Credit for new therapies

Harvard's Dean Flier considers contributions of academia and industry to drug discovery.
The Journal of Clinical Investigation

The numbers tell the story

Vaccines have saved hundreds of thousands of American lives.
New York Times

Four-letter suffixes out for older biologics

Already approved or licensed biological products will not need four-letter suffixes as per earlier FDA draft guidance.
FDA News

Philanthropic initiatives in life sciences and health care

Report examines changes to corporate philanthropy models.

NIH HEAL Initiative taps committee of experts

The HEAL (Helping to End Addiction Long-Term) Partnership Committee (HPC) comprised of patients, industry representatives, and academics will assist NIH in working to address pain and addiction issues.
National Institutes of Health 

GMO labeling guidelines established by USDA

The National Bioengineered Food Disclosure Standard is set for implementation next year with a mandatory compliance date of January 1, 2022.
U.S.D.A. press release 

US needs policies that foster food innovations

Challenges facing global food supply underscore importance of high-tech food development.
BIOtechNow / Boston Globe

USMCA sets IP standards to further R&D

"The United States-Mexico-Canada Agreement is an important trade deal that fosters a stronger economy, increases job opportunities and improves intellectual property. We are pleased to see that the Administration remains dedicated to enacting policies that promote economic growth in the U.S. We believe that the USMCA will serve to protect the research and innovation practices that enable American industries to develop new products and medications that improve the quality of life for Americans in need." - New England Biotech Association President.

Counterfeit drugs not only harmful but costly

UNC Chapel Hill study shows annual cost of fake drugs ranges from $10 to 200 billion.

Report looks at net medicine spending in the U.S.

IQVIA Institute reports that prescription drug spending increased by 0.6% in 2017 after off-invoice discounts and rebates.
IQVIA Institute Report

Labeling guidance open for comment

FDA issued draft guidance on the Indication and Usage section of labels for drugs and biologics.

Over 500 medicines in development for neurological disorders

74% of medicines in America's biopharma pipeline for neurological disorders are potentially "first in class."

New class of antibiotics

"Malacidins: found in soil microbiomes are active against multi-drug resistant pathogens.

PWC reviews 2017 FDA drug approval rate

Number of approvals rise while enforcement activity sees highs and lows.
Health Research Institute Insight

Looking at an even bigger picture

Collection of RWE adds breadth to clinical trial data.

Life-science research in the year ahead

Research experts take a look at some of 2018's promising technologies.

Academic-Industry partnerships key to translational research

Two BIO reports examine impact of partnerships on innovation and the economy.

Biopharma continues search for Alzheimer's treatments

Research efforts include focusing on combination therapy, gene therapy and early intervention.
Wall Street Journal

Update on CRISPR-based therapies

Next year could bring the first clinical trials in the U.S. and Europe.
MIT Technology Review

Will focus on immuno-oncology persist?

2018 predictions for three key pipeline areas in drug development.

Efforts for more efficient development of antibiotics

FDA, EMA and PMDA are working on an antibiotic development plan to simultaneously satisfy the regulatory requirements of the U.S., Europe and Japan.
Regulatory Focus 

Virtual reality in drug discovery

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

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.

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.

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.

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.
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.

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:

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



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