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Latest News & Analysis

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

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

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

US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say

High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.

United States Manufacturing

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

Antibiotic Development: Limited Population Pathway In US Removes Barrier

Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the provision does not lower FDA's standards of safety.

Drug Approval Standards Clinical Trials

CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.

Approvals Europe

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
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