News

Virtual reality in drug discovery

VR system helps Novartis Institutes for Biomedical Research scientists choose molecules in designing new drugs.
NIBR

PDUFA reauthorized through 2022

Click below for RAPS summary of the law's major provisions.
Zachary Brennan

Biopharma companies looking to AI

GSK is the latest pharma company to explore using supercomputers to help narrow down the list of potential drug molecules.
Reuters

New wave of immunotherapies to fight cancer

Biopharma companies are developing 248 immuno-oncology medicines and vaccines.
2017 ACS CAN Report

New FDA commissioner takes the helm

Senate confirms appointment of Dr. Scott Gottlieb to lead the FDA.
Opening statement to U.S. Senate Committee 

Spirit of collaboration permeates R&D

Biopharma companies work alongside academic organizations, patient groups and other technology companies to bring innovative treatments to patients.
PharmaVOICE

FDA accepting apps for RMAT Designation

The 21st Century Cures Act has opened the doors for accelerated FDA approval of certain regenerative medicine products.
FDA Voice 

Work left to do on biosimilars draft guidance

BIO is concerned that the FDA's latest draft guidance doesn't adequately address safe packaging of biosimilars.
Regulatory Focus

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.
Drug Target Review

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.
RAPS

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.
FDA

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.
IPEC Joint Strategic Plan

Congress passes patient-driven legislation

President Obama signs 21st Century Cures Act into law.
H.R. 34 Text

Second Green Revolution in the making?

University of Illinois scientists alter photosynthesis to increase productivity of test plant by 20%.
New York Times

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.
Regulations.gov

Frameworks are valuable if done right

ICER's methodology for assessing drug value should include whole of patient's life.
The Hill

Biopharma companies taking on superbugs

In their continued efforts to combat antimicrobial resistance, 13 major drug companies outline goals to reach by 2020.
Business Insider

Innovative drugs that cure diseases are the solution

BIO's new website: biotech companies' research investments are saving lives and money.
Innovation Saves

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:
USDA AMS

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.
New York Times

Drugmakers outline communication principles

BIO and PhRMA released guidelines for improving communication between biopharma companies and health care professionals.
Morning Consult

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.
The Washington Post

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.
World Pharma News

Current regulations hamper fair drug prices

Modifying certain regulatory structures can encourage price competition and innovation simultaneously.
HealthAffairsBlog

CRS report on Congress' medical innnovation bills

How does the Senate's medical innovation package compare to the House's 21st Century Cures Act?
Congressional Research Service

Bioscience industry shows growth in jobs and wages

BIO and TEConomy Partners released latest analysis of bioscience activity across the U.S.
GEN News Highlights

FDA updates compassionate use program

The FDA revamped application guidelines for expanded access to investigational therapies.
FDA.gov

GMOs and a growing world

Biotechnology continues to improve crops that are needed to feed many millions worldwide.
Texas A&M AgriLife

Price controls short-sighted

Policy that inhibits market factors serve to disincentivize innovation. 
Boston Globe

Final guidance for naming drugs

FDA released final guidance for premarket review of proprietary drug names.
Regulatory Focus

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.
Reuters

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.
FDA Voice

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.
FierceBiotech 

Purdue University studies effects of no GMOs

Study looked at what would happen to the environment and economy if GMOs were banned.
Purdue University Agriculture News

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.
RAPS

Research funding proposals in 2017 budget

ScienceInsider's look at President Obama's proposals for funding science in the next fiscal year. 
Science

 

 

   

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