NEWS

BI Collaborates with Re-Vana Therapeutics to Develop Long-Acting Therapeutics for Eye Diseases

Shots: BI & Re-Vana Therapeutics have entered into a strategic collaboration & license agreement to develop extended-release therapies for eye diseases As per the deal, BI will obtain target exclusivity, while Re-Vana will receive over $1B in total potential deal value for the initial 3 targets, incl. upfront, development, regulatory, & commercial milestones, plus royalties…

July 29, 2025

PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Shots: The US FDA has approved Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in adults & pediatric pts (≥1mos.) with sepiapterin-responsive PKU; review is ongoing in Japan & Brazil Approval was based on APHENITY study results & long-term extension data showing durable effects and…

July 29, 2025

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…

July 29, 2025

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Shots: The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.) Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…

July 28, 2025

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…

July 28, 2025

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Shots: The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25 Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

July 28, 2025

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025 Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…

July 28, 2025

GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications

Shots: GSK will obtain an exclusive global license to HRS-9821, an add-on maintenance therapy for COPD, along with exclusive option rights to develop & commercialize ~11 more programs in oncology, respiratory, immunology, & inflammation globally (excl. mainland China, Hong Kong, Macau, & Taiwan for both) Each of the ~11 additional programs will have its own…

July 28, 2025

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…

July 28, 2025

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots: Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI) A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025 StaySure, marketed as Navina Insert in the EU, is…

July 25, 2025

NEWS

BI Collaborates with Re-Vana Therapeutics to Develop Long-Acting Therapeutics for Eye Diseases

PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

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