | by David McHugh, AP Business Writer | News | Comments

German drug company Merck says it has agreed to buy St. Louis-based chemical firm Sigma-Aldrich Corp. for $17 billion. Darmstadt-based Merck KGaA said Monday it is paying $140 per share in cash for all of Sigma-Aldrich's share. Read more...

Gilead Cancer Drug Approved in Europe

September 19, 2014 9:22 am | News | Comments

Gilead Sciences Inc. announced that the European Commission has granted marketing authorization for Zydelig (idelalisib), a first-in-class oral treatment for chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). Read more...     

China Fines GSK $492M for Bribery

September 19, 2014 9:13 am | by Joe McDonald, AP Business Writer | News | Comments

Drug maker GlaxoSmithKline was fined $492 million on Friday for bribing doctors in China in the biggest such penalty ever imposed by a Chinese court. Read more...                         

EC Approves Xultophy for Adult Diabetes

September 18, 2014 11:03 pm | News | Comments

Novo Nordisk announced that the European Commission has granted marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...                       

White House Orders Plan for Antibiotic Resistance

September 18, 2014 10:57 pm | News | Comments

Signaling the seriousness of the threat posed by antibiotic-resistant germs, President Barack Obama on Thursday ordered the government to create a national plan to fight them by early 2015. Read more...             

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:41 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. Read more...                         

CDC Tells Healthy Adults Not to Forget Flu Vaccine

September 18, 2014 4:08 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

It's time for flu vaccine again and while it's important for the whole family, this year health officials have some different advice for different ages. Read more...                         

FDA OKs Faster-Acting Label for ED Drug Stendra

September 18, 2014 3:43 pm | News | Comments

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated. Read more...                       

Bayer to Split Off Polymer Division

September 18, 2014 7:40 am | News | Comments

German pharmaceuticals and chemicals company Bayer AG says it plans a separate stock listing for its polymer division. The move is part of an effort to focus the group on its health care and crop science businesses. Read more...     

Auxilium Adopts 'Poison Pill' Plan After $1.41B Offer from Endo

September 17, 2014 10:21 am | News | Comments

The board of Auxilium Pharmaceuticals Inc. has adopted a "poison pill" shareholder rights plan to ward off a hostile takeover after Endo International PLC announced an unsolicited offer worth about $1.41 billion for its fellow drugmaker. Read more...

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