Medical Tidbits,Phosphagenics Initiates Arbitration against Mylan

vascular dynamics

MELBOURNE, Australia–(BUSINESS WIRE)–Australian biotechnology company, Phosphagenics Limited (ASX:POH; OTCQX:PPGNY), announced today that it has commenced legal action against Mylan Laboratories Limited (Mylan), a wholly-owned subsidiary of Mylan Incorporated, by filing notices of arbitration at the Singapore International Arbitration Centre. read more

Gilead Terminates Phase 2 Study of Simtuzumab in Patients With Idiopathic Pulmonary Fibrosis

– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its Phase 2 clinical study of the investigational monoclonal antibody simtuzumab among patients with idiopathic pulmonary fibrosis (IPF). This decision follows an analysis of unblinded efficacy and safety data by the study’s Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. Gilead has also reviewed the data and determined the study has not shown evidence of a treatment benefit in the group of patients randomized to receive simtuzumab. – read more

Quartet Medicine Announces Strategic Partnership with Merck

CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Quartet Medicine, a biotechnology company focused on the development of novel treatments for chronic pain and inflammation, today announced it has entered into a strategic agreement with Merck, known as MSD outside the United States and Canada, in connection with Quartet’s pipeline of novel small molecule drugs modulating the tetrahydrobiopterin (BH4) pathway. read more

Mylan Launches Generic Ortho Tri-Cyclen Lo® Tablets

HERTFORDSHIRE, England and PITTSBURGH, Jan. 5, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, which is the generic version of Janssen’s Ortho Tri-Cyclen Lo® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy.(1)read more

NextCure, Inc., New Immuno-Oncology Firm, Announces $67 Million Series A Financing

GERMANTOWN, Md. and NEW HAVEN, Conn., Jan. 6, 2016 /PRNewswire/ — NextCure, Inc., a newly formed biopharmaceutical company focused on the discovery and development of new immuno-oncology products, today announced that it has raised a $67 million Series A financing. Major investors in the financing Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors, Pfizer Inc. and Sofinnova Ventures, were joined by Alexandria Venture Investments. read more

Immunocore and GlaxoSmithKline Select First ImmTAC Clinical Candidate in Discovery Collaboration

Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, viral infections and autoimmune disease, today announced that GlaxoSmithKline (GSK) has selected the first clinical candidate as part of a discovery collaboration, resulting in an undisclosed milestone payment to Immunocore.

The candidate selected ImmTAC addresses a target relevant in a number of different cancer indications including synovial sarcoma, bladder and non-small cell lung (NSCL) cancers. read more

Glide Technologies Announces Successful Proof-of-Concept With Novel Exenatide Solid Dose Formulation

Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines, today announced that the Company has successfully completed a pre-clinical proof-of-concept study with its novel solid dose formulation of exenatide, a GLP-1 agonist for the treatment of type 2 diabetes.  Results from the pharmacokinetic study show that there was no statistical difference (p<0.05) between Glide’s solid dose formulation and the clinical dose of Byetta® (exenatide 10 mcg), the currently marketed liquid product. read more

Complix Enters into Strategic Collaboration with MSD to Develop Cell-Penetrating Alphabodies to Treat Cancer

Complix, a biopharmaceutical company developing a pipeline of transformative protein therapeutics, called Alphabodies™, for the treatment of cancer and severe autoimmune diseases, announced it has entered into a strategic drug discovery collaboration with Merck & Co., Inc. (known as “MSD” or “Merck” (in the United States and Canada)) through its subsidiary, Merck Sharp & Dohme Corp., to develop Cell-Penetrating Alphabodies (CPABs) for the treatment of cancer. read more

HemoShear Therapeutics Races Toward Discovery of Treatments for Children’s Rare Diseases

HemoShear Therapeutics, LLC, (HemoShear) a privately held discovery-stage biotechnology company, and Children’s National Health System, a non-profit leading research and treatment center for children with rare diseases, today announced study results that demonstrated successful restoration of propionic acidemia (PA), a rare metabolic disorder, using explanted liver tissue from a child with the disease. This study, published in the Journal of Molecular Genetics and Metabolism, demonstrated a novel method of recreating the disease in the laboratory for discovery of treatments for PA that may extend the lives of these children and possibly cure the disease. read more

Ipsen and Galderma Expand Current Distribution Agreement for Dysport® in Aesthetic Indications to Some Key Asia-Pacific Territories1

PARIS & LAUSANNE, Switzerland–(BUSINESS WIRE)–Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical company, and Galderma, a global healthcare company focused on medical solutions in dermatology and skin health, today announced that they have expanded the geographical scope of their neurotoxin partnership, whereby Galderma acquires the exclusive rights to develop, promote and distribute Dysport® in the aesthetic indications in the APAC1 Territory. Ipsen and Galderma initiated their partnership in 2007 for the commercialization of Azzalure® in the aesthetic and dermatology indications in Europe, further extended for Dysport® to Mexico, Brazil, Argentina and Australia. In 2014, the companies significantly strengthened their collaboration by prolonging their partnership until 2036, by expanding the geographical coverage to the US and Canada, and by increasing the scope of their R&D collaboration.

Vascular Dynamics’ MobiusHD™ System Receives CE Mark for the Treatment of Resistant Hypertension

MOUNTAIN VIEW, Calif.–(EON: Enhanced Online News)–Vascular Dynamics, Inc., a private medical device company developing novel solutions for the treatment of hypertension, today announced receipt of CE Mark approval for its MobiusHD™ System, a minimally invasive system for the treatment of resistant hypertension. Approximately one in 10 people with high blood pressure, or nearly 100 million people worldwide, have drug-resistant hypertension.1    

 read more

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