Tagged with R

Pharma Legal Handbook Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are clinical trials required to be conducted locally…

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What is the authorization process for the marketing of new drugs,…

Pharma Legal Handbook The ins and outs of traditional medicines and OTC products in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or…

Pharma Legal Handbook  The low-down on the situation regarding product liability in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What types of liability are recognized in your jurisdiction? The…

Pharma Legal Handbook All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the basic requirements to obtain patent and trademark…

Pharma Legal Handbook The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Italy, the…

Australia A roundup of some of the latest news from Australian pharma, including CSL’s unification of business units, a workers strike at Pfizer’s manufacturing plant, a new USD 173 million research centre, and a billionaire’s bet on biotech.   New $173M research centre for pandemic drug discovery (Endpoints News) In the…

Global AstraZeneca’s CEO Pascal Soriot warns that the new US legislation controlling drug prices would reduce innovators’ capacity to recover drug development investments and therefore discourage innovation, especially for drugs with smaller patient pools. In a Reuters interview last week Soriot said the law recently passed in the United States that would…

Middle East & Africa Samir Khalil, executive director for the Pharmaceutical Research and Manufacturers of America (PhRMA) Middle East and Africa, touts the USD 1.1 trillion that its member companies have invested in R&D since 2000 and analyses the opportunities in Egypt as the country moves closer to implementing universal healthcare. In addition, he…

Indonesia Takeda gets a first approval for QDENGA, its dengue vaccine, which has been given the green light by the Indonesian National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), making it the only dengue vaccine approved in the country for use in individuals aged 6 to…

Global After the prolonged underperformance of its generics division, Sandoz, Novartis has announced a spin off that will allow the company to focus on its core business and which is part of a broader paring down strategy. For Novartis, the separation of Sandoz would further support our strategy of building a…