Medical Tidbits,DARZALEX® (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma

PR Newswire, HORSHAM, PA, November 16, 2015
Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced today the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and immunomodulatory agent.1 This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.2,3 Refractory cancer occurs when a patient’s disease is resistant to treatment or in the case of multiple myeloma, the disease progresses within 60 days of their last therapy.4,5 Relapsed cancer means the disease has returned after a period of initial, partial or complete remission.6  read more

Amgen to Present IMLYGIC™ (Talimogene Laherparepvec) Data at the 2015 International Congress of the Society for Melanoma Research

Highlights Include Analyses From Pivotal Study and New Data From Phase 1b Combination Trial in Metastatic Melanoma

THOUSAND OAKS, Calif., Nov. 16, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Company will present eight IMLYGICTM (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck’s anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research (SMR), to be held on Nov. 18-21 in San Francisco. read more

Medtronic Showcases Aortic Leadership in Innovation with Clinical Release and Pipeline at VEITH 2015

New Aortic Data Demonstrates Medtronic’s Commitment to Innovation

 Medtronic plc (NYSE: MDT) today announced notable clinical studies and innovative technologies that will be presented at the annual VEITHsymposium, the world’s premier conference for vascular surgeons specializing in the most current information and new developments in clinical practice and research. The conference is taking place in New York City from November 17-21, 2015. read more

Mylan Authorizes $1 Billion Share Repurchase Plan

HERTFORDSHIRE, England and PITTSBURGH, Nov. 16, 2015 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE; MYL) today announced that the Board of Directors of Mylan N.V. (the “Company”) has authorized share repurchases by the Company of its ordinary shares in an amount up to $1 billion, either in the open market through privately-negotiated transactions or in one or more self tender offers. The repurchase program does not obligate the Company to acquire any particular amount of ordinary shares. The authorization expires on Aug. 27, 2016.  read more

Gilead /Interim Analyses Results from Study 115 to be Presented as a Late-Breaking Abstract at the American Society of Hematology (AS

H) Annual Meeting —

FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 16, 2015– Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. (NASDAQ:GILD) today announced that its Phase 3 Study 115 evaluating Zydelig® (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. read more

Advanced Medical Isotope Corporation Reports Progress Towards Seeking FDA Clearance for the Y-90 RadioGel™ Device

CEO Jim Katzaroff and the lead scientific and medical advisory team from AMIC met at the FDA offices last week to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and AMIC team are working closely in order to obtain all appropriate data and benchmarks the FDA requires in order to proceed with providing final clearance for marketing the device in the United States. AMIC intends to seek classification and clearance as a class II medical device through a de novo application.

Ophthotech Announces that Genentech, a Roche Wholly-Owned Subsidiary, Elects to Exercise Its Right to Opt-in to the Novartis Portion of the Ophthotech / Novartis Ex-US Agreement for Fovista® to Treat Wet Age-Related Macular Degeneration

NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (Nasdaq:OPHT) announced today that Genentech, a Roche wholly-owned subsidiary, has elected to exercise its option to participate in the financial arrangements relating to Novartis’ rights under the Ophthotech/Novartis ex-US agreement for Fovista® (pegpleranib) to treat wet age-related macular degeneration (AMD). Roche’s option originates from a pre-existing agreement between Roche and Novartis. Ophthotech’s agreement with Novartis and its financial terms remain unchanged including potential payments to Ophthotech of over $1 billion in upfront and milestone payments, and future royalties on ex-US Fovista® sales. Ophthotech continues to retain sole rights to Fovista® in the United States.

Medivir terminates the ADAM8 inhibitor project for pancreatic cancer

Medivir AB (Nasdaq Stockholm: MVIR) today announces that it will terminate its ADAM8 inhibitor project for pancreatic cancer. The closure of the project follows a semi-annual review of the company’s R&D project portfolio, which deprioritized the project based on data generated during the last six months. As a consequence the license agreement with Cancer Research Technology (CRT) for ADAM8 inhibitors and the collaboration with CRT and TransMIT GmbH will be terminated.

With the closure of this project, internal resources are transferred to the company’s other oncology discovery projects. These projects are focused on the identification of new treatments for hepatocellular carcinoma, pancreatic cancer and other areas of high unmet medical need among cancer patients, and utilize Medivir’s core technologies of protease inhibitor design and nucleoside/nucleotide science.

POXEL Announces Patent Access Agreement with ENYO

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, today announced a second agreement with ENYO Pharma SA, by which Enyo accesses a key patent on the use of FXR technology to develop treatments for hepatitis B. The FXR Agonist technology was discovered and patented by Poxel together with academic partners represented by Inserm Transfert and the Lyon-based company EDELRIS. Inserm Transfert has been appointed to represent all parties in the patent agreement with Enyo. Enyo and Poxel signed a license agreement, which was announced May 6, 2015, on Poxel’s FXR Agonist program for infection-related indications. No financial terms of either agreement have been disclosed.

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