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Featured Stories

Canada: National Pharmacare Or ‘Fill The Gaps’?

A national pharmacare program in Canada could make it harder to access higher cost drugs.

North America Canada Healthcare Systems

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 Regulation

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 Quality

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 Guidance Documents

Insulin Application Reviews Would Continue After March 2020 Under Senate Bill

Bill would change US FDA's approach to handling follow-on applications submitted under Section 505 once products become "deemed" as biologics 23 March 2020, and could amend a provision in the Senate HELP Committee's health care bill, which aligns with FDA policy.

Biosimilars Biologics Legislation

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.

Download Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 BioPharmaceutical

Latest From Regulation

‘UK Waiver’ For SPCs Proposed In Case Of No-Deal Brexit

Draft legislation has been published by the UK’s Intellectual Property Office to ensure that the EU’s supplementary certificate protection manufacturing waiver will continue to function in the case of a no-deal Brexit outcome.

Intellectual Property Brexit

US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound?

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.

Manufacturing Quality

Dsuvia: A Dull US FDA Review Preceded The Controversial Approval

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

Drug Review Profile Neurology

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

Set Alert for Clinical R&D

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

Set Alert for Commercial

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

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

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

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

US And EU Look To Expand Inspection Agreement

Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.

Enforcement Manufacturing

US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound?

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.

Manufacturing Quality