Shots: Insitro to receive $15M upfront, $35M near term operational milestone, $200M as preclinical, development, regulatory and commercial milestones on each 5 targets & royalties on sales. Insitro has also an option to co-develop & co-detail in the US with profit share in China and will receive milestones and royalties on sales (Ex-US) Gilead will […]Read More
Shots: Thermo Fisher and NX Prenatal enter into a collaboration to develop proteomics assays by combining NX Prenatal’s NeXosome platform with Thermo Fisher’s LC-MS instrumentation for monitoring the maternal & fetal health and evaluating the risk of complications The focus of the collaboration is to provide a diagnostic solution to both clinical and medical professionals […]Read More
Shots: The P-III STR1VE study involves assessing of Zolgensma in 22 patients with SMA Type1 + one or two copies of the SMN2 backup gene + bi-allelic SMN1 gene deletion or point mutations aged < 6mos. at the time of gene therapy The P-III STR1VE study results: alive patients (95%); patients reached 10.5mos. (86%); CHOP-INTEND […]Read More
Shots: The P-III ILLUMINATE-B study will assess Lumasiran in 8 patients with primary hyperoxaluria type 1 (PH1) aged < 6yrs., associated 1EPs as reduction of urinary oxalate in 6mos. & 2EPs as evaluating glomerular filtration rate (GFR), safety, tolerability, with its expected initial results in mid-2020 The company also reports the result of P-II OLE […]Read More
Shots: Janssen has initiated P-Ib proof-of-concept clinical trial assessing Guselkumab vs PBO in 72 patients with familial adenomatous polyposis (FAP). With the initiation of P-Ib study for FAP, MorphoSys will receive milestones from Janssen Earlier, Janssen collaborated with MorphoSys to develop Guselkumab utilizing MorphoSys’s HuCAL antibody technology (Human Combinatorial Antibody Library), a platform for invitro […]Read More
Shots: Fibrocell to receive $7.5M upfront, $2.5M on first patient enrollment, $30M on BLA approval, $75M as commercial milestones and 30% of profit on product sales. Castle Creek to get an exclusive right to commercialize FCX-007 in the US and will responsible for its development and manufacturing expenses up to $20M prior to BLA filing […]Read More
Shots: The P-III DELOS study involves assessing of Idebenone (900 mg/day) vs PBO in 64 patients with Duchenne muscular dystrophy (DMD) for 52wks. & P-II DELPHI study with 2-year extension study (DELPHI-E). SYROS study involves assessing of Idebenone (900 mg/day) in 18 patients under Expanded Access Programs (EAPs) who completed the DELOS study The P-III […]Read More
Shots: Dr. Reddy’s acquires a portfolio of 42 approved, non-marketed Abbreviated New Drug Applications (ANDAs) in the US, including >30 generics injectable The focus of the acquisition is to enhance Dr. Reddy’s injectable portfolio in the US and globally Dr. Reddy’s will launch the products within the next one to two years and according to […]Read More
Shots: The P-III ENVISION study involves assessing of Givosiran vs PBO in patients with acute hepatic porphyria (AHP) ENVISION study results:74% mean reduction of annualized rate of porphyria attacks; 90% median reduction in composite annualized attack rate (AAR); overall safety and tolerability; AEs (89.6% vs 80.4%); attack free (50% vs 16.3%); @3/6mos. 91%/83% in urinary […]Read More
1.Omron Healthcare Receives FDA’s Approval for Complete a Blood Pressure Monitoring Device with ECG Facility Published: April 12, 2019 | Tags: Omron Healthcare, Receives, FDA, Approval, Complete, Blood Pressure, Monitoring, Device, EKG, Facility 2.Gilead and Novo Nordisk Collaborate to Conduct a Combination Therapy Trial in NASH Published: April 12, 2019 | Tags: Gilead, Novo Nordisk, Collaborate, Conduct, […]Read More
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