Pharmaceutical Science Update

India Seeks to Stifle Sham Stem Cell Therapies by Regulation

FDA Chief Wants to Set New Record for Generic Drug Approvals

FDA Hustles to Inform Drugmakers on Their Compliance Status

FDA to Set Digital Health Framework for Drug Development

U.K. Urged to Step Up Post-Brexit Plans for Life Sciences

FDA to Prioritize Biosimilars in Plan to Tackle Drug Prices

Does Faster Mean Better for Cancer Drugs? This Study Says No

Berkeley's MIT, Harvard CRISPR Battle Hinges on Expectations

China Slashes Tax Rates on Imported, Cancer-Fighting Drugs

Feds Move on Calif., Fla. Stem Cell Clinics at FDA’s Request

FDA’s Regulatory Agenda Sheds Light on Research Rule Changes

8,000 Volunteers in Week One of NIH Precision Medicine Study

Tariffs on Chinese Goods May Trigger Drug, Device Shortages

Checklist Helps Research Institutions Follow Federal Rules

NIH Lays Out New Roadmap to Tackle Alzheimer Cure

Drug-Device Rules Could Give FDA Leg Up in Industry Fights

Lawmakers at Work on Bill to Spur Generic Drugs

What Does Trump Drug Cost Plan Mean for Targeted Therapies?

Senate Panel Approves Uptick in FDA Funding for 2019

Libertarian Groups Eye Off-Label Drug Promotion Laws

Teens Should Be Included in Adult Oncology Trials: FDA

Right-to-Try Experimental Drugs Is Officially Law. Now What?

FDA to Branded Drugmakers: Play Fair, We’re Watching

Canadian Biosimilar Approval May Indicate Policy Shift

With Big Data Comes Big Responsibility: NIH’s New Data Plan

FDA to Biosimilar Sponsors: Let’s Talk

FDA Starts Shift to Patient Perspectives in Drug Development

House Passes Bill to Expedite NIH Opioid Research

House Plan Again Boosts Medical Research Spending for 2019

Patients Getting More Say in Drug Development under FDA Plan

NIH Details $500 Million Opioid Research Plan

Research Spending Limits Could Upend U.S. Lead in Science

What’s in the Works at NIH for Opioid Research?

FDA Will Waive User Fees for Innovative HIV Drugs

FDA Withdraws Some ‘Best Practices’ for Biosimilar Makers

Va. Biotech’s Stock Falls Despite Win Over Study Contractor

Help on Research Reg Changes May Be on the Way From HHS

Standards to Speed New Drug Approvals Coming Soon: FDA

Precision Medicine Needs to Address Growing Genetic Diversity

NIH Trial Leads to $1.5B Savings as Many Women Can Skip Chemo

Strings Attached to Burden-Reducing Parts of Research Rule?

Common Sense to Be Used in Enforcing New Research Rule

High Court Pick Kavanaugh’s Pharma, Device Experience

FDA Hopes to Tackle Drug Shortages with Congress, Drugmakers

Prominent House Democrat Seeks Hearing on Generic Drug Bills

FDA Offers Gene Therapy Advice on Hemophilia, Other Diseases

FDA Pushes More E-Data Use in Drug, Device Studies

MIT, Harvard Face New Challenge to Gene-Editing Patent

FDA to Allow Biosimilar Makers to Use European Drug Samples

HHS Offers First Sign of Help for Human Research Reg Changes

FDA: Drug Companies Can’t Game Pediatric Drug Laws Anymore

New Gene Editing Safety Concerns May Crimp Therapy R&D

NIH May Cut Paperwork in Conflict-of-Interest Policy

NIH Nixes Ethics Review of Human Research Grant Proposals

White House Science Pick Could Influence NIH Policy, Budget

FDA Chief Wants to Break Down Rare Disease Drug Monopolies

Biological Markers to Measure Pain Could Lead to Better Meds

Pandemic, HHS Funding on Congress’ Postsummer To-Do List

FDA Would Get nearly $3B in Senate’s FY 2019 Funding Bill

PREP Act’s ‘Liability Vaccine’ for Zika Raises Fairness Question

Look Beyond Drug Use Stats to Treat Opioid Addiction: FDA

Cancer Clinical Trial Proposal Could Open Door to Thousands

FDA Pushes for Streamlined Human Trials to Study Cancer Meds

Opioid Production Cuts Urged by Justice Department

NIH to Streamline Oversight of Studies for Gene Therapy Work

Interest in Gene-Therapy Fast-Tracking on the Rise: FDA

Every State a Winner as Senate Moves Medical Research Billions

Espionage Risk Seen Rising in NIH Medical Research Grants

NIH Vying With Apple, Amazon for Top Data Scientists

Do Cancer Researchers Disclose Clinical Trial Funding?

DOJ Restraining Orders Strip Docs’ Opioid Prescribing Rights

More Money, Fewer Problems: NIH Funds Catching Up to Inflation

Biosimilar Drugmakers Could Suffer From Trade Pact Changes

‘Idea Incubator’ to Spur More FDA Drug Approvals for Unmet Needs

Chile’s Power to Break Gilead’s Hep C Patent May Cut Drug Prices

HHS to Fund Effort to Diversify Massive Government Health Study

FDA Chief Blames Drug Supply Chain for Hampering Biosimilars

Opioid-Like Kratom Gets FDA Scrutiny as False Ads, Abuse Mount

FDA to Tackle ‘Anti-Competitive’ Citizen Petitions by Drugmakers

Cancer Diagnoses to Jump 37 Percent by 2035, Researchers Say

Opioid-Like Kratom Gets FDA Scrutiny as False Ads, Abuse Mount

Health Care Funding Hikes Folded into Congressional Spending Deal

First Study of Gene Editing for Sickle Cell Disease on Horizon

Chemo Side Effects Need More Focus in Drug Review: FDA Official

Medical Research Money Needs Better Tracking: Bioethicist

Clinical Trial Reporting Requirements Finally Getting Teeth

Stopping Harassment in Research Goal of Expected NIH Policies

Last-Minute Changes to Opioids Package Slip through House

Opioid Crisis Showing Signs of Abating, HHS Official Says

We Want Your Input on Complex Drug Trials: FDA to Industry

Pharma, Tech Could Be Big Winners under New IRS Spinoff Study

Real-World Drug Data Could Be Cherry-Picked: FDA Official

Data from Massive NIH Study Could Spur Targeted Therapy Advances

NIH’s Opioid Response to Speed Up under New Spending Authority

Blockbuster Drug Avastin May End Up on California Toxics List

Mexico, Canada Trade Pact Includes Drug Data Protection

FDA Aims to Find Common Ground with HHS Research Rule

Drugmakers Feel the Heat to Diversify Drug Trials

Small Biotech, Device Companies Face Research Oversight Hurdles

NIH Mulls Turning Up Heat to Improve Data Sharing

NIH Is Spending $86 Million to Study Gene Editing Side Effects

Drug, Device Makers Face Inconsistent Human Research Rules

FDA Dodges Death-Inspired Suit over Study Volunteer Consent

FDA Won’t Require Study Sponsors to Report Suspected Misconduct

Digital Health Platform for Drug Delivery Coming Soon from FDA

Massachusetts Biotechs Look for Money to Fuel Cuba Deals

A CAR-T ‘Cookbook’ Could Speed Up New Cancer Therapies

U.K. Drug Companies Fear Impact of ‘No Deal’ Brexit

FDA Defends Decision to Approve AcelRx’s Potent New Opioid

FDA Advances Plans for Regulating Genetically Modified Organisms

Hepatitis B Targeted in FDA’s Latest Disease-Specific Drug Advice

Medicare Pricing Plan Would Stifle Drug Development: Think Tank

DeGette, Key Health Lawmaker, Eyes House Leadership Role

How Will Dems’ House Takeover Affect Research Funds?

Tell People about Studies Using Their Data, Even If Not Required

Fetal Tissue Research Is Back Under the Microscope at HHS

FDA Aims to Ease Ethics Review for Low-Risk Studies

HHS Guidance on Human Research Rule Revisions

Drug-Related Software, a Gray Regulatory Area, Sees FDA Inquiry

Alzheimer Bill Heads to Full Senate with Bipartisan Backing

Using Routine Health Data in FDA Drug Reviews May Raise Oversight

Drugmakers Face Rising Costs to Prepare for ‘No Deal’ Brexit

HIV Drugs to Get Speedier Reviews from World Health Organization

Drugmakers Face Extra Costs under Russia’s New Quality Law

HHS Disputes Claims It Pulled Fetal Tissue Grant

NIH Chief Seeks Global Crackdown on Gene Editing of Human Embryos

Endo Patent Decision Appeal May Shift Life Sciences Investment

FDA’s Real-World Evidence Framework Is Out. Now What?

Relaxed Clinical Trial Reporting Rules Draw Lawsuit

NIH to Keep Funding Fetal Tissue Study as It Seeks Alternatives

No-Deal Brexit Will Require New U.S.-U.K. Drug Inspection Pact

NIH Gets More Prescriptive About Private Money It Will Accept

2019 Outlook: Curbing Harassment Tops NIH Policy Chief’s Agenda

2019 Outlook: Curbing Harassment Tops NIH Policy Chief’s Agenda