Search This Blog

Tuesday, June 2, 2020

Nicox launches first late-stage NCX 470 trial in Glaucoma

Nicox SA (OTCPK:NICXF) has initiated the first Phase 3 clinical trial, named Mont Blanc, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, by enrolling the first 12 patients.
The Mont Blanc trial will evaluate the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005%.
The primary efficacy is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3.
Adaptive dose selection in Mont Blanc will allow the start of the second Phase 3 trial, Denali.
https://seekingalpha.com/news/3579559-nicox-launches-first-late-stage-ncx-470-trial-in-glaucoma

Sanofi’s Sarclisa reduced risk in late-stage multiple myeloma study

Sanofi (SNY) announces more positive results from a Phase 3 clinical trial, IKEMA, evaluating Sarclisa (isatuximab), added to Amgen’s Kyprolis (carfilzomib) and dexamethasone, in patients with relapsed multiple myeloma (MM).
The addition of Sarclisa reduced the risk of cancer progression or death by 47% (hazard ratio = 0.53) compared to carfilzomib and dexamethasone alone. It showed a consistent treatment benefit across a range of subgroups.
The company announced positive topline data from the study on May 12.
Interim data will be virtually presented at the European Hematology Association Congress on June 14.
The company expects to file global marketing applications later this year.
The CD38-directed cytolytic antibody is currently approved in the U.S. and Europe for relapsed/refractory MM when combined with Bristol Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone.
https://seekingalpha.com/news/3579558-sanofis-sarclisa-reduced-risk-in-late-stage-multiple-myeloma-study

Novacyt announces strong ramp in COVID-19 test sales

Novacyt (OTC:NVYTF) provides an update on its polymerase chain reaction (PCR) test for COVID-19.
As of 1 June, COVID-19 test sales were €45M (£40M).
The company has received orders for, or been contracted to deliver, a further €90M (£80M) of its COVID-19 test.
During H2, additional COVID-19 related sales are expected from Company’s new products, Exsig Direct and Exsig Mag, and from mobile testing solution. Both Exsig extraction reagents will launch during June and the mobile COVID-19 system will launch in July.
Also, the company has earned a contract for the supply of 1.5M tests in Zimbabwe. The initial purchase order for the first 500,000 tests has been received and will be shipped immediately.
Haute Autorité de Santé, an advisor the French government on medical reimbursement, did not approved company’s COVID-19 test for reimbursement in France.
Novacyt has secured registrations and regulatory approvals in the following new markets for its COVID-19 test: Panama, Ecuador, Columbia, Peru, Paraguay and the UAE.

FDA OKs emergency use of Philips monitors for COVID-19 use

The FDA has signed off on emergency use of Royal Philips’ (PHG -0.6%) Intellivue Patient Monitors MX750/MX850 and Intellivue Active Displays AD75/AD85 for remotely monitoring hospitalized COVID-19 patients.
The devices were CE Mark’d last year and are in use in hospitals across Europe.
https://seekingalpha.com/news/3579576-fda-oks-emergency-use-of-philips-monitors-for-covidminus-19-use

Moderna highlights pipeline progress at Science Day event

Moderna (NASDAQ:MRNA) is hosting its third annual Science Day event today during which it will virtually present advances in its platform science and vaccines. Highlights:
T7 RNA polymerase engineered not to produce double-stranded RNA impurities (a technical issue in the production of mRNA therapeutics).
Update on research in delivery science to optimize its lipid nanoparticles, specifically, an engineered lipid that enhances its interactions with mRNA. It will be used with candidate mRNA-3745 for glycogen storage disease type 1a.
Company’s mRNA platform enabling rapid design and clinical testing of HIV-1 vaccine (designed to deliver an engineered HIV immunogen).
Pipeline consists of 23 mRNA candidates. 13 clinical trials in process.
https://seekingalpha.com/news/3579508-moderna-highlights-pipeline-progress-science-day-event

Monday, June 1, 2020

Sign here first: U.S. salons, gyms, offices require coronavirus waivers

As U.S. businesses reopen after weeks of pandemic lockdowns, many have been posting coronavirus disclaimers or requiring employees and patrons to sign waivers before entering.
From hair salons and recreation centers to stock exchanges and wedding photographers, the notices have sprung up across the country, asking guests to acknowledge they might contract a disease that has so far killed over 100,000 Americans.

Companies are using signs, forms and website postings as a shield against lawsuits, but the measures do not prevent people from seeking damages due to negligence, the same way someone might sue after falling on a slippery floor or getting sick from walls covered in lead paint, experts said.
Lawyers said it would be tough to prove a business caused a customer’s illness, but concerns are so intense that a waiver may soon become the new normal.

Entities including the YMCA of Greater Oklahoma City, a real estate agency in Arizona, a racecar speedway in Seinsgrove, Pennsylvania, and the New York Stock Exchange have introduced waivers disavowing responsibility for anyone who might contract the disease onsite, Reuters has learned.
Missoula, Montana-based lawyer Paige Marie Griffith created a waiver for COVID-19, the respiratory illness related to the novel coronavirus, that business owners can buy and customize online. Events industry workers, including makeup artists and wedding photographers, are using them, she said.
“As essential as we feel, everyone getting their hair done is choosing to do so,” said Cody Brooke, who owns 10th Avenue Hair Designs in Pensacola, Florida. “We don’t want the salon or stylist to be held liable knowing that they chose to come in.”
Since reopening on May 11, the salon requires clients to sign a form stating they have no COVID-19 symptoms and have not visited a “hot spot” with high infection rates in the last 30 days. It releases the salon from liability for “unintentional exposure” to the virus.
Ryan Reiffert did not mind signing a waiver recently for the gym where he practices martial arts near San Antonio, Texas. He had symptoms in March and later learned from antibody testing that had likely contracted the virus.

“But even if I hadn’t had it,” he said, “I’d happily sign the waiver.”
A gym attendant sprayed disinfectant on Reiffer’s hands and feet before he could enter, he said.
Bigger companies are taking similar steps.
Walt Disney Co’s website cites “severe illness and death” risks for customers at its Orlando, Florida, amusement parks due to reopen on July 11th.
That warning did not deter the throngs who waited for hours to buy Mickey Mouse swag or apparel from familiar brands outside the Disney Springs shopping center that reopened on May 20.
A Disney spokeswoman did not respond to a request for comment.
New York Stock Exchange-owner Intercontinental Exchange Inc and commodities exchange CME Group Inc also require entrants to sign waivers. Floor traders at the exchanges have historically shouted in close proximity to one another, sans masks, but that has changed.
“I cannot stress enough that we will not be able to guarantee the safety of traders, clerks or other trading personnel that choose to access the trading floor,” said CME Chief Executive Terry Duffy. “It will have risk and will continue to have risk until there is a vaccine or some other cure for this disease.”
https://www.reuters.com/article/us-health-coronavirus-disclaimers-busine/sign-here-first-u-s-salons-gyms-offices-require-coronavirus-waivers-idUSKBN238298

Official medical examiner report rules homicide in George Floyd’s death

The county medical examiner overseeing George Floyd’s case in Minnesota ruled his death a homicide in a report released Monday.
“Cause of death: Cardiopulmonary arrest complicating law enforcement subdual, restraint, and neck compression,” according to the official report by the Hennepin County Medical Examiner’s Office.
“Manner of death: Homicide. How injury occurred: Decedent experienced a cardiopulmonary arrest while
being restrained by law enforcement officer(s),” the report said.
It added that it also found while performing an autopsy on the 46-year-old black man “other significant conditions: Arteriosclerotic and hypertensive heart disease; fentanyl intoxication; recent methamphetamine use.”
The report noted, “Manner of death classification is a statutory function of the medical examiner, as part of death certification for purposes of vital statistics and public health. Manner of death is not a legal determination of culpability or intent, and should not be used to usurp the judicial process.
“Such decisions are outside the scope of the Medical Examiner’s role or authority.”
The issuance of the report came just several hours after private medical examiners hired by Floyd’s family said he was the victim of homicide caused by pressure to his neck and back by white cops during a routine bust in Minneapolis on March 25.
https://nypost.com/2020/06/01/official-me-report-rules-homicide-in-george-floyds-death/