Tagged with pharma

APAC This week’s Asia healthcare and pharma roundup from PharmaBoardroom content partner Selesta covers China’s USD 36.2bn in outbound licensing agreements, Henlius & EssexBio meeting Phase III endpoints, Organon acquiring US rights of tocilizumab biosimilar from Biogen, GE Healthcare’s acquisition of Japan’s Nihon Medi-Physics, Wuxi Biologics’ disposal of vaccine facility to…

Italy A roundup of some of the biggest pharma and healthcare stories coming out of Italy, including the country’s ever-falling birth rate; Chiesi’s new manufacturing investment; Doc Generici’s rebrand to DOC Pharma; Menarini’s oncology partnership with Insilico Medicine, and Angelini’s brain health deal with Cureverse.   Italian drug maker Recordati boosts…

APAC This week’s Asia healthcare and pharma roundup from PharmaBoardroom content partner Selesta covers the AACR 2025 ADC pipeline list from China, Puhe out-licensing global rights of a PRMT5 inhibitor to Bayer, AbbVie accusing Genmab of ADC trade secret theft on ADC technology used by ProfoundBio, and Singapore’s A*STAR investing in…

Spain A roundup of the biggest pharma news from Spain, including Grifols’ comeback after a turbulent 2024 when the company lost 30 percent of its market value; Almirall’s revenue and value surge; Rovi’s contract manufacturing downturn, and Lilly’s USD 50 million Madrid plant expansion.   Grifols expects to boost revenue and…

Saudi Arabia Cooper Pharma, with its 90-year legacy, is at the forefront of transforming the pharmaceutical landscape in the Middle East. From localizing production in Saudi Arabia to pioneering collaborations with global institutions, the company is driving innovation in a rapidly evolving market. As Saudi Arabia’s Vision 2030 reshapes the future of…

Denmark Zealand Pharma’s transformational journey from a niche biotech to a commercial-stage player in the booming global obesity market has reached another major milestone. As part of a USD 5.3 billion partnership with pharma giant Roche, Zealand will receive a USD 1.65 billion upfront payment, with Roche set to deliver Zealand’s…

Global As healthcare systems grapple with rising costs and the need for broader access to treatment, off-patent medicines have taken on increasing importance. With budgets under pressure and blockbuster drugs losing exclusivity, the generics market is on track to reach USD 600 billion by 2033, with these five players leading the…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and the National Health Insurance House (http://www.cnas.ro/).   2. What is…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.  …

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case. Additionally, the competent authorities in various fields can apply fines and other sanctions when the breach is related…