Pfizer and BioNTech forge new COVID-19 vaccine deal with U.S. government

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine. 

The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the agreement, the government will receive 105 million additional doses of the vaccine at the 30 µg, 10 µg and 3 µg dose levels. 

The deal could include an omicron-adapted COVID-19 vaccine, assuming FDA authorizes an updated booster. 

Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to back the use of omicron-containing boosters.

Pfizer announced that it could begin shipping doses for the deal as soon as the late summer and continue into the fourth quarter of 2022. 

The U.S. government also has the option to buy up to 195 million additional doses for a total of 300…

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Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals. [Photo courtesy of Blackrock]Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

Get the full story at our sister site, Medical Design & Outsourcing.

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Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals [Photo courtesy of Blackrock]

Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

“Through this expansion…

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How Cybin aims to maximize the potential of two classical psychedelics 

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression. 

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects. 

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin. 

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…

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Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

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GE Healthcare’s Carescape ventilator battery recall is Class I

(Image from GE Healthcare)

The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind.

GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on batter power only when the battery fails, the ventilation could stop completely, preventing the user from receiving oxygen and breathing support.

Carescape R860 uses main AC power via a wall plug to operate, but has a backup battery intended to keep the ventilator operating for a certain amount of time if a main AC power supply is not available. An example of this occurrence would be a patient transport. Replacement backup batteries are available for use when the original backup battery expires.

The issue can potentially cause a lack of oxygen (hypoxia), especially if it occur…

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FDA places clinical hold on Astellas clinical trial focused on Pompe disease

Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant.

Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead to pain, numbness and weakness.

The FORTIS study had focused on the experimental adeno-associated virus gene replacement therapy AT845 in adults with late-onset Pompe disease.

Pompe disease is a rare genetic disorder associated with the buildup of glycogen in cells. The disease can lead to progressive muscle weakness and reduced life expectancy. Disease progression is associated with the age of onset.

Classic infantile-onset Pompe disease occurs in the first few months of life. Non-classic infantile-onset manifests around 1 year of age while late-onset appears after that — often in adolescence or adulth…

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Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Philips said last year that it wasn’t taking orders for sleep therapy systems as it dealt with the Class I recall that knocked it out of the market for a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.

In April, the Amsterdam-based company revealed a Department of Justice subpoena f…

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First Zantac trial slated for February 2023

[Image courtesy of Wikimedia Commons]

The California State Court Judge overseeing litigation related to Zantac (ranitidine) issued a pretrial order scheduling the first of four bellwether trials for February 13, 2022, in Oakland.

Honorable Judge Evelio M. Grillo for the California Superior Court of Alameda County will preside over the litigation. Before the cases head to trial, Judge Grillo will verify that the experts tapped by the plaintiffs and defendants used sound logic in arriving at their scientific conclusions. Then, if plaintiffs’ experts persuade the judge, the first bellwether trial will proceed.

The heartburn medication Zantac, launched in 1983, was the best-selling drug in history in 1996. First developed by Glaxo Holdings Ltd, ranitidine remained popular until FDA yanked it from the market in 2020. The agency noted that the drug frequently contained the potentially cancer-causing contamin…

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Varian wins FDA IDE for Flash radiation therapy

Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program.

Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second.

The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment of symptomatic bone metastases (FAST-02) with the IDE now secured, according to a news release.

“Receiving IDE approval for FAST-02 reaffirms our confidence in the potential of Flash therapy and represents an important step toward delivering this groundbreaking therapy in a clinical setting,” Varian VP of Flash Solutions Agam Sharda said in the release. “Together with our FlashForward Consortium, we have expanded Flash therapy research using our systems as we work to improve the patient experience. We look forward to continuing to collaborate with experts aro…

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FDA launches 5-year initiative for rare neurodegenerative diseases 

FDA has unveiled its Action Plan for Rare Neurodegenerative Diseases, including amyotrophic lateral sclerosis (ALS).

The plan will involve the use of public-private partnerships and incorporate feedback from patients. The initiative will encompass regulatory science initiatives, changes to existing programs and new policy initiatives.

Milestones of the initiative include the creation of an FDA rare neurodegenerative diseases task force and public-private partnerships for rare neurodegenerative diseases in the fiscal year 2022. In addition, from fiscal years 2022 to 2026, the plan aims to develop disease-specific science strategies.

The initiative is an outgrowth of a Public Law 117-79, the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS) President Biden signed into law on December 23, 2021.

“We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” said…

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FDA prevented 317 drug shortages in 2021

FDA worked with pharma companies to avert a record number of drug shortages in 2021 based on a recent report to Congress that tracked data starting in 2012 when the FDA Safety and Innovation Act (FDASIA) was passed.

In 2021, 115 manufacturers notified the FDA of 777 potential drug and biologic shortages.

Ultimately, the agency worked to prevent 317 drug shortages “through the use of a range of available tools, including regulatory flexibility and discretion when appropriate,” the report noted.

Drug shortages can be especially dangerous when they involve “a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as a shortage of blood pressure medications,” FDA explained in the report.

The report noted that the agency continues to keep a close watch on the medical product supply chain, which has grown less reliable during the pandemic.

The report notes that drug shortages quadrupl…

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