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Senate Drug Pricing Legislation Clears Committee With Generic Exclusivity “Parking” Provision Unchanged

US Senate health committee advanced the Lower Health Care Costs Act with few pharma-related changes. Bill’s drug pricing provisions include the CREATES Act and a requirement that manufacturers report to HHS on price increases.
Pricing Debate Generic Drugs Legislation

New IMI Funding For EU Research Into ATMPs, Health Outcomes & Drug Info

Projects on T cells and advanced therapy medicinal products for rare diseases, patient reported outcomes in cancer clinical trials, and improvements to patient drug information are among the latest topics to be offered funding under Europe’s Innovative Medicines Initiative.
Europe Research & Development Cancer

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’s Higher Bar For Postmarketing Pregnancy Studies Shown By AMAG’s Vyleesi, Sprout’s Addyi

Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.

Drug Approval Standards Drug Safety United States

US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals

The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
Drug Review FDA Regulation
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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.

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Policy & Regulation Explore this Topic

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USMCA Trade Negotiations: Could US House Dems' Talks Open Door For AAM Changes?

Biologics exclusivity remains a contentious issue as US Trade Representative and House Democrats begin discussions on the trade pact with Mexico and Canada.

 

Trade Biologics Legislation

Latest From Regulation

Lapses In Drug Quality - Marketers Will Also Be Accountable In India

New proposed rules in India require the marketer of a drug to share responsibility for its quality along with the manufacturer.
India 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

Latest From Policy

EU Council Calls For More Action On Developing New Antimicrobials

The Council of the EU has published its conclusions on making the EU a “best practice region” in combatting antimicrobial resistance. While there are plenty of recommendations, little concrete action is proposed.

Europe Netherlands

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

EU Council Calls For More Action On Developing New Antimicrobials

The Council of the EU has published its conclusions on making the EU a “best practice region” in combatting antimicrobial resistance. While there are plenty of recommendations, little concrete action is proposed.

Europe Netherlands

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

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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