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Dr. Craig Landau named CEO of U.S. Purdue Pharma

The Board of Directors of the independently associated worldwide Purdue/Napp/Mundipharma network of companies announces that Dr. Craig Landau is appointed President and CEO for the U.S. operations, Purdue Pharma L.P., headquartered in Stamford, Connecticut, with immediate effect, and will retain responsibility for Purdue Pharma (Canada). CEO Mark Timney is leaving Purdue to pursue other career opportunities. Purdue Pharma is a privately-held pharmaceutical company and is part of a global network of independent associated companies known for pioneering research in chronic pain and opioids with abuse deterrent properties.

By |June 27th, 2017|News|0 Comments

FDA grants Cara kidney drug breakthrough status

Cara Therapeutics reports that the FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in chronic kidney disease (CKD) patients undergoing hemodialysis. "The FDA's decision is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We have already initiated our Phase 3 program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible." [...]

By |June 27th, 2017|News|0 Comments

Flublok® vaccine demonstrates superior protection

Protein Sciences has announced the publication of clinical trial results comparing Flublok® Quadrivalent – the quadrivalent version of Flublok® influenza vaccine – to a traditional egg-based quadrivalent inactivated vaccine. The data published in the June 22 issue of the New England Journal of Medicine show that Flublok Quadrivalent provided significantly improved protection against laboratory confirmed influenza illness in older adults. “This study shows that Flublok® Quadrivalent, produced with modern recombinant technology can provide better protection against confirmed influenza-like illness among older adults than standard-dose quadrivalent influenza vaccine produced with traditional technology,” said Lisa Dunkle MD, Chief Medical Officer of Protein Sciences. more

By |June 26th, 2017|News|0 Comments

FDA issues draft guidance re generics

The FDA has released draft guidance that lays out the process that sponsors must follow for priority review of generic drugs that are in short supply, are sole-source or first-in-class generics, or could help alleviate public health emergencies.​ Under Generic Drug User Fee Amendments (GDUFA II), the FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or amendment. more

By |June 22nd, 2017|News|0 Comments

Medtronic ‘artificial pancreas’ makes debut

Medtronic’s hybrid closed-loop system, the world’s first “artificial pancreas,” is hitting the U.S. market. The system is the only FDA-approved insulin pump that automatically delivers basal insulin to control blood glucose levels in people with Type 1 diabetes. The system includes a glucose sensor which measures glucose levels in the fluid just under the skin, the MiniMed 670G insulin pump and an infusion patch, which delivers insulin through a catheter. It uses an algorithm to self-adjust the delivery of basal, or background, insulin every five minutes based on real-time data gathered from the sensor. more

By |June 22nd, 2017|News|0 Comments

Supreme Court rules in high-profile biosimilars case

The U.S. Supreme court recently delivered a unanimous opinion in Sandoz v. Amgen. This complicated case centers on Biosimilars, which are generic versions of biologic drugs, and the dance of patent litigation that can ensue when a generic manufacturer seeks approval for a product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The BPCIA provides an abbreviated pathway for obtaining FDA approval of the generic form of an already approved reference biological product. Under the BPCIA, a generic manufacturer must notify the originator at least 180 days before launch of their product. In its decision, the Supreme Court [...]

By |June 22nd, 2017|News|0 Comments

FDA approves Melinta’s Baxdela™ delafloxacin

The FDA has approved Baxdela™ (delafloxacin) from Melinta Therapeutics, indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations. more

By |June 22nd, 2017|News|0 Comments

Intensity Therapeutics wins patents

Intensity Therapeutics, a privately held clinical-stage, biotechnology company developing proprietary cancer immunotherapy products, reports patents in the US and Australia. “Intensity’s DfuseRxSM  platform has identified our lead drug, INT230-6. This novel product, now in clinical trials, has shown great promise in regressing tumors and extending life in animal models of metastatic cancer,” said Intensity’s President and CEO, Lewis H. Bender. “A newly issued U.S. patent and soon-to-be issued Australian patent allow us to protect our unique technology. The Company now has multiple issued patents and several patent applications in the U.S. and countries around the world.” more

By |June 22nd, 2017|News|0 Comments

CT House takes action on healthcare data

Substitute for S.B. No. 968 AN ACT ESTABLISHING A HEALTH DATA COLLABORATIVE WORKING GROUP will now go to the Governor for his consideration and signature. Under the bill, the CHDC must examine and make recommendations on: 1. initiatives to support precision medicine and personalized health R&D; 2. economic growth initiatives for in-state businesses working in bioscience, biopharma, biotech, genomics, clinomics, epigenomics, pharmacogenomics, the microbiome field, and related fields; 3. health data access, privacy, and security initiatives; and 4. advancements in health data and population health to promote efficient and innovative platforms for collecting health data in order to understand the [...]

By |June 16th, 2017|News|0 Comments

CURE welcomes new member The Summit Group

The Summit Group a consulting firm that specializes in Performance and Leadership development. As experts in transformation, they consult and coach client organizations committed to elevating the performance of their executives, teams and enterprises as a whole. more

By |June 16th, 2017|News|0 Comments