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The Lead

Life Sentence for German Nurse Who Killed Patients

February 26, 2015 3:21 pm | News | Comments

A German court sentenced a male nurse to life in prison on for killing patients with overdoses of heart medication that he confessed to administering because he enjoyed trying to revive them.

Catalent Expands European Clinical Packaging Capabilities

February 26, 2015 3:01 pm | News | Comments

Catalent Pharma Solutions has announced several expanded capabilities within its European...

Biota Pharmaceuticals to Acquire Anaconda Pharma

February 26, 2015 8:07 am | News | Comments

Biota Pharmaceuticals has entered into a definitive agreement to acquire Anaconda Pharma, a...

UN Health Agency Urges Europe to Step Up Measles Vaccination

February 25, 2015 8:28 am | News | Comments

The World Health Organization is urging Europe to step up measles vaccination efforts as...

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Jacobs to Design Ireland Biologic Facility for BMS

February 24, 2015 8:03 am | News | Comments

Jacobs Engineering Group has received a contract from Bristol-Myers Squibb Company to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland.

Alkermes Appoints Senior Vice President of Research, Pharmaceutical and Nonclinical Development

February 23, 2015 8:24 am | News | Comments

Alkermes has appointed Mark Namchuk, Ph.D., as Senior Vice President of Research, Pharmaceutical and Nonclinical Development. Dr. Namchuk will be responsible for advancing the company’s early-stage product pipeline.

Hospira Launches First Biosimilar in Major European Markets

February 17, 2015 8:22 am | News | Comments

Hospira today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis and plaque psoriasis.

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Berlin Measles Traced to Refugees, But Two Cases Linked to US

February 13, 2015 8:00 am | News | Comments

Authorities in Berlin say a spike in measles infections has been traced to unvaccinated refugees but at least two measles cases appear to have come from the United States.

Bayer Announces Reorganization as ‘Pure Life-Sciences Company’

February 12, 2015 10:39 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The company announced the overhaul of its HealthCare, CropScience and other operations in a letter sent to employees Wednesday, though it indicated specific decisions on what the company will look like next January haven't yet been made.

GSK Acquires GlycoVaxyn for $212M

February 11, 2015 8:36 am | News | Comments

Edmond de Rothschild Investment Partners announced today that its BioDiscovery 3 portfolio company, GlycoVaxyn AG, a privately held specialist vaccine biopharmaceutical company, has been acquired by GlaxoSmithKline in an all-cash transaction valuing the company at approximately $212M.

Christie Declines to Take Questions After Vaccination Flap

February 3, 2015 1:15 pm | by JILL COLVIN, Associated Press | News | Comments

The Republican governor and likely presidential contender had originally been scheduled to address the press three times during the final day of his three-day trip to the United Kingdom. Instead, the availabilities vanished from his schedule, which included lunch with the chancellor of the exchequer and a visit to the famous Globe Theatre.

GlobalData: France’s Pharmaceutical Market Value Will Crawl to $48.2B by 2020 as Generics Limit Growth

February 3, 2015 10:47 am | News | Comments

The French pharmaceutical market is forecast to grow at a tepid Compound Annual Growth Rate (CAGR) of 0.7% from $46.2 billion in 2014 to $48.2 billion by 2020, restricted by an increasing focus on generic drugs, according to research and consulting firm GlobalData.

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Mylan Shareholders Approve Abbott Business Purchase

January 29, 2015 1:13 pm | News | Comments

Mylan announced that its shareholders approved its purchase of an Abbott Laboratories business and its tax-reducing move to the Netherlands. The company also said European Union regulators cleared the deal, which Mylan values at about $5.3 billion.

Vetter Completes Structural Work on New Multi-Functional Development Service and Information Technology Building

January 29, 2015 10:40 am | News | Comments

Following 16 months of construction, the first phase of a modern, multi-functional building at Vetter’s Ravensburg Schuetzenstrasse site has been completed. Estimated to be fully operational by the beginning of 2016, the new facility will contain high-tech laboratories and workplaces for Vetter Development Service, as well as a highly secure data center and additional office space for a total area of 8,500 sqm.

Photo of the Day: Novartis CEO Joe Jimenez

January 28, 2015 11:16 am | by Mike Auerbach, Editor In Chief | News | Comments

It’s financial reporting season and the pharmaceutical industry is no exception. This week Novartis reported that its fourth quarter net income dropped a whopping 26% or “only” $1.49B compared to $2B from a year ago.      

PPD Expands Clinical Supplies Facility in Athlone, Ireland

January 28, 2015 8:07 am | News | Comments

Pharmaceutical Product Development, (PPD) has completed an expansion of its clinical supplies facility in Athlone, Ireland, that will enable the company to double its packaging warehousing capabilities and quadruple its distribution services. Those increases are the result of PPD more than tripling the size of the facility as part of its long-term strategy to expand its global depot network.

Novartis Posts Fourth Quarter Profit Drop

January 27, 2015 6:53 am | News | Comments

Novartis AG says fourth quarter net income dropped 26 percent but the company still posted a healthy 2014 annual profit. The Basel, Switzerland-based company said Tuesday that fourth quarter net income came in at $1.49 billion, down from $2 billion in the same quarter the year before.

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CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.

FDA Approves Octapharma's Second Octagam® 10% Manufacturing Site

January 26, 2015 10:24 am | News | Comments

Octapharma announced that the FDA has approved the company’s manufacturing facility in Vienna, Austria for the production of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation], which became available in the U.S. during October 2014.

EMA Recommends Suspending GVK Biosciences Medicines over Flawed Studies

January 23, 2015 8:06 am | News | Comments

A number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, says the European Medicines Agency (EMA).     

Catalent Expands Integrated Softgel Operations Through Coating and Packaging Investment In Eberbach, Germany

January 22, 2015 10:44 am | News | Comments

Catalent Pharma Solutions will adding new coating and blister packaging equipment at its 360,000 sq ft, Eberbach, Germany softgel manufacturing facility, expanding the integrated softgel solutions available.       

PPD Expands GMP Laboratory in Athlone, Ireland

January 21, 2015 9:50 am | News | Comments

Pharmaceutical Product Development, LLC (PPD) has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility.

UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam

January 21, 2015 7:58 am | News | Comments

In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.

SAFC Opens Dry Powder Media Manufacturing Facility in Irvine, Scotland

January 15, 2015 8:02 am | News | Comments

The Irvine expansion, announced in March 2013, was initiated as part of a five-year capital investment plan designed to support SAFC customers with critical products and services across the globe. Now fully validated, the site acts as the European counterpart to the Lenexa, Kansas, Center of Excellence for cell culture media manufacture and supply in the U.S.

SGS Expands Biomarker Services

January 14, 2015 8:28 am | News | Comments

SGS Life Science Services today announced that its laboratory in Poitiers, France, has successfully completed a full analytical validation of the novel Meso Scale Discovery (MSD®) V-PLEX 10-plex Proinflammatory Panel I, for use with human plasma samples.

Roche, Meiji and Fedora to Collaborate on New Antibiotic to Fight Increasing Bacterial Resistance

January 13, 2015 11:26 am | News | Comments

Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development. Under the agreement, Roche obtains worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji will retain sole commercialization rights.

Biogen Idec Acqures Convergence Pharmaceuticals

January 12, 2015 8:32 am | News | Comments

Biogen Idec announced today that it has agreed to acquire U.K.-based Convergence Pharmaceuticals, a clinical-stage biopharmaceutical company with a portfolio of ion channel-modulating product candidates for neuropathic pain.     

Shire to Pay $5.2B for NPS Pharma

January 12, 2015 8:28 am | by The Associated Press | News | Comments

The acquisition will expand Shire's portfolio of specialty drugs, medications for niche diseases and conditions that typically command much higher price tags than conventional medications. Shire's best-selling drugs currently include the attention deficit disorder drugs Vyvanse and Adderall XR.

EMA Recommended Record Number of Rare Disease Medicines for Approval in 2014

January 9, 2015 10:49 am | News | Comments

In 2014, the European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing authorization in a year. Out of the 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, providing therapies for patients who often have only few or no treatment options.

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