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Medicare Part D Plans To Control Opioid Access With ‘Lock In’ Program

Addiction prevention legislation empowers Medicare drug plans to restrict prescriber, pharmacy access to opioids for ‘at risk’ beneficiaries.

Legislation Policy BioPharmaceutical

PDUFA's 'Real-World' Journey Expected To Be Slow Walk

Manufacturers are enthusiastic about the possibility of using real-world evidence to expand product indications. But even with new resource support, they know it's a long road to get there.

Regulation Post-Marketing Studies Review Pathway

Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline

Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.

Europe Regulation Clinical Trials

Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol

The latest drug development news and highlights from our FDA Performance Tracker

Keeping Track Performance Tracker United States

FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation

Set Alert for Policy & Regulation

Germany May Make Drug Prices Confidential In AMNOG Update

Under forthcoming changes to the law, companies could gain confidential pricing in Germany, which could make it easier to defend a higher price in other countries. But sponsor of some orphan products may face a rockier path to market.

Regulation Germany Market Access

Latest From Regulation

FDA's NDA And BLA Approvals

Original new drugs and biologics recently approved by FDA.

Approvals Regulation

FDA's ANDA Approvals

Generic drug approvals and tentative approvals in mid- and late July.

Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

Latest From Policy

Off-Label Convictions Of Device Execs Could Impact Pharma Sales Reps

Jury acquits former executives from J&J's Acclarent division of felony charges but convicts them on misdemeanor counts for marketing a sinus dilation device for use with a steroid; sales reps statements showed intended use.

Legal Advertising Promotion & Regulation

Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?

Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.

Policy Biosimilars

Diabetes Drug Safety Might Be Best Assessed With Real-World Data

Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.

Policy Drug Safety

Clinical / R&D

Set Alert for Clinical / R&D

Latest From Research & Development

ICH Consults On Supporting Multi-Regional Trials, Non-Clinical Evaluation Of Anticancer Drugs

The International Council on Harmonisation has endorsed draft versions of two new guidelines – one on conducting multi-regional clinical trials and the other on supporting the non-clinical evaluation of anticancer medicines. The ICH is now seeking stakeholder feedback on both documents.

Clinical Trials Regulation

Inside A Phase III Disappointment: Santhera Reduced Target Population, Now Needs Another Trial

FDA seemed on board with Swiss drugmaker's plans for study of Duchenne muscular dystrophy candidate Raxone, but didn't look too kindly on firm's decision to drop subjects using concomitant glucocorticoids.

Research & Development Regulation

'Surrogate Of A Surrogate' Not Good Enough For Raxone Accelerated Approval

FDA’s decision to require second pre-approval trial for Santhera’s DMD candidate is just latest example of the inability of rare disease treatments with surrogate endpoints to qualify for pathway.

Drug Approval Standards Research & Development


Set Alert for Commercial

Latest From Commercial

Bundled Contracts To Defend Against Biosimilars May Face Payer Skepticism

J&J plans to rely on its broad portfolio to contract favorably in a 'post-biosimilar world,' but cross-category bundling is generally discouraged by payers.

Commercial Policy

Crestor Generics To Launch After 12-Day Delay

AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.

Legal Commercial

J&J Consumer Products Business Steers Toward Acquisitions For Growth

Sales of Tylenol, Motrin and other analgesics increased more than 13% during the firm's latest quarter as total US OTC sales reached $389m. Sales of the Listerine line grew 7% to drive domestic oral care product sales up 8.2% to $159m.

Consumer Commercial


Set Alert for Manufacturing

Latest From Manufacturing

GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says

Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.

Manufacturing BioPharmaceutical

WHO Pilots Pre-Submission GMP Inspections To Facilitate Prequalification Of Medicines

The WHO pilot will allow drug makers seeking prequalification for their medicinal products to work simultaneously on addressing GMP issues and preparing their dossiers for submission.

Regulation Africa

FDA Says Preapproval Inspections Will Not Trigger Surveillance Audits

Decisions to conduct GMP surveillance audits for currently marketed products are not triggered by pending NDAs subject to preapproval inspections, FDA official confirms. The two types of inspections are “delinked” from each other.

BioPharmaceutical Manufacturing

Consumer / OTC Drugs

Set Alert for Consumer / OTC Drugs

Latest From Consumer

OTC Drug Industry News Roundup

Merck expands US life sciences facility; Ei moves R&D lab; AZO offers UTI defense; and more news in brief.

Consumer Consumer

Judge Slams J&J Spin On Study Suggesting Acetaminophen-Induced Liver Damage

Johnson & Johnson should address perceived flaws in evidence supporting liver damage by acetaminophen in cross-examination instead of trying to exclude the evidence, says the federal judge overseeing a suit alleging liver damage from use of Tylenol Extra Strength.

United States Consumer

J&J Consumer Products Business Steers Toward Acquisitions For Growth

Sales of Tylenol, Motrin and other analgesics increased more than 13% during the firm's latest quarter as total US OTC sales reached $389m. Sales of the Listerine line grew 7% to drive domestic oral care product sales up 8.2% to $159m.

Consumer Commercial