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Revised Guide Clarifies Scope Of EMA Policy On Proactive Publication Of Clinical Data

The European Medicines Agency has issued revised guidance to further clarify what information in regulatory submissions is covered by its policy on the proactive publication of clinical data. The updated guideline also addresses certain procedural issues to help companies submit proposed redactions.

Clinical Trials Regulation Europe

Patient Experience Data May Require Separate Label, Genentech Suggests

US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.

FDA Approvals Regulation

Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk

Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.

Risk Management Drug Safety Liver & Hepatic

Gottlieb's Tweets: Skirting The Rules Or Advancing Policy?

The current FDA commissioner discussed use of the social media platform with his predecessor Robert Califf at a meeting on real-world evidence.

Advertising, Marketing & Sales FDA Policy

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Industry Lodges Legal Challenge To Turkey’s Local Drug Production Policy

Turkish drug industry association AIFD is demanding that the court cancels a government policy under which multinational companies are facing the threat of having their medicines removed from the reimbursement list unless they produce them locally.

Reimbursement Legal Issues Market Access

Latest From Regulation

Allergan Seeks Quick Vraylar Turnaround After US FDA Refuses To File

Supplemental application for negative symptoms associated with schizophrenia has robust data, Datamonitor Healthcare analyst suggests, but was incomplete.

Drug Review Drug Approval Standards

Deciphering US FDA’s Keytruda Safety Announcement

Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.

Cancer Drug Safety

FDA Approval Round Up: Keytruda, Opdivo Add Claims

Cancer supplements took center stage for US FDA this week, but OptiNose Inc.'s corticosteroid Xhance also took a bow.

Drug Review Approvals

Latest From Policy

Product Liability Litigation Playbook: Pros And Cons For Pharma

Drug makers are winning cases by getting expert testimony tossed, but the AndroGel verdict shows how narrow claims can benefit plaintiffs. The Pink Sheet offers a look at drugs in multidistrict litigation from Abilify to Zoloft.

BioPharmaceutical Policy

New HTA Methodology Could Solve Value Conundrum

A new methodology for evaluating the benefits of new medicines aims to make funding decisions more transparent and structured. It could also offer an alternative to the way health technology appraisals reflect value.

Cost Effectiveness Health Technology Assessment

Payers Could Guarantee Biosimilar Market Share, FDA's Gottlieb Suggests

Commissioner worries that fewer drugs may enter market in some categories because of drug development costs, and offers some post-market strategies for encouraging biosimilar development.

Biosimilars Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

Biosimilars Statistical Guidance Reflects Early Development Approach

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Biosimilars Research & Development

Clinical Trial System 'Broken,' But Modernization Long Way Away – Woodcock

CDER Director says current system is stifles innovation, calls for integration of health care and trial process.

Clinical Trials Regulation

Real-World Evidence Requires 'Leap Of Faith' For Industry, FDA – Gottlieb

US FDA Commissioner says agency will soon offer more clarity on using real-world evidence in drug development, but notes industry needs to take risks of its own.

Research & Development Review Pathway

Commercial Explore this Topic

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Latest From Commercial

Pfizer Skeptical About Value-Based Contracting In Current Environment

'We have about 18 different projects underway but we've achieved' only one value-based deal, Pfizer CEO Ian Read says. 'The risks and incentives have to be with the providers. … That's how you get the best health care.'

Pricing Strategies Market Access

UK’s NICE Backs BMS's Opdivo In Lung Cancer, But Only Via CDF With Price Cut

UK HTA body NICE has decided to make Bristol-Myers Squibb's PD-1 inhibitor Opdivo available for non-small-cell lung cancer, but only through the UK's revamped Cancer Drugs Fund, and at a discounted price.

Commercial Companies

Switches, Pediatric Products Highlight OTC Outlook In Independent Pharmacies

OTC cold and allergy product sales lead the health, wellness and beauty segment in 16,000 US independent pharmacies, says Hamacher Resource Group. Vitamins and supplements, which lead other categories in chain retail pharmacies, are the No. 2 category in independent pharmacies.

Consumer Advertising, Marketing & Sales

Manufacturing Explore this Topic

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Latest From Manufacturing

Best Practices Identified For Reducing Pharmaceutical Packaging Defects

An industry group has proposed some best practices for validating pharmaceutical packaging processes to minimize packaging defects. The paper is designed to fill a knowledge gap: while there is no shortage of information on how manufacturers can validate their manufacturing processes, less information is available on how manufacturers can validate packaging.

Manufacturing Quality

Biosimilar Post-Approval Change Guidance Coming From US FDA

Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.

Manufacturing Biosimilars

Merck Cyberattack Recovery: Congress Scrutinizes Manufacturing Problems

A House committee has requested a briefing from Merck on the June 27 NotPetya malware attack that has impeded manufacturing operations, and on the pharmaceutical company's subsequent remediation efforts. Meanwhile, a pharmaceutical industry group is bringing experts together to brainstorm on cyber security best practices.

Cybersecurity Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Public Citizen Attempts To Force FDA Decision On Benzocaine Petition

FDA is sued by Public Citizen after failing to make a decision on a 2014 citizen petition urging the agency to remove an infant teething indication for OTC benzocaine products. The complaint asks a federal court to order a response from the agency within 30 days.

Consumer FDA

Colgate's UK Whitening Claims Shine On Clinical Data, Consumer Perception

Colgate substantiates claims in TV and online ads for Colgate Max White Expert White toothpaste and Max White toothbrush with clinical and consumer perception studies showing the products could make teeth “3 shades whiter” in five days.

Consumer Advertising, Marketing & Sales

Perrigo Positioned To Prosper From Potential Amazon OTC Product Play

CEO John Hendrickson says Perrigo would work with Amazon to develop its own private label OTC line and would not expect to lose existing customers. At a recent investor conference, he said Amazon’s commitment to the OTC category would help grow the market, not take market share from other firms.

Consumer Business Strategies