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FDA to speed generics, NIH to fund data commons

The FDA has taken major steps toward increasing generic drug competition by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug ... more Separately, the  National Institutes of Health has earmarked $21 million over the next four years to fund a network of research groups that will help build a data commons to serve as a cloud-based platform for storing, sharing, accessing, and computing biomedical data and other digital objects ... more

By |July 10th, 2017|News|0 Comments

CURE welcomes new member Pulse Infoframe

Focusing on rare diseases and cancer and incorporating patient-reported outcomes, Pulse Infoframe builds comprehensive disease registries aggregating data from multiple sources. The firm incorporates real-time analytics and visualization to generate real-world evidence and accelerate time-to-value by providing insights for drug discovery, clinical studies and health economics. more

By |July 6th, 2017|News|0 Comments

Atlas rolls out biotech fund totaling $350 million

Cambridge venture capital firm Atlas Venture has raised its 11th fund, totaling $350 million, as it looks to advance its mission of “doing well by doing good” for biotechs. Atlas has had a hand in a number of major startups over the years through funding rounds, incubation and launches. Over the past year, Atlas has helped with a series of funding rounds for biotechs, and late last year, in a first for the life science venture capital world, it teamed up with Third Rock in a $48.5 million series A to create and launch Magenta Therapeutics, a new biotech that [...]

By |July 6th, 2017|News|0 Comments

Melinta agreement to finance Baxdela™ expansion

Melinta Therapeutics has entered into a loan and securities financing agreement with Oberland Capital Management​. Proceeds from this financing will be used primarily to fund commercialization activities for Baxdela™, which was recently approved by the FDA for the treatment of Acute Bacterial Skin and Skin Structure Infections. “This largely non-dilutive financing gives us increased flexibility to fund our continuing commercialization efforts for Baxdela’s first approved indication, and to support indication-expanding studies in community-acquired bacterial pneumonia,” said Paul Estrem, Melinta’s chief financial officer. more

By |July 5th, 2017|News|0 Comments

Cybrexa secures $6 million Series B financing

Cybrexa Therapeutics, a start-up cancer therapeutics company, has secured a Series B round of financing in the amount of $6 million. An investment vehicle affiliated with HighCape Partners, Connecticut Innovations, and a group of private investors participated in the round. The Series B funding will enable Cybrexa to complete the build-out of its facilities and continue the development its tumor-localizing DNA repair inhibitors, which they refer to as Tumor Specific Drugs (TSDs). Cybrexa was founded by Per Hellsund, Kevin Didden and Kevin Rakin, who most recently built and successfully exited Cyvek, Inc. Hellsund serves as the President and CEO, and [...]

By |July 5th, 2017|News|0 Comments

CURE welcomes new member InClinica

The mission of InClinica is to apply in-depth experience and expertise in clinical research and drug development to lead clients’ compounds and devices toward regulatory approval. InClinica has experience across all phases of clinical development, with particular strength assisting small to mid-sized companies that are entering first-in-human trials and Phase 2 studies. more

By |July 5th, 2017|News|0 Comments

PITCH established to encourage commercialization

A consortium known as Program in Innovative Therapeutics for Connecticut’s Health, or PITCH, was established in 2016 to encourage commercialization of research from the state’s universities through the discovery of novel drug compounds. The initiative is supported by a three-year, $10 million investment managed by Connecticut Innovations. “Programs like PITCH are critical to advancing academic discoveries that will help patients and grow Connecticut’s economy,” says Radenka Maric, vice president for research at UConn and UConn Health. “It also attests to UConn and Yale’s commitment to support cross-disciplinary collaborative research that addresses significant patient needs.” more

By |July 5th, 2017|News|0 Comments

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