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US FDA’s Slow Start To Approvals In 2019: Don’t Panic

US FDA approved just six new molecular entities in the first quarter of 2019, which seems like quite a letdown after a record-setting year in 2018. But don’t despair: the pattern of NME approvals was back-loaded a year ago – and should be again this year.

Approvals FDA Regulation

HHS Rebate Reform: An Air Of Inevitability In Stakeholder Comments

Manufacturers, pharmacy benefit managers and insurers weigh in on the Trump administration’s most significant drug pricing action to date – the HHS Office of Inspector General's proposed rule aimed at eliminating rebates.

Regulation Reimbursement Pricing Debate

Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates

US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.
Review Pathway FDA Regulation

Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs

Amgen might have to conduct a randomized CV outcomes trial for Evenity if it's possible; a Pink Sheet analysis reveals that feasibility has been a factor in the US FDA's postmarketing requirements and commitments for other osteoporosis drugs as well. 
Post Market Regulation & Studies Orthopedics Drug Safety

Life After FDA: Rachel Sherman To Tackle Real World Evidence, Clinical Trial Efficiency

Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.

FDA Appointments Clinical Trials

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – March 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

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

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Amyloidosis Drug PROs Supported Clinical Meaningfulness Of Objective Measures

In pivotal trials for Alnylam’s Onpattro and Ionis’ Tegsedi, statistically persuasive results on a patient-reported, quality-of-life measure were needed to show the drugs had a meaningful benefit on how hATTR patients with polyneuropathy feel and function, US FDA said.

Drug Review Profile Approvals Rare Diseases

Latest From Regulation

US FDA's Submission And Review Estimates For 2020

US FDA's FY 2020 budget request include estimates of new, generic and OTC drug reviews and approvals, although some estimates may not represent the agency's expectations.
Review Pathway FDA

Keeping Track: Approval Of First Intranasal Naloxone Copycat Highlights Otherwise Generic Week

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

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Latest From Policy

US PTO's Patent Eligibility Guidance Draws Industry Plaudits, Request For More Specifics

BIO, PhRMA, Novartis, Amgen, and Genentech suggest revisions to guidance on hot-button issue of subject matter patent eligiblity; patent owners group says 'best approach' is to enact legislation to restore patent eligibility law.

Intellectual Property Legal Issues

NICE Says Yes To Akcea’s Tegsedi After ‘Improved’ Commercial Offer

NICE has given the green light to Akcea Therapeutics’ ultra-rare disease treatment Tegsedi (inotersen) after the company offered a better “commercial arrangement.”

Europe United Kingdom

The PBM Business Model, As Told To Sen. Cornyn

Execs offer (mostly) consistent responses as congressmen come out of the woodwork to grill the PBMs on their business practices.
Pharmacy Benefit Management Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

Baby Steps To Real-World Evidence Of Efficacy: External Controls Gain Popularity In Rare Disease Trials

The Pink Sheet takes a closer look at recent clinical announcements showing how rare disease therapy sponsors are already increasingly reliant on natural history studies to guide drug development.

Drug Approval Standards Rare Diseases

Myeloma CAR T-Therapy Among New EMA PRIME Winners

Janssen, Krystal Biotech and Takeda are the latest companies to win a place on the European Medicines Agency’s popular priority medicines scheme for getting drugs for unmet medical needs through the review process faster.

Research & Development Review Pathway

Patient Engagement In Clinical Trials Needs More FDA Guidance, Stakeholders Say

Industry urges US FDA guidance on developing plain language summaries, which could help improve the release of clinical trial results to patients. 
Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

US FDA Squashes Sprout's Attempt To Remove Boxed Warning From Addyi Label

In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.

Drug Safety Post Market Regulation & Studies

Rebate Reshuffle: Could Pharma Foot The Bill To Offset Higher Premiums?

Bernstein Research analysts said CMS could charge pharmaceutical manufactures a fee to offset increases in insurance premiums anticipated from the elimination of rebates in a "win-win" move.

Pricing Debate Reimbursement

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

Survey Finds Growing Interest In Continuous Manufacturing Of New Drugs

A recent survey shows that pharmaceutical manufacturers are increasingly interested in adopting continuous manufacturing. Most respondents say they plan to use this mode of manufacturing for their new drugs.

Manufacturing Quality

ICH To Partner For Training Of Regulators, Industry On Key Guidelines

The organization that works to harmonize drug review requirements across a growing number of regulatory authorities aims to partner with non-profit groups to train regulatory authorities and industry on its guidelines, starting with guidelines on stability testing, good clinical practice and good manufacturing practices for active pharmaceutical ingredients.

Manufacturing Quality

Pharmakon CEO Convicted Over Life-Threatening Potency Failures

Jury convicts Pharmakon CEO of conspiracy to defraud the FDA and nine counts of adulterating drugs. The firm allegedly ignored and tried to cover up dangerously out-of-specification potency testing results for morphine and other compounded drugs. In one case, providers resorted to naloxone to rescue an overdosed infant.

Manufacturing Quality