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Romosozumab Among Latest Drugs Up For CHMP Opinion

Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.
Europe Approvals Drug Review

Pediatric Cancer: US FDA Will Take ‘Rational’ Approach To Requiring Combination Studies

Agency urged to prioritize studies based on strength of preclinical and adult data, and good mechanistic understanding of how multiple therapies are expected to work together; new pediatric study requirements for molecularly targeted agents take effect in August 2020.

Pediatrics Clinical Trials Rare Diseases

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

Russia Puts The Squeeze On Essential Drug Prices

Pharmaceutical companies operating in Russia will need to re-register the prices of their medicines in 2019-20, according to a new law passed this month.

Russian Federation Europe Pricing Strategies

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Our take on the US FDA's new draft guidance on risk/benefit analysis of opioids, a new version of Senate drug pricing legislation and new FDA data on paragraph IV certifications.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
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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
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Do Consumers Understand TV Ads For Oncology Drugs?

US FDA plans to conduct a study to evaluate consumer comprehension of oncology indications in direct-to-consumer television advertising.

Advertising, Marketing & Sales Regulation BioPharmaceutical

Latest From Regulation

Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says

Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.

Post Market Regulation & Studies Clinical Trials

Setback For Glenmark As FDA Hands Out CRL For Ryaltris

India's Glenmark gets US Complete Response Letter for Ryaltris but emphasizes the FDA hasn’t faulted the clinical data for the product, and that the action won’t impact recent alliances for the rhinitis asset.

 

India Regulation

For All The Palace Intrigue, Rebate Rule, IPI Go To OMB For Review

For all the rumors of political infighting, the two cornerstones of the Trump administration’s blueprint on drug pricing are in the final phase for review.

Pricing Debate Medicare

Latest From Policy

How To Pay For AMR Drugs: Pull, Not Just Push

Encouraging companies to develop new antimicrobials requires a new way of thinking about value assessment. A UK five-year AMR plan takes this into consideration.

Europe United Kingdom

Data Aggregation Standards Should Be Based On HIPAA, CRO Association Chief Argues

Efforts by US states such as California to create their own deidentification standards could be very disruptive, ACRO's Doug Peddicord tells DIA annual meeting.

Legal Issues Research and Development Strategies

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

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says

Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.

Post Market Regulation & Studies Clinical Trials

Data Aggregation Standards Should Be Based On HIPAA, CRO Association Chief Argues

Efforts by US states such as California to create their own deidentification standards could be very disruptive, ACRO's Doug Peddicord tells DIA annual meeting.

Legal Issues Research and Development Strategies

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

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

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

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
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