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Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government

High court is to determine whether the government can dismiss an FCA complaint after initially declining to take it on. In recent years, the government has dismissed numerous qui tam suits against pharma companies in which it did not intervene.

Enforcement Medicaid Reimbursement

Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur

Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.

Drug Approval Standards Review Pathway Cancer

Industry Calls For Canadian Pricing Guideline Consultation To Be Suspended

IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”

North America Canada Market Access

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Keeping Track: Early Thanks Given By ImmunoGen, Provention Bio; More PD-1/L1 Combo Approvals

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – October 2022

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.

Guidance Documents Regulation International

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Latest From Regulation

EMA To Address Problems With CTIS By Key January Deadline

The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.

Clinical Trials Europe

Pharma Firms Must Act On Biodiversity Footprinting To Avoid Business Risks

Biodiversity footprinting may still be a new concept for pharmaceutical companies, but they need to put a clear supply chain strategy in place now, particularly as the COP 15 conference in December is expected to discuss mandatory reporting of biodiversity risks, says Luka Brown.

International Business Strategies

Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard

Current drug classification standard was originally designed for the Medicare Part D program, which does not cover obesity drugs.

Regulation Reimbursement

Stakeholders Gather To Discuss Pandemic Response And Next Steps

As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.

Europe International

US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’

Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.

Clinical Trials Review Pathway

Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019

US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.

FDA Clinical Trials

Latest From Policy

Gilead Wins Breach Of Contract Suit Against CDC But Damages, Patent Dispute Are Unresolved

Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.

Intellectual Property Legal Issues

Lunsumio Provides First Test For Korea's Breakthrough Therapy Program

South Korea's breakthrough therapy system, Global Innovative Products Fast Track, kicks off with Roche’s follicular lymphoma drug becoming the first to test the new system. Meanwhile, a state-run group is linking with pharma firms to rapidly bring in global new drugs.

South Korea Innovation

Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?

Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.

Reimbursement Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019

US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.

FDA Clinical Trials

Lilly CEO: Realistic Expectations Needed For Current Wave of Alzheimer’s Treatments

Successive waves of Alzhiemer’s therapies are going to be needed, David Ricks said as his company awaits Phase III data on donanemab, the last of three late-stage anti-amyloid drugs to report results.

Drug Approval Standards Clinical Trials

US FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials

Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.

Clinical Trials Guidance Documents

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New FDA Fecal Transplant Guidance Should Ease Ferring’s Path To Commercialization

Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.

Guidance Documents Enforcement

Political Trials On All Sides: Lilly CEO Laments Loss Of ‘Chamber of Commerce Republicans’

David Ricks says the challenging political environment is empowering regulators. The Lilly leader also talked Twitter and drug prices, in a STAT Summit interview.

Politics United States

Departing Words: Merck’s Ken Frazier Cautions Against Profit Maximization

Pharma CEOs must balance optimizing access and profitability, former Merck CEO and soon-to-be ex executive chairman of the company said. Frazier says health care industry must come to table and admit the “system ain’t working,” talks about the need to protect democracy, in a sweeping interview at the STAT Summit.

Leadership Pricing Debate

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Latest From Manufacturing

Pakistan Proposes Risk-Based Inspections Approach ‘Capable Of Revealing Weaknesses’

Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.

Pakistan Manufacturing

Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

Gene Therapy Manufacturing

New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.

Innovation Manufacturing
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