Peru

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Gedeon Richter and Mithra have expanded their partnership on an in-development contraceptive, Estelle, to cover several Latin American territories on top of Europe and Russia.

Global free trade agreements are having a detrimental effect on savings that can be achieved by using generics and biosimilars across healthcare systems worldwide, according to a new IQVIA report hosted by the IGBA.

A recent survey commissioned by the Latin American Alliance for Responsible Nutrition (ALANUR) shows almost half of urbanites in Chile and Peru used dietary supplements in the last three months.

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

"Patient advocacy groups should be in the business of advocating for patients, not advocating for specific drugs or development programs," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), insisted last week at the Biotechnology Industry Organization's 2015 Patient and Health Advocacy Summit in Washington.

Some form of consensus among the 12 countries taking part in the Trans-Pacific Partnership free trade talks may have been reached on the highly charged issue of biologics' exclusivity, but there is still a lack of transparency on the details while the basic deal seems to be satisfying no one outside the closed circle of negotiators.

Teva Pharmaceutical Industries Ltd seems to have outbid a number of rivals to win Mexican drugmaker Rimsa for $2.3bn cash, a move which will bolster the Israeli generics giant's presence in Latin America and position it for further acquisitions in that fast growing region.

Abbott has sold part of its branded generics business to Mylan in exchange for a stake in the company. However, Abbott has retained the emerging markets portion of the business from which it anticipates major growth.

Abbott Laboratories has agreed to acquire the Chilean branded generics company CFR Pharmaceuticals for around $2.9bn. CFR's share price shot up 46% to CLP181.50 ($0.33) on the Santiago stock exchange in reaction to the news, which comes three months after CFR's own $1.3bn bid to buy the South African firm Adcock Ingram fell through in the face of local and shareholder opposition.

Each country in South America brings its own unique challenges to those wanting to place clinical trials there. Here, in-country experts share their knowledge of how to get going, and making it a success.

Fearing the spread of fake and low-quality drugs, China's State Food and Drug Administration has issued a new regulation which came into immediate effect at the end of July that targets domestic contract drug manufacturers receiving orders from foreign buyers.

Pozen has filed a motion in a federal court to prevent generics maker Par Pharmaceutical from launching a generic version of its migraine combination treatment, Treximet (sumatriptan and naproxen sodium), in the US marketplace. Treximet is marketed in the US by GlaxoSmithKline.

The humanitarian body Médecins Sans Frontières (MSF) staged a protest outside the EU-India summit held at the European Commission HQ in Brussels involving about 100 demonstrators, on 10 December against the proposed EU-India free trade agreement fearing it will hinder access to affordable generic medicines in both India and in developing countries.The summit also saw media speculation that India may bilaterally resolve the EU generics seizure issue, while agency UNAIDS called on countries to ensure trade agreements do not affect access to HIV drugs

The UK firm Masters has signed an exclusive deal with Brazil's state-owned Pharmaceutical Laboratory of Pernambuco (Lafepe) for the global distribution of benznidazole for the treatment of Chagas disease.

It looks as though the European Commission could be willing to make more concessions on intellectual property (IP) rights in its negotiations with the Community of Andean Nations (CAN) members still participating in free trade agreement talks.

Growing use of intellectual property protection following the Central American Free Trade Agreement (CAFTA) is risking access to lower-cost drugs in Guatemala, claims a new study.

Canada and Panama concluded a free trade agreement last week, shortly after a similar deal between Canada and Peru came in to force.

The European Commission may be relaxing its stance on intellectual property rights in its free trade negotiations with the Andean Community of Nations. It is no longer insisting that the Andean countries introduce supplementary patent protection certificates.

Ecuador may be stepping back from the EU-Community of Andean Nations (CAN) free trade agreement negotiations. The country's new constitution seems to be at odds with the European Commission's proposals on intellectual property.