Opinion & analysis

EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

Drug Firms Fear PBM ‘Discrimination’ Over List Price Reductions, Azar Tells Hearing

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

GE Healthcare’s New Value Proposition: The Strategic Language Of Software

State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

Pharma’s New R&D Models: Federating Innovation

Bayer’s US Playbook: The Smart Way To Top-Line Growth

Paying For Gene Therapy: Will Pharma Be First In Line?

It’s Complicated: FDA Prohibits CBD In Supplements, Enforcement Priority On Disease Claims

Cosmetic Preservatives Crisis Creeping Into CIR Program

Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens

J&J Scores Early In ‘Hypoallergenic’ Case; Plaintiff’s Definition ‘Implausible,’ Court Says

Colgate/Tom’s Of Maine Pays Back Unilever For ‘Naturally Dry’ Loss

Thinking about using CMMI? Here are tips from the experts

Regulatory headaches: Brexit’s not the only thing you need to worry about

Sunshine rules in the EU: Implications of a piecemeal approach

FDA investigator insights: Device makers forget about the humans who use their products

Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose

Novartis’ New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands

ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

The Blockbusters No One Talks About

Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology

Father of Humira, Greg Winter, Wins 2018 Nobel Prize For Chemistry

Eight Things To Know From Novartis’ Third Quarter Call

Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars

Cell And Gene Therapies Test New Waters In Pricing And Reimbursement

Takeda To Press On With Core R&D Strategy Post-Shire

European Commission Sheds Light On MDR/IVDR Progress In Vital Update

What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

CMS Actively Looking For New Reimbursement Pathway For Innovative Devices

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

Repositioning Market Access: A Function Fit For Purpose In A New Era Of Costly Cures

The Emergence Of IO

As Humira Biosimilars Arrive, Battle Lines Shift From Education To Sustainability

Immuno-Oncology: Unicorns, China And The Perfect Storm

Unilever Seeks End To Litigation Over St. Ives Scrub, Plaintiffs’ ‘Fake Medical Condition’

Nail Polishes Contain Undeclared DEHP, Among Other ‘Regrettable Substitutions’ – Study

FDA Ban On Flavoring Ingredients Should Prompt Removal From Fragrances – WVE

What Do Cosmetics Reform Campaigners Dream Of At Night? Rep. Schakowsky Just Reintroduced It

DECIEM, Truly ‘The Abnormal Beauty Company,’ Faces Uncertain Future

Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets’ Utility And Limitations