Amazon to pay $500K for neglecting to tell workers about COVID-19 outbreaks

 

• California’s attorney general opened an investigation into Amazon’s COVID-19 practices at its California facilities last year.
• The retail giant agreed to pay out $500,000 towards enforcement of California’s consumer protection laws while also submitting to new COVID-19 safety protocols.
• Amazon will now have to report new COVID-19 cases to workers within one day and to local health authorities within 48 hours.

A year after California’s attorney general's office opened an investigation into Amazon workers’ safety concerns, the retail giant agreed to pay out $500,000 and notify its workers and local health agencies of new COVID-19 cases.

The investigation began a year ago, under former attorney general Xavier Becerra, and focused on Amazon’s workplace practices in light of the coronavirus pandemic. One employee filed a lawsuit against the company alleging Amazon had put workers at “needless risk,” by forcing workers to share equipment and failing to allow workers extra time for safe social distancing.

On Monday, Rob Bonta, California’s new attorney general, announced Amazon would submit to monitoring by the state regarding it’s COVID-19 practices and pay $500,000 towards further enforcement of California’s consumer protection laws.

Under California law, employers are required to notify workers of COVID-19 cases at their worksites and provide employees with information on COVID-19-related benefits and protections. They also must share their disinfection and safety plan and report COVID-19 cases to local health agencies. 

In Monday’s announcement, Bonta said in part, “Today’s first-of-its-kind judgment will help ensure Amazon meets that requirement for its tens of thousands of warehouse workers across California. Bottom line: Californians have a right to know about potential exposures to the coronavirus to protect themselves, their families, and their communities.”

Amazon will now be required to notify its California employees within one day the exact number of COVID-19 cases in their workplaces and notify local health agencies of new COVID-19 cases within 48 hours. The company will also submit to monitoring by the Office of the Attorney General regarding COVID-19 notifications and pay $500,000 towards enforcement of California’s consumer protection laws.

According to the Associated Press, it’s not clear how many Amazon employees have been exposed to COVID-19 over the course of the pandemic, but in October 2020 the company disclosed that nearly 20,000 of its front-line U.S. workers had tested positive for the virus or were presumed infected. 

https://thehill.com/changing-america/well-being/prevention-cures/581697-in-landmark-case-amazon-will-pay-500000-for

Bristol Myers/J&J Milvexian: Favorable Antithrombotic Profile Across a Wide Range of Doses

 Milvexian demonstrated efficacy and no increase in bleeding across doses, with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery

AXIOMATIC-TKR is the first of two studies to read out from the Phase 2 milvexian program, which together will inform the design and dose regimens of the Phase 3 program

Data simultaneously published in The New England Journal of Medicine and presented at the American Heart Association Scientific Sessions 2021

Milvexian is being developed by The Bristol Myers Squibb-Janssen Collaboration

https://finance.yahoo.com/news/breaking-phase-2-data-investigational-161800322.html

Cyclo Therapeutics Eyes Advancing Phase 2 Study for Alzheimer's Treatment

– Biologic similarities demonstrated between Niemann-Pick Disease Type C and Alzheimer’s Disease, including cholesterol accumulation in regions of the brain, elevated levels of Tau in CSF, and amyloid plaques in the brain, bolsters rationale for studying Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease

– Phase 2 protocol was developed based clinical data from completed and ongoing trials in Niemann-Pick Disease Type C and on 18 months of data from a single late-onset Alzheimer’s patient being administered monthly intravenous doses of Trappsol® Cyclo™ under compassionate use

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) ("Cyclo Therapeutics" or the "Company"), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced it has submitted its initial investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease (AD).

"We are excited to have submitted our Initial IND to evaluate Trappsol® Cyclo™ for the treatment of Alzheimer’s Disease. The feedback and recommendations received from our Type B Meeting with the FDA have provided valuable input that we believe positions us for success in advancing this asset. We have taken another step towards commencing our Phase 2 study and, importantly, bringing a much-needed treatment option to patients and families," commented Michael Lisjak, Chief Regulatory Officer, Senior Vice President for Business Development of Cyclo Therapeutics.

Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin and in multiple clinical studies has shown encouraging results to effectively manage the transportation of cholesterol. Many of the known risk factors for AD are associated with cholesterol metabolism. Cholesterol imbalance in AD patients is well known, and significant research exists suggesting these imbalances are responsible for Aβ and tau accumulation. Furthermore, neurons, because of their high metabolic demands, experience an increased level of oxidative stress. Oxidative stress has also been linked to abnormal cholesterol accumulation and processing. AD shares features with NPC-1, a neurovisceral, genetic disease in which cholesterol accumulates in lysosomes, including progressive decline in cognitive ability, amyloid beta plaques in the CNS, and increased levels of tau in the cerebrospinal fluid (CSF). Cyclo Therapeutics is currently testing the same investigational Trappsol® Cyclo™ drug in clinical trials for the treatment of Niemann-Pick Disease Type C1 (NPC-1). Taking the place of the defective NPC-1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so it can be further processed.

https://finance.yahoo.com/news/cyclo-therapeutics-submits-investigational-drug-130500012.html

Molecular Partners stops recruiting hospitalized patients in Covid trial

 

• Following the futility analysis, the independent Data and Safety Monitoring Board (DSMB) recommends that the recruitment of patients in the ensovibep arm of ACTIV-3 not continue in hospitalized patients

• The global phase 2-3 EMPATHY study in non-hospitalized patients is still ongoing with topline data from phase 2b expected in early 2022

Ad hoc announcement pursuant to Art. 53 LR:
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced that a planned futility analysis of ensovibep in the ongoing ACTIV-3 clinical study (NCT04501978) has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting. This global Phase 3 ACTIV-3 platform study is being conducted by the National Institutes of Health (NIH) as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is evaluating multiple therapies for COVID-19 to see what, if any, benefit can be seen over current standard of care. At the time of the analysis, 470 patients had been randomized in the ensovibep arm of the study. Ensovibep was observed to be generally safe and well tolerated with reported side effects consistent with standard of care.

“Demonstrating efficacy in hospitalized patients with COVID-19 has proven particularly challenging for antiviral therapies, with most investigational agents tested so far in the ACTIV-3 study not passing futility criteria – potentially due to the multi-systemic inflammatory component of late-stage COVID-19 disease. We wish to thank our collaborators and patients for participating in this study. When available, we will share any potential learnings to better inform this population, which is still in great need for treatment options,” said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. “We are encouraged that ensovibep’s safety profile continues to be supported, and we are now focused on its performance for patients in earlier stages of the disease. Ensovibep’s unique mechanism has the potential to meaningfully expand the medical toolkit in our collective fight against the ongoing pandemic, particularly in the face of global under-vaccination and the threat posed by continual new viral strains where we continue to retain potency.”

https://finance.yahoo.com/news/molecular-partners-provides-activ-3-060000619.html

CytoDyn Submits the First of 3 Main Sections of HIV BLA to FDA

 Second portion out of three major portions of BLA (CMC portion) will be submitted shortly

Clinical section (last portion to complete BLA) expected to be submitted during Q1 2022

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has initiated the resubmission of its Biologics License Application (“BLA”) for HIV under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”).

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to begin the HIV BLA resubmission process with continued guidance from the FDA. Due to the work of our management and regulatory advisory team, we believe the application’s issues have been successfully addressed, allowing us to advance the process. The resubmission will include non-clinical and CMC sections during November, followed by submission of the clinical section in Q1 of 2022. Meanwhile, we are very excited that patients who participated in the CD02, pivotal, Phase 3 trial, who needed to continue with leronlimab, are now reaching, in some cases, 4 years with suppressed viral load in an extension arm of our CD02 trial. Therefore, CytoDyn will also file for expanded access use of leronlimab for a fee to MDR HIV patients who might need leronlimab urgently, possibly as soon as next week. CytoDyn ultimately selected a new BLA team to replace its prior contract research organization. While a difficult decision, it was in the Company’s best interest due to the revisions needed in many areas of the BLA. We would like to thank our partners who worked over the past year to get us to where we are today. This is an exciting step for CytoDyn, and we look forward to sharing continued positive developments.”

https://baytownsun.com/coronavirus/article_64df03f8-f05a-54ce-acb4-030c06ce583d.html

Trial of nasal vaccine for Alzheimer's disease underway at Brigham and Women's

 Brigham and Women’s Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow the progression of Alzheimer’s disease.

The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of proteins derived from bacteria and has been used safely in humans as an adjuvant for other vaccines.

It is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger clearance of beta-amyloid plaques — one of the hallmarks of Alzheimer's. I-Mab Biopharma (I-Mab) and Jiangsu Nhwa Pharmaceutical (NHWA) are responsible for the development, manufacturing and commercialization of Protollin.

The trial represents the culmination of nearly 20 years of research led by Dr. Howard L. Weiner, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.

“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD. If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk.”

The trial will be a single ascending dose (SAD) trial of 16 participants, all of whom will be enrolled from the Ann Romney Center. Trial participants will be between 60 and 85 years of age with early, symptomatic Alzheimer's Disease.

Participants will receive two doses of the nasal vaccine one week apart.

The Phase I trial’s primary objective will be to determine the safety and tolerability of the nasal vaccine. The research team will also measure the effect of nasal Protollin on participants’ immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles and functional assays.

https://www.wcvb.com/article/clinical-trial-of-nasal-vaccine-for-alzheimers-disease-underway-at-brigham-and-womens-hospital/38263903

Theravance halts Crohn's Phase 2 study

 Theravance Biopharma, Inc. (the "Company") is announcing that it has voluntarily discontinued its Phase 2 study of izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) in Crohn's disease (Study 0173). The Company's decision was made following the planned review of trial data by the independent data monitoring committee who determined that, while there are no safety concerns, there are concerns about the ongoing benefit-risk of continuing the trial, and the committee recommended the sponsor discontinue the study. The Company has made the decision to discontinue the study.

https://www.marketscreener.com/quote/stock/THERAVANCE-BIOPHARMA-INC-16501278/news/THERAVANCE-BIOPHARMA-INC-Other-Events-form-8-K-37038943/