Medical Tidbits,Cardinal Health Supportive Culture for Executive Women Recognized by National Association for Female Executives

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Cardinal Health is one of the 2016 National Association for Female Executives (NAFE) Top Companies for Executive Women, which recognizes American corporations that have moved women into top executive positions and created a culture that fosters the careers of talented women. This is the fifth consecutive year NAFE recognizes Cardinal Health. read more

Reapplix Receives US FDA 510(K) Clearance

Reapplix’s proprietary simple-to-use device technology has been cleared for the following indications for use: “The 3C Patch System™ is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System™ is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.” read more

Today the FDA announced actions to provide important information about the risks of Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.  This also includes ordering Bayer to conduct a postmarket surveillance study to obtain more data to better define and understand certain outcomes and events associated with Essure, and issuing a draft guidance to require manufacturers of all permanent hysteroscopically-placed tubal implants intended for sterilization include key information in patient and physician labeling.  Additional information about the Agency’s actions can be found on the Essure Permanent Birth Control website.

Provectus Biopharmaceuticals Awarded Patent Extending Protection of the PV-10 Manufacturing Process

KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or “The Company”), today announced that it has received a patent from the U.S. Patent and Trademark Office, U.S. Patent No. 9,273,022. The patent extends the scope of protection of the manufacturing process conferred initially by U.S. Patent No. 8,530,675, issued in 2013, to include coverage of the use of an alternative raw material in manufacturing the active ingredient (API) in PV-10.  read more

MiMedx Supports FDA’s Decision to Postpone April 13th Hearing on Draft Guidance Documents

MARIETTA, Ga., March 1, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic membrane and other birth tissues, human skin and bone, and patent-protected processes and proprietary platforms to develop and market advanced products and therapies, supports the decision by the Food and Drug Administration (“FDA”) to postpone the April 13, 2016 hearing regarding the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”) in order to accommodate the significant interest and response to be heard on this matter. The Company stated that the FDA’s decision benefits patients, physicians, the industry and the FDA. read more

EUSA Pharma and AVEO Announce Submission of Marketing Authorization Application for Tivozanib in Advanced Renal Cell Carcinoma

HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.–(BUSINESS WIRE)–EUSA Pharma, a newly-established specialty pharmaceutical business, and AVEO Oncology (NASDAQ:AVEO) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The filing is based on tivozanib’s existing dataset and follows positive interactions with the Rapporteur and Co-Rapporteur during 2015 which indicated support for a filing using the phase III TIVO-1 trial as the pivotal study. EUSA Pharma submitted the application under the European Union’s centralized procedure, which permits the agency to issue a single marketing authorization that is valid across all EU countries read more

Exelixis and Ipsen Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Regions Outside the United States, Canada and Japan

PARIS & SOUTH SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib, Exelixis’ lead oncology drug. Under the agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside the United States, Canada and Japan, including COMETRIQ®, which is currently approved in the European Union (EU) for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The companies have agreed to collaborate on the development of cabozantinib for current and potential future indications. Exelixis will maintain exclusive commercial rights for cabozantinib in the United States and Canada, and continue its discussions to partner commercial rights in Japan.

NANO: LATE-BREAKING ABSTRACT ON BETALUTIN® PHASE 1/2 STUDY ACCEPTED FOR PRESENTATION AT AMERICAN ASSOCIATION FOR CANCER RESEARCH ANNUAL MEETING 2016

Nordic Nanovector ASA (OSE: NANO), a company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology, announces that a late-breaking abstract on its Phase 1/2 clinical study with Betalutin® has been accepted for presentation at the American Association For Cancer Research (AACR) annual meeting (16-20 April 2016, New Orleans, LA, USA).  read more

Lilly to Present Phase 3 Data at the American Academy of Dermatology (AAD) Annual Meeting for Ixekizumab in Psoriasis and Psoriatic Arthritis

29 abstracts will highlight new data for ixekizumab, including 60-week safety and efficacy results in moderate-to-severe plaque psoriasis –

INDIANAPOLIS, March 1, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) will showcase results from pivotal Phase 3 data investigating ixekizumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis at the 74th annual meeting of the American Academy of Dermatology (AAD), which will take place March 4-8, 2016, in Washington, D.C.

A total of 29 abstracts, including three oral presentations, will feature Lilly’s ixekizumab data for the treatment of moderate-to-severe plaque psoriasis across a number of areas, including efficacy and safety data at 12 weeks and 60 weeks, patient-reported outcomes and data evaluating the efficacy and safety of ixekizumab compared to etanercept. Two abstracts evaluating the efficacy and safety of ixekizumab for the treatment of active psoriatic arthritis will also be presented.

“Moderate-to-severe plaque psoriasis can significantly impact all aspects of a person’s life, including both physical and emotional burdens,” said Aarti Shah, Ph.D., Vice President and Global Brand Development Leader, Ixekizumab, Eli Lilly and Company. “We are pleased to bring a comprehensive review of data for ixekizumab to this year’s American Academy of Dermatology annual meeting, which we believe highlights the potential for ixekizumab, if approved, to address the challenges faced by people living with this disease and physicians looking to provide a new treatment option for their patients.”

ALZHEIMERS FOUNDATION OF AMERICA CELEBRATES SOCIAL WORK MONTH WITH DEBUT OF NEW WEBINAR SERIES Studies, as well as the times and locations of the data sessions, are highlighted below.

In honor of social work month, the Alzheimer’s Foundation of America (AFA) is kicking off a new webinar series designed just for social workers. The webinars are free and social workers who attend and complete a short evaluation, following the webinar, will receive one continuing education contact hour. The first in the series, “Celebrating Social Workers As Partners In Care,” takes place March 16. read more

 

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