- The European Medicines Agency (EMA) has begun its first rolling review of COVID-19 vaccine data on AstraZeneca (NASDAQ:AZN) and the University of Oxford's candidate AZD1222/ChAdOx1. The review committee will be evaluating the first batch of nonclinical data from lab studies so it is premature to expect a conclusion on safety and effectiveness.
- A rolling review is way of accelerating the process. The FDA uses the same approach for high priority medicines and vaccines.
- Selected tickers: Pfizer (NYSE:PFE), BioNTech SE (NASDAQ:BNTX), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NASDAQ:MRNA), Sanofi (NASDAQ:SNY), GlaxoSmithKline (NYSE:GSK), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX)
- https://seekingalpha.com/news/3618847-first-rolling-review-of-covidminus-19-vaccine-data-underway-in-europe
Thursday, October 1, 2020
First rolling review of COVID-19 vaccine data underway in Europe
- CareDx (CDNA +10.6%) is up on modestly higher volume in reaction to the release of final local coverage determination by Medicare administrator Palmetto MolDx for AlloSure Heart, a donor-derived cell-free DNA (cfDNA) test that identifies underlying cell injury leading to organ rejection.
- The company says the coverage decision paves the way for patient/provider availability of HeartCare, the combination of AlloSure Heart and AlloMap Heart, an 11-gene panel that detects changes in gene expression associated with acute organ rejection.
- https://seekingalpha.com/news/3618887-caredx-up-11-on-medicare-coverage-of-organ-rejection-test
Novartis says data confirms benefit of Zolgensma gene therapy for babies
Novartis said new interim data from an ongoing phase clinical trial for its $2.1 million-per-patient gene therapy Zolgensma showed spinal muscular atrophy patients experienced significant therapeutic benefit.
Nearly two-thirds of patients aged less than six months in the STR1VE-EU study have already achieved developmental motor milestones not observed in natural history of SMA type 1, a rare genetic disease, at a mean duration of follow-up of 10.6 months, Novartis said in a statement on Thursday.
The Swiss drugmaker said last month that Zolgensma faced a possible delay after the U.S. Food and Drug Administration (FDA) requested an additional study to examine the therapy’s efficacy in older children.
Pulmonx prices 10M IPO above range at $19
- Pulmonx (LUNG) has priced its upsized IPO of 10M common shares at $19.00/share, higher than the already raised price range of $17-$18 for gross proceeds of $190M.
- Underwriters' over-allotment is an additional 1.5M shares.
- Trading commences October 1.
- Closing date is October 5.
- https://seekingalpha.com/news/3618676-pulmonx-prices-10m-ipo-above-range-19
Dr. Reddy's launches generic Sensipar in U.S.
- Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of Cinacalcet Tablets, a therapeutic equivalent generic version of Amgen's Sensipar (cinacalcet) Tablets.
- According to IQVIA Health, the Sensipar had U.S. sales of ~$312M for twelve months ended July 2020.
- Dr. Reddy’s Cinacalcet Tablets are available in 30, 60, and 90 mg tablets.
- https://seekingalpha.com/news/3618696-dr-reddys-launches-generic-sensipar-in-u-s
Wednesday, September 30, 2020
Exclusion of Older Persons From Vaccine, Treatment Trials for Covid19—Missing the Target
doi:10.1001/jamainternmed.2020.5084
Older adults are at greatest risk of severe disease and death due to coronavirus disease 2019 (COVID-19). Globally, persons older than 65 years comprise 9% of the population,1 yet account for 30% to 40% of cases and more than 80% of deaths.2
Unfortunately, there is a long history of exclusion of older adults from clinical trials. In response, the National Institutes of Health instituted the Inclusion Across the Lifespan policy, requiring the inclusion of older adults in clinical trials.3 Thus, we reviewed all COVID-19 treatment and vaccine trials on http://www.clinicaltrials.gov to evaluate their risk for exclusion of older adults (≥65 years).
Results
Table 1 identifies clinical trials by treatment with an exclusion by age. We found large variability in the age exclusions. Among the 847 trials, 195 (23%) included an age cut-off.
Table 2 displays indirect age-related exclusions preferentially affecting older adults; each trial could have multiple exclusions. The most common age-related exclusion was compliance concerns (213 trials), and 129 of these were related to consent. Next, were broad nonspecified exclusions, specific comorbidities, requirement of technology, and other reasons. A total of 366 (43%) trials had any exclusions, of which 252 (30%) did not have an age-based exclusion. Combining the results of age-based exclusions (Table 1) and exclusions preferentially affecting older adults (Table 2), 447 (53%) trials were considered high risk for excluding older adults.
In 232 phase 3 clinical trials, 38 (16%) included age cut-offs and 77 (33%) had exclusions preferentially affecting older adults; thus, 115 (50%) were considered high risk for excluding older adults. Of 18 vaccine trials, 11 (61%) included age cut-offs, and the remaining 7 had broad nonspecified exclusions; thus, 100% were considered high risk for excluding older adults.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091
Nasal Calcium-Rich Salts for Cleaning Airborne Particles from Airways
Full text: https://www.worldscientific.com/doi/abs/10.1142/S2529732520400040#
Abstract
To improve hygiene in the COVID-19 pandemic, we evaluated the intranasal delivery of calcium-enriched saline to suppress breath particles in practical settings reflecting essential worker hygiene, quarantine hygiene, and back-to-school hygiene. In studies with 92 men, women, and children, we observed that nasal salt aerosols lowered exhaled particles for the group by around 75%, and outperformed surgical face masks in the clearing of sub-micron particles.
https://www.worldscientific.com/doi/abs/10.1142/S2529732520400040
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