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Policy & Regulation

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Real-World Evidence At US FDA: Bavencio, Blincyto Approvals Point Way Toward Broader Use

Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study. 
Drug Review Profile Drug Approval Standards Cancer

‘No-Deal’ Brexit: First Govt Docs This Week May Show Impact On Life Sciences

The BioIndustry Association says life sciences could be among the first sectors to be addressed in the UK government’s planned release of “technical notices” regarding the effects of a “no-deal” Brexit.

Brexit Regulation United Kingdom
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Regulation

Set Alert for Regulation

Latest From Regulation

Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39

The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.

Brexit Regulation

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

EMA Targets Sponsors That Post Trial Results Too Late

Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.

Clinical Trials Compliance

EU Approval Set For Three New Orphans And Lilly’s Emgality; Exondys Appeal Fails

The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.

Europe Drug Review

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says

Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
Advertising, Marketing & Sales FDA
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Policy

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Latest From Policy

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Biosimilar Action Packages Low On US FDA Priority List For Redaction And Posting

Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.


Biosimilars Drug Review

US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Drug Review Approvals

PCMA’s Merritt Reflects On 15 Years At The Helm Of PBM Advocacy

Outgoing Pharmaceutical Care Management Association chief discusses fight over rebates, future of pharmacy benefit management, opportunities and challenges facing his successor.

Pharmacy Benefit Management Policy

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Cigna Acquisition Of Express Scripts 'Unlikely' To Harm Competition, DOJ Concludes

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

Pharmacy Benefit Management Private Payers
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