Medical Tidbits, Valeant Provides Update Regarding Government Inquiries

MacroFORM_delivery

LAVAL, Quebec, Oct. 14, 2015 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) and (TSX: VRX) today responded to a letter from Senator Claire McCaskill (D-MO) concerning the company’s products Nitropress and Isuprel. In his response to Senator McCaskill, J. Michael Pearson, the chairman of the board and chief executive officer of Valeant, addressed the history of Nitropress and Isuprel, the reimbursement process for hospital procedures involving Nitropress and Isuprel, the analysis and reasons underlying Valeant’s pricing decisions, and Valeant’s programs designed to improve patient access, among other topics. The company also disclosed that it is beginning outreach to hospitals where the impact of a price change was significantly greater than the average.  read more

FDA declines to expand approval of Pfizer arthritis drug

U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz to treat moderate to severe cases of the scaly skin condition plaque psoriasis, the drugmaker said on Wednesday.

Pfizer said it received a so-called complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order to gain U.S. approval. read more

Medtronic Drug-Coated Balloon Sustains Superiority Over Balloon Angioplasty at Two Years in Patients with Peripheral Arterial Disease

DUBLIN and SAN FRANCSICO – October 14, 2015 – Medtronic plc (NYSE: MDT) announced today that new two-year clinical data from the pivotal IN.PACT SFA Trial revealed that the IN.PACT® Admiral® drug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg – specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries). The data was presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference during a “First Report Investigation” session and also published simultaneously in the Journal of the American College of Cardiology (JACC). read more

Isarna Therapeutics and Autotelic Signed Asset Sale and Purchase Agreement for Trabedersen

MUNICH & FOUNTAIN VALLEY, Calif.–(EON: Enhanced Online News)–Isarna Therapeutics, the leader in transforming growth factor beta (TGF-β) isoform targeted antisense therapeutics, and Autotelic Inc., a specialist in therapeutic drug monitoring and development, today announced an asset sale and purchase agreement for trabedersen, Isarna’s TGF-β2 antisense oligonucleotide. Autotelic acquires full and worldwide rights to develop trabedersen, which had previously reached Phase 3 clinical evaluation to treat recurrent high-grade glioma. No financial details of the agreement have been disclosed. read more

NovaBone Receives Notice of Allowance on Fourth New Collagen Patent

JACKSONVILLE, Fla.–(EON: Enhanced Online News)–NovaBone Products, a leading biologics medical device company, today announces that the U.S. Patent and Trademark Office (USPTO) has issued notice of allowance for U.S. Patent application 14188-54 for its “Combination Products Including Bioactive Glass and Collagen and Kits Including the Same.” read more

Alnylam Demonstrates Continued Commitment to Transthyretin-Mediated Amyloidosis Patients with Advancement of ALN-TTRsc02, an Investigational RNAi Therapeutic with Potential for Low Volume, Once Quarterly, Subcutaneous Dose Regimen

CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it presented key pre-clinical data and provided program guidance for ALN-TTRsc02, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR amyloidosis). The new data were presented at the 11th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS), held October 11 – 14, 2015, in Leiden, Netherlands. In pre-clinical studies, including those in non-human primates (NHPs), ALN-TTRsc02 achieved potent and highly durable knockdown of serum TTR of up to 99% with multi-month durability achieved after just a single dose, supportive of a potentially once quarterly dose regimen. Based on these pre-clinical data, ALN-TTRsc02 is the most potent and durable investigational RNAi therapeutic discovered at Alnylam to date. The company is currently conducting Investigational New Drug (IND)-enabling studies and plans to file an IND or IND-equivalent in early 2016 with initial data in late 2016. Assuming positive clinical results, Alnylam expects to initiate a Phase 3 study for ALN-TTRsc02 in 2017. read more

Harpoon Medical reports results of ten patient early feasibility trial of its repair system for off-pump, minimally invasive treatment of mitral valve regurgitation (“MR”)       

BALTIMORE, Oct. 15, 2015 /PRNewswire/ — Harpoon Medical, Inc. a medical device company focused on minimally invasive mitral valve repair, announced that it has presented clinical results of ten patients enrolled in an Early Feasibility Study of its repair system for the minimally invasive, beating-heart treatment of MR. The results were reported by Dr. James Gammie, Chief of Cardiac Surgery at the University of Maryland School of Medicine, at the 2015 Transcatheter Therapeutics Conference in San Francisco.  Harpoon enrolled ten patients with severe degenerative mitral valve disease at two clinical centers in Poland and assessed echocardiographic results using the Massachusetts General Hospital’s Core Echocardiography Lab. read more

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