Drug Approval | October 15, 2024
Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024
Declan brings over 25 years of expertise in the pharmaceutical and biotech sectors
Strokes are affecting approximately 1.8 million people annually
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma
CSPC will receive an upfront payment of $100 million from AstraZeneca
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