Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Trump’s Drug Pricing Remarks: A Gambit For Industry Self-Restraint?

Comments during recent interview shows president-elect continues to view drug pricing as populist issue, revives speculation he may take action to control prices.

Pricing Debate US Election 2016 Policy

A Candid Behind-The-Scenes Look At PRIME with Novimmune & Biogen

Novimmune and Biogen encountered surprises, challenges and opportunities with PRIME, the European Medicines Agency’s new priority medicines scheme. The two companies have some advice on how to keep pace with expectations under the initiative and make the most of the scheme for taking drugs for unmet medical needs to patients faster.

Review Pathway Drug Review Europe

FDA’s Tough Stance On Patient-Reported Outcomes Underscored At Repros Meeting

US FDA advisory committee's insistence on symptom benefit as an efficacy endpoint for obesity-related secondary hypogonadism highlights importance of Repros' current efforts to lay groundwork for a patient-reported outcomes instrument for further study of enclomiphene.

Regulation Advisory Committees Drug Approval Standards

Global Pharma Guidance Tracker – November 2016

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.

Regulation BioPharmaceutical
Advertisement


FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Sun Hit As US FDA Raises Fresh Concerns Over Key Halol Plant

Indian generic giant Sun Pharma says the US FDA has flagged up new potential violations of good manufacturing practices at the company's key Halol factory, which exports a large number of products to the crucial US market and had been expected to overcome its past compliance problems.

India Manufacturing Compliance

Latest From Regulation

EMA On Safety, Real-World Data & More: Tweeted Takeaways From Adaptive Pathways Workshop

Following the completion of the European Medicines Agency’s pilot project on adaptive pathways in August, stakeholders gathered at the regulator’s workshop in London to explore the next steps for this concept and how it might help get drugs for unmet needs to patients faster. Here are some initial takeaways, tweeted by the Pink Sheet from the event.

Review Pathway Approvals

Chantix's Boxed Warning: Will A Positive Vote Justify A Negative Outcome?

FDA could use advisory committee members' comments to maintain the smoking cessation drug's boxed warning, even though they voted to remove it.

Advisory Committees Clinical Trials

Pfizer's Pitch For Chantix Warning Reduction Focuses On Those With Mental Illness

Those patients need more options for smoking cessation, Pfizer says, but that is the group FDA most worries about when deciding whether to remove its boxed warning.

Advisory Committees Drug Review

Latest From Policy

The Unlikely Savior Of ‘21st Century Cures’ Is Donald Trump

The ‘21st Century Cures’ bill made it through the US Congress in 2016 after all; advocates can thank the unexpected presidential victory of Donald Trump for helping make that happen.

US Election 2016 Legislation

Turkey Works To Expand Non-Rx Drug List

The first meeting between government officials, industry representatives, pharmacists and academics to determine a new list of drugs that can be sold without prescription in Turkey took place in late November. Since almost 99% of drugs in the country are currently sold on prescription, the outcome will strongly shape the future of the market.

Prescription To Otc Switch Turkey

Price Increases Accounted For Over Half Of Drug Spending Growth In 2015

CMS National Health Expenditures report finds continued double-digit growth rates for retail prescription drug spending in Medicare and Medicaid.

Pricing Debate Reimbursement

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Cancer Trials: Broader Eligibility Criteria Could Mean Novel Labeling Claims

Enrolling patients with stable brain metastases, HIV-positive status and other traditionally excluded groups could give sponsors a marketing edge, but trials should be designed to examine drug effects on such populations separately from the more traditional study population, stakeholders said.

Regulation Clinical Trials

Endpoint Selection Could Help Determine The NASH Race

Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.

Clinical Trials Drug Approval Standards

Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin

The latest drug development news and highlights from our FDA Performance Tracker.

Approvals Regulation

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Calif. Prop 61 Raises Industry Concerns Over Ripple Effect

Industry executives are speaking out against the measure that would require California state agencies to pay no more than the US Department of Veterans Affairs pay for drugs.

Commercial Policy

Diabetes Treatment Shift Coming? Cleveland Clinic’s Nissen Declares Victory

A 'complete shift' in diabetes prescribing practices toward cardiovascular protective agents is occurring more slowly than anticipated, but Cleveland Clinic Cardiology chief Steve Nissen is ready to claim success in decade-long effort to shift diabetes drug treatment focus from blood sugar to cardiovascular mortality.

Drug Safety Drug Approval Standards

340B Impact: Roche Starts Educating Investors About Discount

The 340B hospital discount program has a much higher profile in the Rx policy world than it did before the Affordable Care Act was signed into law; now, Roche is starting to highlight the impact of the program to a different audience: its investors.

Pricing Debate Medicare

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Draft ICH Q11 Q&A Guidance Would Clarify Starting Materials Selection

ICH regulatory members have agreed to request comment on draft Q11 Q&A guidance that is meant to clear up ambiguities on starting materials selection that have fueled debate between industry and regulators for years. The guidance also clarifies the difference between custom-manufactured and commercially available chemicals.

Manufacturing Quality Control

FDA’s Revised Quality Metrics Program: Voluntary Now, Mandatory Later

US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.

Manufacturing Quality Control

Final FDA Quality Agreements Guidance Retains Focus On Commercial Manufacturing

Final US FDA guidance on contract manufacturing quality agreements retains draft version’s focus on commercial activities even though industry asked for it to also cover arrangements between manufacturers and contract partners developing investigational drugs.

Quality Control Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Moberg Adds DermoPlast Line With Bondholders' Blessing For More

Moberg says sales of DermoPlast sprays were $12m in the 12 months through September and its purchase price is around 8.9 times the estimated EBITDA for the brand during the period.

Deals Consumer

Turkey Works To Expand Non-Rx Drug List

The first meeting between government officials, industry representatives, pharmacists and academics to determine a new list of drugs that can be sold without prescription in Turkey took place in late November. Since almost 99% of drugs in the country are currently sold on prescription, the outcome will strongly shape the future of the market.

Prescription To Otc Switch Turkey

Consumer Industry Roundup: Catalent Acquires Accucaps; CHPA Adds Lobbyist; Zeasorb Recall

Mylan's Schloss joins CHPA government affairs; Catalent expands softgel capabilities with Accucaps acquisition; GKSk recalls a half million bottles of mislabeled Zeasorb; and more news in brief.

Consumer Drug Safety
UsernamePublicRestriction

Register