31 March 2025 Following the negative results of the COAST Phase III trial announced on 24 March, Australia-based Opthea announced has updated on its clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and accelerated top-line results from its second Phase III trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD.

The Trump administration's moves to reduce government funding for the US Food and Drug Administration (FDA) and other agencies, such as the National Institutes of Health, will impact the biotech sector in several important ways, making it likely that companies will seek to combine with peers or be acquired by large pharma players, according to Andrew Goodman, a partner in the M&A practice at ...

Mar 5, 2025 · Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). Fourth-quarter net sales of $2.7 billion, up by 9% in constant currencies (+7% in $).

Dec 30, 2024 · The life sciences industry experienced volatility in 2024, marked by pipeline growth, biologics breakthroughs, and evolving GLP-1 therapies. Challenges in trials, manufacturing, and commercialization persisted, driving adoption of AI and innovative pricing models as the sector prepares for further innovation in 2025.

Dec 2, 1996 · In the USA, the Food and Drug Administration has approved Merck & Co's Stromectil (ivermectin) for its first non-veterinary use, the chemotherapy of two parasitic infections, strongyloidiasis and onchocerciasis, in humans.

February 27, 2025 The 3rd Bioequivalence Conference, co-hosted by the International Generic and Biosimilar Medicines Association (IGBA) and Medicines for Europe, concluded yesterday in the Netherlands. This landmark event brought together experts from regulatory authorities, industry, and academia to discuss the evolving bioequivalence landscape and its critical role in improving global access ...

Feb 27, 2025 · Berlin, Germany-based radioisotopes specialist Eckert & Ziegler today announced a comprehensive strategic partnership with the USA’s Bicycle Therapeutics, which is pioneering a new and differentiated class of therapeutics based …

Feb 17, 2025 · Germany’s Formycon (ETR: FYB) has decided today to prematurely terminate the Phase III trial (Lotus) for its biosimilar candidate FYB206. Based on an intensive scientific dialogue with the Food and Drug Administration (FDA), the executive board, after careful consideration, has concluded that the continuation of the study is no longer necessary for the development and approval of FYB206 in ...

Feb 27, 2025 · A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage list. The lawsuit, filed in a federal court in Texas, challenges the decision, which means compounders must halt ...

Jan 17, 2025 · Even as the global diabetes war continues to rage, Indian pharmaceutical companies are emerging from the shadows, armed with an arsenal of innovative drugs and therapies. Several homegrown giants are not only tackling the diabetes crisis within the country, but also making waves on the international stage, …