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Blood Clot Concerns Prompt EU Restrictions For Pfizer's Xeljanz

The European Medicines Agency's pharmacovigilance committee has launched a fresh review of Xeljanz and has also recommended suspending all fenspiride medicines, which are used to treat non-serious cough but are associated with heart rhythm problems.
Europe Drug Safety Regulation

Drug Pricing Hearing Takes A Partisan Turn As Gilead’s O’Day Holds His Own

Republicans took off the gloves at House oversight hearing on PrEP, arguing Democrats are more interested in scoring political points than seeking policy solutions to high drug costs.
Pricing Debate Legislation Infectious Diseases

Canadian Policy Paper Demystifies Autologous Cell Therapy Rules

Health Canada says there is uncertainty on how autologous cell therapy products are regulated under the current framework.
Canada Regulation Regenerative Medicine

US FDA's Real-Time Oncology Review Times Coming Into Focus

With approval of AbbVie Inc./Genentech Inc.'s Venclexta as seventh under RTOR pilot, a roughly two-month median review time under the program could be taking shape.

Cancer Drug Review Review Pathway

TB Drug Access Plan Moves On Amid Concerns From Health Advocates

The creators of a proposed new mechanism for stimulating R&D into new medicines for tuberculosis have replied to a number of concerns raised by health and market access advocates who say the model might serve to perpetuate the existing “flawed” funding model in lower income countries.

Market Access International Health Technology Assessment

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – April 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Europe Australia India

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

Download Whitepaper

Policy & Regulation Explore this Topic

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Pink Sheet Podcast: Oncology Reviews, Biosimilars, and More Biosimilars

Our discussion of US FDA's two-drug Oncologic Drugs Advisory Committee meeting, the recent biosimilar insulin public hearing, and the new final biosimilar interchangeability guidance.
Advisory Committees Biosimilars Regulation

Latest From Regulation

ImmunoGen Regroups After FORWARD Setback, Looks To New Ovarian Cancer Phase III

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

Cancer Drug Approval Standards

Keeping Track: Resubmissions For Tlando And Twirla NDAs, And A BTD For Pomalyst

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

Latest From Policy

CAR-T Coverage: CMS Takes Gradual Approach With Eye Toward New Entrants, Indications

As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.

Reimbursement Cancer

UK’s NICE Price Discounts ‘Pass Risk To Patients’

Health technology appraisal mechanisms like discounts do nothing to address a lack of clinical evidence and simply transfer the uncertainty to patients, NICE’s recent annual conference heard.

Europe United Kingdom

UK Rare Disease Drug Review Reform Urged As Spinraza Finally Gets NICE OK

It has taken 17 months of negotiations but soon 600-1,200 people in the UK may be able to get Biogen's spinal muscular atrophy therapy now that an access agreement has been inked.

Health Technology Assessment Market Access

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

ImmunoGen Regroups After FORWARD Setback, Looks To New Ovarian Cancer Phase III

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

Cancer Drug Approval Standards

Pediatric Oncology Advances Could Prompt More FDA-Required Studies

Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.

Pediatrics Cancer

Power Of Rare Disease Patient Registries Touted By US FDA, Patients

Patients describe how they connect with each other and advance research through registries; agency says it has accepted registry data as real-world evidence of a product's benefit.
Drug Approval Standards Rare Diseases

Commercial Explore this Topic

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Latest From Commercial

Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Biosimilars Metabolic Disorders

Pfizer, Express Scripts Clash Over Biosimilar Formulary Placement

Pfizer VP blames rebate strategies of innovators for difficulty in getting biosimilars on formularies while Express Scripts official says it is all about net cost during House hearing on lowering Rx drug prices.

Market Access Biosimilars

Amgen Resolves Repatha Access Kerfuffle With Express Scripts

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

Market Access Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

EU Proposal To Ban Microplastics In Pharmaceutical Ingredients Has US Excipient Industry On Edge

A proposal by the European Chemicals Agency that would add microplastics to the list of banned chemicals in the EU under its REACH regulation has come under attack by the US excipient industry. Officials argue that the proposal is misguided in that it considers polymers as microplastics and would unnecessarily restrict the availability of medicines that contain polymers in formulations.

Europe Manufacturing

US FDA's New Global Office Aims To Elevate and Enhance Agency’s Role On World Stage

There is growing recognition that the US FDA can use trade agreements to help confront the challenges of globalization and that these agreements can play an increasingly important role in fostering regulatory alignment and improving the quality of imports, agency official says.

Manufacturing Quality

US FDA ‘State Of Quality’ Report Targets Unreviewed, Uninspected Risks

The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.


Quality Manufacturing