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The Lead

Obama Wants Limits on US Company Mergers Abroad

July 25, 2014 8:32 am | News | Comments

Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded "economic patriotism" from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers.      

Allergan's OZURDEX® Receives European Positive Opinion for the Treatment of Diabetic Macular Edema

July 25, 2014 8:03 am | News | Comments

Allergan announced today that the European Union’s Committee for Medicinal Products for Human...

GSK Asks European Regulator to OK Malaria Shot

July 24, 2014 8:18 am | News | Comments

The experimental shot is the most advanced candidate vaccine for malaria but results from...

EU Regulator: Morning-After Pill OK for All Women

July 24, 2014 8:11 am | News | Comments

The European Medicines Agency says a commonly used morning-after pill is suitable for use by...

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Salix Pharmaceuticals to Combine with Cosmo Technologies to Form Salix Pharmaceuticals, plc

July 9, 2014 8:57 am | News | Comments

Salix Pharmaceuticals, Ltd. and Cosmo Pharmaceuticals S.p.A. announced a definitive merger agreement under which Salix will combine with Cosmo Technologies Limited (“Cosmo Tech”), a subsidiary of Cosmo. Under the terms of the agreement, Salix will become a wholly-owned subsidiary of Irish domiciled Cosmo Tech.

$580M EU Antitrust Fine for Drug Makers

July 9, 2014 8:14 am | News | Comments

The European Union's antitrust body is imposing a fine of 428 million euros ($580 million) on France's pharmaceutical company Servier and five producers of generic medicines for distorting competition.        

EYLEA Injection Recommended for Approval for the Treatment of Visual Impairment due to Diabetic Macular Edema in the EU

June 27, 2014 8:33 am | News | Comments

Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME).

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Vertex Receives European CHMP Positive Opinion for KALYDECO in Eight Non-G551D Gating Mutations

June 27, 2014 8:24 am | News | Comments

Vertex Pharmaceutical today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of KALYDECO™ (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European Union

June 27, 2014 8:20 am | News | Comments

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes.   

Europe Euthanasia Rulings Spark Debate

June 25, 2014 8:35 am | by LORI HINNANT, Associated Press | News | Comments

A French doctor was acquitted Wednesday of poisoning charges after giving lethal injections to seven terminally ill patients, and Britain's Supreme Court said an assisted-suicide ban is incompatible with human rights, fueling the arguments of those who say the duty of doctors is to end the suffering of those beyond treatment.

Shire Rejects Offer from AbbVie

June 20, 2014 7:33 am | by The Associated Press | News | Comments

The Dublin-based drugmaker Shire said Friday it has rejected an unsolicited 27 billion-pound ($46.2 billion) offer from AbbVie Inc., arguing that it fundamentally undervalues the company and its prospects. The company said in a statement Friday that U.S.-based AbbVie's proposal was for 20.44 pounds ($34.78) and 0.7988 shares per Shire share.

ViiV Healthcare to Collaborate with Janssen to Develop Single-Tablet HIV-1 Treatment

June 13, 2014 8:51 am | News | Comments

ViiV Healthcare has entered into an agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialization of a single-tablet combining dolutegravir (Tivicay) and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine (Edurant).

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Lonza Invests in Single-Use Technology and Facility Upgrades for Clinical Antibody Drug Conjugate (ADC) Manufacturing

June 11, 2014 8:34 am | News | Comments

The planned upgrades include the introduction of single-use technology for flexible ADC manufacturing, along with a recently optimized plant layout and revamping of the Heating, Ventilation, Air Conditioning (HVAC) systems, which has resulted in a larger ADC production area.

Xcelience Opens UK/European Packaging and Distribution Hub

June 10, 2014 11:24 am | News | Comments

Xcelience announced today the opening of a 3,000 square foot facility in Birmingham, UK, making it the first small to mid-sized American CDMO to launch international operations. The new plant will become a gateway for the Florida-based company’s clinical packaging and distribution services in the UK, Europe and abroad.

Bayer CEO to Leave Company at End of 2016

June 4, 2014 8:16 am | News | Comments

In line with his own wishes, the contract of Dr. Marijn Dekkers will be extended by just two years on expiration of the initial five-year period. Dekkers cited family reasons for extending his contract only until the end of 2016.    

Glenmark Pharmaceuticals Opens New Antibody Manufacturing Facility in Switzerland

June 4, 2014 7:59 am | News | Comments

Glenmark Pharmaceuticals S.A (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), announced the opening of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland.  

Italy Seeks $1.6B in Damages from Novartis and Roche

May 29, 2014 1:45 pm | News | Comments

Italy's health ministry is seeking 1.2 billion euros ($1.63 billion) in damages from Swiss pharmaceutical giants Novartis and Roche after an anti-trust court ruled the two companies colluded to prevent the distribution of an eye medication.  

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Thirty Percent of World is Now Fat, No Country Immune

May 29, 2014 8:23 am | by MARIA CHENG, AP Medical Writer | News | Comments

Researchers found more than 2 billion people worldwide are now overweight or obese. The highest rates were in the Middle East and North Africa, where nearly 60 percent of men and 65 percent of women are heavy. The U.S. has about 13 percent of the world's fat population, a greater percentage than any other country.

Doctors Design Mini Dialysis Machine for Babies

May 23, 2014 8:14 am | by MARIA CHENG, AP Medical Writer | News | Comments

Usually, doctors adapt standard dialysis machines for babies, but that can be risky since the devices can't always be accurately tweaked. About 1 to 2 percent of hospitalized infants have kidney problems that may require dialysis, which cleans toxins from the blood when the kidneys aren't working.

European Commission Approves Jardiance Tablets for Use in Adults in Europe

May 23, 2014 8:02 am | News | Comments

The European Commission granted marketing authorization for Jardiance (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced.

FDA Targets Illegal Online Pharmacies in Globally Coordinated Action

May 22, 2014 1:37 pm | News | Comments

The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers.     

Jazz Pharmaceuticals Names Chief Operating Officer

May 19, 2014 2:07 pm | News | Comments

Jazz Pharmaceuticals has announced the appointment of Russell J. Cox to the newly created position of chief operating officer (COO).  Mr. Cox, who joined Jazz Pharmaceuticals in July 2010, most recently served as executive vice president and chief commercial officer at the company.

Merck Sells Ophthalmology Products in Japan and Key Markets in Europe and Asia Pacific to Santen

May 13, 2014 8:04 am | News | Comments

Santen will make an upfront payment of approximately $600 million and additional payments based on defined sales milestones as needed. The annual sales of these ophthalmology products in the markets within the scope of the agreement are approximately $400 million.

UK PM Says He's Playing Fair on AstraZeneca Deal

May 12, 2014 8:26 am | by DANICA KIRKA, Associated Press | News | Comments

With fears growing that British jobs will be lost and the nation's science base undermined in the potential merger, Prime Minister David Cameron denied in a BBC interview that he was favoring the American company.      

Meda Rejects Revised Offer from Mylan

April 28, 2014 7:33 am | by The Associated Press | News | Comments

Swedish pharmaceutical company Meda says it has rejected another offer from U.S. generic drugmaker Mylan Inc. Meda says its board decided to reject a revised Mylan proposal because the deal lacks support from Meda's largest shareholder, which the company did not name in a brief statement.

AstraZeneca Shares Soar on Pfizer Interest

April 28, 2014 5:31 am | by The Associated Press | News | Comments

AstraZeneca shares have jumped 15 percent in early trading after U.S. pharmaceutical firm Pfizer publicly disclosed details of a $100 billion bid approach. Pfizer said today that AstraZeneca rejected an initial approach in January valuing the company at about 59 billion pounds ($100 billion).

J&J Says Europe Clears New Diabetes Treatment

April 25, 2014 12:37 pm | by The Associated Press | News | Comments

Johnson & Johnson said Friday that European Union regulators approved a pill that combines its diabetes drug Invokana with metformin, an older treatment for the disease. Janssen-Cilag International will market the drug under the name Vokanamet.

Celgene Acquires Late-Stage Product for Crohn’s Disease and Other Gastrointestinal Disorders

April 24, 2014 8:14 am | News | Comments

Celgene Corporation entered into a global license agreement with Nogra Pharma Limited, a private pharmaceutical company based in Dublin, Ireland, to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn’s disease and other indications.

EMA Provides Update on Stolen Vials of Herceptin

April 18, 2014 8:26 am | News | Comments

Italian law enforcement authorities are currently investing the theft. However, the situation goes beyond EU and national current practices for handling quality or product defects; these are extraordinary circumstances driven by criminal activities that require special measures and strong collaboration from authorities across the EU.

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