Medical Tidbits,Amgen Receives Positive CHMP Opinion To Extend Indication Of Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma

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/PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis® (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.

“In the first ever comparative Phase 3 head-to-head study of two proteasome inhibitors in relapsed multiple myeloma, Kyprolis in combination with dexamethasone nearly doubled progression-free survival compared to a current standard of care regimen,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis.” read more

ASTRAZENECA’S FASLODEX MET PRIMARY ENDPOINT IN FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER

AstraZeneca today announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer.

Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of extended progression-free survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines. read more

ASTRAZENECA RECEIVES COMPLETE RESPONSE LETTER FROM US FDA FOR SODIUM ZIRCONIUM CYCLOSILICATE (ZS-9) FOR ORAL SUSPENSION FOR TREATMENT OF HYPERKALAEMIA

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. read more

Future Heparin Treatment to Include Administering Personalised Dose to Further Improve Its Efficacy and Security

MONTPELLIER, France–(BUSINESS WIRE)–Heparin is the most commonly used medication in thrombosis prevention and treatment. Heparin is on the World Health Organisation’s list of essential medicines and, according to calculations, it saves more than 100 million lives every year. Additionally, recent studies show that there is no standard response to Heparin treatment and that it must be adapted for each patient to further improve its efficacy and security. read more

Masimo to Showcase Next Generation SedLine® Brain Function Monitor at 2016 Euroanaesthesia Congress

NEUCHATEL, Switzerland–(EON: Enhanced Online News)–Masimo (NASDAQ: MASI) announced today the CE mark and scheduled full market release of Next Generation SedLine® Brain Function Monitoring technology at the European Society of Anaesthesiology’s (ESA) 2016 Euroanaesthesia Congress in London, England. read more

Genentech’s Gazyva® Showed Superior Progression-Free Survival Compared to Rituxan® in People with Previously Untreated Follicular Lymphoma

SOUTH SAN FRANCISCO, Calif.–(EON: Enhanced Online News)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the pivotal Phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL). The study compared the efficacy and safety of Gazyva® (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva alone, head-to-head with Rituxan® (rituximab) plus chemotherapy followed by Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to Rituxan-based treatment. Adverse events with either Gazyva or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration. read more

The Medicines Company Announces Completion of Patient Enrollment in Phase 3 TANGO 1 Study of CARBAVANCE® (meropenem-vaborbactam) for Treatment of Complicated Urinary Tract Infections (cUTI)

PARSIPPANY, N.J.–(EON: Enhanced Online News)–The Medicines Company (NASDAQ:MDCO) has announced the completion of patient enrollment in the Phase 3 TANGO 1 study of CARBAVANCE® (meropenem-vaborbactam), an investigational agent being developed for the treatment of complicated urinary tract infections (cUTI). TANGO 1 was initiated in the fourth quarter of 2014 under a cost-share agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of CARBAVANCE. Top-line data are expected in the second half of 2016.

Shire Receives Positive CHMP Opinion in Europe for Revestive® (Teduglutide) for Paediatric Patients with Short Bowel Syndrome

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive[®*] (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS). Teduglutide is an analogue of human glucagon like peptide 2 (GLP-2) that enhances key structural and functional adaptations in the intestinal mucosa.[i]

The European Commission (EC) will now consider the CHMP positive opinion in its final decision of whether to extend marketing authorisation for teduglutide in paediatric patients with SBS in the European Union; a final decision from the EC is expected in August 2016.

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