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Policy & Regulation

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Biosimilars In 2017: Crowded US FDA Review Queue, Key Legal Decisions

At least five biosimilars could gain US licensure in the coming year on first-cycle review, including subsequent competitors to Remicade and Humira; however, patent litigation is expected to increase and will continue to slow the march of products from FDA approval to commercialization.

Biosimilars Regulation Legal Issues

Carrots and Stick: Biopharma At The White House

Drug industry executives discuss drug pricing and tax and regulatory reform in a high-profile meeting with President Trump at the White House.

Pricing Debate US Election 2016 Medicare
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Regulation

Set Alert for Regulation

Latest From Regulation

User Fee Bill Could Become Ensnared In US Abortion Politics

Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would be 'problematic,' to say the least, for Democrats.

FDA Legislation

Mylan’s Generic Advair Delay Gives Leverage To Rivals

Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.

Generic Drugs Drug Approval Standards

Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.

Approvals Biologics

Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee

Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.

Advisory Committees Drug Review

India’s E-Plan To Map Drug Sales – Turning Point For Better Traceability?

A government plan aimed at putting in place an e-platform to regulate the sale of medicines in India, is expected to bolster end-to-end traceability and help lower the risk of fake drugs in the supply chain. But the platform’s proposed revenue model appears to be a sticking point, at least for now, among other tricky areas.

Policy & Regulation Regulation

EMA Expanding Use Of Early Background Summaries To Support Initial Drug Evaluations

The European Medicines Agency is expanding an initiative in which its product team summarizes critical background information about new drugs to help the agency’s scientific committees assess initial marketing authorization application.

Regulation Europe
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Policy

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Latest From Policy

Cost Sharing Fight: PhRMA Says Insurance Design Is Real Pricing Culprit

New report finds increase in use of deductibles and coinsurance charging members list prices.

Policy Pricing Debate

Pfizer Ex-Marketing Director Agrees To Injunction, Ending Trade Secret Suit

Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.

BioPharmaceutical Policy

Antibiotic Incentives: Pfizer’s Read Touts Exclusivity Voucher

Providing a transferable period of patent-life extension in exchange for US FDA approval of a new antibiotic would incentivize ‘the whole ecosystem’ to find new treatments for emerging diseases, CEO Ian Read says.

Policy Pricing Debate

New Korea Fund To Nurture Early Stage Biotech Start-Ups

South Korea is broadening its state support for the biotech industry, which it sees as a new growth engine, this time by focusing on early stage biotech start-ups, amid industry views that such support and investment in the country has so far been lacking.

South Korea Policy

US Healthcare Bill's Failure Could Have Unpleasant Ripple Effects For Pharma

Having sat on the sidelines during the unsuccessful effort to repeal and replace Obamacare, the pharma industry may find the rest of its legislative agenda, from taxes to even user fee reauthorization, could become more difficult.

US Election 2016 Legislation

Biopharma Asks US Supreme Court Not To Limit Patent Litigation Venue

Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.

Legal Issues Intellectual Property
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