Browsing Tag
Astellas Pharma
24 posts
Ocugen has FDA alignment and a 2028 filing target. Now OCU410 needs to prove the Phase 2 signal was real
Ocugen starts Phase 3 testing of one-time OCU410 gene therapy for geographic atrophy after a 31% Phase 2 reduction in lesion growth.
Ocugen pairs OCU410 regulatory progress with a $130m balance-sheet reset
OCU410 gains FDA RMAT status as Ocugen prepares a 300-patient Phase 3 trial and funds development with convertible debt.
One leadership change, several major catalysts: What Vir Biotechnology must prove next
Vir Biotechnology’s finance leadership change comes as the biotechnology company manages more than $1 billion of financial resources, an important Astellas Pharma alliance and several potentially valuation-shaping clinical milestones.
Pfizer (PFE), Merck (MRK) win FDA expansion for Padcev plus Keytruda in all MIBC patients
Pfizer (PFE) Padcev+Keytruda MIBC label expands to all patients as first platinum-free regimen; AstraZeneca's Imfinzi cisplatin-only slot loses ground.
Why a tiny cancer biotech suddenly looks worth more than $2bn to Eli Lilly
Eli Lilly is reportedly nearing a $2 billion-plus Kelonia deal. Read what it could mean for Lilly’s cancer pipeline, CAR-T economics, and LLY stock.
Can immunotherapy finally replace chemo in bladder cancer? Keytruda–Padcev combo shows the way
Explore how Merck’s Keytruda and Padcev combo is redefining bladder cancer treatment without chemo. Survival gains, sector impact, and what’s next in focus.
Bayer’s FDA review extension for elinzanetant signals global push for hormone-free menopause therapies
Bayer receives FDA review extension for elinzanetant menopause drug; U.S. approval still likely, with global rollout underway and analysts optimistic.
Axcelead DDP partners with Astellas for targeted protein degrader discovery
Axcelead Drug Discovery Partners, Inc. (Axcelead DDP) has entered into a strategic service agreement with Astellas Pharma, Inc.,…
Astellas Pharma opens $90m innovation center in South San Francisco
Astellas Pharma Inc. has inaugurated a new $90 million, state-of-the-art center at 480 Forbes Boulevard in South San…
Japan’s MHLW grants priority review for PADCEV and KEYTRUDA combo in urothelial cancer
In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of…