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The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma
CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS
The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
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The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states
EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU
Crinetics plans…
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The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26
Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…
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Welcome to the 2025 series of Know Your Investor, featuring top venture capital firms focused on healthcare.
This edition highlights Janus Henderson Group Plc, a global investment firm managing approximately $378.7B in assets across Equities, Fixed Income, Multi-Asset, and Alternatives.
In 2024, the firm invested $5.36B across six funding rounds, adding 39 healthcare and…
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Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025)
Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These…
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The March edition highlights Perceptive Advisors, a New York-based investment firm specializing in public and private investments within the healthcare and life sciences sectors
In 2024, Perceptive Advisors invested approximately $5.81B in 44 companies through six funding rounds, including private and debt financing
For the complete report, reach out to us at connect@pharmashots.com
With…

