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The Lead

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...

Report: Single-Use Bioreactors Market to Grow to $471M by 2019

January 28, 2015 8:02 am | News | Comments

The single use bioreactors (SUBs) market is expected to grow at a double digit CAGR of 18.4% to...

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...

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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).     

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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.

Catalent Biologics and MGC Pharma Announce Partnership for Biomanufacturing in Asia

January 19, 2015 12:29 pm | News | Comments

Catalent Pharma Solutions and Mitsubishi Gas Chemical Company, Inc. (MGC), have entered into a partnership agreement to co-promote Catalent’s proprietary GPEx® technology in the Asian market.          

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.

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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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Proteros and Bayer to Develop New Cardiovascular Drug Compounds

January 8, 2015 8:45 am | News | Comments

The program is based on Proteros' structure-guided lead discovery platform which combines structure analysis, medicinal chemistry and other discovery technologies to drive potency, selectivity, and safety of novel lead compounds.    

Pfizer Acquires Redvax GmbH

January 5, 2015 8:05 am | News | Comments

Pfizer has acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. This transaction provides access to a preclinical human cytomegalovirus (CMV) vaccine candidate.

Health Canada Quarantines Products From Two Indian Companies

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

This action comes in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these sites. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk.

PPD and SNBL to Provide Clinical Development Services in Japan

December 24, 2014 8:25 am | News | Comments

Pharmaceutical Product Development and Shin Nippon Biomedical Labs have formed a joint venture that will provide a full range of clinical development services in Japan, including Phase I-IV clinical trial monitoring, project management, site intelligence and activation, biostatistics, data management, medical writing, pharmacovigilance, regulatory and FSP services.

Sartorius Selling Industrial Technologies Division to Minebea Co.

December 22, 2014 8:36 am | News | Comments

Sartorius, an international laboratory and pharmaceutical equipment provider, is selling its Industrial Technologies Division (Intec) to the Japanese Minebea Co., Ltd. (Minebea) and their partner, the Development Bank of Japan Inc.   

Judge Halts Alzheimer's Drug Swap Until July

December 16, 2014 8:47 am | by MICHAEL VIRTANEN, Associated Press | News | Comments

U.S. District Judge Robert Sweet told Dublin-based Actavis PLC to continue making the drug Namenda available for 30 days after generic alternatives become available on July 11 "in order to allow for an orderly transition."     

France Wants to Legalize Terminal Sedation

December 15, 2014 8:57 am | by SYLVIE CORBET, Associated Press | News | Comments

France's president wants to allow doctors to keep terminally ill patients sedated until death comes, amid a national debate about whether to legalize euthanasia. Francois Hollande stopped short of recommending lethal injections and avoided the terms euthanasia and assisted suicide, highly sensitive issues in this majority-Catholic country.

Swiss Researchers Suspend Ebola Vaccine Trial

December 11, 2014 10:05 am | by The Associated Press | News | Comments

Swiss researchers have suspended the testing of one of the leading Ebola vaccine candidates after some volunteers reported unexpected side effects. The Hopitaux Universitaires de Geneve said the trial had been suspended "as a precautionary measure." The study involving 59 people began in November.

Paralegal Says Sanofi Fired Her for Whistleblowing

December 8, 2014 8:41 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

A paralegal recently fired by French drugmaker Sanofi has filed a whistleblower lawsuit, claiming she was discharged after protesting an alleged kickback scheme to increase U.S. sales of its insulin medicines.       

Charges Dropped Against Two Former Lilly Scientists

December 8, 2014 8:34 am | News | Comments

Two former Eli Lilly and Co. employees who were accused of sending trade secrets worth more than $55 million to a competing Chinese drug company will no longer face charges, the U.S. attorney's office announced Friday.      

Meda to End Penicillin Contract with Recipharm; Layoffs Forecast

December 4, 2014 1:44 pm | News | Comments

Meda, a Recipharm’s customer, announced that they will transfer supply of their mainly Swedish penicillin products and manufacture offshore with other suppliers. The manufacturing contract with Recipharm Strängnäs will therefore be terminated as of December 31, 2015.

Catalent and Sellas to Collaborate on Therapeutic Reprofiling of Zolpidem

December 4, 2014 10:00 am | News | Comments

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with Swiss-based development-stage biopharmaceutical company SELLAS Life Sciences Group, to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC® OptiDose™ drug delivery technology.

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