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Featured Stories


Pharma Cases Show How Brexit Could Hit Alignment Of UK & EU Competition Law

Brexit could result in a gradual divergence of competition law decisions in the UK and the EU, according to one law firm, which already detects evidence of this in recent competition cases. 
Legal Issues Europe United Kingdom

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 Compliance

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Following draft guidance that looks likely to reject Spinraza, the US biotech believes that UK health technology body NICE is not using the right mechanisms to evaluate rare disease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

Biosimilars At US FDA: Personnel Spending Losing Influence Over Program

Percentage of personnel spending as a proportion of biosimilar review costs dropped more than 17% over three-year period as equipment and other spending more than doubled.

Biosimilars Review Pathway Regulation

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

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 Europe

Latest From Regulation

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expand And Constrict

The latest drug development news and highlights from our US FDA Performance Tracker. 
US FDA Performance Tracker Drug Review

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

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

Latest From Policy

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

Genentech Wins Attorneys' Fees After Phigenix's Aggressive Patent Suit

"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.

Legal Issues Intellectual Property

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

Two Neurodegenerative Disease Drugs Secure EMA's Coveted PRIME Designation

What is claimed to be the first therapy targeting the underlying cause of Huntington’s disease and a gene therapy for Lorenzo’s Oil disease have become the latest investigational products to make it onto the European Medicines Agency’s priority medicines scheme.

Europe Innovation

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

China Regulatory Shakeup: Top Regulator Out, Commissioner Reprimanded Amid Vaccine Scandal

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

China Drug Safety

FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals

FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II. 

United States Manufacturing

The Quality Lowdown: A Week Of International Intrigue

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

Quality Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

OTC Private Labelers Recall CVS, Walmart Brand Products

Recalls include one lot of CVS Health Sinus Relief manufactured by Product Quest Manufacturing, Walmart's Equate laxative made by Lupin's US office and 12 cough and cold products marketed under Preferred Plus Pharmacy and other private label brands and made by RIJ Pharmaceutical Corp. Chart provides update on recent US OTC recalls.

Consumer Recalls

Bausch Health Boosts Ad Spending For Expanding OTC Eye Care Lineup

"We're investing more to drive growth as we allocate capital to support the launches of new products in the segment like Lumify, for DTC advertising that continue to drive sales growth of other US consumer products like our eye vitamins," says CEO Joseph Papa.

Consumer Ophthalmic
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