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NEWS

Abbvie
AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus
Shots: The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis Label expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks. Trial…
June 12, 2025
Deep Apple Therapeutics Enters a Research Collaboration and Licensing Deal with Novo Nordisk to Advance Oral Small Molecules
Shots: Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…
June 12, 2025
Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B
Shots: Philochem and RayzeBio (BMS) entered into a development and commercialization agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize its radiopharmaceutical agent OncoACP3 for prostate cancer  Under the agreement, Philochem will receive $350M up front and is eligible for up to $1B in development, regulatory, and commercial milestones, plus…
June 11, 2025
Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM
Shots: The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026 Preclinical studies showed that NVC-001 significantly improved survival and cardiac function. They planned a P-I/II trial, a 52-week, open-label, multicenter ascending-dose study to assess the safety, tolerability, and…
June 11, 2025
OS Therapies & EVERSANA Partner to Commercialize OST-HER2 in the US for Pediatric Osteosarcoma
Shots: OS Therapies joined hands with EVERSANA to commercialize OST-HER2 in the US for the treatment of pediatric lung metastatic osteosarcoma This partnership leverages EVERSANA’s integrated commercialization platform, including market access, medical affairs, field deployment, patient services, and stakeholder engagement enabling OS Therapies to bring OST-HER2 to market rapidly and cost-effectively OS Therapies recently secured…
June 11, 2025
ImmVira Reports First Patient Dosing in P-II Study Evaluating MVR-T3011 in Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients
Shots: ImmVira dosed the first pt with NMIBC in a P-II study evaluating MVR-T3011. Based on approval discussion with the US FDA the company aims to confirm the recommended P-II dose (RP2D) of intravesical administered MVR-T3011 and assess its anti-tumor efficacy in BCG-unresponsive NMIBC pts MVR-T3011 preliminary data presented at ESMO’24 showed a high CRR…
June 11, 2025
Jazz Pharmaceuticals
Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC
Shots: The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025) The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…
June 11, 2025
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