Pfizer asks hourly staffers to return overpayments in aftermath of vendor's cyberattack

 A little extra cash is always a welcome surprise—until your employer asks you to pay it back, that is.

In December, a ransomware attack struck Ultimate Kronos Group, a vendor that Pfizer uses to track work time and pay out hourly staffers, WWMT reported earlier this week. Employees were under- and overpaid as a result, according to a letter from the company obtained by the CBS/CW-affiliated news outlet.

Now, the drug behemoth is repaying those who were shortchanged—but it’s also asking overpaid staffers to return their surplus cash.

One anonymous employee told WWMT they hadn’t realized they were overpaid and had already spent the money Pfizer’s now requesting.

“We all feel this is Pfizer’s payroll mistake,” the employee told the outlet. “We never asked for this money, we were never consulted on whether we wanted extra money.”

"Pfizer has and continues to take a fair and equitable approach to the unforeseen situation created by the Kronos ransomware attack,” a company spokesperson told the news channel. “Our priority always has been to ensure colleagues receive their weekly pay in a timely fashion.”

Pfizer did not immediately respond to Fierce Pharma’s request for comment.

In its letter to employees, meanwhile, Pfizer said those who were overpaid could return the money over one, three or six months. “Please be assured that money will not be taken from your paycheck without prior notification,” the company added.

To compensate employees for their trouble, Pfizer also said it’s offering $250 to those affected by the Kronos outage—however, if the employee was overpaid, that amount will be deducted from the balance they owe.

One employee told the channel they owed more than $800 in overpayment, while another said the issue was affecting hourly workers across the company.

Pfizer isn’t the only corporation dealing with the fallout of last year’s cyberattack. Tesla and PepsiCo have filed a class-action lawsuit that contends Ultimate Kronos Group owes damages because it was negligent in guarding against an attack, Endpoints News points out. 

While Pfizer’s experiencing some headache from this incident, it’s nothing like the Merck & Co. attack back in 2017. The New Jersey pharma was just one of many global companies hit by the Russian military-linked strike in June of that year.

The cyber assault hamstrung Merck’s in-house API production and affected its formulation and packaging systems, plus R&D and other operations.

Merck and its insurers are still fighting over more than $1 billion in losses from the attack, though the company in January notched a win when its insurers lost a bid to exclude the so-called NotPetya incident under an “act of war” exclusion.

The insurers’ rationale? The attack originated from the Russian government as part of its hostility toward Ukraine. Merck, for its part, took the opposite stance, and a New Jersey judge agreed, concluding the act of war exclusion doesn’t apply since it’s intended for actual armed conflict.

Separately, numerous COVID-19 players, Pfizer included, were swept up in a spate of breaches and cyberattacks in 2020. Moderna, AstraZeneca and BioNTech were among those affected, with coronavirus vaccine data often a prime target.

https://www.fiercepharma.com/pharma/pfizer-asks-staffers-return-overpayments-aftermath-timeclock-service-cyberattack

Finch clips wings of hepatitis B program, hitting pause on clinical plan to focus on C. diff and autism

 Finch Therapeutics has joined the ranks of biotechs that are narrowing their focus. With its lead program under clinical hold, the microbiome specialist has pulled out of a planned study in chronic hepatitis B.

Development of CP101 in chronic hepatitis B is on pause after a strategic review persuaded Finch to preserve its cash for programs targeting recurrent Clostridium difficile infection and autism. Finch made the decision to focus on those two internal programs, plus partnered work with Takeda on inflammatory bowel disease, to make the best use of the $133.5 million it had in the bank as of the end of 2021.

The removal of hepatitis B from the list of priority programs at Finch marks a sharp shift in strategy. Back in August, Finch signaled its intent to expand a planned phase 1b in hepatitis B, doubling the number of cohorts to enhance its ability to detect a signal among key exploratory endpoints.

At that time, Finch planned to start the phase 1b trial, RECLAIM, early in 2022. The timeline would have put Finch on track to deliver an initial safety readout in the first half of 2022 and follow up with top-line results in multiple cohorts by the end of the year. Those targets are now delayed indefinitely. 

Finch still plans to advance its autism spectrum disorder prospect, FIN-211, but its progress into the clinic has hit a delay. One month ago, the FDA put Finch’s phase 3 trial of CP101 in recurrent C. difficile on hold as it sought more information about SARS-CoV-2 donor screening protocols for the microbiome therapy. 

The autism candidate is different, but, as it also uses donor-derived components, Finch has determined it will be affected by the FDA’s request. Finch needs to complete additional manufacturing activities for components of FIN-211 and expects at least a one-quarter delay to the start of the phase 1b trial. 

Enrollment in the phase 3 C. difficile trial remains paused, but Finch is working toward the resolution of the impasse. Since disclosing the clinical hold in early March, Finch has sent a complete response to the agency and received additional feedback. Again, Finch expects at least a one-quarter delay.

Each delay moves Finch closer to the end of its cash runway. Finch, which has seen its share price fall 50% to $5 this year, expects its cash reserves to last through to mid-2023. 

https://www.fiercebiotech.com/biotech/finch-clips-wings-hepatitis-b-program-hitting-pause-clinical-plan-focus-c-diff-and-autism

SAB vows to plow ahead with COVID-19 therapy after NIH drops out

 SAB Biotherapeutics is hoping to continue work on its COVID-19 antibody treatment after the National Institutes of Health (NIH) shut down a funded phase 3 clinical trial when the omicron wave slowed earlier this year.

With NIH out of the picture, SAB is hoping to forge ahead with SAB-185, the company said in a fourth-quarter earnings update earlier this week. The company is expecting a full data readout in mid-2022 from a previous phase 2.

SAB said the treatment, which is derived from bovine antibodies, could be used for immunocompromised patients or to help battle future variants of the coronavirus. But the NIH's shutdown of ACTIV-2 leaves the study without enough data to determine statistical significance. SAB-185 was being evaluated in patients with mild to moderate infections at higher risk of progression to hospitalization.

Analysts from Chardan noted that the NIH’s position “does not imply a lack of efficacy for SAB-185,” in a Friday note.

The company is now evaluating ways to continue studying the therapy in COVID-19 patients, especially in targeted patient populations who may benefit. SAB specifically highlighted the potential for use as a prophylactic or therapeutic in high-risk populations. The company is also considering developing an injectable formulation.

SAB says data collected on the candidate already support continued advancement. SAB-185 cleared a phase 2 and was advanced to the phase 3 trial and was shown to neutralize the omicron variant in tests conducted in vitro.

As for its financials, SAB said existing cash and government funding already received through Dec. 31, 2021, will provide a runway into the third quarter of 2023. The company tallied $57.2 million in research expenses for 2021 compared to $27.9 million the year before.

https://www.fiercebiotech.com/biotech/sab-vows-plug-covid-19-therapy-after-nih-drops-out

Despite 0% response rate, 4D hits primary endpoint in Keytruda combo trial

 Can a 0% response rate represent success in an oncology clinical trial? Investors said yes on Wednesday, sending shares in 4D pharma up 30% after enough patients in its Keytruda combination trial had stable disease for the study to hit its primary endpoint.

To meet the primary endpoint in the second part of the kidney cancer trial, 4D needed to show that giving its microbiome therapy MRx0518 in combination with Keytruda provided clinical benefit to more than three out of 30 patients. The trial defined clinical benefit as complete response, partial response or stable disease for at least six months.

So far, 4D has enrolled 20 renal cell carcinoma (RCC) patients who previously progressed after treatment with an immune checkpoint inhibitor. Four of the first 16 evaluable patients had stable disease for at least six months after receiving MRx0518 in combination with Keytruda, causing the clinical trial to hit its primary goal. 

“Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC,” Alex Stevenson, chief scientific officer at 4D, said in a statement. Investors agreed, sending shares in 4D up 30% to over $6 each in premarket trading.

The excitement reflects the early sign that 4D’s live biotherapeutic may be able to enhance the effects of checkpoint inhibitors. Some patients who previously progressed on a checkpoint inhibitor stabilized when they began taking daily capsules of MRx0518. Yet, in a field typically defined by evidence that interventions shrink tumors and prolong lives, success based on stable disease in four patients could be seen as slight.

4D is now preparing for further tests of its candidate. The British biotech plans to talk to its advisory board about the development path, including a potentially pivotal study in RCC patients who are refractory to immune checkpoint inhibitors. 

https://www.fiercebiotech.com/biotech/despite-0-response-rate-4d-hits-primary-endpoint-keytruda-combo-trial-sending-stock-skyward

ACC: Bristol Myers drug helps patients avoid heart procedure amid FDA countdown

 If you’re a patient, avoiding a potentially invasive surgical procedure is a pretty obvious goal—especially if it involves the heart. Bristol Myers Squibb is presenting data this weekend that shows its targeted heart drug mavacamten helped reduce the risk of needing septal reduction therapy.

In the phase 3 VALOR study, mavacamten significantly reduced the need for the procedure in patients with severely symptomatic obstructive hypertrophic cardiomyopathy. In this disease, the wall of the heart thickens, sometimes progressing to the point where blood flow is obstructed.

At the end of the study’s 16 weeks, 82% of patients taking mavacamten had not proceeded with septal reduction therapy and no longer met the criteria for the procedure. In the placebo arm, just 23% patients had the same result. The results are being presented Saturday at the American College of Cardiology’s 71st Annual Scientific Session & Expo.

Septal reduction therapy can be done one of two ways. In the less invasive procedure, a catheter is threaded from the groin up to the heart to inject an alcohol solution to “cause a controlled heart attack,” according to Amy Sehnert, BMS VP and mavacamten clinical development team lead, speaking to Fierce Biotech. The solution kills the heart muscle in a very targeted way to reduce the thickened wall and form scar tissue.

But not all patients are eligible for that less invasive option. For those that are not, the procedure must be done via open-heart surgery to physically remove muscle from the wall in the lower chambers of the heart. Either way, the procedures come with risks.

“They're both very mechanical, they're obviously not treating the underlying cause of the disease or function,” Sehnert said.

Patient may also require a pacemaker or defibrillator post-surgery due to scarring. About 2,500 to 3,000 of these procedures are performed in the U.S. each year, she added.

“Alternative treatment options … appear to be very much desired by the patients themselves and many of them do continue on the study, which was designed to have continuation beyond Week 60,” Sehnert said.

Previous data collected on mavacamten have shown the therapy works well with traditional beta blocker therapies, improved heart function and oxygen consumption. The VALOR trial also has an open label extension.

The VALOR results are the latest to pile on to the record for mavacamten, the heart disease drug BMS picked up from the $13 billion buyout of MyoKardia in 2020. BMS is awaiting an FDA decision on the therapy based on earlier results from the phase 3 EXPLORER program. The FDA is due to make its decision by April 28, a date that slid from January to the spring as the agency worked out a Risk Evaluation and Mitigation Strategy (REMS).

The REMS program was always in the plan given mavacamten’s mechanism of action, according to Marie-Laure Papi, VP and cardiovascular development program lead at BMS. She said the FDA needed a bit more time to work on the program, and BMS continues to work with the agency to fine-tune the details.

“The optimal outcome of the label and the REMS and the approval for mavacamten is to make sure that we continue seeing the excellent benefit-risk profile that we see in the trial, and we think that having a well-defined REMS program will help us achieve that,” said Papi.

Sehnert said the data package BMS has collected so far “has been very satisfying as a clinical researcher,” given its consistency across multiple findings.

https://www.fiercebiotech.com/clinical-data/bristol-myers-heart-drug-helps-patients-avoid-heart-procedures-countdown-fda-decision

Red Cross trying again to escort evacuation convoy out of Ukraine's Mariupol

 The Red Cross was renewing efforts to evacuate civilians in a convoy from the besieged port of Mariupol on Saturday as Russian forces looked to be regrouping for fresh attacks in southeast Ukraine.

Encircled since the early days of Russia's five-week old invasion, Mariupol has been Moscow's main target in Ukraine's southeastern region of Donbas. Tens of thousands of civilians are trapped there with scant access to food and water.

The International Committee of the Red Cross (ICRC) sent a team on Friday to lead a convoy of about 54 Ukrainian buses and other private vehicles out of the city, but they turned back, saying they were unable to proceed.

"They will try again on Saturday to facilitate the safe passage of civilians," the ICRC said in a statement on Friday. A previous Red Cross evacuation attempt in early March failed.

Russia and Ukraine have agreed to establish various humanitarian corridors during the war to allow the evacuation of civilians from cities, and have traded blame when evacuations failed.

People who have managed to get out of Mariupol and through Russian lines to reach the city of Zaporizhzhia described their journey as an ordeal during which Russian soldiers repeatedly stopped them to check for the presence of Ukrainian fighters.

"They stripped the men naked, looked for tattoos," said Dmytro Kartavov, a 32-year-old builder, adding that the troops paid particular attention to the men's knees.

"I work, I do repairs, naturally my knees - these are working knees. They say - (you) climbed trenches, dug, and the like."

Another group said they were stopped around 17 times at Russian checkpoints as they made their way out of Mariupol.

https://finance.yahoo.com/news/top-wrap-3-red-cross-033906214.html

Experimental nasal spray prevents COVID-19 in mouse models

 New research led by a team from Cornell University and the University of British Columbia has demonstrated a novel nasal spray can prevent infection from SARS-CoV-2. The experimental treatment was found to be effective in preliminary animal studies with the researchers now looking to optimize the spray and move to human trials in the near future.

A nasal spray that can protect a person from a SARS-CoV-2 infection is certainly a compelling prospect. Imagine taking a few short puffs in the morning before heading out in the world and knowing that you are protected from one of the most infectious airborne viruses known to humanity. It’s an ambitious goal, and a new study is indicating it could be possible.

An article published in Nature is describing the discovery and development of a new small molecule that can inhibit the entry of SARS-CoV-2 particles into animal cells. The molecule, dubbed N-0385, was discovered as researchers explored a variety of ways to inhibit the mechanisms SARS-CoV-2 uses to enter human cells.

To test the new molecule the researchers turned to a special kind of engineered mouse model. Normal mice, the mainstay of lab research, unfortunately are not useful for most COVID-19 studies because they don’t carry the same receptors that SARS-CoV-2 attaches to in humans. Scientists have, however, genetically engineered a specific mouse model to express those human receptors and enable effective testing of new COVID-19 treatments.

The new research tested intranasal dosages of N-0385 in this particular mouse model and found it effectively prevented SARS-CoV-2 infection. The nasal spray was protective against the original strain of SARS-CoV-2, as well as several variants including Alpha and Delta. It has yet to be tested against Omicron, but the researchers expect it to remain effective.

As well as working successfully as a prophylactic the nasal spray was found to also serve as an effective treatment, reducing disease when it was administered within 12 hours of the animals being exposed to the virus. Hector Aguilar-Carreno, senior author on the study, said this new molecule is unique in its ability to work as both a preventative tool and an antiviral treatment.

"There are very few, if any, small molecule antivirals that have been discovered that work prophylactically to prevent infection," said Aguilar-Carreno. "This is the first of its kind. One advantage is that it works early in the infection, even after someone has already acquired the virus."

The research is not the first to look at developing a nasal spray that can prevent SARS-CoV-2 infection. A human clinical trial is already underway in Australia testing a widely used anti-coagulant called heparin for this very purpose. That Australian research expects to have some results to report later this year.

The team behind N-0385 optimistically suggest it is possible the treatment could be available by the end of the year. But that timeframe depends on large volumes of money being quickly raised and every stage of human trials going perfectly.

It is more likely this research will move a little more slowly as plenty of work is still needed to establish the safety of this new molecule in humans. Aguilar-Carreno does indicate this molecule is promising as it could hypothetically be used to target a number of viral infections such as influenza and other coronaviruses that rely on this same mechanism of cellular entry.

"The N-0385 therapy is simpler and less expensive to mass produce than other types of COVID-19 treatments, such as monoclonal antibodies," added Aguilar-Carreno.

The new study was published in the journal Nature.

Source: Cornell University

https://newatlas.com/health-wellbeing/nasal-spray-prevents-covid19-infection-mice-cornell/