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EMA’s Future Home: Assessment Of Bids Nears Completion Amid Growing Staff Concerns

Sept. 30 is the date by which the European Commission must complete its assessment of member states’ bids to host the European Medicines Agency after Brexit. The agency has again highlighted the pressures it is under as a result of the relocation, and the situation has worsened after some LGBT staff members expressed concern about their rights in certain potential host countries in eastern Europe.

Brexit Regulation Europe

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 Commercial

Turkey Finds Permanent Solution To Tamoxifen Shortage

The Turkish government plans to fix the country’s tamoxifen drug shortage problem by allowing by a local company to manufacture the product.

Market Access Pricing Debate Manufacturing

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 Policy

Policy & Regulation Explore this Topic

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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 BioPharmaceutical

Latest From Regulation

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

Yet Another Call For Views On What Brexit Means For Pharma, Regulation & Health

Another inquiry investigation into the consequences of Brexit in the life sciences area has been launched, this time by the House of Commons health committee. Stakeholders are asked to comment on issues like the impact on the regulation of medicines and medical devices, how to ensure continued access to medicines, and whether transitional arrangements will be needed.

Brexit Regulation

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Latest From 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

Pfizer v. J&J Sets Stage For Biosimilar Showdown Over Exclusive Contracts

Pfizer's suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any of Pfizer's biosimilar Inflectra is reimbursed, but J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues

Opioid Industry's 'Superstructure' Targeted By State Attorneys General

Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors – pursued in multistate investigation that follows individual AG inquiries and flurry of state, city, and county suits.

Legal Issues Advertising, Marketing & Sales

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

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Latest From Commercial

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

Commercial Capsules: BMS's Opdivo Knock; Novo Nordisk Vs Eli Lilly; Roivant Raises; Sun Plunges; Other R&D Stumbles

Bristol-Myers Squibb faces a second clinical disappointment with Opdivo/Yervoy, allowing Exelixis to take advantage; Novo Nordisk claims a victory over Eli Lilly in the GLP-1 space; Roivant Sciences closed a $1.1bn equity financing; India’s biggest drug firm, Sun Pharma, slid into the red; Regeneron drops out of RSV; and Zynerba's cannabidiol gel misses again. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Commercial

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

Hispanic Market OTCs Caught In Recalls Of PharmaTech-Made Drugs

FDA's Sept. 20 update to its recalls database includes listings for Doctor Manzanilla Allergy & Decongestant Relief and Cough & Cold oral solutions made by PharmaTech. Also recalled is a mis-labeled Medline Industries ointment.

Consumer Recalls

Consumer / OTC Drugs Explore this Topic

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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