3+ day, 4+ hour ago   (417+ words) Patients with a rare autoimmune disease known as MOGAD could be just a few months away from having the first approved treatment. The FDA has just started a priority review of Roche's anti-IL-6 inhibitor Enspryng (satralizumab) for MOGAD – myelin oligodendrocyte…...

3+ day, 5+ hour ago   (562+ words) Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option. Hyrnuo (sevabertinib) has been cleared for earlier use…...

3+ day, 7+ hour ago   (403+ words) Pharmaceutical firms are making an expensive mistake. They develop a drug, see it through clinical trials, and only then pause to ask whether it will secure reimbursement. But by then, capital has already been committed, and the drug has already…...

4+ day, 4+ hour ago   (616+ words) The FDA has started a priority review of AstraZeneca's IL-33-targeting antibody tozorakimab for chronic obstructive pulmonary disease (COPD), setting up a decision on the would-be blockbuster in the first quarter of 2027. It's an indicator of AZ's excitement about tozorakimab that…...

4+ day, 7+ hour ago   (441+ words) Every few years, drug development goes through a moment where a new technology promises to change everything. Artificial intelligence is having that moment now. Unlike some previous waves of hype, this one is grounded in something real, but only if…...

5+ day, 3+ hour ago   (563+ words) Aerial view of Sandoz' drug substance facility in Lendava, Slovenia, part of a $1bn European hub for biosimilar development and production. Sandoz has told investors that it intends to double its net sales between 2025 and 2035, and sees a pivot towards biosimilars…...

5+ day, 2+ hour ago   (552+ words) Swiss biotech Pharvaris has reported positive data from a phase 3 trial of its drug for hereditary angioedema (HAE), setting up marketing applications next year. The drug – an extended-release formulation of bradykinin B2 receptor antagonist deucrictibant – achieved an 83% reduction compared to placebo…...

5+ day, 5+ hour ago   (809+ words) Drug development is an inherently risky endeavour, with the average probability of approval for a drug entering Phase I studies now sitting at just 6.7%. While much of this can be attributed to lack of efficacy, factors such as poor clinical…...

5+ day, 6+ hour ago   (592+ words) ABPI chief executive Richard Torbett. The UK is starting to benefit from a "real partnership" between the pharma industry and government that is reversing years of diminishing investment, but more must be done to secure the gains. That's the conclusion…...

6+ day, 2+ hour ago   (508+ words) London-based Claret Capital Partners has closed its fourth European Growth Capital Fund, raising €575 million ($668 million), which will be used to "back Europe's boldest innovators." The new fund – which has overshot its expected tally of €500 million – is earmarked for companies operating…...