Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed… Read More »Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan
Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan
Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos.… Read More »Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan
Shots: Chugai gets exclusive development and commercializing rights for AT-527 in Japan Earlier, Roche and Atea collaborated to jointly develop AT-527. If approved, Atea to distribute AT-527 in the US and Roche will be responsible for global manufacturing and distribution outside the US AT-527 is… Read More »Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan
Shots: Daiichi Sankyo signs an outsourcing Agreement to Manufacture AstraZeneca COVID-19 Vaccine AZD1222 in Japan Following the AstraZeneca’s agreement with the Japanese government to manufacture and supply COVID-19 vaccine, Daiichi Sankyo will use undiluted solutions to manufacture COVID-19 vaccines in the Japan including vial filling… Read More »Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan
Arsenic is not just considered to be a carcinogen; it’s also designated as a “nonthreshold carcinogen, meaning that any dose, no matter how small, carries some cancer risk”—so there really isn’t a “safe” level of exposure. Given that, it may be reasonable to “use the… Read More »Is White Rice a Yellow-Light or Red-Light Food?
Shots: The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval The study showed a reduction in rate of… Read More »AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD
Shots: The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech’s biosimilar portfolio in Japan Fuji Pharma currently owns a minority stake in Alvotech and now can enter new therapeutic areas following the agreement With the extension of the agreement,… Read More »Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan
Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while… Read More »Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan
A daily half-cup of cooked rice may carry a hundred times the acceptable cancer risk of arsenic. What about seaweed from the coast of Maine? “At one point during the reign of King Cotton, farmers in the south central United States controlled boll weevils with… Read More »Cancer Risk from Arsenic in Rice and Seaweed
Shots: The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D The study demonstrated reduced the risk of the composite outcome by 26% along with a… Read More »AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure
At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take a drop of blood, smear it between two pieces of glass, and view at it under a microscope: a whole… Read More »What White Blood Cell Count Should We Shoot for?
Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study… Read More »Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan
The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.
Improving cognitive performance with aromatherapy in young, healthy volunteers is one thing, but how about where it really matters? As I discuss in my video Best Aromatherapy Herb for Alzheimer’s, a group of Japanese researchers had a pie-in-the-sky notion that certain smells could lead to… Read More »Topical Lemon Balm Lotion for Alzheimer’s
Good bacteria, those living in symbiosis with us, are nourished by fruits, vegetables, grains, and beans, whereas bad bacteria, those in dysbiosis with us and possibly contributing to disease, are fed by meat, junk food and fast food, seafood, dairy, and eggs, as you can… Read More »Updating Our Microbiome Software and Hardware
Shots: Takeda and Blackstone sign an agreement to divest it consumer health care business unit for $2.3B. The transaction expected to be closed by Mar 31, 2021 The portfolio to be divested includes OTC medicines and health products along with its lead product in the… Read More »Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan
The clinical trial had already been placed on hold in connection with the two prior patient deaths, which were linked to the higher dose of 300 trillion viral vectors per kilogram, while no deaths have been reported among those receiving the lower dose of 100… Read More »Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial
AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer
Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for… Read More »AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer
Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan
Shots: Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW Solasia will lead clinical development activities in Japan… Read More »Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
CPhI Japan – organised by Informa Markets – announces that, following a detailed review with partners and key industry stakeholders and to ensure the health and safety of our community, the event will be postponed until April 14-16, 2021. The event organiser’s move to the… Read More »CPhI Japan rescheduled for Spring 2021 with digital solutions to be launched
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.
The vast majority of breast cancers start out hormone-dependent, where estradiol, the primary human estrogen, “plays a crucial role in their breast cancer development and progression.” That’s one of the reasons why soy food consumption appears so protective against breast cancer: Soy phytoestrogens, like genistein,… Read More »What Does Drinking Soy Milk Do to Hormone Levels?
TOKYO: Eisai Co., Ltd. announced today that the new drug application for approval of its in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, has been accepted by… Read More »First New Drug Application for Dayvigo in Asia outside Japan
Eating seaweed salad may boost the efficacy of vaccinations and help treat cold sores, herpes, Epstein-Barr virus, and shingles. Billions of pounds of seaweed are harvested each year, the consumption of which “has been linked to a lower incidence of chronic diseases,” both physical and… Read More »Eating Seaweed Salad May Boost Immune Function
Tea consumption is associated with a reduced risk of heart disease, stroke, and premature death in general, with each additional cup of green tea a day associated with a 4-percent lower mortality risk. So, perhaps “drinking several cups of tea daily can keep the doctor… Read More »Using Green Tea to Help Prevent Cancer and Treat Cancer
According to the second World Cancer Research Fund/American Institute for Cancer Research expert report, “[s]alt is a probable cause of stomach cancer,” one of the world’s leading cancer killers. If the report’s estimate of an 8 percent increase in risk for every extra gram of… Read More »What About the Sodium in Miso?
“Endometriosis is a major cause of disability and compromised quality of life in women and teenage girls.” It “is a chronic disease which is under-diagnosed, under-reported, and under-researched…[and for patients, it] can be a nightmare of misinformation, myths, taboos, lack of diagnosis, and problematic hit-and-miss… Read More »How to Treat Endometriosis with Diet