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EU Council Takes Only Small Steps Towards Consensus On HTA Regulations

EU member state have several concerns about the European Commission’s plans for improving cooperation on health technology assessments, making it difficult for the Council of the EU to reach a common position on the proposals.

Europe Health Technology Assessment Market Access

DSCSA Pilot Explores Feasibility Of Food Blockchain Program For Pharmaceutical Track-And-Trace Compliance

Safe lettuce to safe pills? Participants in a US FDA pilot program are seeing if a food tracking blockchain program can also be used to track pharmaceuticals under a DSCSA pilot program now underway; KPMG officials touts data security as one of the main advantages of blockchain.

Manufacturing Quality Distribution

New Japan PMDA Head Brings Strong Clinical, Patient Focus To Role

The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.

Japan Regulation Drug Review

US FDA First-Cycle ANDA Approvals Not Rising Along With Full Clearances

While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.
Generic Drugs Review Pathway Regulation

Pink Sheet Podcast: New Opioid Approval Standards, Drug Pricing Legislation And New Paragraph IV Data

Our take on the US FDA's new draft guidance on risk/benefit analysis of opioids, a new version of Senate drug pricing legislation and new FDA data on paragraph IV certifications.
Drug Review Legislation Generic Drugs

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – May 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.
International Europe Australia

NEW from CMIC: Tailoring Bioanalytical Testing In A New Era Of Drug Development

With unrelenting pressure to enhance the speed, efficiency and cost-effectiveness of drug discovery and development, companies need to be confident their Bioanalytical testing is not only tailored to these translational goals, but delivers added value in an environment in which scientific innovation, commercial imperatives and unmet patient needs are rapidly transforming the drug-development paradigm.

Read the Whitepaper

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

Set Alert for Policy & Regulation

Call For National Pharmacare Program In Canada Grows Louder

An advisory council established by the Canadian federal government is recommending the country implement a universal, single payer public pharmacare program.

Canada Market Access Reimbursement

Latest From Regulation

US FDA Begins Building Pharma Industry Activity Prediction Tool

Algorithms are intended to help predict incoming workload, which will be used to help set user fees.

FDA Review Pathway

Australian Regulator: Don't Let New Ingredient Name Deadline Sneak Up On You

The Therapeutic Goods Administration is urging companies to update their medicine labels and documentation with new ingredient names.

Regulation Australia

Global Inspection Scheme Increases Burden On Pre-Accession Applicants

Changes have been proposed to help ensure that national competent authorities interested in joining the Pharmaceutical Inspection Co-operation Scheme do not end up submitting 'premature' membership applications.
International Manufacturing

Latest From Policy

ICER Faces New Foe As Patient, Disability Alliance Takes Aims At Reports On Mayzent, Spravato

Groups oppose use of quality-adjusted life year metric, noting ICER’s work is becoming more influential among payers. However, patient advocates do not suggest a uniform methodological alternative.

Reimbursement Pricing Debate

Congress’ Next Steps On REMS Abuses: Will Improving FDA-FTC Communication Help?

US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.

Generic Drugs Legal Issues

How Should Medicaid Pay For Cures? Sen. Grassley Likes Annuity Model

Finance Committee chairman wants a provision allowing Medicaid to make installment payments for high-cost curative treatments in drug pricing legislation. But Democrats worry such a model might encourage high prices.

Reimbursement Pricing Strategies

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

US FDA Gives RMAT Boost To AlloVir As Viralym-M Phase III Planning Continues

Multi-virus specific T-cell brings the number of known RMAT awards to 29, as detailed in our updated RMAT tracker table. AlloVir's product aims to restore natural T-cell immunity in immunocompromised patients.
Review Pathway Clinical Trials

Blueprint Medicines Aims For Genomically Defined GIST Indication With Avapritinib NDA

Kinome-focused Blueprint Medicines plans to follow up its first NDA, for all lines of therapy in patients with exon 18 mutant GIST or fourth-line use in non-genomically selected patients, with submissions for third-line GIST and advanced systemic mastocytosis in 2020.

Clinical Trials Research & Development

US FDA's New Paragraph IV Data Further Illustrates Generic Competition Problems

Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.

Generic Drugs Legal Issues

Commercial Explore this Topic

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Latest From Commercial

BIO 2019 Notebook: Lartruvo Lookback, M&A Soars, BIO Vs. ASCO

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Drug Review Review Pathway

A New Drug Price Milestone

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

Pricing Debate Rare Diseases

BIO 2019 Notebook: Merck; RMAT; Out-Licensing Deals

News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.

Regenerative Medicine Financing

Manufacturing Explore this Topic

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Latest From Manufacturing

Global Inspection Scheme Increases Burden On Pre-Accession Applicants

Changes have been proposed to help ensure that national competent authorities interested in joining the Pharmaceutical Inspection Co-operation Scheme do not end up submitting 'premature' membership applications.
International Manufacturing

Pharmacy Urges US FDA To Disallow Levels Of DMF Solvent It Found In Valsartan

The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.


Manufacturing Quality

‘Impossible' To Prepare UK Supply Chain For October No-Deal Brexit

The UK parliament's Exiting the EU Committee has heard strong words from industry representatives who say that the sector will not be ready for a no-deal Brexit in in October and that such a scenario would result in stockpiling problems, drug shortages and safety issues.  
Brexit United Kingdom