All articles by Vidya Sagar Maddela
Vidya Sagar Maddela
Gilead partners with six generic drugmakers to boost access to lenacapavir
The six companies will manufacture and supply high-quality, low-cost versions of Lenacapavir for the treatment of HIV in heavily treatment-experienced adults with multi-drug resistant HIV in 120 low- and lower-middle-income countries
Enhertu granted FDA Priority Review in treating advanced breast cancer
The FDA Priority Review for Enhertu is based on the Phase 3 DESTINY-Breast06 clinical trial which showed a statistically significant and clinically meaningful progression-free survival (PFS) benefit for Enhertu
Fresenius Kabi, Formycon secure FDA approval for Stelara biosimilar Otulfi
Otulfi is approved to treat the same conditions as Stelara, including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, in both subcutaneous and intravenous formulations
Aktis Oncology announces $175m financing to advance radiopharmaceutical pipeline
Proceeds to further advance the company’s differentiated radiopharmaceuticals pipeline, including its first-in-class Nectin-4-targeted miniprotein radioconjugate
BlueRock’s cell therapy bemdaneprocel shows positive results in PD study
Data from the Phase 1 exPDite trial showed positive results for bemdaneprocel, a clinically advanced investigational cell therapy intended for treating individuals living with Parkinson’s disease (PD)
Regeneron, Sanofi’s Dupixent approved to treat COPD in US, China
The US FDA approved Dupixent for adults with inadequately controlled COPD and an eosinophilic phenotype, and China’s NMPA as an add-on maintenance treatment for adults with uncontrolled COPD with raised blood eosinophils
AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
Bristol Myers Squibb gets FDA nod for Cobenfy to treat schizophrenia in adults
Cobenfy is the first new pharmacological approach to treat schizophrenia in decades, with a distinct mechanism of action, and is approved based on positive data from the EMERGENT clinical programme
Evotec partners with Novo Nordisk to develop stem cell-based therapies
Novo Nordisk will provide funding for technology development activities at Evotec’s facilities in Germany and Italy, to support the clinical development and commercial manufacturing of stem cell-based therapies
Pharming announces marketing authorization in the U.K. for Joenja® (leniolisib)
Pharming gets UK marketing authorisation for Joenja. (Credit: Ranys Tuunainen from Pixabay)