Cannabis Industry Giant WayofLeaf.com Expands Health-Specific Content, Introduces Medical Review Team

Prnewswire | September 30, 2020

Cannabis Industry Giant WayofLeaf.com Expands Health-Specific Content, Introduces Medical Review Team
In a bid to improve the quality and availability of information on health-specific cannabis use, industry giant WayofLeaf.com has introduced a team of doctors and health experts to review thousands of topics relating to the use of medical cannabis and CBD for specific health conditions. The website, which for years has provided a reliable informational resource for medical cannabis patients, believes it is time for cannabis users of all types to have access to trustworthy, research-backed content on specific conditions and ailments. "There's no shortage of information out there in terms of using cannabis medicinally," says WayofLeaf Medical Director Dr. Lynn Marie Morski. "However there is a need for more trustworthy, research-backed information that medical cannabis and CBD users can rely on."

Spotlight

Alzheimer’s disease (AD) is one of the most common multifactorial diseases, including a range of abnormal cellular/molecular processes occurring in different regions of the brain. This disease is considered to be a major contributor to dementia in elderly people. The pathophysiology involves the accumulation of extracellular plaques containing the β-amyloid protein which is generated by the breakdown of the β-amyloid precursor protein (APP) in the brain.

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PHARMACY MARKET

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

Pfizer | August 17, 2021

Pfizer Inc. and BioNTech SE today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.” Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant. Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the U.S., Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorization is based on information from an independent report evaluating safety and effectiveness of a third dose in people who received solid organ transplants. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm). myocarditis and pericarditis Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

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Argenx lights up bridges, teases documentary in myasthenia gravis awareness push

Fiercepharma | June 08, 2020

Argenx is launching its first awareness efforts for autoimmune disease myasthenia gravis. The campaign began recently with a virtual conference, light-up nights around the country, a patient website debut and the promise of an upcoming documentary. The kickoff event on June 1, which was also the first day of MG Awareness Month, was a virtual meeting of physician and patient speakers along with the first MG Illuminate night that lit up the Zakim Bridge in Boston in the color teal. Throughout the month, more cities across the country⁠—including Kansas City, Los Angeles, Detroit, Minneapolis and Atlanta⁠—will light up buildings, bridges and other structures in teal to draw attention to the disease. Argenx also debuted its first patient-focused website, MG United, which includes financial and emotional well-being resources along with features such as symptom tracking and career management. The site was built on information gathered through meetings and focus groups with MG patients and caregivers, said Keith Woods, Argenx’s chief operating officer.

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How AI is helping pharma cope with supply chain disruption

EPM Magazine | June 25, 2020

As the Covid-19 crisis continues to unsettle global economies and business sectors worldwide, pharma companies are facing huge disruption to their supply chains and clinical research. And while research into potential Covid-19 vaccines and treatments is speeding along, the pandemic has slowed or brought to a halt clinical trials for other diseases, with organisations like Eli Lilly and other big name pharma’s’ putting the brakes on non Covid-19 trial activity. In fact, 50% of respondents in a recent BSI survey said they will be making changes to their supply chain moving forward. In this climate, with pharmaceutical supply chains under so much pressure, businesses are understandably focused on protecting supplier relationships as different parties are forced to cancel agreements, delay their contractual obligations or renegotiate key terms.

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Spotlight

Alzheimer’s disease (AD) is one of the most common multifactorial diseases, including a range of abnormal cellular/molecular processes occurring in different regions of the brain. This disease is considered to be a major contributor to dementia in elderly people. The pathophysiology involves the accumulation of extracellular plaques containing the β-amyloid protein which is generated by the breakdown of the β-amyloid precursor protein (APP) in the brain.