Medical Tidbits,Teleflex Incorporated Announces Worldwide Recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

biosimilars, breaking medical news, biotech news

WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX) announces worldwide recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. The Arrow® IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart. read more

Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle

PRNewswire/ — Allergan plc (NYSE: AGN) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its Prior Approval Supplement (PAS) for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, Multi-Dose Preservative-Free (MDPF) presentation. read more

FDA Accepts Amgen’s Supplemental Biologics License Application For The Expanded Use Of Enbrel® (Etanercept) To Treat Pediatric Patients With Chronic Severe Plaque Psoriasis

PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s supplemental Biologics License Application (sBLA) for the expanded use of Enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.

“If approved, ENBREL would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need.” read more

Lundbeck starts clinical phase III program with Lu AF35700 in patients with treatment resistant schizophrenia

A clinical phase III multi-national study with approximately 1,000 patients has been initiated

  • Lu AF35700 has a novel pharmacological profile with predominant D1 vs. D2 dopamine receptor occupancy combined with high 5-HT6 receptor occupancy. The program follows demonstration of good safety profile in phase I trials in both healthy subjects and patients with schizophrenia
  • Lu AF35700 may become the first new pharmacotherapy in decades for patients with treatment resistant schizophrenia (TRS)
  • Patients with treatment resistant schizophrenia account for a significant part of the total health care costs associated with schizophrenia[i]   read more

ADC Therapeutics Doses First Patient in Phase I Trial of ADCT-402 in CD-19 Positive B-cell Non-Hodgkin Lymphomas

LAUSANNE, Switzerland & LONDON & MURRAY HILL, N.J.–(BUSINESS WIRE)–ADC Therapeutics (ADCT), the oncology drug development company, announces that the first patient has been dosed in a Phase I trial to evaluate its antibody drug conjugate (ADC) ADCT-402 in B-cell non-Hodgkin Lymphoma (B-NHL). read more

Study results presented in New England Journal of Medicine strengthen Hansa Medical’s belief in the potential of IdeS

A recent study published on March 10, 2016 in the New England Journal of Medicine (Orandi et al. 2016;374:940-50) demonstrates a clear survival benefit in patients who received kidney transplants from HLA-incompatible live donors, compared to patients who remained on the waiting list for kidneys from deceased donors, or no transplant at all.“The study highlights the need for and benefit from desensitization in kidney transplantation. Although IdeS was not subject of this study, it strengthens our belief that IdeS has the potential to play a very important role in kidney transplantation going forward. Our vision for IdeS is to make desensitization possible for highly and moderately HLA-sensitized patients relying on either deceased or living donor donation.” comments Göran Arvidson, CEO of Hansa Medical AB.

Dr. Reddy’s and TR-Pharm Announce Strategic Collaboration in Turkey

 HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s and TR-Pharm announced today a strategic collaboration agreement involving 3 biosimilar products. A total of three products will be registered and subsequently commercialized as a part of this agreement by TR-Pharm in Turkey. TR-Pharm will also manufacture the drug substance and drug product upon completion of its facility investment. read more

Alzheon Announces Efficacy Analyses of Prior Tramiprosate Phase 3 Studies Showing Clinically Meaningful Benefits on Key Clinical Endpoints in Alzheimer’s Disease Patients with APOE4 Genotype

FRAMINGHAM, Mass.–(BUSINESS WIRE)–Alzheon, Inc., today announced the presentations of new data analyses from two Phase 3 studies of tramiprosate in Alzheimer’s disease (AD) patients based on their APOE4 genotype. Tramiprosate is the biologically active agent of ALZ-801, a prodrug developed by Alzheon and currently being advanced into pivotal Phase 3 studies in AD patients with the APOE4/4 homozygous genotype, a patient population known to have high prevalence and burden of cortical amyloid pathology, a hallmark of Alzheimer’s disease. read more

Envision Healthcare Named One of World’s Most Admired Companies

GREENWOOD VILLAGE, Colo.–(BUSINESS WIRE)–Envision Healthcare Holdings, Inc. (NYSE: EVHC) (Envision), has been named by Fortune Magazine as one of the World’s Most Admired Companies of 2016.

“We are honored to be included in such a prestigious group and I want to thank our more than 50,000 providers and support professionals who have made this possible

Envision’s portfolio of companies are not only among the best in their respective disciplines, their ability to create integrated solutions across the pre-hospital, inpatient and post-acute care environments is unmatched in the healthcare industry.

Bioengineered Organ Implant Developer HART Names Accomplished Biotechnology Executive Dr. Blaine McKee to its Board

/PRNewswire/ — Harvard Apparatus Regenerative Technology, Inc. (Nasdaq: HART), a biotechnology company developing bioengineered organ implants for life-threatening conditions of the esophagus, trachea and bronchus, today announced the appointment of Blaine McKee, Ph.D., Senior Vice President and Head of Transactions at Shire plc, to HART’s Board of Directors. Dr. McKee has also been named to the Board’s Audit Committee, bringing HART back into compliance with the Nasdaq Capital Market’s requirement for audit committee composition.

Dr. McKee is a broadly skilled senior executive with over 20 years leadership experience in global biotechnology business development. Dr. McKee joined Shire in 2014 to lead its business development function. He was previously EVP and Chief Business Officer at 480 Biomedical, following 15 years at Genzyme Corporation, where he served as SVP of Strategic Development, leading global business development for the Organ Transplant, Oncology and Multiple Sclerosis business units. Dr. McKee successfully grew the oncology business at Genzyme from an early-stage research operation to a competitive and sustainable oncology and solid organ transplantation

Eigen USA and Hitachi Medical Systems Europe Switzerland Announce a Collaborative Agreement for Hitachi to Distribute the Artemis, Eigen’s Robotic 3D Targeted Prostate Biopsy Device

Eigen, Grass Valley, California and Hitachi Medical Systems Europe announce a collaborative agreement for Hitachi to distribute the Artemis, Eigen’s robotic 3D targeted prostate biopsy device, through their subsidiaries’ sales network in Europe. In addition to co-marketing, both companies are collaborating to expand the versatility of Eigen’s Artemis and Hitachi Aloka’s suite of advanced ultrasound units, including their newest and most compact ultrasound unit yet, the Noblus.

Regeneron and Sanofi Announce Topline Results of Phase 3 Monotherapy Study Demonstrating Superiority of Sarilumab vs. Adalimumab in Patients with Active Rheumatoid Arthritis

PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA®) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at Week 24. The study, called SARIL-RA-MONARCH, also met important secondary endpoints including other measures assessing improvements in signs and symptoms of RA and physical function. Sarilumab is an investigational, human IL-6 receptor antibody. read more

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