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Featured Stories


Lack Of National Planning For No-Deal Brexit Makes UK Drug Shortages More Likely

The trade association, NHS Providers, has warned of shortages and stockpiles of medicines in the UK, as well as problems with public health and disease control, if contingency planning for a “no-deal” Brexit is not coordinated at national level.

Brexit Distribution Healthcare Systems

How a Rapid and Well-Messaged US FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

Consultant examines why FDA seems to be accomplishing so much under FDA Commissioner Gottlieb’s leadership and how this could inform future leadership selections.

FDA Leadership United States

UK's NICE In The Dock Again After 'No' For Biogen SMA Drug

Following draft guidance that looks likely to reject Spinraza, the US biotech believes that UK health technology body NICE is not using the right mechanisms to evaluate rare disease drugs.

United Kingdom Health Technology Assessment Rare Diseases

PCSK9 Inhibitor Labeling Parity Is Within Reach As Praluent And Repatha Strive To Make Commercial Case

Sanofi and Regeneron’s Praluent could draw even with Amgen’s US Repatha in approved FDA indications in 2019. While the injectable PCSK9 inhibitors battle for payers and prescribers, Esperion is readying its oral bempedoic acid to join the lipid-lowering fray – and strategizing towards what could be the first statin intolerance indication.

Cardiovascular Drug Approval Standards United States

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?

Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.

Generic Drugs FDA Regulation
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – July 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Subsys Makes A Bad Impression On FDA REMS Panel Members

CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.

Regulation Risk Management Drug Safety

Latest From Regulation

US FDA Scientists Give Leadership High Marks; Some Worry About Industry Influence

Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

FDA BioPharmaceutical

Two States Require Industry To Pay For Ongoing Drug Take-Back Programs

Consumer Healthcare Products Association looks to stem expansion of state-mandated drug take-back programs with programs that use existing facilities and infrastucture and don't require industry funidng, says state affairs VP Carlos Gutierrez. State bills limiting sales of DXM to minors and expansion of the NPLEx system to track PSE sales also are on CHPA’s radar.

Safety State News

‘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

Latest From Policy

Devalued Lira Threatens Access To Drugs In Turkey

A political crisis between Turkey and the US has seen the Turkish lira plunge in value against the euro and other major currencies and is having a negative impact on the availability of drugs in Turkey.

Market Access Pricing Strategies

Medicare Part B Step Therapy Policy May Get Further Guidance From HHS

HHS meeting with stakeholders may lead to adjustments to plan for implementing step therapy in Medicare Advantage for Part B drugs.

Policy Pricing Debate

ICER’s 2019 Agenda Includes CAR-T Therapy, Drugs For Depression, Arthritis, AMD

Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.

Policy Cost Effectiveness

Clinical / R&D Explore this Topic

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Latest From Research & Development

Neonates, Prolonged Seizures Feature In Latest EU Guidance On Epilepsy Drugs

The European Medicines Agency is revising its guidance on clinical trials of drugs for treating epileptic disorders.

Clinical Trials Neurology

PD-1 Fatigue: Cross-Labeling May Help Pare Checkpoint Inhibitor Pipeline

US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development. 

ImmunoOncology Drug Approval Standards

Fauci: Concerns About Exclusive Licensing Of Government-Developed Products Are Misguided

NIAID director says granting exclusive licenses to drug companies is necessary for late-stage development and production of government-developed products. 
Vaccines Research & Development

Commercial Explore this Topic

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Latest From Commercial

Paratek And The “Blockbuster” vs. Steady “Stewardship” Approach In Antibiotics

US FDA Antimicrobial Drugs Advisory Committee Chair Baden offers warning about “overuse” to emerging antibiotic sponsor.
Advisory Committees Infectious Diseases

Stand-Off: Vertex Refuses NICE Data on CF Drug Symkevi, HTA Body Awaits Next Move

Vertex says it will not file data on its cystic fibrosis drug Symkevi (tezacaftor/ivacaftor) until the UK's NICE changes the way it assesses drugs.

Approvals Commercial

Perrigo's OTC Core Could Expand To Include National Brands

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Prescription To Otc Switch Advertising, Marketing & Sales

Manufacturing Explore this Topic

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Latest From Manufacturing

The Quality Lowdown: Cadmium, Quality Metrics, Heparin Testing And Continuous Manufacturing

ICH relaxing a new limit for inhaled cadmium in drugs; FDA relaxes timeline for quality metrics site visit invitations; US FDA looks for heparin test to sort the porcine from the bovine and ovine; and universities win FDA grants for research into continuous pharmaceutical manufacturing.

Manufacturing Quality

Final FDA Guidance Delivers More Digestible Tablet Chewing Index

FDA’s final guidance on chewable tablets clarifies what is meant by a “chewing difficulty index” to assess product hardness. Properly formulating these products is key to avoiding quality failures such as choking patients.

United States Manufacturing

FDA Warns Apotex Management To Demand Quality, Meet Specs

Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Final FDA Guidance Delivers More Digestible Tablet Chewing Index

FDA’s final guidance on chewable tablets clarifies what is meant by a “chewing difficulty index” to assess product hardness. Properly formulating these products is key to avoiding quality failures such as choking patients.

United States Manufacturing

Two States Require Industry To Pay For Ongoing Drug Take-Back Programs

Consumer Healthcare Products Association looks to stem expansion of state-mandated drug take-back programs with programs that use existing facilities and infrastucture and don't require industry funidng, says state affairs VP Carlos Gutierrez. State bills limiting sales of DXM to minors and expansion of the NPLEx system to track PSE sales also are on CHPA’s radar.

Safety State News

Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

 

Dermatology Consumer
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