Shares of Curis Inc. CRIS,
Tuesday, December 8, 2020
Curis triples after upbeat leukemia treatment trial results
FDA accepts Pfizer's application for pneumococcal conjugate vaccine
- Under priority review status, the FDA has accepted to review Pfizer's (NYSE:PFE) 20-valent pneumococcal conjugate vaccine for the prevention against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, in adults ages 18 years and older.
Agency's goal date for a decision is in June 2021.
Amazon Web Services launches HealthLake data analysis for health organizations
- Amazon Web Services (NASDAQ:AMZN) announces the Amazon HealthLake service for aggregating, normalizing, and identifying data for healthcare and life sciences organizations.
- The HIPAA-eligible service structures all of the data into the Fast Healthcare Interoperability Resources industry standard format.
- "With Amazon HealthLake, healthcare organizations can reduce the time it takes to transform health data in the cloud from weeks to minutes so that it can be analyzed securely, even at petabyte scale. This completely reinvents what’s possible with healthcare and brings us that much closer to everyone’s goal of providing patients with more personalized and predictive treatment for individuals and across entire populations," says Swami Sivasubramanian, VP of Amazon Machine Learning for AWS.
- Amazon has made its own push into healthcare in recent years, including the $753M acquisition of online pharmacy PillPack and the Amazon Care primary care clinics that initially launched for employees.
- https://seekingalpha.com/news/3642617-amazon-web-services-launches-healthlake-data-analysis-service-for-healthcare-organizations
Harpoon Therapeutics reports partial response in early-stage prostate cancer study
- Harpoon Therapeutics (HARP +3.7%) has reported a confirmed partial response for its most advanced program, HPN424 in Phase 1/2a study for the treatment of metastatic castration-resistant prostate cancer.
- At the highest fixed dose tested to date, 160ng/kg, one patient out of 7 showed confirmed partial response with tumor lesion reduction of 43%, and 3 of 7 patients have had serum PSA declines from baseline, including one patient with a PSA reduction greater than 50%.
- HPN424 was generally well tolerated and cytokine-related adverse events have been manageable. Severe adverse events include cytokine release syndrome (10%), ALT increase (11%) and AST increase (11%).
- Presentation of Phase 1 data and initiation of an expansion cohort is planned for 1H of 2021. Interim data from this expansion cohort is anticipated by the end of 2021.
- Also, another candidate HPN536 in Phase 1/2a, showed that among the relapsed/refractory ovarian cancer patients, 8 of 12 (67%) patients demonstrated stability of target lesions. HPN536 appears to be well tolerated. One CRS grade 3 occurred in the absence of dexamethasone premedication treatment. Initiation of an expansion cohort is anticipated by 2H of 2021, with data presentation of Phase 1 by year-end 2021.
- https://seekingalpha.com/news/3642620-harpoon-therapeutics-reports-partial-response-from-hpn424-early-stage-study-in-prostate
Novo Nordisk, Procyon in licensing pact for stem-cell based type 1 diabetes therapy
- Privately-held Procyon Technologies has entered into an exclusive research collaboration and license agreement with Novo Nordisk (NVO +0.5%) to develop an implantable cell encapsulation device to be used by latter with its stem cell-derived insulin-secreting cells for the development of Type 1 diabetes therapies.
- Novo Nordisk will be responsible for the development, manufacturing and commercialization of the products resulting from the collaboration. Financial details were not disclosed.
- Procyon cell encapsulation device mitigates foreign body response, promotes the formation of vascular structures on its surface enabling the rapid diffusion of nutrients to the cells inside and the rapid absorption of insulin.
- https://seekingalpha.com/news/3642624-novo-nordisk-procyon-inks-licensing-pact-for-stem-cell-based-therapies-for-type-1-diabetes
Assembly Biosciences pulls the plug on microbiome program
- Assembly Biosciences (NASDAQ:ASMB) has announced to wind-down its microbiome program, enabling the company to prioritize resources and focus on hepatitis B virus programs.
- While Assembly Bio will continue its ongoing review of potential strategic options for the microbiome program in the interim, absent an alternative, it expects to wind-down the microbiome program on or around January 31, 2021.
- As of September 30, the company had cash, cash equivalents, and marketable securities of ~$238M, and is projected to fund planned operations into 2H of 2022.
- Last month, the company announced a partnership with Door Pharmaceuticals focused on the development of a class of hepatitis B virus core protein modulators.
- https://seekingalpha.com/news/3642664-assembly-biosciences-pulls-plug-on-microbiome-program
Demand for COVID-19 tests to outstrip supply for months: Roche CEO
Global demand for COVID-19 testing devices is expected to outstrip supply for a long time, Roche Chief Executive Severin Schwan said on Tuesday.
“We still have little information about duration and efficacy of vaccines (...) So diagnostics will remain very important, not only for the months to come but the years to come,” Schwan said in a briefing of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
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