Medical Marijuana Allowed in California K-12 Schools

LabRoots | October 11, 2019

Gavin Newson, the governor of California and the leading 2016 proponent of the recreational pot legalization initiative Proposition 64, signed a bill on Wednesday that will allow parents of students in some California school districts to bring cannabis to their children at K-12 campuses. The bill states that medical cannabis can be administered to students by parents on campus if approved by their school board. However, the law indicates that cannabis cannot be administered through vaping or smoking form. Senator Jerry Hill of San Mateo, California, emphasized the importance of the bill in allowing hundreds of students who suffer from illnesses, including epilepsy, to access their prescribed dosages of cannabis oils, pills, and creams. He also explained that for many of these youth, medical marijuana is the only medication that works. This bill will allow them to receive these cannabis products with as little disruption as possible during the school day.  Parents will be required to obtain a doctor's note to administer to their students on campus. There is push back as to whether this bill will be beneficial or harmful to school-aged youth, as well as if it's even necessary to allow administration in the school environment. Scott Chipman of American Against Legalizing Marijuana called the bill "an unnecessary stunt." He notes that the FDA has approved a drug for epilepsy that is administered in the morning and evening. He argues that daily dosages can be taken in the hours before and after school.

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The market for the use of biosimilars in the treatment of rheumatoid arthritis is rapidly expanding as many high-profile therapies come off patent. Despite the increasing number of biosimilars, there remain clinical, regulatory and market access challenges for developers.


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ApiJect Announces Investment by Royalty Pharma and Jefferies

ApiJect Systems Corp. | May 19, 2022

ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment. This investment round values ApiJect at approximately $300 million. The new round was led by Royalty Pharma and Jefferies Financial Group (NYSE: JEF), which acquired a revenue interest in addition to equity. Jefferies and ApiJect's other lenders also converted all of their debt into ApiJect equity, such that following this transaction, ApiJect has no debt on its balance sheet. The funds will be used for continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes. Royalty Pharma and Jefferies are represented on ApiJect's Board of Directors, along with ApiJect co-founders Jay Walker and Marc Koska, and Hanjin In, the CEO of Tae-Chang Industrial Co., Ltd., ApiJect's South Korean cannula supplier. ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies. Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines. "This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world. The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines." ApiJect Chief Executive Officer Jay Walker Mr. Walker further said: "We welcome Royalty Pharma's commitment to the ApiJect mission. Royalty Pharma has a proven track record in selecting successful partners and in assisting in advancing its partners' goals. We could not ask for a better strategic partner from within the pharma industry. In Jefferies, we have a partner that has been with us from virtually the beginning of ApiJect." "We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and Chief Executive Officer. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the U.S. as well as globally. ApiJect is developing a truly innovative technology, that could transform the manufacturing and delivery of life-saving injectable drugs in a way that would also make these medicines safer and more readily accessible for patients around the world." "We are proud of our association with ApiJect and believe strongly that their solutions will be a positive gamechanger in many of the most critical aspects of improving health globally," said Rich Handler, CEO of Jefferies. The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the healthcare professional. This new type of prefilled injector will be ApiJect's first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration. A pen-needle-style hub that turns the BFS container into an injection device. Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging. ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the U.S. critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development. ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually. About ApiJect Systems ApiJect Systems, Corp., is a public-benefit medical technology company working to use our platform to bring more prefilled, single-dose injections to patients everywhere. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own Blow-Fill-Seal packaging lines with ApiJect-licensed technology, or at one of ApiJect's world-class manufacturing partners.

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BUSINESS INSIGHTS

New Interactive App From rXperius Set to Provide Pharma Industry with Vital Patient Experience Insights

rXperius | February 16, 2022

Patients can now provide pharmaceutical manufacturers with real-time feedback on prescription medicines they are taking following the launch of a new app by rXperius, a Raleigh, NC-based company that specializes in the design of innovative technology platforms. The MedXer app, which can be downloaded from the Apple and Google app stores, is the first prescription survey app that allows patients to give feedback on their medications in real time, and over time. MedXer pays patients for their experiences. The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences. MedXer is designed to complement other data analytics on consumer insights that drugmakers are already collecting. “We know how hard it can be for pharma to reach their true end users – patients. Pharmaceutical companies only receive direct feedback from a limited number of patients. Often, they have to rely on second- or third-hand information to gain any kind of understanding of patients’ medicines experiences. MedXer will bring the patients’ story to the manufacturer in a dynamic and actionable way,” Steve Castillo, Founder of rXperius Pharmaceutical companies will have access to an interactive dashboard that is updated daily to reflect the latest information collected through the app. All patient data is anonymized and aggregated before it is shared with third parties. The stakes for the pharmaceutical industry are high; manufacturers only have around five to seven years to recover the money they invest in bringing a medicine to market. A company will typically spend around $3.5 billion developing and launching a drug, but 40 percent of recent drug launches have failed to achieve a return on investment. Since the launch of MedXer on January 1, approximately eight percent of people who have viewed the app have downloaded it, above market trends of 1-2%. MedXer, which is currently available for migraine and depression medications, will be expanded to include medicines from other disease areas following completion of the initial launch phase. About rXperius rXperius is a data analytics startup that was established in 2019 by veterans of the pharmaceutical industry with a combined pharma experience of more than 100 years. rXperius was incorporated in Delaware in 2020 with HQ in Raleigh, NC.

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PHARMACY MARKET

Alpha Cognition Announces Positive Neuroprotection Data from Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury

Alpha Cognition Inc. | February 23, 2022

Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI. “These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.” Denis Kay, the Company’s Chief Scientific Officer In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison. Compared to vehicle treatment, ALPHA-1062 Demonstrated statistically significant reduction in lesion size measured at 35 days after injury. Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression. Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment. Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation. Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.” About Alpha Cognition Inc. Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options. ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.

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PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

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Spotlight

The market for the use of biosimilars in the treatment of rheumatoid arthritis is rapidly expanding as many high-profile therapies come off patent. Despite the increasing number of biosimilars, there remain clinical, regulatory and market access challenges for developers.

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