Medical Tidbits, BioPorto decides to reapply for FDA approval of The NGAL TestTM

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BioPorto decides to reapply for FDA approval of The NGAL TestTM Copenhagen Stock Exchange:BIOPOR

BioPorto A/S (BioPorto) has decided to reapply for approval of the Company’s kidney injury test, The NGAL Test™, with the Food and Drug Administration (FDA) in USA. The decision follows a positive dialogue with FDA on factors involved in the decision to decline the company’s previous application for approval, see company announcement no. 13 of May 28, 2016.

FDA approval is important for large-scale commercialization of The NGAL Test™ in the United States. FDA declined the previous application on grounds that it did not present adequate clinical and analytical data to support approval of the device, especially in mild cases of acute kidney injury. The Company expects to base the reapplication on new data to be collected as soon as possible. read more

Bristol-Myers Squibb Acquires Cormorant Pharmaceuticals

Gains full-rights to Cormorant’s HuMax-IL8 antibody program and lead asset HuMax-IL8 in Phase 1/2 Development

Broadens Bristol-Myers Squibb’s oncology pipeline focus on the tumor microenvironment and combination therapy

NEW YORK & STOCKHOLM–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and Cormorant Pharmaceuticals announced today that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormorant, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases. The acquisition gives Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a potentially complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules.

Juniper Pharmaceuticals Announces that Merck KGaA, Darmstadt, Germany, has Obtained Regulatory Approval for OneCrinone® in Japan

BOSTON, July 5, 2016 /PRNewswire/ — Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper” or the “Company”), a women’s health therapeutics company, today announced that for the Japanese market Merck KGaA, Darmstadt, Germany (XETRA: MRK.DE), acting through its biopharma business, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone® 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.

“This approval further expands the global Crinone® progesterone gel franchise into the world’s’ third largest pharmaceutical market, giving women and couples struggling with infertility in Japan a new, patient-friendly therapeutic option for luteal phase support,” said Frank Condella, Juniper’s CEO. “We look forward to supporting the launch of OneCrinone® in Japan later this year.”

Coventus Extends Distribution Agreement for SUPARTZ FX

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has entered into an agreement with Seikagaku Corporation to continue distributing SUPARTZ FXin the US after the current distribution agreement expires in May 2017. Under terms of this extension, Bioventus will continue to distribute SUPARTZ FX in the US through May 2019. 

Magellan Health Completes Acquisition of Armed Forces Services Corporation

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Magellan Health, Inc. (NASDAQ:MGLN), a leader in complex care and special population management, today announced that it has completed its acquisition of Armed Forces Services Corporation (AFSC), a company with extensive experience providing and managing behavioral health and specialty services to various agencies of the federal government, including all five branches of the U.S. Armed Forces.

The 27th Neuronal Plasticity Prize of the Fondation IPSEN Has Been Awarded to David Attwell, Pierre Magistretti and Marcus Raichle

PARIS–(BUSINESS WIRE)–The 27th annual Neuronal Plasticity Prize of the Fondation IPSEN will be awarded to three leading scientists for their pioneering work in the field of neuroenergetics: David Attwell(University College London, UK), Pierre Magistretti(Brain Mind Institute, EPFL, KAUST, Lausanne, Switzerland) and MarcusRaichle(Washington University School of Medicine, St Louis, USA). The prize will be awarded on July 5th, 2016 at the 10th FENS (Federation of European Neurosciences Societies) Forum of Neurosciences in Copenhagen by an international jury led by Nikos Logothetis (Max Planck Institute for Biological Cybernetics, Tübingen, Germany).

Celltrion Healthcare announces its commitment to develop anti-drug antibody and drug concentration assay to enable evidence-based decision-making in anti-TNF treatment

News follows recent FDA approval of InflectraTM (biosimilar infliximab, other brand name Remsima®), now the first and only biosimilar monoclonal antibody (mAb) approved in the US

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion Healthcare, a global biopharmaceutical company, today announced its research commitment to develop laboratory tests that will determine both drug and anti-drug antibody (ADA) levels in the blood, enabling physicians to identify when patients on an anti-tumour necrosis factor (anti-TNF) drug require a change of dose or a switch to a different treatment in the class. read nore
PR Newswire for Journalists | Sysmex Inostics Blood-based RAS Biomarker Test Now Available in Italy

Sysmex Inostics Blood-based RAS Biomarker Test Now Available in Italy

NAPLES, Italy, July 5, 2016 /PRNewswire/ –Assessing RAS mutation status in patients with mCRC has shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies can improve outcomes in patients with RAS wild-type mCRC. Using the OncoBEAM® RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, the RAS mutation status can now also be determined using the blood: a rapid and simple method allowing even more patients to have access to personalized mCRC therapy.  This should reduce the clinical turn around time for Oncologists allowing them to make informed therapy decisions in a timely manner and reducing the complications for patients currently undergoing tissue biopsies.  The first center of excellence that implemented the OncoBEAM® RAS test in Italy is the Centro di Ricerche Oncologiche di Mercogliano (CROM) in Naples.

SIP Skills Strategy Shows Demand for 250,000 Jobs in the Science Industries by 2025

 LONDON, July 5, 2016 /PRNewswire/ —

The Science Industry Partnership (SIP) has published its firstSIP Skills Strategy, based on a major research exercise into the skills required through to 2025 in order to ensure a globally competitive science industry sector- which includes the chemicals, pharmaceuticals, bio-technology and medical technology industries.

The Skills Strategy forecasts the sector’s demand for skilled people out to 2025 – a projection of between 180,000 – 260,000 new scientific staff, many in new technology-based occupations. This includes:

  • up to 142,000 professional level graduate-entry jobs
  • up to 73,000 technical level apprenticeship-entry roles

Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (Daclizumab) Approved in European Union for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous injection. read more

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