Showing all posts written by Mark Rubinshtein
Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the modular factory consists of six ISO-sized shipping containers that will arrive in Rwanda sometime in early 2023. Reports indicate that the modular units were manufactured in Germany and will be filled and finished by local partners in Ghana and South Africa.
According to reports, this modular mRNA vaccine factory will allow for the bulk production of BioNTech’s COVID-19 vaccine in areas with limited technological resources. Each modular factory “is expected to produce 50 million COVID vaccine doses per year” that will be sold on a not-for-profit basis. BioNTech expects completion of this modular vaccine factory to proceed in parallel with construction of a “state-of-the-art manufacturing facility in Kigali, Rwanda,” which broke ground in June 2022. Additional BioNTainer factories may be shipped to Senegal and South Africa in the near future. BioNTech’s press release explains that these modular vaccine factories are intended to become part of a network to provide African nations with access to its COVID-19 vaccine.
In addition to its COVID-19 vaccine, BioNTech is reportedly “advancing mRNA-based vaccine candidates to address malaria and tuberculosis.” BioNTech initiated early-stage in-human studies for a malaria vaccine candidate in December 2022, and expects additional vaccine candidates to start in-human trials in “early 2023.”
(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox. The U.S., Canada, and Europe have approved an oral formulation for treating smallpox, and Europe has also approved it for treating monkeypox and cowpox. The newly approved intravenous formulation provides an option for patients who are unable to swallow.
The approval is welcome news as over 100 cases of monkeypox have been identified outside its endemic area. Australia, Belgium, France, the U.K., Sweden, Italy, Spain, Portugal, Canada, and the United States have reported cases. The World Health Organization (WHO) warns more cases are likely.
Monkeypox is endemic to Central and West Africa and belongs to a subset of the Poxviridae virus family, which includes smallpox and cowpox. Monkeypox symptoms (fever, sweating, headaches, enlarged lymph nodes) are generally much milder than smallpox. The infection generally spreads from animal to human. However, it can also be transmitted between humans. This can occur through contact with bodily fluids, lesions on the skin or on internal mucosal surfaces, such as in the mouth or throat, respiratory droplets, and contaminated objects.
TPOXX is the first antipoxviral drug approved in the United States.
(December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products.
Edge Pharma issued a voluntary recall for all drug products produced in its FDA-registered 503B outsourcing facility in Colchester, VT. Edge stated that products were removed as a result of “process issues” that may have impacted the sterility of its drug products. The recall includes a wide variety of sterile products. These include lidocaine, vancomycin, norepinephrine, and methotrexate, as well as a number of non-sterile products. The use of non-sterile drug products that are intended to be sterile may result in serious, possibly fatal, infections.
Also this month, Teligent, Inc. issued a voluntary worldwide recall on two lots of their topical lidocaine solution due to superpotency. The two lots had been distributed throughout the United States. Superpotent lidocaine can be dangerous to patients and has the potential to cause systemic toxicity leading to hypotension, brachycardia, and possible cardiovascular collapse. In October, the New Jersey company issued a similar recall in connection with five lots of topical lidocaine solution.
Fortunately, no adverse events related to the December recalls by either Edge or Teligent have been reported.
The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.
Food Allergy & Research reports that as many as 15 million people in the U.S. have food allergies, which results in about 200,000 needing emergency medical care per year. Commenting on the approval, U.S. FDA Commissioner Scott Gottlieb stated:
This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.
Analyst reports indicate wholesalers are not expecting to receive the generic epinephrine autoinjectors from Teva for several months. A Teva spokesperson commented that the company “is applying its full resources to this important launch in the coming months and is eager to being supplying the market.” Currently, Mylan’s EpiPen® 0.3 mg autoinjector 2-pack sells for about $697 at HealthWarehouse.com. Teva has not yet indicated the price of its generic autoinjector.
Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S. market. According to the companies, the device is designed to help patients rehabilitate from conditions leading to lower limb disorders, including spinal cord injuries and strokes. There are currently about 200,000 people in the United States that have such injuries.
According to Cyberdyne, HAL® is the world‘s first cyborg-type robot, by which a wearer‘s bodily functions can be improved, supported and enhanced. Cyberdyne explains that wearing HAL® leads to a fusion of “man,” “machine,” and “information.” HAL works by detecting small electrical signals in the patient’s body through the use of small sensors placed on the skin. The signals are detected by HAL®, which responds with a movement at the joint. Dr. Robert McIver, the director of clinical technology at Brooks Rehabilitation, commented that patients using HAL® have seen greater functional changes in a shorter amount of time than with any other intervention method tried in spinal cord injured patients.
The press release notes that HAL® received approval and marked clearance from the U.S. Food and Drug Administration in 2017. The device was previously only available in the EU and Japan, but has been in use in Japan since 2011. In 2011, the suit was estimated to cost approximately between $14,000 and $19,000, down from the $50,000 cost for the first prototypes unveiled in 2006. The monthly rental for a HAL® suit is expected to be $1,000.
According to USPTO public records, Cyberdyne is a listed assignee of a number of U.S. Patents, including, 9,943,458 and 8,773,148, as well as design patents D749,227, and D786,446. Cyberdyne notes that the International Patent Application relevant to HAL® was accredited as a Notable Invention by the World Intellectual Property Organization (WIPO).
Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic treatments.
According to Da Volterra, many orally administered antibiotics are only partially absorbed in the upper intestinal tract upon ingestion, and much of the administered drug passes into the lower intestinal tract. These drugs can then wreak havoc on the natural intestinal microbiota of patients and allow several potentially harmful bacterial strains to proliferate. In particular, the bacterium Clostridium difficile proliferates and can cause potentially life-threatening infections. DAV132 is co-administered with antibiotics and functions as a non-specific adsorbent that can capture antibiotics in the lower intestinal tract before they can signficantly alter the patient’s microbiota. However, DAV132 is said to be inactive in the upper intestinal tract and does not interfere with the drug’s therapeutic efficacy. The function of DAV132 is demonstrated in the video below.
DAV132 was co-administered with moxifloxacin in a randomized controlled clinical trial performed in 44 healthy human volunteers. According to DaVolterra, Phase I study results show that DAV132 reduced the exposure of intestiinal microbiota by 99% and maintained 97.8% of the microbiome’s genetic richness while protecting 93% of bacterial species. This sharply contrasts to a gene richness of 54% and 39% of bacterial species protected when moxifloxacin was administered alone. Dr. Jean de Gunzburg of De Volterra commented on the results of the study in a recent publication of the Journal of Infectious Diseases:
DAV132 was highly effective to protect the gut microbiome of moxafloxacin-treated healthy volunteers and may constitute a clinical breakthrough by preventing adverse health consequences of a wide range of antibiotic treatments.
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will allow patients to monitor their glucose levels the without painful and inconvenient finger pricks of traditional glucose monitoring.
According to an Abbott press release, the FreeStyle Libre system will allow patients to self-apply the sensor (which is about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with painless scans of a small hand-held reader over the scanner. This is in contrast to traditional blood glucose monitoring, which may require some patients to finger stick up to 12 times per day.
According to the Centers for Disease Control and Prevention, over 29 million Americans have diabetes. The FreeStyle Libre system, which became available by prescription from most retail pharmacies in the U.S. by the end of 2017, should enable patients to better manage their disease. Healthline reports that the product has been available for several to patients in other areas of the world. Dr. Maria Tulpan of Lenox Hill Hospital in New York, NY commented:
What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.
Abbott states that the FreeStyle Libre Flash Glucose Monitoring System is based on proprietary technology and lists over 50 U.S. Patents issued to Abbott Diabetes Care, Inc., that is believes are associated with the device. Representative examples include U.S. Patent Nos. 8,889,305, 9,000,929, and 9,014,774.
According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.
Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within the ENT anatomy during surgery and allows surgeons to track the locations of instruments during procedures, much like a GPS system used for cars. The surgeons can view 3-D structures on a 27-inch, high-resolution touch-screen monitor. Medtronic already markets a similar system, the StealthStation™ S8, for use in neurosurgery and spine procedures.
The press release reports that StealthStation™ ENT system provides surgeons with enhanced visualization during procedures and also includes several software and hardware innovations such as Virtual Endoscopy. Virtual Endoscopy gives surgeons a simulated view of a patient’s sinus cavities that have previously been unavailable using traditional endoscopy. Thus, Medtronic explains, a surgeon can load a Virtual Endoscopy with a patient’s pre-operative data and practice that patient’s surgery prior to setting foot in the operating room.
The StealthStation™ ENT system should enhance patient outcomes and provide a valuable tool to surgeons. Dr. Joseph Raviv, director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem commented:
The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery . . . . It provides an added level of assurance and may allow for a more thorough sinus procedure.
BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital use. The device will be available in the European Economic Area, Iceland, Liechtenstein and Norway.
According to BodyCap, the e-Celsius® device is a disposable electronic capsule coated in a biocompatible medical grade plastic and allows for the continuous and non-invasive monitoring of a patient’s core temperature. The pill wirelessly transmits temperature measurements to a monitor viewable by a health care professional and exits the body in about 1 to 3 days. Sébastien Moussay, co-founder of BodyCap stated:
“The e-Celsius device is a true alternative method to the current use of rectal or eosophageal probes, which are invasive, uncomfortable, generate stress and limit the patient’s mobility.”
“Our device is less intrusive and requires less from the medical staff, while at the same time increasing the well-being of both patients and healthcare personnel by lightening the workload. With the internal memory embedded in each capsule, e-Celsius ensures the monitoring of the patient’s temperature kinetics in real time or deferred time, whatever the measurement conditions.”
BodyCap’s website indicates that the broad medical applications of the e-Celsius® capsule ranges from general diagnostic to monitoring of patients during surgery or chemotherapy. Related e-Celsius® capsules have already been used outside the hospital setting, particularly in the monitoring of athletes. The device has previously been used during athletic events including the New York Marathon and the 2016 Summer Olympics.
Persistent Market Research estimates the market for global ingestible e-pills will reach almost $1.5 billion by the end of 2024. The e-Celsius® capsules reportedly will be sold for a unit price of $42 to $63, depending on volume, according to a MedGadget article.
Other ingestible sensors on the market include products by Proteus Digital Health.
According to public databases, BodyCap is the listed Applicant of U.S. Pat. No. 9,559,290.