Pharmaceutical Science Update

2019 Outlook: Drug Competition Stays at Forefront of FDA Agenda

Human Research Rule Revisions Enter Final Compliance Countdown

No. 2 Role at FDA to Go to Roche Subsidiary Official

Shutdown Impact: Who Will Work, Who Won’t at Health Agencies

FDA to Keep Reviewing Risky Medical Products during Shutdown

New House Science Chair Makes Curbing Harassment Top Priority

Grassley Worried About Foreign Threats to NIH-Funded Research

Research Reg Changes Apply to 20 Agencies’ Grants—Half Are Closed

Declining Minority Representation in MS Studies Raises Concerns

FDA Taps into E-Health Records to Monitor Drug Safety

U.K. Reiterates IP Guidance as ‘No Deal’ Brexit Looms

FDA Hiring of Scientists Hampered by Government Shutdown

Will Shutdown Acrimony Hurt Medical Research Funding?

Gene Therapy Drug Approval to Skyrocket by 2025, FDA Says

A ‘Slower Burn’ on FDA Funding Will Buy Five Weeks, Agency Says

NAFTA 2.0 Drug Provisions Pose Potential Obstacle for Passage

HHS Plan to Revamp Oversight of Gene Transfer Study Draws Concerns

FDA Expands Work during Shutdown Following Safety Concerns

NIH’s Experimental Ebola Medicine Clears Initial Safety Testing

New FDA Program Could Bring Clinical Trials to Patients

Gene Editing International Oversight Panel in the Works

FDA’s Biologics, Biosimilar Programs Getting a New Leader

Drug Backlog Due to Shutdown Unclear, but Could Set FDA Back Months

Trump to Request Childhood Cancer Research Funds in 2020 Budget

Black Research Volunteers Improved Diversity in New Drug Trials

Curbs on Animal Testing in NIH Research Find Hill Backers

Drugmakers Should Set Higher Standards for Safety, FDA Says

NIH-Funded Scientists Flagged for Potential Foreign Influence

Holes Identified in NIH’s Security Measures for Research Data

Breakthrough Cancer Therapy Stalls in Manufacturing Bottleneck

Better Health Data Access May Boost FDA, NIH Research Priorities

Supplement Industry May Be Next in FDA’s Crosshairs

Drug Prices Are Rising. So Is Compensation for Pharma CEOs

FDA Safety Program Failed to Restrict Access to Deadly Opioids

Almost 50 Lead Scientists Disciplined for Sexual Harassment: NIH

Overseas Drug Bribery Probes Turn to Drug Testing, Payments

Federal Drug Patent Grab Means Fewer New Medicines: Think Tank

Drug Applicants Get New FDA Advice on Measuring Patient Uptake

Gender Gap in First NIH Grants Hinders Women’s Careers: Study

Ban Human Germline Editing until International Standards Set, NIH Says

Legacy in Mind, Gottlieb Has Handpicked List of FDA Successors

2020 White House Budget Slashes NIH Funding by $6 Billion

Clinical Trials Open to More Cancer Patients with FDA Guidance

Rare Disease Drug Developers Get Boost in New FDA Guidance

Billions in Biomedical Grants at Stake Under Free Speech Order

Clinical Trial Consent Forms to Post on NIH, Regulation Sites

Stop Opioid Approvals Until System Is Fixed, FDA Adviser Says

Biotech Grant Program Vulnerable to Fraud, Watchdog Says

Generic Drug Competition Bill Inches Forward in House

Experimental Drug Access Push Won’t Slow Approvals, FDA Says

Cancer Researchers Grapple for Money despite Funding Spikes

Pharma Companies Eyeing Blockchain for Fight Against Fake Drugs

NIH Braces for Funding Cliff in Cancer, Precision Medicine

Lawmakers Likely to Snub Trump Bid to Cut HIV Research Funding

FDA Biologics Inspections to Shrink in Trump Deregulation Push

Brazil Introduces Program to Reduce OTC Drug Price Controls

Hepatitis, HIV Infections Fueled by Opioid Abuse Draw NIH Concern

Spike in Research Theft by Foreign Scientists Draws NIH Probe

Tossing Out Obamacare Would Take Down Avenue for Cheaper Drugs

Drug, Device Recalls Are Top of Mind for New FDA Head

Faster Drug Approvals Possible as AI Speeds FDA Reviews

Blockchain Can Speed Recalls of Unsafe Drugs, Devices, FDA Says

MD Anderson Chinese Researchers Out Over Foreign Influence

Expanded White House Policy Could Stifle FDA’s Industry Advice

Gene Transfer Gets Looser Federal Reins on Clinical Trials

Cancer Therapy Triggers Battle over Innovation, Medicare Costs

Medical Research Spending Tops $41 Billion under House Proposal

Customized Therapy Research Gets Closer as NIH Database Expands

From Your Fitbit to Pharmaceuticals, FDA Eyes Real-World Data

Cut Out of Experimental Drug Talks, FDA Takes Vow of Silence

FDA Warns Drugmakers Over Manufacturing and Distribution Practices

FDA Gets U.S. One Step Closer to Interchangeable Biosimilars

‘Concierge Service’ for FDA’s Experimental Drug Program Coming

Fears of Slow Research Halt Federal Advisory Panel Bill

Clinical Use of Genetic Engineering Focus of New Global Panel

Potential Sickle Cell Cure Has HHS Pondering How to Pay for It

FDA Issues Warnings on Manufacturing Practices

Cancer Therapy Decision Needs More Time, Medicare Chief Says

FDA Wants Input on Which Opioids Should Go in Blister Packs

HHS Takes Action on Findings of Research Misconduct

Faster Treatments Needed as HHS Tries to Close 17-Year Gap

Few Quick-Approved Cancer Drugs Extend Survival, Study Shows

Fetal Tissue Research Gets No New Money, Trump Team Says

Single-Patient Clinical Trial Policy under Development at FDA

Gene Therapy Explosion Has FDA’s Tiniest Office Plotting Growth

Fewer New Policies Expected From FDA with Acting Chief in Place

FDA Warns Company of cGMP Violations

Data Security Holes Found in NIH’s Precision Medicine Forms

Slow Response by Stem Cell Developers Prompts New FDA Program

Add Pregnant Women, HIV Patients to Clinical Trials, FDA Says

Human Research Advisory Panel at HHS Back to Full Strength

DNA Diagnostic Tests Spat Has Congress Eyeing New FDA Powers

Senator to Meet with Acting FDA Head, Discuss Permanent Role

New FDA Opioid Guide Adds Abuse Risks to Approval Deliberation

Generic Drugs to Hit Market Faster with FDA Patent Form Change

Sham Stem Cell Studies Force NIH to Weed Its Research Database

Modernizing Clinical Trials Leaves FDA ‘a Large Load of Work’

Botched Investigations and Bad Data Need Fixes: FDA

Gilead Withheld Safer HIV Drugs from Market, Lawsuit Claims

Biomedical Innovation May Get Fresh Boost from House Duo

Plan to Cut Paperwork Leaves Some Studies Scrambling for Forms

Diabetes Research at Risk without Congress Acting, Official Says

HIV Prevention Vaccine Heads to Final Trial This Fall

Democrats Seek Fetal Tissue Research Ban Documents

Tax-Funded Drug Research Should Mean Cheaper Drugs

Access to Trial Meds Needs Market Incentive, Conservatives Say

FDA Warns High Chemical and Indoco Remedies

Medical Research Funding Increase Expected with New Budget Deal

Risk-Based Trials Could Speed Drug Development, FDA Says

Fetal Tissue Scientists Need to Submit New Justifications

Trump Team’s Drug Importation Plan to Lower Costs

Ebola Treatment Study May Finish Before Outbreak Ends: NIH

NIH Delays Enforcement of Some Clinical Trial Posting Mandates

Senators Seek Discounts on Drugs Developed with Federal Research

Draft Guidance Gives Clarity on Rare Pediatric Disease Priority Reviews

U.S. Taxpayers Fund Antibiotics for China as Industry Flails

Drug-Resistant Superbugs Spur Pharma’s Plea for More U.S. Help

Francis Collins: Two Presidents, Ten Years, and One NIH Chief

Research, Not Heavy Hand, to Tamp Down Drug Costs: NIH’s Collins

Drug Maker Payments to Cancer Center Heads Raise Questions: JAMA

FDA Warns Drug Makers over Sterility and Quality Issues

Scientists Race for Global Rules before Next Gene Editing Fiasco

Startup Mentality: HHS Seeks to Speed Medical Breakthroughs

Breakthrough Blood Cancer Therapy Looms as Medicare Weighs Costs

Fitbit Data Means New Ethics Conundrums for Clinical Trials

NIH’s Sexual, Gender Minority Definition Made More Inclusive

FDA Warns Device Maker Over Validation of Design Changes

FDA Warns Indian Drugmaker and ORI Finds Research Misconduct

Stem Cells Explored as Opioid Alternative for Lower Back Pain

FDA Acting Head Confirms He Is on a Short List for Permanent Job

No Breast Cancer Drugs for Men, So Put Them in Trials, FDA Says

Smallpox Weapon Fears Have U.S. Eyeing $2 Billion Vaccine Stash

White House Supports Biomedical Research despite Seeking Budget Cut

Chinese Vitamin C Price-Fixing Case Could Alter U.S. Drug Market

Medical Research to Get $3 Billion Boost in Senate Spending Bill

U.S. Drugmakers Face New Intellectual Property Hurdles in China

FDA Will Reject Petitions Solely Meant to Delay Generic Drugs

FDA Prepares to Bolster Data Use in Drug, Device Approvals

FDA Eyes Technology Upgrades to Keep Pace with New Treatments

FDA: Innovative Clinical Trials Are Great but Talk to Us First

Fetal Tissue Research Studies on Hold with No HHS Ethics Board

NIH Invests $1 Billion in Opioid Research, Double 2018 Amount

Holes Found in NIH Oversight of Conflicts, Foreign Influence

Research Hubs Get $20 Million Boost From NIH to Speed Treatments

Conflicts in NIH Foundation Questioned by House Oversight Leader

Trump Taps Former Labor Counsel as White House Regulatory Chief

FDA Warns Fertility Clinic Over Donor-Screening Violations

Trump Plan to Import Drugs Now Under Regulatory Review

FDA Cuts Red Tape in Diagnosis Applications for Cancer Trials

Trump Orders Limit Effect of Agency Guidance on Industry

INSIGHT: Data Fabrics, Health Data Analytics, and Emerging Legal Issues

Humana Sues Teva for Leading ‘Scheme’ to Inflate Generics Prices

Novartis Soaring but Health Officials Fear Rare Disease Gold Rush

FDA Warns Imaging Drug Maker Over Fungal Contamination

Canadian Patent Rules Cut Filing Delay Time for Multinationals

Gilead’s Truvada Defense Misunderstands Antitrust Law, FTC Says

FDA Warns Another Imaging Drug Maker Over Sterility Problems

China Approves First New Alzheimer’s Drug in 17 Years

FDA Official Urges Wealthy Nations to Align Gene Therapy Rules

Trump to Name Texas Cancer Doctor Stephen Hahn to Run FDA

Canadians Want Trudeau to Put Brakes on U.S. Drug Importation

Animal Rights Groups Sue USDA to Improve Primate Care Standards

NIH Wields Research Money to Force Scientists to Share Data

FDA Warns Drugmakers Over Dirty Products, Computer Access

'Frankenfish,’ Stem Cells, Vaping Top Questions Facing FDA Pick

Glaxo Wants to Look Inside Your Gut to Discover New Vaccines

INSIGHT: Alexion to Acquire Achillion With Contingent Value Rights

Alnylam Wins FDA OK for First Therapy for Rare Blood Disorder

‘Next Big Thing’ at Risk as Fewer Women, Minorities Get Patents

BGOV Bill Summary: H.R. 3460, Neglected Tropical Diseases R&D

Astellas to Buy Audentes in $3 Billion Gene-Therapy Deal

Merck Cyberattack’s $1.3 Billion Question: Was It an Act of War?

FDA Approving Drugs at Breakneck Speed, Raising Alarm

Find a Novel Use for an Existing Drug? FDA Has an App for That

Sanofi to Buy U.S. Biotech Firm for $2.5 Billion in Cancer Push

Lagging FDA Human Research Rules Draw Cures Law Architects’ Ire

Unapproved Umbilical Cord Products Bring Rebuke From FDA

Facebook Ads Cause Patients to Stop, Switch HIV Prevention Drug