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Biosimilars In EU: From 'New Mess' To Beacon For Safety

Finnish Medicines Agency's Ekman says neither regulators nor industry knew what to do when the biosimilars regulatory framework was first introduced, but there haven't been any differences in adverse events between biosimilars and their reference products.

Biosimilars Drug Safety Drug Review

Chief Scientist At US FDA Is Hinton As Borio Moves To White House

Luciana Borio is detailed to National Security Council; FDA promotes Denise Hinton to acting chief scientist.

FDA Policy Infectious Diseases

New Irish Generics Body Wants “Fundamental” Reform Of Medicines Procurement

Two generic industry associations have merged to form a single body that includes the largest generic companies in Ireland. Medicines For Ireland has marked its creation by saying it plans to push for a reform of Irish medicines procurement policies, particularly in areas such as tackling drug shortages, and has called for action to promote the use of biosimilars.

Generic Drugs Biosimilars Ireland

FDA’s Definition of Statistical Significance: P=.05 – ish

FDA’s approval of Portola’s anticoagulant Bevyxxa is the latest reminder that the conventional standard for statistical significance, p=.05, is not a “pass/fail” standard. Even if the agency itself sometimes acts like it is.

Drug Approval Standards Regulation BioPharmaceutical
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Policy & Regulation Explore this Topic

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FDA Offers To Expedite 'Priority' ANDA Reviews By Previewing Facility Information

An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.

Manufacturing Quality BioPharmaceutical

Latest From Regulation

EMA, FDA Talk Real World Evidence, Mutual Recognition, Generic Drugs

US FDA and European Medicines Agency may expand sharing beyond manufacturing inspections to clinical trials and generic drug applications.

FDA Drug Approval Standards

Are You Ready? EU Launches Test Environment For New EudraVigilance System

The European Medicines Agency has now launched the test environment for its enhanced EudraVigilance system and has published a raft of instructions and guidelines to help drug companies, trial sponsors and regulators get used to the new system before it goes live in November.

Drug Safety Post Market Regulation & Studies

EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November

EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.

Manufacturing Regulation

Latest From Policy

FDA Getting Reg Slashing Directive In Trump Executive Order

Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.

Pricing Debate Generic Drugs

Trump Exec Order On Drug Costs: Seeking To Balance Access, Innovation

Draft version of order signals a focus on insurance benefit design, accelerating drug approvals and de-regulation.

Pricing Debate Market Access

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Clinical Trials Research & Development

Was PD-L1 Test To Blame For Failure Of Bristol's Opdivo In '026 Trial?

NEJM editorial suggests that differences in PD-L1 testing may explain why Bristol's Opdivo failed in first-line lung cancer trial whereas Merck's Keytruda succeeded, but some analysts aren't so sure.

ImmunoOncology Clinical Trials

US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb

Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.

Drug Approval Standards Rare Diseases

Commercial Explore this Topic

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Latest From Commercial

Best Of BIO: Policy & Regulatory Updates From BIO 2017

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

ImmunoOncology Market Access

Prestige Brands Updates PediaCare NDC Information A Year After Sale

The OTC drugs and personal care products company will correct Structured Product Labeling information in the US NDC Directory for PediaCare Children’s Plus Multi-Symptom Cold and Children’s Plus Flu to include one of the products' active ingredient, phenylephrine.

Commercial Regulatory

Value & Pricing Perspectives From ASCO, In Brief

Round-up of commentary on oncology drug value and costs during the American Society for Clinical Oncology annual meeting, including value frameworks, ways to lower drug costs and payer data.

Pricing Debate Health Technology Assessment

Manufacturing Explore this Topic

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Latest From Manufacturing

EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November

EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.

Manufacturing Regulation

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.

Biosimilars Complete Response Letters

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Perrigo Predicts Upturn On OTC Private Label Breadth, Depth And Bandwidth

Perrigo counts on its OTC private label dominance to thwart new store brand entries and give it a leg-up in e-commerce sales, which are growing at 50% year-to-year. Private label is "a distinctly different business than the national brand space," says consumer health executive Jeffrey Needham.

Consumer Prescription To Otc Switch

Oral Contraceptive Switch Advocates Reject User Age As Approval Factor

FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.

Prescription To Otc Switch Consumer

States Ease Access To Oral Contraceptives Despite Rx Requirement

Changes range from allowing pharmacists to prescribe the drugs to requiring insurers to insurers to cover purchases of the products.

Prescription To Otc Switch Consumer
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