Tags : Oral

Chugai Reports NDA Submission of Risdiplam to the MHLW as

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More

AstraZeneca Acquires Dogma Therapeutics’ Oral PCSK9 Inhibitor Program

Shots: Dogma to receive upfront along with global regulatory and commercial milestones. AstraZeneca to get the rights to an orally active drug inhibiting PCSK9, offering a patient-friendly alternative to current cholesterol-lowering therapies that are delivered via a needle The agreement allows the AstraZeneca to develop the first small molecule, orally bioavailable PCSK9 inhibitor for patients […]Read More

Athena Bioscience’s Qdolo (tramadol hydrochloride) Receives US FDA’s NDA Approval

Shots: Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus Qdolo is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative […]Read More

AbbVie and Neurocrine’s Oriahnn Receive the US FDA’s Approval as

Shots: The approval follows P-III ELARIS UF-I and ELARIS UF-II studies assessing Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) vs PBO for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women for up to 24mos. The study met its 1EPs of clinically meaningful reduction in bleeding (defined as the […]Read More

Janssen (J&J) Expands its PTG-200 Collaboration with Protagonist for Second

Shots: Protagonist to receive $25M upfront, $1.0B as development, regulatory & commercial milestones & royalties on product sales with rights to co-detail both products. Janssen to get exclusive WW rights to develop & commercialize both candidates and will pay certain costs and milestones for advancing preclinical candidates through P-I In 2017, the companies entered into […]Read More