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Trump's Medicaid Funding Change Could Alter Drug Access, Rebates

Budget proposal to fund state Medicaid programs through per capita cap or block grant would save $610bn over 10 years, administration says; budget calls for clarifying treatment of value-based pricing and fostering exchange of pre-approval information between manufacturers and payers.

Pricing Debate Medicaid Medicare

Biomarker-Led Claim Is Small Step For Merck's Keytruda, Giant Leap For Cancer Indications

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US FDA has granted an indication that does not specify the location of the tumor – a change precision medicine researchers have been eager to make.

Approvals Personalized Medicine Cancer

New EudraVigilance System To Usher In Simplified Reporting of ADRs From Nov. 22

The European Medicines Agency is asking drug companies and EU national competent authorities to prepare for the late November launch of the new EU pharmacovigilance database, which will have enhanced functionalities for reporting and analysing suspected adverse reactions.

Regulation Safety Europe

FDA Safety Initiatives Could Suffer Under Trump's Budget Proposal

User fee-heavy budget proposes appears to tie into Trump's broader deregulatory strategy; CDER and CBER would have to make cuts to non-user fee safety initiatives.

FDA Legislation Regulation
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Policy & Regulation Explore this Topic

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Opioid Policy At US FDA To Become 'More Forceful,' Gottlieb Says

Whether to require physician education, when to limit the doses prescribed to patients, and how to weigh societal abuse potential in approvals are the initial questions for the Opioid Policy Steering Committee.

FDA Neurology Drug Safety

Latest From Regulation

FDA Panel Recommends Approval Of Sickle Cell Disease Treatment Despite FDA's Efficacy Concerns

The Oncologic Drugs Advisory Committee voted 10-3 in favor of approving Emmaus' L-, touting its strong safety profile and the unmet clinical need in spite of questions about efficacy.

Advisory Committees Drug Review

Neratinib’s FDA Panel Nod Weighed Down By Indication Breadth Worries

Puma’s tyrosine kinase inhibitor gains approval recommendation from US FDA advisory committee but faces concerns the proposed indication for extended adjuvant treatment in HER2-positve breast cancer is overly broad given unfavorable subgroup results in pivotal trial.

Advisory Committees Drug Review

NEJM Takes Aim At Expensive Accelerated Approval Drugs Amid Congressional Drug Pricing Debate

The authors propose imposing penalties on drugmakers who don't start confirmatory trials shortly after accelerated approval and additional discounts for public payers; the proposals could pick up steam among congressional democrats amid their renewed call for lower drug prices.

Drug Approval Standards Government Payers

Latest From Policy

Indian Insurer Urges Hospitals To Prescribe Generics As ‘No Name’ Campaign Gathers Pace

A major Indian health insurance provider is pushing hospitals to prescribe no-name generic medicines – a move that if adopted industry-wide could potentially lower patient bills, reduce insurance payouts, cut premium rates and help address glaring challenges around healthcare financing in the country.

India Policy

Biopharma Patent Disputes: Upheaval Likely As US Supreme Court Limits Litigation Venue

Decision requiring suits to be filed in state where defendant is incorporated may deter consolidation of ANDA suits and increase venue fights; Court to hear challenge to PTAB inter partes review process.

Intellectual Property BioPharmaceutical

Foreign Pharma Takes Simmering Price Concerns To New Korea Govt

Amid an escalating tussle with the health ministry over the level of South Korean drug prices, foreign pharma firms operating in the country are now proposing the launch of a new joint study on the issue with the incoming government.

South Korea Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.

Research & Development Regulation

RSV Vaccines Need Multiple Animal Models Before Infant Testing, Panel Says

US FDA's advisors want data from three animal models – not just the cotton rats that Janssen was hoping for – before candidate vaccines are tested in healthy infants.

Advisory Committees Vaccines

FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says

Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.

Drug Approval Standards Neurology

Commercial Explore this Topic

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Latest From Commercial

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

Robert Califf Talks Verily, Hopes Gottlieb Can Push Back On Trump

Former US FDA Commissioner is joining the health-technology firm Verily, a Google spin off. In a podcast interview he discusses his new advisory role with the company and expresses his hope that new FDA Commissioner Scott Gottlieb would stand up to any 'whimsical directives' from President Trump.

FDA Legislation

Amgen's Repatha Contract With Harvard Pilgrim Includes A Full Refund

Harvard Pilgrim Chief Medical Officer Michael Sherman said the full warranty behind the agreement is the right kind of deal to balance access and cost.

Reimbursement Pricing Strategies

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Urged To Rethink Warning Letters To Avoid ‘Collateral Damage’

Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance

Compliance Manufacturing

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Manufacturing Regulatory Updates In Brief

FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.

Quality Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Consumer Health Weekly Trademark Review May 16, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

Consumer Trademarks

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer
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