28 November 2016
CRISPR patent battle heats up as new email disputes Zhang’s claims
Ben Adams / Fierce Biotech
The ongoing patent battle over just who owns the rights to the cutting-edge CRISPR-Cas9 technology has heated up this week with a new email from a junior scientist putting more confusion over who invented the gene-editing process first.
28 November 2016
Jill Wechsler / BioPharm International
Biopharmaceutical companies no longer consider FDA an obstacle to innovation and in need of major reform, according to leading observers of the drug regulatory process. “We now have clear expectations about review times,” said Jim Greenwood, president of the Biotechnology Innovation Organization (BIO), at a forum sponsored by the Bipartisan Policy Center. So we “don’t need someone saying this place is a disaster and let’s blow it up.”
24 November 2016
Launching a drug? Be prepared to show it's cost-effective up front, consultant says
Eric Sagonowsky / FiercePharma
On the heels of Trinity Partners’ first medicines index, president John Corcoran said the biopharma industry can expect a continued focus on specialty drugs and drastically different drug launches in the years to come.
24 November 2016
Pharma and healthcare ahead of other industries in implementing mobile strategies: survey
Beth Snyder Bulik / FiercePharmaMarketing
Pharma and healthcare companies are ahead of the curve when it comes to mobile business strategies, according to a new survey from Red Hat. In the survey, 82% of healthcare and pharma companies said they have a fully implemented mobile strategy, compared with just 52% of all commercial enterprises surveyed in Red Hat’s broader study last year.
24 November 2016
A new strategic direction for behavioral and social sciences research at NIH
U.S. National Institute of Health
The Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health has released a new strategic plan for 2017 through 2021. The plan focuses on scientific priorities, which reflect key research challenges that OBSSR is uniquely positioned to address. Developed with considerable input from internal and external NIH stakeholders, the plan ensures OBSSR continues to fulfill its mission.
23 November 2016
Real world evidence: a reality check for pharma?
Matt Fellows / PharmaLife
Rising demands on the industry has pharma firms calling for a more-effective, fit-for-purpose methodology for generating clinical data. Could the answer be real world evidence? Originally published in the November issue of Pharmafocus, Matt Fellows examines this promising research practice and how it could revamp the pharma R&D landscape.
23 November 2016
Continuing progress and promise in pediatric drug development
Dr. Christopher-Paul Milne / PhRMA
It has been almost two decades since the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were passed in order to increase the number of medicines appropriately labeled for safe and effective use in children.
22 November 2016
Biotech Venture Capital Mythbusting Redux
Bruce Booth / LifeSciVC
Venture capital has been on a good run over the past few years across a range of sectors; even with recent slowdown relative to 2014-2015, venture-backed investments remain above historic averages. In fact, the first three quarters of 2016 alone are already higher than the annual rate of venture investing in all but two years since 2002.
22 November 2016
Reflecting on terrific progress in treating diabetes
Bill Chin, M.D. / PhRMA
There is no doubt that diabetes is a complex disease to diagnose and treat. That’s something I’ve seen firsthand as an endocrinologist. Over the years, I treated a number of patients that had a variety of endocrine disorders, including type 1 and type 2 diabetes. For each patient, finding the right treatment and helping them manage the disease was a challenge.
22 November 2016
Biotech breakthroughs that broke down
Ben Adams / Fierce Biotech
An FDA “Breakthrough” tag, which has been around since 2012, was once a highly coveted badge that in essence allows the regulator to help speed up development of new meds, and it was believed initially that these would be fairly rare occurrences held back for some truly innovative treatments.
The RMI group has completed sertain projects
The RMI Group has exited from the capital of portfolio companies:
Marinus Pharmaceuticals, Inc.,
Syndax Pharmaceuticals, Inc.,
Atea Pharmaceuticals, Inc.