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Featured Stories


Republicans Push Back Against Rx Pricing Transparency Bills At House Hearing

Pricing transparency legislation requests too much information, Republicans say during hearing in US House Energy and Commerce Subcommittee on Health.
Pricing Debate Legislation Policy

Are You Prepared For Russia’s New Track And Trace System?

Pharmaceutical companies need to start preparing now if they are to meet the requirements of the new and complex Russian track and trace system that will be fully up and running by the beginning of 2020.

Expanded Access: Reducing The Contract Delay

While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.
Clinical Trials Cancer Regulation

Canada Moves To Reduce Industry Adverse Action Re-Reporting

The Canadian regulator has clarified that cases identified from the pharmacovigilance online database should only be re-submitted if they contain additional information.
Canada Drug Safety Regulation

Gene Therapy In The Real World: Long-Term Follow Up Is Key – If Patients Are Willing

The first of what promises to be a wave of potentially curative gene therapies are coming to market. One of the challenges for sponsors will be how to deliver long-term outcomes data demanded by regulators and payors from patients who don’t have any reason to go to the doctor.

Gene Therapy Post Market Regulation & Studies Drug Safety
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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.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

No Shocks Expected In EU Quality Guidance For Drug-Device Combinations

Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.

Combination Products Quality Regulation

Latest From Regulation

US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered

New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.

Clinical Trials Cancer

WHO Consults On New Framework To Evaluate And List Regulatory Authorities

The new framework, when finalized, will replace the widely-recognized concept of "stringent regulatory authorities." 
International Regulation

Pharma ‘Making Progress’ On Medicines Access, But Gaps Remain

A new report says that the 20 major companies in the Access to Medicines Index have made progress in areas like inclusive business models, R&D prioritization and equitable pricing, but not enough is being done to develop new medicines for less profitable diseases or to support flexibilities such as compulsory licensing.
International Business Strategies

Latest From Policy

A Complete Retreat: “Protected Classes” Stay Protected In US Medicare

CMS has abandoned its plan to give private plans more leverage in the “protected” drug classes in Part D. It will probably be a long time before anyone tries to change the protected classes again.

Medicare Reimbursement

An Independent US FDA: Gottlieb Supports Position, But Is Pessimistic About Prospects

In an interview with the Pink Sheet, Scott Gottlieb agrees with other ex-commissioners that there are benefits to an independent agency, but he thinks political forces would prevent it from ever happening.

Leadership FDA

Product Liability: Discussions With FDA Remain Key In Defeating State Tort Suits

US Supreme Court says judges, not juries, should decide if FDA would have rejected additional label warning; Merck appears to have the support of three justices who note FDA's position that it decided not to require a change to Fosamax labeling.

Legal Issues Drug Safety

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

Set Alert for Manufacturing

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
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