Tagged with IRA

Italy Banking on three key therapeutic areas, including a newly established rare disease franchise, the Italian midcap Chiesi has pursued a sweeping transformation in recent years. In its reboot efforts, the company has not only made significant R&D investments, but pursued key M&A and partnership deals, and aimed for global expansion.…

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…

USA The US pharmaceutical industry is scrambling to align with President Donald Trump’s policy agenda, but may not get all it wishes for…   In its first few weeks in power, the emboldened second Trump administration has enacted a scattergun set of executive orders, covering everything from swingeing cuts to the…

China Deng Haoqing, President and General Manager of Chiesi China, explores the company’s strategic growth in one of the world’s most dynamic healthcare markets. Deng discusses the alignment of Chiesi’s “AIR, CARE, and RARE” focus with China’s evolving healthcare priorities, highlighting efforts to bring innovation through local and global collaborations, including…

Spain A roundup of some of the top stories coming out of Spain’s life sciences sector, including Brookfield’s ongoing interest in Grifols; Rovi’s change of heart about selling its CDMO business; Reig Jofre’s partnership with startup DyCare for an AI-powered digital rehabilitation platform; Almirall’s European filing for its triazole antifungal compound;…

Hong Kong With its dual business approach – commercializing acquired products while developing a novel respiratory disease pipeline – Nuance Pharma, after closing Series D funding and establishing a solid revenue stream, has set its sights on Asia Pacific. Founder and CEO Mark Lotter, discusses the regulatory and talent acquisition challenges in…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority responsible for drugs, biologicals, and medical devices in Iraq is the Ministry of Health “MoH”. There is a dedicated body within the MoH known as the Iraq Drug Regulatory Authority…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? In Iraq, it is not always explicitly required that the clinical trials be conducted locally for marketing approval. However, if local data are requested, companies must comply with these requirements. Local clinical…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? In Iraq, the authorization process for marketing new drugs, biologics, medical devices, over-the-counter “OTC” medications, and other medicinal products is managed by Iraq Drug Regulatory Authority “IDRA” at Ministry…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices in Iraq are subjected to the regulations of Iraq Drug Regulatory Authority “IDRA” under the Ministry of Health “MoH”. Manufacturers or importers of these products must ensure…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Iraq recognizes several types of liability, including: Product Liability: Relating to harm caused by defective products. Tort Liability: Involving personal injury or property damage due to negligence or other wrongful acts. Contractual Liability: Stemming from breach of contract or warranty.…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Patent: To obtain a patent, the invention must be new (novel), involve an inventive step (non-obvious), and be capable of industrial application. In Iraq, the invention must be disclosed in a clear and complete manner. Trademark: To obtain…