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The Lead

Experimental Ebola Drug Heals All Monkeys in Study

September 2, 2014 | by MARILYNN MARCHIONE, AP Chief Medical Writer | Comments

The monkeys were given the drug, ZMapp, three to five days after they were infected with the virus and when most were showing symptoms. That is several days later than any other experimental Ebola treatment tested so far.     

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Particle Sciences Expands Drug Eluting Device Capabilities and Overall Clinical Trial Manufacturing Resources

September 2, 2014 2:39 pm | Comments

Particle Sciences, a CDMO for drug eluting devices, has added to its investment in development and manufacturing capabilities with the addition of a new 18mm extruder. The company now has over 6000ft2 of operating cleanroom and cGMP warehouse space including ISO5 (sterile) and two dedicated highly potent suites.

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Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

September 2, 2014 9:34 am | Comments

Actavis plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D).

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EMD Serono Appoints New Senior Vice President, Neurology and Immunology

September 2, 2014 9:09 am | Comments

EMD Serono announced today that Drew Young has joined the company as Senior Vice President, Neurology and Immunology. In this capacity, he will be responsible for leading the strategic direction of the U.S. Neurology and Immunology franchise, including future products.

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Regeneca Worldwide Expands Voluntarily Recall of Regeneslim Appetite Control Capsules

September 2, 2014 9:04 am | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA.

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Insufficient Postage Leads to Bust of Fake Drugs

September 2, 2014 8:29 am | Comments

British, Hungarian and Austrian police were involved in the sweep that culminated Monday in eight arrests, including the suspected head of the scam in Vienna, police said.             

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Virginia Facility Processes Crab Blood for Medical Tests

September 2, 2014 8:19 am | by CONNIE MORRISON, Eastern Shore News | Comments

Wako Chemicals' Cape Charles facility extracts the naturally pale blue blood of horseshoe crabs and processes it to yield a protein used in the medical industry to test instruments, implants and pharmaceuticals.       

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Survey: Pharmaceutical and Other Foreign Companies in China Feel 'Targeted'

September 2, 2014 8:14 am | by JOE McDONALD, AP Business Writer | Comments

Foreign companies in China feel increasingly targeted for unfair enforcement of anti-monopoly and other laws and might cut investment if conditions fail to improve, a U.S. business group said Tuesday.         

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Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

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DPx Holdings B.V. Reaches Definitive Agreement to Acquire Gallus BioPharmaceuticals

August 28, 2014 11:55 am | Comments

DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners.

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Novo Nordisk Buys Production Plant in New Hampshire

August 28, 2014 11:47 am | Comments

The facility was established in 1989, expanded in 2003-2006 and acquired by Olympus Biotech in 2011. It has been used primarily for mammalian cell manufacturing until production was phased out earlier this year.       

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Merck Serono Breaks Ground for New Pharmaceutical Manufacturing Facility in China

August 28, 2014 10:48 am | Comments

The new facility, which will be the group's second-largest pharmaceutical manufacturing facility worldwide, will focus on the bulk production and packaging of Glucophage®, Concor® and Euthyrox®, Merck Serono's leading brands for the treatment of diabetes, cardiovascular diseases and thyroid disorders, respectively.

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WHO: Ebola Cases Could Eventually Reach 20,000

August 28, 2014 9:29 am | by JOHN HEILPRIN, Associated Press; KRISTA LARSON, Associated Press | Comments

The Ebola outbreak in West Africa eventually could exceed 20,000 cases, more than six times as many as are now known, the World Health Organization said Thursday. A new plan by the U.N. health agency to stop Ebola also assumes that the actual number of cases in many hard-hit areas may be two to four times higher than currently reported. If that's accurate, it suggests there could be up to 12,000 cases already.

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US to Begin Safety Testing Ebola Vaccine Next Week

August 28, 2014 9:26 am | by SETH BORENSTEIN, AP Science Writer | Comments

The National Institutes of Health announced Thursday that it is launching the safety trial on a vaccine developed by the agency's National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. It will test 20 healthy adult volunteers to see if the virus is safe and triggers an adequate response in their immune systems.

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FDA Removes Partial Clinical Hold on OncoMed Pharmaceuticals' Vantictumab

August 28, 2014 8:40 am | Comments

Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. 

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IBM’s Watson Ushers in a New Era of Pharmaceutical Data-Driven Discoveries

August 28, 2014 8:30 am | Comments

IBM today announced significant advances in Watson's cognitive computing capabilities that are enabling researchers to accelerate the pace of scientific breakthroughs by discovering previously unknown connections in Big Data.    

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