FDA accepting apps for RMAT Designation
The 21st Century Cures Act has opened the doors for accelerated FDA approval of certain regenerative medicine products.
Work left to do on biosimilars draft guidance
BIO is concerned that the FDA's latest draft guidance doesn't adequately address safe packaging of biosimilars.
New life sciences industry standards group formed
Top pharma companies, including GlaxoSmithKline, Novartis and Pfizer have formed Align Biopharma, agroup dedicated to setting technology standards for connecting healthcare professionals and the life sciences industry.
Finalized guidance on naming biosimilars
The FDA will assign four-letter meaningless suffixes to the nonproprietary names of biosimilars and biologics that are submitted for approval.
FDA overview of 2016 new drug approvals
In 2016, the FDA approved half the number of new drugs than the prior year, and the lowest number since 2010.
White House outlines 3 yr plan to protect IP
U.S. Intellectual Property Enforcement Coordinator (IPEC) provides recommendations for securing America's innovation economy at home and abroad.
Congress passes patient-driven legislation
President Obama signs 21st Century Cures Act into law.
Second Green Revolution in the making?
University of Illinois scientists alter photosynthesis to increase productivity of test plant by 20%.
Federal review of biotech approval process continues
Click below to submit comments on the government's revamping of USDA, FDA and EPA roles in regulating biotechnology.
Frameworks are valuable if done right
ICER's methodology for assessing drug value should include whole of patient's life.
Biopharma companies taking on superbugs
In their continued efforts to combat antimicrobial resistance, 13 major drug companies outline goals to reach by 2020.
Innovative drugs that cure diseases are the solution
BIO's new website: biotech companies' research investments are saving lives and money.
Implementation of federal GMO disclosure law
The Agricultural Marketing Service of the USDA will develop the national mandatory GMO labeling system. See link below for updates:
Immunotherapy alters the cancer treatment landscape
A series of New York Times articles, Cell Wars, discusses immunotherapy and how it is changing our approach to cancer treatment.
Drugmakers outline communication principles
BIO and PhRMA released guidelines for improving communication between biopharma companies and health care professionals.
Research partnership, CARB-X, formed to fight antibiotic resistance
Britain's Wellcome Trust and the U.S. Health and Human Services Department will oversee this collaboration among academia, industry and other nongovernmental organizations in the research and development of new antibiotics.
FDA drafts guidance on NGS-based tests
The 90 day period is open for submitting comments on two draft guidances issued by the FDA regarding development of next generation sequencing tests.
Current regulations hamper fair drug prices
Modifying certain regulatory structures can encourage price competition and innovation simultaneously.
CRS report on Congress' medical innnovation bills
How does the Senate's medical innovation package compare to the House's 21st Century Cures Act?
Bioscience industry shows growth in jobs and wages
BIO and TEConomy Partners released latest analysis of bioscience activity across the U.S.
FDA updates compassionate use program
The FDA revamped application guidelines for expanded access to investigational therapies.
GMOs and a growing world
Biotechnology continues to improve crops that are needed to feed many millions worldwide.
Price controls short-sighted
Policy that inhibits market factors serve to disincentivize innovation.
Final guidance for naming drugs
FDA released final guidance for premarket review of proprietary drug names.
GSK new gene therapy headed for approval in Europe
The European Medicines Agency has given the nod to GSK's Strimvelis, a groundbreaking gene therapy for children with ADA-SCID.
Clinical Trial Protocol Template Posted for Public Comment
NIH and FDA are seeking feedback from stakeholders on a draft standardized format for submitting clinical trial protocols.
EMA launches PRIority MEdicines (PRIME)
The European Medicines Agency has added a priority medicines framework for accelerated assessment of treatment for patients with unmet medical needs.
Purdue University studies effects of no GMOs
Study looked at what would happen to the environment and economy if GMOs were banned.
Industry comments on draft guidance for safety assessments
The FDA's current draft guidance on safety assessments for IND applications calls for the creation of safety assessment committees.
Research funding proposals in 2017 budget
ScienceInsider's look at President Obama's proposals for funding science in the next fiscal year.