Provention Bio Resubmitting Biologics License Application for Type 1 Diabetes

 Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced its intent to resubmit the teplizumab Biologics License Application (BLA) for the delay of clinical type 1 diabetes in at-risk individuals following its Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration (FDA).

The purpose of the Type B pre-BLA resubmission meeting was to discuss FDA feedback and obtain agreement on Provention's proposed clinical pharmacology data package, including data and analysis from the pharmacokinetic/pharmacodynamic (PK/PD) substudy completed by the Company to address the FDA's PK comparability considerations contained in the complete response letter (CRL) issued last July. In preliminary meeting comments, the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure. To address this concern, the FDA proposed, and the Company agreed, to use PK modeling to adjust the 14-day dosing regimen for the planned commercial product to match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80-125% range. On this basis, the FDA agreed that Provention could proceed to resubmit the BLA.

Based on the Company and FDA's agreed upon PK modeling, and the Company's experience with various doses and regimens tested in prior clinical trials, the Company will propose in the BLA resubmission a modified 14-day course of therapy to address the FDA's comparability considerations. The BLA resubmission will also include responses to address the CRL's Chemical, Manufacturing, and Controls (CMC) and product quality considerations, as agreed with the FDA at a Type A meeting held in August last year. The Company believes it will be in a position to resubmit the BLA in the first quarter.

Conference Call and Webcast Information:

Provention Bio will discuss these updates results via conference call tomorrow, Friday, January 28, 2022 at 8:00 am ET. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international) ten minutes prior to the start time and ask to be connected to the "Provention Bio Call." An audio webcast will also be available on the "Events and Webcasts" page of the Investors section of the Company's website, www.proventionbio.com. An archived webcast will be available on the Company's website approximately two hours after the conference call.

https://finance.yahoo.com/news/provention-bio-resubmitting-biologics-license-210500771.html

Stryker Cites Volatility in Short-term Outlook

 Stryker Corp. expects a roughly 6% to 8% annual sales increase on an organic basis and warned of pandemic-related volatility.

The company, which previously pointed to labor and staffing shortages in healthcare, on Thursday said it expects an adjusted profit for the year of $9.60 to $10 a share and said that foreign currency exchange rates could have a moderate benefit on profit and sales.

The company said it expects unfavorable price reductions of about 1% in 2022.

Analysts surveyed by FactSet expect an adjusted profit of $10.16 a share and about $18.31 billion in revenue.

https://www.marketscreener.com/quote/stock/STRYKER-CORPORATION-14536/news/Stryker-Cites-Volatility-in-Short-term-Outlook-37665451/

China's Walvax says has most participants for large mRNA COVID vaccine trial

 

China's Walvax Biotechnology has recruited most of the 28,000 participants needed for a large clinical trial of its mRNA COVID-19 vaccine candidate, a senior company official said on Thursday.

China has yet to approve a Chinese vaccine of the novel messenger RNA (mRNA) technology and has yet to import a foreign mRNA vaccine.

The issue has become more urgent as studies have shown China's most frequently used shots from Sinovac and Sinopharm are less effective against the highly contagious Omicron than against some previous variants.

From next week, a Phase III trial for Walvax' potential mRNA vaccine will shift its focus from recruiting participants to identifying potential COVID-19 infections for data analysis, Walvax's vice chairman Huang Zhen said on Thursday.

He declined to provide any timeline for when the trial could establish the efficacy of the vaccine.

"The first step is to identify all those cases and not to miss any," Huang said in a phone call, citing concerns that some participants might not report their disease for fear of being quarantined.

Recruiting participants from overseas for the trial was slow initially, but accelerated after researchers moved the recruitment to smaller, less-vaccinated cities.

The ARCoV vaccine, which Walvax co-developed with Suzhou Abogen Biosciences and a Chinese military-backed research institution, is being tested in a Phase III trial across countries including China, Mexico and Indonesia.

Finding and analysing cases from a Phase III trial is essential to calculating a vaccine's efficacy, which usually requires comparing the number of cases among those vaccinated and those not.

Another China-based clinical trial to test ARCoV as a booster dose has recruited more than 1,000 participants and collected blood samples for analysis, Huang said, without saying when the results could be ready.

Walvax has an annual capacity to make 200 million doses of the vaccine in the form of bulk substance, and the company intends to increase that capacity, Huang said.

https://www.marketscreener.com/quote/stock/WALVAX-BIOTECHNOLOGY-CO--11318055/news/China-s-Walvax-says-has-most-participants-for-large-mRNA-COVID-vaccine-trial-37662215/

Anti-vaccine Canada truckers roll toward Ottawa, praised by Tesla's Musk

 

Canadian truck drivers determined to shut down central Ottawa over a federal government vaccine mandate rolled across the country toward the capital on Thursday, boosted by praise from Tesla Chief Executive Elon Musk.

The protesters are unhappy that Prime Minister Justin Trudeau's Liberal government has imposed a COVID-19 vaccine mandate for cross-border truck drivers.

Industry officials say 90% of drivers traversing the U.S. frontier are inoculated but a minority have refused, saying the mandate contravenes personal freedom.

"Canadian truckers rule," tweeted Musk, who in September 2020 said he would not get vaccinated for COVID-19 on the grounds he and his family were not at risk. In November 2020 he said he most likely had a mild case.

Hundreds of truckers, converging on Ottawa from several directions, are due to arrive on Friday and aim to park their rigs on Parliament Hill, paralyzing downtown traffic.

Organizers insist the demonstration will be peaceful. Some protesters, however, have talked about blocking hospitals, assaulting Trudeau and even a coming civil war.

"We are aware of inappropriate and threatening language on social media related to this event," the Ottawa police force tweeted on Thursday. "There will be consequences for persons engaging in criminal conduct (and) violence."

The more extreme comments pose a challenge for the official opposition Conservative Party. Senior party members are praising the truckers, and say the mandate will hit food supplies and spark inflation.

"You're bound to have a number who say unacceptable things ... but that doesn't mean we disparage the thousands of hardworking, law-abiding, and peaceful truckers, who quite frankly, have kept all of you alive for the last two years," legislator Pierre Poilievre told reporters.

Trudeau on Monday accused conservative politicians of stoking fear over the mandate.

https://www.marketscreener.com/news/latest/Anti-vaccine-Canada-truckers-roll-toward-Ottawa-praised-by-Tesla-s-Musk--37664509/

Mastercard brushes off Omicron threat after profit beat

 

Mastercard Inc beat quarterly profit estimates on Thursday as an uptick in international travel powered card spending and said a recent drag on cross-border travel from the Omicron variant was unlikely to persist.

Increased vaccinations and easing pandemic-related curbs had backed a recovery in spending, but surging COVID-19 infections from the Omicron variant pressured cross-border travel in the tail end of the fourth quarter and into January.

Chief Executive Officer Michael Miebach, however, said cross-border travel will return to pre-pandemic levels by the end of the year.

"There are early signs that the Omicron will be relatively short-lived."

Shares of the company rose 4.3% to $359.22 as cross-border volumes - a key metric that tracks card spending beyond the country of issue - surged 53% during the quarter.

Mastercard's gross dollar volumes jumped 23% to $2.1 trillion from a year earlier. The metric represents the dollar value of the transactions processed.

Rival American Express Co also beat quarterly profit estimates on record levels of spending through its cards, while Visa Inc is slated to report earnings later in the day.

Mastercard's net revenue rose 27% to $5.2 billion in the quarter ended Dec. 31, above estimates of $5.16 billion, according to Refinitiv data.

But its operating expenses, excluding acquisition costs, rose 12% on the back of higher spending on personnel, marketing and data processing.

Profit rose to $2.4 billion, or $2.41 per share, from $1.8 billion, or $1.78 per share, a year earlier.

On an adjusted basis, Mastercard earned $2.35 per share, above estimates of $2.21.

https://www.marketscreener.com/quote/stock/MASTERCARD-INC-17163/news/Mastercard-brushes-off-Omicron-threat-after-profit-beat-37658980/

Novo Nordisk's Wegovy, hamstrung by Catalent FDA write-up, could correct by mid-2022

 Worry not, Wegovy fans: There’s reason to believe supply of Novo Nordisk’s obesity med could resume as planned by the middle of the year. That’s according to Jefferies analysts’ chat with a manufacturing expert, who weighed in on the FDA write-up at a Catalent facility behind the production dilemma.

As Novo Nordisk suggested, Catalent could resolve the problems behind Wegovy’s current supply hitch within about six months, followed by some one to two months of FDA follow-up, the manufacturing expert said. Operating on that timeline, production could restart at Calalent’s Brussels filling factory in mid-2022. That would in turn help Novo meet its goal to satisfy Wegovy demand in the U.S. for the second half of the year.

The Wegovy problem is tied to an October inspection of Catalent’s Brussels plant, which ultimately yielded a Form 483. The regulator’s warning letter covered seven observations that knocked Catalent for faulty air filtration systems, “alarming” bacterial growth in a sterile room and more, the Jefferies team wrote in a note to clients Thursday.

Some of those issues were first flagged back in 2017, but remediation efforts only started in 2020 and proved “inadequate,” the Jefferies analysts said. The expert noted that Novo Nordisk should have been apprised of the issues.

With that in mind, none of the issues outlined in the FDA’s Form 483 are “especially challenging” and should be addressable in a six-month timeframe, the expert explained.

“Issues flagged by FDA are numerous and some serious but all can be rectified, as per our expert, with a re-inspection before reopening unlikely,” the Jefferies analysts said.  

The expert flagged two worst case scenarios that could knock Catalent and Novo’s plans off track. Production could face further delays if contamination is found again during test manufacturing, and the source of the contamination is unknown. Secondly, the FDA could also drag its feet to review remediation documents.

“In one case the expert had been involved with, the FDA took 6 months to give the company the go ahead to resume manufacturing,” the Jefferies team noted.

The expert, meanwhile, was “encouraged” by the fact that Catalent shut down its entire Brussels facility, which suggests the CDMO is taking remediation efforts seriously.

Even so, “this Form 483 was viewed to be in the top-25% of worst letters seen (of many 100s),” the Jefferies team said. That heightens “the risk FDA could still issue a Warning Letter in the future should it deem the remediation insufficient or issues recur.”

While details were slim initially, Novo Nordisk in December said that a contract manufacturer in charge of syringe filling for Wegovy pens had temporarily halted deliveries following issues with good manufacturing practices. A Novo Nordisk spokesperson this month confirmed that "the contract manufacturer referred to in the Dec 17 Company Announcement is Catalent.”

Catalent last week told Fierce Pharma it had “received Form 483 observations after a recent FDA inspection of its Brussels sterile filling facility.

“Catalent takes all FDA observations seriously and has made a proactive decision to implement engineering and quality upgrades for the air filtration system," a company spokesperson said via email.

Novo Nordisk, for its part, plans to "relaunch promotional campaigns to raise awareness" among patients and doctors about Wegovy once supply issues have subsided, Doug Langa, Novo's executive vice president of North America operations, said. 

https://www.fiercepharma.com/manufacturing/novo-nordisk-s-wegovy-hamstrung-by-catalent-fda-write-up-could-correct-course-by-mid

How to properly store at-home COVID-19 tests so they stay accurate

 

• At-home COVID-19 tests are being widely used across the country and are available at drug stores and pharmacies.
• Health experts are warning that test kits are incredibly sensitive to extreme temperatures.
• The ideal location of an at-home COVID-19 test is a dry, room temperature place.

There’s been a rapid rise in the use of at-home COVID-19 tests, but health experts are warning that for those tests to provide accurate results, people must use them appropriately.  

Many drug stores and pharmacies across the country have been selling at-home tests and the federal government has also made four tests available to every American free of charge, but once those tests arrive in peoples’ homes, there are specific steps that need to be taken to ensure the tests are accurate. 

Amy Mathers, associate professor of medicine and pathology and director of clinical microbiology at the University of Virginia, told NBC News that exposure to extreme hot or cold temperatures may affect the accuracy of at-home tests. 

“When you cook an egg, it denatures the proteins,” said Mathers.  

“And in this test are proteins that are going to be very sensitive to becoming too hot,” Mathers added. 

Mathers said after exposure to very high temperatures, at-home tests may be permanently damaged in a way that affects the sensitivity of the tests.

Colder temperatures are also risky, as Mathers warned not to use at-home test kits whose liquids have frozen.  

All at-home tests are slightly different, but they are all meant to be kept within a specific range of temperatures. Omai Garner, associate clinical professor and director of clinical microbiology at University of California at Los Angeles Health, also told NBC that in general people should keep their at-home tests between 35 to 86 degrees Fahrenheit.  

That means if someone is ordering at-home tests online they shouldn’t leave them outside after they’ve been delivered or leave them in a car for too long where temperatures can easily fluctuate. 

The ideal location for an at-home COVID-19 test is a dry, room temperature place.  

Another important aspect to using at-home tests is simply reading the instructions, as Mathers explained the process requires a person’s full attention.  

“These are medical tests,” said Mathers.  

“They’re developed for use in medical settings by trained personnel. So, you really, really need to follow the instructions to the exact letter,” Mathers added. 

Garner also pointed out that when it comes to running the at-home COVID-19 test, temperature is even more important as most tests work best when between 65 and 85 degrees Fahrenheit. 

Taking at-home tests outside isn’t recommended, as extreme weather conditions could impact the accuracy as well.  

Lastly, Garner emphasized the most common rapid test mistake is not reading the results within the proper period. 

At-home tests typically require a user to wait 15 to 30 minutes after taking the test for results to appear and reading the results too soon could result in a false-negative. Reading the results too late could also give a false-positive result. 

Though at-home tests are convenient, Michelle Barron, senior medical director of infection prevention and control for UC Health in Colorado, warned they’re only accurate about 80 percent of the time.  

Barron said not to assume an at-home test is accurate if you’re feeling sick and get a negative test result. She also recommended not assuming an at-home test is accurate if you’ve been in close contact with someone who tested positive for the virus and you’re feeling sick.  

“Use your common sense. Do not use a negative result with an at-home test as a free pass to go out if you have symptoms. If you have a sore throat, a runny nose, a headache or any of the other symptoms of COVID-19 and you get a negative test result, you probably have COVID-19 and the test is missing it,” said Barron. 

https://thehill.com/changing-america/well-being/prevention-cures/591679-how-to-properly-store-at-home-covid-19-tests-so