NEWS

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

Shots: The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…

March 3, 2025

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025) Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then…

March 3, 2025

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025 Opinion was based on various clinical data, incl. P-I/II (GEM-1)…

March 3, 2025

Magnet Biomedicine Partners with Eli Lilly to Advance Molecular Glue Therapeutics in Oncology

Shots: Magnet Biomedicine & Eli Lilly have entered into a collaboration & license agreement to identify, develop & commercialize molecular glue therapeutics in oncology using Magnet's TrueGlue discovery platform As per the deal, Magnet will get ~$40M in upfront, near-term payments & equity, plus more than $1.25B in milestones across development, regulatory, & commercial…

March 3, 2025

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

March 3, 2025

ALK Reports US FDA Approval of Odactra to Treat Children with House Dust Mite Allergy

Shots: The US FDA has approved Odactra tablet to treat house dust mite (HDM) induced allergic rhinitis, with or without conjunctivitis, in children (5-11yrs.). Regulatory review in Canada is ongoing Approval was based on P-III (MT-12) study assessing Odactra showed significant efficacy & safety in ~1,460 children across North America & EU. Data published…

February 28, 2025

Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

Shots: The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma Patients in the trial have previously received 1-3 prior lines of therapy,…

February 28, 2025

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots: The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…

February 28, 2025

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25 Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper…

February 28, 2025

Teleflex Enters a Definitive Agreement to Acquire BIOTRONIK’s Vascular Intervention Business for ~$797.7M (€760M)

Shots: Teleflex to acquire BIOTRONIK's vascular intervention business for ~$797.7M (€760M) in cash, subject to adjustments. Closing expecting in Q3’25 Acquisition will expand Teleflex’s interventional portfolio with coronary products like Pantera Lux Catheter, PK Papyrus Covered Stent & Orsiro Stent, plus peripheral product like Passeo-18 Lux Catheter, Dynetic-35 Stent, & Pulsar-18 T3 4F Stent,…

February 28, 2025

NEWS

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

Magnet Biomedicine Partners with Eli Lilly to Advance Molecular Glue Therapeutics in Oncology

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

ALK Reports US FDA Approval of Odactra to Treat Children with House Dust Mite Allergy

Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Teleflex Enters a Definitive Agreement to Acquire BIOTRONIK’s Vascular Intervention Business for ~$797.7M (€760M)

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