Shots:
Servier has entered into a definitive agreement to acquire Day One Biopharmaceuticals
As per the deal, Servier will acquire Day One for $21.5/share in cash, representing the total equity value of ~$2.5B, with remaining shares acquired later via a second-step merger; closing expected in Q2’26
Acquisition will strengthen Servier’s leadership in pediatric low-grade glioma…
Shots:
Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI
As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…
Shots:
The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states
Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…
Shots:
Servier has entered into a definitive agreement with Kaerus Bioscience to acquire KER-0193, a potential treatment for Fragile X syndrome (FXS)
As per the deal, Kaerus will receive a total of ~$450M incl. an upfront payment as well as development & commercial milestones
KER-0193 is a BK channel modulator, which showed improvement across syndrome-relevant…
Shots:
IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights
IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
Shots:
The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states
The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…
Shots:
The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery
Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…
Shots:
In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile
While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma
With a fast-track designation and breakthrough therapy…
Shots:
The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023
In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…
Shots:
The EMA approved 3 New Chemical Entity (NCE) and 7 Biologic Drugs in May 2023, leading to treatments for patients and advances in the healthcare industry
In May 2023, the major highlights drugs were Breyanzi’s Approval for relapsed or refractory large B-cell lymphoma, Ultomiris (ravulizumab) for neuromyelitis optica spectrum disorder
PharmaShots has compiled a…

