FDA clears Beckman automated blood bank analyzer

The FDA has granted 510(k) clearance to Danaher (NYSE:DHR) unit Beckman Coulter’s PK7400 Automated Microplate System and reagents for use in blood banks, plasma centers and larger reference labs.

The system can process up to 300 samples per hour. Assays include ABO blood grouping, Rh typing, weak D testing, Rh-Kell phenotyping and qualitative tests (yes/no result) for syphilis and CMV.

https://seekingalpha.com/news/3594251-fda-clears-beckman-automated-blood-bank-analyzer

FDA lifts all clinical holds on CymaBay’s seladelpar

CymaBay Therapeutics (NASDAQ:CBAY) jumps 22% premarket on the heels of its announcement that the FDA has removed clinical holds on seladelpar for all three IND Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).

On November 25, 2019, CymaBay halted all clinical trials based on initial histological findings observed in the Phase 2b study of seladelpar in NASH.

An in-depth investigation was conducted and the expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study. The panel unanimously supported re-initiating development of seladelpar pending FDA approval.

Based on these results, the Agency concluded that clinical trials for NASH, PBC and PSC may resume.

Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases with the lead indication being PBC.

https://seekingalpha.com/news/3594259-fda-lifts-all-clinical-holds-on-cymabays-seladelpar

FDA OKs Abbott smartphone app for patients with neurological conditions

The FDA approves Abbott’s (NYSE:ABT) iOS-compatible Patient Controller app for use on smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their own smartphone.

The nod eliminates the need to carry a separate patient programmer device.

The company plans to integrate the app into its broader NeuroSphere Digital Care platform launched in May.

https://seekingalpha.com/news/3594283-fda-oks-abbott-smartphone-app-for-patients-neurological-conditions

AcelRx inks deal with Zimmer Biomet to distribute Dsuvia

Zimmer Biomet’s (NYSE:ZBH) Dental division has agreed to distribute AcelRx Pharmaceuticals’ (NASDAQ:ACRX) opioid pain med Dsuvia (sufentanil sublingual tablet) within the U.S. dental and oral surgery markets. Financial terms are not disclosed.

https://seekingalpha.com/news/3594293-acelrx-inks-deal-zimmer-biomet-to-distribute-dsuvia

China’s Sinopharm says coronavirus vaccine could be ready by year-end

A coronavirus vaccine candidate developed by China National Pharmaceutical Group (Sinopharm) could be ready for public use by the end of this year, state media reported on Wednesday, ahead of a previous expectation it may become available in 2021.

Sinopharm Chairman Liu Jingzhen told state broadcaster CCTV the company expects to finish late-stage human testing within about three months.

Sinopharm’s unit China National Biotec Group (CNBG), which is responsible for two coronavirus vaccine projects, said in June the shot may not be ready until at least 2021 as a lack of new infections in China made it difficult to find people to test it on.

But China has since found alternative trial sites abroad, overcoming some of the obstacles it faces in the global race to produce a vaccine to fight a pandemic that has killed over 600,000 people globally.

Sinopharm’s experimental shot has entered a Phase III trial involving around 15,000 participants and two vaccine strains in the United Arab Emirates.

Another potential vaccine, developed by Chinese firm Sinovac Biotech using a similar technology, has also been given to participants in a Phase III trial in Brazil.

A vaccine candidate developed by CanSino Biologics Inc and China’s military research unit, which appears to be safe and induced immune responses in most subjects in a closely-watched mid-stage study, is also looking for opportunities to run a Phase III trial outside China.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china/chinas-sinopharm-says-coronavirus-vaccine-could-be-ready-by-year-end-state-media-idUSKCN24O0PM

BrainStorm’s NurOwn shows encouraging action in lung inflammation model

BrainStorm Cell Therapeutics (NASDAQ:BCLI) announces encouraging results from a preclinical study assessing NurOwn (MSC-NTF cells) in a mouse model of lipopolysaccharide (LPS)-induced acute respiratory syndrome (ARDS).

Intratracheal administration of NurOwn-derived exosomes showed statistically significant improvements in multiple lung parameters. MSC-NTF cell-derived exosomes also demonstrated a superior effect compared to exosomes derived from naïve mesenchymal stem cells (MSC) from the same donor.

The company regards the results as the first milestone in developing NurOwn for the treatment of severe COVID-19 infection.

It plans to submit the data for publication.

https://seekingalpha.com/news/3594209-brainstorms-nurown-shows-encouraging-action-in-lung-inflammation-model

Nurix Therapeutics to offer 11M shares in planned IPO, priced at $17 to $18

Nurix Therapeutics Inc. NRIX, set terms for its initial public offering on Thursday, with plans to offer 11 million shares priced at $17 to $18 each. The company has applied to list on Nasdaq, under the ticker “NRIX.” JPMorgan, Piper Sandler, Stifel and Needham & Co. are underwriting the deal. Proceeds will be used to fund clinical research and R&D, as well as for working capital and general corporate purposes. “We are a biopharmaceutical company focused on the discovery, development and commercialization of oral, small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders,” the company says in its prospectus.

https://www.marketwatch.com/story/biotech-nurix-therapeutics-to-offer-11-million-shares-in-planned-ipo-priced-at-17-to-18-each-2020-07-23