Abbott (NYSE:ABT) announces Medicare coverage of its next-generation FreeStyle Libre 2 continuous glucose monitoring system. The device measures blood sugar levels every minute via a sensor worn on the back of the upper arm for up to 14 days.
Tuesday, September 1, 2020
Vanda Pharma issues developmental plans for tradipitant
Tradipitant is advancing in a Phase III study for the treatment of both diabetic and idiopathic gastroparesis. The study is expected to complete target enrollment of 200 patients in H1 2021.
A robust package of preclinical work for tradipitant has been completed, including a 2-year carcinogenicity study.
Vanda believes this entire preclinical package is adequate to support NDA filings for the short-term indications. However, the FDA has recommended that for treating patients beyond 12 weeks, the company would require to conduct a standard 9-month non-rodent chronic toxicity study.
Potential timeline and estimated milestones for tradipitant in gastroparesis:
Q3 2020, Expanded Access individual patient program
H1 2021, Enrollment completion of the Phase III study
H2 2021, NDA submission for tradipitant in gastroparesis
H2 2022, Commercial launch of tradipitant for the treatment of gastroparesis, if approved.
Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia.
Vanda is pursuing multiple short-term and long-term indications for tradipitant, including treatment of gastroparesis, motion sickness, and atopic dermatitis.
AstraZeneca’s Imfinzi OK’d in Europe for first-line lung cancer
AstraZeneca’s (NYSE:AZN) Imfinzi (durvalumab) has been approved in the European Union for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
The approval was based on positive results from the Phase III CASPIAN trial of Imfinzi plus chemotherapy in ES-SCLC.
It also follows the recommendation for approval by the EMA’s advisory group CHMP in July 2020
FDA OKs Roche HIV-1/HIV-2 combo test
The FDA approves Roche’s (OTCQX:RHHBY) cobas HIV-1/HIV-2 Qualitative Test for the qualitative detection and differentiation of HIV-1 and HIV-2 RNA in serum or plasma. The nucleic acid amplification assay is performed on the fully automated cobas 6800/8800 systems in the U.S.
Oxford Biomedica inks COVID-19 vaccine supply deal with AstraZeneca
Oxford Biomedica plc (OTCPK:OXBDF) has signed an 18-month supply agreement under a three-year master supply and development contract with AstraZeneca (NYSE:AZN) for the large-scale commercial manufacture of COVID-19 vaccine AZD1222.
By mutual agreement, the supply period may be extended for an additional 18 months.
Under the terms of the deal, AZN will pay Oxford £15M upfront as a capacity reservation fee. Assuming all goes according to plan, Oxford expects to receive more than £35M in additional revenue plus certain materials costs for the production of multiple large-scale batches of AZN1222 until year-end 2021.
Oxford will reserve capacity for AZN in up to three suites in the Group’s new 7,800 sq. meter manufacturing center, OxBox, for the initial 18-month period. The new GMP facility can accommodate up to 1,000-liter scale.
MediciNova up on advancement of COVID-19 vaccine
MediciNova (NASDAQ:MNOV) updates investors on the advancement of its intranasal SARS-CoV-2 vaccine utilizing a viral vector derived from the recombinant human parainfluenza virus type 2 (hPIV2) called BC-PIV, developed by Mie University and BioComo.
Results (neutralizing antibody titers) from preclinical studies in mice are being analyzed. Prototypes have been narrowed down to several candidates.
Additional tests, including the induction of mucosal immunity and measurement of the antibody titer, analysis of cell-mediated immunity and efficacy by nasal spray, are next up.
Development partner BioComo is building a master cell bank.
Production to start to supply product for safety tests and clinical trials.
BC-PIV can also be developed as an intramuscular injection. The intranasal formulation is expected to induce local mucosal immunity.
FDA accepts Athenex application for oral paclitaxel for breast cancer
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