FDA clears new B + L contact lenses

The FDA issues 510(k) clearance for Bausch Health Companies (NYSE:BHC) unit Bausch + Lomb’s INFUSE daily disposable silicone hydrogel contact lenses.

B + L says INFUSE lenses feature a next-generation material called kalifilcon A that delivers “outstanding” breathability for healthy lens wear while providing all-day comfort and high definition optics.

https://seekingalpha.com/news/3580357-fda-clears-new-b-l-contact-lenses

Vapotherm to scale up production for nasal cannula systems for COVID-19

Vapotherm (NYSE:VAPO) announces expansion in its capital equipment manufacturing capabilities.

This increased capacity is anticipated to increase production of its Precision Flow systems by up to 20X above pre-COVID-19 levels.

At maximum capacity, the increased production could create up to an additional 350 jobs at its New Hampshire facility.

This scaling up is in response to a potential increase in demand for the company’s Precision Flow Hi-VNI system, an advanced high-flow nasal cannula system used to treat the respiratory distress experienced by COVID-19 patients.

https://seekingalpha.com/news/3580371-vapotherm-to-scale-up-production-for-nasal-cannula-systems-for-covidminus-19

Anavex on go to expand Anavex 2-73 study in Alzheimer’s

Anavex Life Sciences (NASDAQ:AVXL) has received a No Objection Letter from Health Canada and Medicines and Healthcare products Regulatory Agency in the UK to expand the Phase 2b/3 study of ANAVEX2-73-AD-004 of ANAVEX 2-73 (blarcamesine) for the treatment of early Alzheimer’s disease (AD) into Canada and the UK, respectively.

The 48-week study using biomarker and precision medicine in 450 patients with early AD is ongoing and currently over 50% enrolled.

https://seekingalpha.com/news/3580384-anavex-on-go-to-expand-anavex-2minus-73-study-in-alzheimers

Can-Fite advancing Namodenoson in liver cancer

Subsequent to a meeting with the EMA, Can-Fite BioPharma Ltd. (NYSEMKT:CANF) says it now has sufficient regulatory guidance to conduct a pivotal Phase 3 clinical trial evaluating Namodenoson in hepatocellular carcinoma patients with Child Pugh Class B7 (moderately severe) cirrhosis.

The primary endpoint of the 450-subject study will be overall survival (OS).

Namodenoson failed to beat placebo in OS in a Phase 2 trial.

https://seekingalpha.com/news/3580387-can-fite-advancing-namodenoson-in-liver-cancer

FDA OKs use of Aldeyra Therapeutics’ RASP in dry eye disease

Aldeyra Therapeutics (NASDAQ:ALDX) reaches an agreement with the FDA for the use of RASP (reactive aldehyde species) as an objective sign for the treatment of dry eye disease.

RASP are pre-cytokine pro-inflammatory mediators that are elevated in the tears of patients with dry eye disease, and correlate with dry eye disease symptoms and signs.

RASP inhibitor, reproxalap, when administered topically to the eye has demonstrated statistically significant and clinically relevant activity in dry eye disease, allergic conjunctivitis, and other forms of ocular inflammation across numerous Phase 2 and Phase 3 clinical trials.

Further updates on development plans and remaining NDA requirements for reproxalap in dry eye disease will be provided in July 2020.

https://seekingalpha.com/news/3580394-fda-oks-use-of-aldeyra-therapeutics-rasp-in-dry-eye-disease

Heat Bio making headway in COVID-19 vaccine

Heat Biologics (NASDAQ:HTBX) announces further progress on its COVID-19 vaccine program.

The company has achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in its clinically validated human cell line, enabling selection of the COVID-19 vaccine. These steps are necessary precursors to completion of company’s vaccine in preparation for its manufacture and use in clinical trials.

Heat Bio is on track to complete design and development of the COVID-19 vaccine in July, and expects its gp96/nCoV-2 expressing cell line to be available for clinical-grade manufacturing with partner, Waisman Biomanufacturing, in early August.

https://seekingalpha.com/news/3580407-heat-bio-making-headway-in-covidminus-19-vaccine

AbbVie’s upadacitinib shows durable benefit in rheumatoid arthritis studies

AbbVie (NYSE:ABBV) announces positive long-term results from two Phase 3 clinical trials, SELECT-COMPARE and SELECT-MONOTHERAPY, evaluating Rinvoq (upadacitinib) in rheumatoid arthritis (RA) patients. The data were presented at EULAR.

Patients in the first study who received daily doses of 15 mg of upadacitinib with methotrexate continued to experience improved signs and symptoms of RA at week 72.

Patients in the second trial who received 15 mg of upadacitinib alone each day maintained their improved responses at week 84.

96-week data from another late-stage study, SELECT-EARLY, showed that upadacitinib was effective in inhibiting structural joint damage as monotherapy or in combination with methotrexate.

No new safety signals were observed.

The FDA approved the JAK inhibitor for RA in August 2019. It was approved in Europe in December 2019.

https://seekingalpha.com/news/3580421-abbvies-upadacitinib-shows-durable-benefit-in-ra-studies