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The Lead

Bayer to Split Off Polymer Division with IPO

September 18, 2014 7:45 am | by The Associated Press | News | Comments

German pharmaceuticals and chemicals company Bayer AG says it plans a separate stock listing for its polymer division. The Leverkusen-based company that invented aspirin said Thursday the move would be part of an effort to focus the group on its health care and crop science businesses.

A Tale of Two Cities - SAFC's Irvine, Scotland and Lenexa, KS Dry Powder Media Facilities

September 11, 2014 1:38 pm | by Mike Auerbach, Editor In Chief | Articles | Comments

SAFC, a global company that supplies a multitude of services to the biopharm/pharmaceutical...

Ajinomoto Althea Receives European GMP Certification

September 3, 2014 9:13 am | News | Comments

Ajinomoto Althea announced today that it has officially received its European GMP certificate...

Insufficient Postage Leads to Bust of Fake Drugs

September 2, 2014 8:29 am | News | Comments

British, Hungarian and Austrian police were involved in the sweep that culminated Monday in...

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Cilag GmbH International Acquires Covagen AG

August 25, 2014 8:41 am | News | Comments

Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has acquired Covagen AG, a privately-held, biopharmaceutical company specializing in the development of multispecific protein therapeutics through the FynomAb technology platform.

Spanish Ebola Patient Gets Experimental Drug

August 11, 2014 8:00 am | by CIARAN GILES, Associated Press; MARIA CHENG, Associated Press | News | Comments

Spain has imported a U.S.-made experimental Ebola drug to treat a Spanish missionary priest evacuated from Liberia last week after testing positive for the killer virus. The Health Ministry announced Monday that the ZMapp drug, made by Mapp Biopharmaceutical Inc. of San Diego, was obtained in Geneva this weekend and brought to Madrid to treat Miguel Pajares.

Walgreens and Alliance Boots Accelerate Efforts to Fully Combine Both Companies

August 6, 2014 8:07 am | News | Comments

Walgreens today said it has exercised its option to complete the second step of its strategic transaction with Alliance Boots GmbH ahead of the original option period, which was between February and August 2015. The transaction, subject to shareholder and various regulatory approvals, would fully combine the two companies to form the first global pharmacy-led, health and wellbeing enterprise.

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Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

Meda to Acquire Rottapharm

July 31, 2014 8:14 am | News | Comments

Meda announced today that it has entered into a definitive agreement to acquire Rottapharm/Madaus, an Italian company owned by the Rovati family, for a consideration of SEK 21.2 billion on a cash and debt free basis.      

PCI Announces Definitive Agreement to Acquire Penn Pharma

July 30, 2014 8:38 am | News | Comments

Packaging Coordinators has reached a definitive agreement to acquire Penn Pharmaceutical Services Limited. Penn Pharma is headquartered in Tredegar, Wales in the United Kingdom and operates regional offices in New Hope, Pennsylvania and Tokyo, Japan.

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.

PaxVax Acquires FDA-Approved Typhoid Vaccine Vivotif

July 28, 2014 9:19 am | News | Comments

PaxVax, Inc., a specialty vaccine company focused on travel and biodefense, today announced that it has acquired the oral typhoid vaccine Vivotif® from Crucell Switzerland AG, as well as its manufacturing facility in Thörishaus, near Bern, Switzerland.

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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 Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.

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 previous trials have been disappointing. Research published in 2012 showed the shot only reduced malaria cases by about 30 percent in babies aged six to 12 weeks, the target age for immunization.

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 heavier women after reviewing the evidence, sparked by a French pharmaceutical company's declaration last year that the drugs didn't work in women weighing more than 176 pounds.

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.

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$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).

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).

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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