Category: Japan

  • Japan looks set to follow EU in rejecting Alzheimer’s drug Aduhelm

    The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA an outlier in its stance on the drug. An advisory committee to the Ministry of Health, Labour and Welfare (MHLW) has declined to approve Aduhelm (aducanumab), saying the data from […]

  • Neuro drugs dumped by AbbVie are now heading to Neurocrine for $100M up front

    AbbVie returned the rights to the drugs to Sosei Heptares earlier this year. Now Neurocrine Biosciences has agreed to pay the Japanese drug company $100 million to license the rights to these preclinical and clinical-stage compounds that address muscarinic receptors to potentially treat a range of neurological disorders.

  • First launch for Daiichi Sankyo’s oncolytic virus Delytact in Japan

    Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive form of brain cancer. Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing […]

  • BMS’ Catherine Owen: Hybrid communication is here to stay

    The company’s senior vice president for major markets (Europe, Canada and Japan) talks about the continued evolution of pharma’s approach to communications and commercialisation. The core of Bristol Myers Squibb’s commercial business outside its home base of the US covers most of the large countries in Europe, as well as Canada and Japan. These 19 […]

  • Coronavirus treatments: the potential ‘game-changers’ in development

    After positive clinical trials for antiviral drug Molnupiravir, it joins other medicines that have shown promise Coronavirus – latest updates See all our coronavirus coverage The first clinical trial results showing a positive effect for a pill that can be taken at home has been hailed as a potential gamechanger that could provide a new […]

  • Takeda bags Japanese approval for Crohn’s cell therapy Alofisel

    Takeda has chalked up another milestone for its Alofisel cell therapy for a complication of Crohn’s disease, becoming the first allogeneic stem cell therapy to be approved in Japan. Alofisel (darvadstrocel) has been cleared by the Ministry of Health, Labour and Welfare (MHLW) for the treatment of complex perianal fistulas in patients with non-active or […]

  • Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

    Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies in cholestatic indications The collaboration will utilize Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance the product in Japan Mirum has submitted a maralixibat’s NDA to the US […]

  • Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

    Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

  • Astellas Pharma reports fourth patient death in gene therapy clinical trial

    The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.

  • The Effects of Nutritional Yeast for Cancer 

    How can the beta glucan fiber in brewer’s, baker’s, and nutritional yeast improve wound healing and, potentially, anti-cancer immunity?  My video Benefits of Nutritional Yeast for Cancer opens with an image of an article titled “The Treatment of Inoperable Cancer.” It noted that “200 years ago it was observed that a certain number of malignant growths disappeared after an attack of erysipelas [a type of […]

  • ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

    Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]

  • How to Become a Soy Equol Producer 

    Certain gut bacteria can supercharge the benefits of soy foods, resulting in even more bone protection, better control of menopausal symptoms, and lower prostate cancer risk, but how can we foster the growth of these good bacteria?  “Menopause is characterized by a decrease in estrogen, which triggers the uncomfortable symptoms of hot flushes [also known as hot flashes], night […]

  • Japan’s Moderna Covid vaccine rollout hit by recall and contamination scares

    Foreign materials including stainless steel identified in batches of Covid-19 vaccine though no safety or efficacy issues have been reported The Moderna coronavirus vaccine programme in Japan has been hit by a series of contamination incidents, prompting it to recall 1.63m doses found to contain metal fragments. Other potential contaminants have been identified in separate […]

  • Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease

    Shots: The approval is based on the P-III program including 8 studies evaluating Evrenzo in 9600 patients with symptomatic anemia associated with CKD, regardless of dialysis status & prior ESA treatment. Following the EC’s approval, FibroGen to receive $120M milestones along with royalties based upon EU sales The results demonstrated that the therapy was effective […]

  • Daiichi Sankyo claims first okay for oncolytic virus in Japan

    Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment […]

  • Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

    Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS […]

  • Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan

    Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity and safety clinical trial The interim analysis showed that binding Ab and neutralizing Ab titers were elevated @28days after the second dose in 100% of people vaccinated with two 0.5ml […]

  • What’s Best for Eczema (Atopic Dermatitis): Coconut Oil vs. Mineral Oil vs. Vaseline

    Natural topical remedies for eczema, including licorice root gel, St. John’s Wort cream, and emollients such as coconut oil, mineral oil, and petroleum jelly, are put to the test. Despite the availability of drugs with proven efficacy for eczema, like topical steroids, many patients seek out natural alternatives. Which plant, then, should be used for […]

  • Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

    Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to sev. active UC who had an inadequate response or were intolerant to either conventional therapy or a biological agent Results: patients achieved clinical remission @10wks., maintained remission @ 58 wks. […]

  • Are Lectins in Food Good or Bad for You?

    Might lectins help explain why those who eat more beans and whole grains have less cancer? Lectins are to blame for the great “white kidney bean incident” of 2006 in Japan. One Saturday evening, a TV program introduced a new method to lose weight. The method was simple: toast some dry, raw, white kidney beans […]

  • Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

    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 through 12mos. after the second vaccination. Takeda has completed enrollment […]

  • Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 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 an investigational, oral, purine nucleotide prodrug, currently being evaluated in […]

  • Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine 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 and packaging Additionally, Daiichi Sankyo will continue to work to […]

  • Is White Rice a Yellow-Light or Red-Light Food?

    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 conservative ALARA” approach, reducing exposure As Low As Reasonably Achievable. […]

  • Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 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 Roche will be lead manufacturing and distribution activities outside the […]

  • Cancer Risk from Arsenic in Rice and Seaweed

    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 arsenic-based pesticides, and residual arsenic still contaminates the soil.” Different […]

  • What White Blood Cell Count Should We Shoot for?

    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 bunch of little, round, red blood cells and a few […]

  • Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

    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.

  • Topical Lemon Balm Lotion for Alzheimer’s

    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 “nerve rebirth” in Alzheimer’s patients. Twenty years ago, even simply […]

  • Updating Our Microbiome Software and Hardware

    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 see at 0:12 in my video Microbiome: We Are What […]

  • Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

    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 region, Alinamin. Blackstone plans to develop the business together with […]

  • CPhI Japan rescheduled for Spring 2021 with digital solutions to be launched

    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 new dates will provide more time for the market to […]

  • What Does Drinking Soy Milk Do to Hormone Levels?

    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, act as estrogen-blockers and block the binding of estrogens, such […]

  • First New Drug Application for Dayvigo in Asia outside Japan

    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 the Hong Kong Department of Health. This application is the […]

  • Eating Seaweed Salad May Boost Immune Function

    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 mental. For example, women who eat more seaweed during pregnancy […]

  • Using Green Tea to Help Prevent Cancer and Treat Cancer

    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 away,” as well as the mortician—but what about cancer? As […]

  • What About the Sodium in Miso?

    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 salt a day is correct, then in a country like […]

  • How to Treat Endometriosis with Diet

    “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 treatments overlaid by a painful, chronic, stubborn disease.” Pain is […]