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Impact Of Higher Part D Donut Hole Discounts Beginning To Show: Xarelto Sales Down 19%

Performance of Johnson & Johnson’s blockbuster cardiovascular drug is one of the first prominent examples of how the 2019 increase in the discount from 50% to 70% is playing out in the market.

Reimbursement Medicare Pricing Strategies

Merck Scores A First With Keytruda Under Australia's Provisional Pathway

The Therapeutic Goods Administration has provisionally approved new uses of the anticancer medicine based on early clinical data. 
Australia Regulation BioPharmaceutical

New Kisqali Combination Joins Verzenios In England’s Cancer Drugs Fund

Two of the three companies vying for an additional share of England’s CDK4/6 inhibitor market have now secured reimbursement for the use of their products in combination with fulvestrant for advanced breast cancer.
Reimbursement United Kingdom Cancer

PBM Integration: Economists Outline Benefits Of Mergers In Senate Hearing

Recent mergers between PBMs and insurers should address one long-term strategic objective of pharma – the recognition by payors of the value of biopharmaceutical products in relation to other medical costs.

Pharmacy Benefit Management M & A Pricing Debate

US Medicare And Opioids: Inspector General Sees Improvement

HHS is slowly changing its rhetoric on the use of prescription opioids – edging away from crisis to finding positive trends. A new OIG report on opioid use in Medicare Part D emphasizes sustained positive trends in naloxone rescue and medication assisted treatment alternatives to opioid use disorder.

Neurology Medicare Policy
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – June 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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Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data?

Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't contain such data.
Comparative Effectiveness Drug Approval Standards Regulation

Latest From Regulation

US FDA-Funded Heart Failure Study To Focus On Patient-Centric Outcomes

Heart failure drugs do not require favorable effect on survival or hospitalization for approval, US FDA says; correlation between physical function and physiology biomarkers and clinical endpoints to be measured in upcoming clinical trial examining feasibility of capturing patient-centric data.

Clinical Trials FDA

Orphan Drug Makers Would Escape Price Reporting Requirements Under House Bill

Legislation pending in US House Energy and Commerce Committee would exempt drugs treating diseases with less than 200,000 patients from needing to justify price increases.
Rare Diseases Pricing Debate

Views Differ On Australian Proposal To Link Review Of CDx With Drugs

Australian proposal to establish a regulatory framework for companion diagnostics has drawn a mixed response from pharmaceutical, biotech and medtech companies on issues like concurrent evaluation, product classification and unique identification.
Australia Regulation

Latest From Policy

NICE Overcomes UK Reimbursement Doubts Over Forxiga, US FDA Says No To Approval

The health technology appraisal body for England and Wales now says Forxiga can help fill an unmet need for patients with inadequately controlled type 1 diabetes despite optimized insulin therapy. US regulators, meanwhile, have declined to approve the product for use in these patients.
Health Technology Assessment Approvals

A Short Eulogy For The Rebate Rule

The rebate rule is dead, but we should pay tribute to the failed endeavor.

Pricing Debate Medicare

Drug Price Transparency Bills May Be Empty Calories

Price justification legislation is advancing in both chambers of Congress. But CBO scores them as no savings. 
Pricing Debate Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says

Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.

Clinical Trials Research and Development Strategies

An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation

Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.

United States Clinical Trials

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

Commercial Explore this Topic

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Latest From Commercial

Pharma's Big Defeat: US Rebate Proposal Hits The End Of The Road

White House will not move forward with a rebate proposal the drug industry supported as a way to lower patient drug spending.

Regulation Reimbursement

When It Comes To FTC M&A Review, The Times May Be A Changin'

Spark signaled in an SEC filing that its merger with Roche could be delayed into 2020, fueling more speculation that FTC is increasing scrutiny over biopharma mergers.

M & A Pricing Debate

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

Manufacturing Explore this Topic

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Latest From Manufacturing

Final ICH Q12 Post-Approval Changes Guideline Expected In November

A final revision of the ICH Q12 lifecycle management guideline is expected to overcome a conflict with EU variations legislation and offer more clarity on what is, and what is not, an established condition subject to post-approval change reporting requirements.

Manufacturing Quality

US FDA Warning Letter Hits Strides On Data Integrity

Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.

Enforcement Manufacturing

Inspection Data Reveals US/EU Mutual Recognition Agreement's Impact On China and India

The agreement reached in the early days of the Trump administration has been putting China and India drug manufacturing in the crosshairs of the world’s leading pharmaceutical inspectorates.

Enforcement Manufacturing
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