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Business & Regulation

Business & Regulation Small Molecules

Antibiotic Apocalypse: Part I

| Stephanie Vine, Helen Boucher

Antibiotics were once hailed as wonder drugs in the war against infection, but now it looks like bacteria might have the upper hand. How can we turn the tide?

Business & Regulation Business Practice

Tackling Serious Organizational Failure

| Peter Calcott

An FDA Warning Letter can be a real wake up call. How can you address the root of the problem?

Business & Regulation Business Practice

Boosting Access to Medicine

Sitting Down With… Wim Leereveld, founder and CEO of the Access to Medicine Foundation

Business & Regulation Business Practice

Facing up to Neglected Diseases

| Faiz Kermani

The World Health Organization has compiled a list of 17 tropical diseases that deserve higher priority.

Business & Regulation Standards & Regulation

Clinical Compromise for Europe

| Markus Hartmann

After years of intense criticism, the European Parliament has adopted a new regulation for clinical trials that will replace the current EU Clinical Trials Directive by mid-2016.

Business & Regulation Biosimilars

Copycat Drug Drama

| Charlotte Barker

Lilly and Sanofi go head-to-head on a diabetes drug. Meanwhile, Hospira sues the FDA over a new generic approval.

Business & Regulation Standards & Regulation

Controversial Shuffle for EC Pharma Policy

| Charlotte Barker

European Commission (EC) plans to transfer governance of the medicines dossier from health to enterprise has upset public health NGOs.

Business & Regulation Standards & Regulation

FDA’s Most Wanted

| Stephanie Vine

Top food and pharma fugitives are named and shamed.

Business & Regulation Business Practice

The Magazine for Medicine Makers

| Charlotte Barker

If you work in the development or manufacture of drugs and biologics – this is your magazine.

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May Issue of The Medicine Maker