Commercial

Saneca Pharma appoints new CEO

February 19, 2018

Contract development and manufacturing organisation (CDMO) Saneca Pharma has announced the appointment of its new CEO, Richard Král. Richard, who has been the sales and marketing director at Saneca for almost three years, has previously worked for GlaxoSmithKline and Zentiva Group across the Central and Eastern Europe (CEE) and the Commonweath of Independent States (CIS) […]

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February 19, 2018

Pragma Pharmaceuticals, LLC Announces the Launch of Decadron®

February 16, 2018

NEW YORK–(BUSINESS WIRE)–Pragma Pharmaceuticals is pleased to announce that it is planning the launch of Decadron® (dexamethasone) .5, .75, 4 and 6 mg tablets in early 2018. Fera Pharmaceuticals will manage the sales and marketing of the product for Pragma. Decadron has been a staple for decades in physician offices across the United States and […]

Stallergenes Greer Announces Approval in Japan of Pediatric Use for ACTAIR®, Sublingual Immunotherapy Tablet for the Treatment of House Dust Mite Allergy

February 16, 2018

LONDON–(BUSINESS WIRE)–Regulatory News:   “The approval of ACTAIR for pediatric use in Japan will provide a valuable treatment option for patients under the age of 12 suffering from allergic rhinitis caused by an allergy to house dust mites. We are very pleased that this product will be available to even more patients in Japan” Tweet […]

Idaho Blue Cross Jumps Into Controversial Market For Plans That Bypass ACA Rules

February 15, 2018

That didn’t take long.   It’s barely been two weeks since Idaho regulators said they would allow the sale of health insurance that does not meet all of the Affordable Care Act’s requirements — a controversial step some experts said would likely draw legal scrutiny and, potentially, federal fines for any insurer that jumped in. […]

J&J Gets First-Of-Its-Kind Prostate Cancer Approval

February 15, 2018

Dive Brief: In a first-of-its-kind approval on Wednesday, the Food and Drug Administration approved a treatment based on a new endpoint – metastasis-free survival. Johnson & Johnson’s apalutamide is now indicated for non-metastatic castration-resistant prostate cancer. The drug, approved ahead of its April user fee action date, will be sold under the trade name Erleada. […]

FDA approves first blood test that can help diagnose a concussion

February 15, 2018

The Food and Drug Administration on Wednesday approved a first-ever blood test to detect the telltale signs of serious brain injury, bringing to fruition a long quest to make the diagnosis of concussions simpler and more precise. After deliberations that took less than six months, the FDA approved the marketing of the Banyan Brain Trauma […]

ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer

February 15, 2018

HORSHAM, Pa., Feb. 14, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor,1 for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s […]

Oxford BioMedica Announces Collaboration and Licence Agreement with Bioverativ in the Field of Haemophilia Gene Therapy

February 15, 2018

OXFORD, England, February 15, 2018 /PRNewswire/ —   Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has completed a major new collaboration & licence agreement with Bioverativ Inc. for the development and manufacturing of lentiviral vectors to treat haemophilia. The agreement includes a […]

AMAG Pharmaceuticals Announces FDA Approval of Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women

February 15, 2018

WALTHAM, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) approved the Makena® subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in […]

Santhera Obtains Worldwide Exclusive License from Polyphor to Develop and Commercialize Clinical Stage Candidate for Cystic Fibrosis and Other Pulmonary Diseases

February 15, 2018

Pratteln, Switzerland, February 15, 2018 – Santhera Pharmaceuticals (SIX: SANN) announces that it has entered into a license agreement with Polyphor Ltd. for POL6014, a clinical stage selective inhibitor of human neutrophil elastase with the potential to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases such as non-cystic fibrosis bronchiectasis (NCFB), alpha-1 antitrypsin deficiency […]

GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older

February 15, 2018

GSK [LSE/NYSE: GSK] today announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. […]

CRF Health’s ‘Outstanding Innovation’ with Pioneering TrialConsent® Wins 2018 Clinical Informatics News Best Practices Awards

February 15, 2018

Plymouth Meeting, PA – February 15, 2018:  CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, today announced that its electronic informed consent solution, TrialConsent®, has won the 2018 Best Practices Award at this year’s Clinical Informatics News Awards. The Best Practices Awards program seeks to […]

Education system failing to properly prepare STEM students for the working world

February 15, 2018

Survey of chemistry professionals finds 61% believe that curricula are not suitable for industry needs   The inability of chemistry to recruit new STEM students is a crisis for the industry according to more than a third (36%) of 180+ chemistry professionals from academia and industry, in a survey carried out by Elsevier’s Reaxys team. […]

Certara Launches Version 10 of D360, Its Industry-leading Drug Discovery Informatics Platform

February 14, 2018

D360 v10 delivers powerful and intuitive visualization and data presentation tools embedded into the informatics platform, enabling faster and deeper data understanding Certara®, the global leader in model-informed drug development and regulatory science, today announced the launch of version 10 of D360™, its data informatics platform for discovery scientists. D360 is a self-service data access, […]

Recipharm appoints President Development Services to drive end to end offering

February 14, 2018

Contract development and manufacturing organisation (CDMO) Recipharm has appointed Bernard Pluta to lead its new global development organisation. The newly established position forms part of the ongoing transformation of Recipharm’s Development Services, in which a total of 400 employees across six countries are united to deliver a comprehensive development offering. The scientific, chemical and pharmaceutical expertise will cover […]

Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

February 14, 2018

Holzkirchen, February 13, 2018 – Sandoz, a Novartis division, today announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone®* (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). […]

Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures

February 14, 2018

DANVERS, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Impella 2.5® and Impella CP® heart pumps during elective and urgent high risk percutaneous coronary […]

CRISPR – Fast Initial Growth, But Long-Term Revenues Will Depend on “Wins”

February 14, 2018

ROCKVILLE, Md., Feb. 13, 2018 /PRNewswire/ — New York City-based market research firm Kalorama Information projects fast revenue growth for the most important gene editing technology CRISPR/Cas9 – 33.7% growth over the next five years, as revenues grow from $779 million in 2017 to $5.2 billion in 2023.   But Kalorama said the technology revenue […]

Celltrion Receives EU Approval for Trastuzumab Biosimilar

February 14, 2018

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) approved Herzuma® (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The decision follows a positive opinion from the Committee for Medicinal Products […]

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