Japan

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 …

The Effects of Nutritional Yeast for Cancer  Read More »

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 …

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

AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan

Shots: AM-Pharma to receive $23.6M up front, $35.4M in milestones before regulatory submission and ~$230.4M upon submission, NHI price listing & sales milestone along with royalties on sales and a drug supply fee Kyowa Kirin to get the exclusive right to develop and commercialize ilofotase alfa in Japan. Ilofotase alfa is currently being evaluated in …

AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan Read More »

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 …

How to Become a Soy Equol Producer  Read More »

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 …

Japan’s Moderna Covid vaccine rollout hit by recall and contamination scares Read More »

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 …

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

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan

Shots: The filing is based on the results from the P-III IMpower010 study assessing Tecentriq (1200mg, IV) vs BSC in 1,005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT Results: 34% reduction in risk of disease recurrence or death in people with …

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan Read More »

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 …

Daiichi Sankyo claims first okay for oncolytic virus in Japan Read More »

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 …

Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal Read More »

AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19

Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III data from the Oxford University-led clinical trial in the UK, Brazil and South Africa, and a P-I/II trial in Japan PMDA recommends the use of Vaxzevria should be limited to …

AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19 Read More »

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 …

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan Read More »

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

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 …

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

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

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. …

Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Read More »

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan

Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III HELP OLE study and interim results of P-III study that evaluated lanadelumab in Japanese patients. If approved, lanadelumab will be available as a pre-filled syringe …

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Read More »

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan

Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III HELP OLE study and interim results of P-III study that evaluated lanadelumab in Japanese patients. If approved, lanadelumab will be available as a pre-filled syringe …

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Read More »

Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan

Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC, prior treated with PD-1/L1 inhibitor, including those who …

Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan Read More »

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 …

Are Lectins in Food Good or Bad for You? Read More »

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 …

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

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. after the second vaccination with primary results expected in CY2021. …

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan Read More »

Your Wednesday Briefing

Syria’s economy in distress.

Your Wednesday Briefing

Syria’s economy in distress.

Your Wednesday Briefing

Syria’s economy in distress.

Your Wednesday Briefing

Syria’s economy in distress.

Your Wednesday Briefing

Syria’s economy in distress.

Your Wednesday Briefing

Syria’s economy in distress.

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 …

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan Read More »

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 …

Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan Read More »

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. …

Is White Rice a Yellow-Light or Red-Light Food? Read More »

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

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 mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA …

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD Read More »

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

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, Fuji Pharma has a leading biosimilar pipeline in Japan. Fuji …

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan Read More »

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 …

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Read More »

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 …

Cancer Risk from Arsenic in Rice and Seaweed Read More »

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

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 reduction in the risk of CV death or worsening of …

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure Read More »

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 …

What White Blood Cell Count Should We Shoot for? Read More »

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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 results: improvement in motor function in people aged 2-25 with …

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan Read More »

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 …

Topical Lemon Balm Lotion for Alzheimer’s Read More »

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 …

Updating Our Microbiome Software and Hardware Read More »

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 …

Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan Read More »

Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial

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 trillion vectors.

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 4 cycles) while in combination with CT and then q4w …

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer Read More »

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 and will be responsible for registrational filing and approval in …

Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan Read More »

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to 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 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 …

CPhI Japan rescheduled for Spring 2021 with digital solutions to be launched Read More »

AstraZeneca, Daiichi Sankyo sign $6B deal for antibody-drug conjugate

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.

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 …

What Does Drinking Soy Milk Do to Hormone Levels? Read More »

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 …

First New Drug Application for Dayvigo in Asia outside Japan Read More »

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 …

Eating Seaweed Salad May Boost Immune Function Read More »

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 …

Using Green Tea to Help Prevent Cancer and Treat Cancer Read More »

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 …

What About the Sodium in Miso? Read More »

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 …

How to Treat Endometriosis with Diet Read More »