Japan Liquor Businesses Turn to Non-Alcoholic Drinks to Attract Gen Z

 Bucking the age-old stereotype of hard-drinking college students, Manaka Okamoto considers the next day's schedule before cracking open an alcoholic beverage.

"If I have to get up early, and I think 'Oh, I should hold off on drinking,' then I go for a non-alcohol drink to get a sense of alcohol when I'm drinking alone," Okamoto, 22, said at a Tokyo restaurant. "And of course, when hanging out with friends who don't drink, it's nice to have something to toast with."  

The popularity of low- and non-alcoholic drinks has risen worldwide, accelerated by the pandemic, which led many people to be more health conscious. The global market value for the segment rose to just under $10 billion in 2021 from $7.8 billion in 2018, according to researcher IWSR.

The effect has been especially pronounced in Japan, where the population is shrinking and younger people drink far less than in previous decades. Just 7.8% of Japanese people in their 20s were regular drinkers in 2019 compared with 20.3% of that age group in 1999, according to government surveys.

Facing a steady decline in revenue from alcohol sales, Japan's tax office in July launched a contest seeking ideas on how to stimulate demand among younger people.

Japan's major drinks makers are also looking outside the country for growth. The chief of domestic beer leader Asahi Group Holdings told Reuters last month he saw North America as a key market. Suntory Holdings Group is looking to expand its canned cocktail business there.

At home, the companies are coming up with new ways to improve the bar experience for non-drinkers.

On a recent afternoon in the entertainment district of Roppongi, groups of mostly young women gathered at a no-alcohol "beer garden" set up in the shadow of one of Tokyo's tallest buildings.

Beer gardens are a summer tradition in Japan, but this one - promoted by Suntory and broadcaster TV Asahi - skipped the beer, offering patrons a lineup of mocktails and non-alcohol wine instead.

"Consumers are not enjoying just alcoholic beverages. We think they value more of the communication that's generated when drinking or would like to enjoy the atmosphere of the place where they drink," said Suntory general manager Masako Koura.

Competitor Kirin Holdings Co also offers non-alcoholic wines, cocktails and beer. The company said sales of its booze-free beer were up more than two-fold in the three months through June compared with a year ago.

Sapporo Holdings Ltd said domestic sales of low-alcohol and non-alcoholic beer rose 20% in the half year through June, while canned beer sales slid 4%.

In Shibuya, the newly opened Sumadori Bar - a play on the Japanese words for "smart drinking" - offers elaborate, sugary cocktails that can be made with no alcohol or up to 3%. It offers an environment where everyone can enjoy a drink together, said Mizuho Kajiura, chief executive of the Asahi-led venture.

Kajiura worked for two years in Indonesia and said his experience in the mostly Muslim nation gave him an appreciation for creating hospitable environments for non-drinkers.

"The aim of this bar is to value customers who cannot drink so that they can happily come here with people who do drink," Kajiura said. "If other restaurants and bars can understand our aim, I think they would get more customers."

https://money.usnews.com/investing/news/articles/2022-09-11/japan-liquor-businesses-turn-to-non-alcoholic-drinks-to-attract-gen-z

Dutch shareholders threaten to sue Philips over recall

 

Dutch shareholders association VEB is threatening to take Philips to court over its handling of a worldwide recall of respiratory machines, claiming it caused billions in losses by giving incorrect information to shareholders, Dutch paper FD reported on Monday citing a letter the VEB sent the company.

Philips confirmed it had received a letter from the VEB on Sunday night, providing no details of its content.

https://www.marketscreener.com/quote/stock/PHILIPS-NV-6289/news/Dutch-shareholders-threaten-to-sue-Philips-over-recall-media-41748303/

ESMO: Evidence builds for BioNTech’s amplified CAR-T therapy

 BioNTech has been thrust into the limelight with its mRNA-based vaccines and therapeutics – most notably its Pfizer-partnered COVID-19 shot – but the other side of its business is CAR-T therapies for cancer, and it is making progress in this area as well.

At the ESMO congress, the German biotech reported updated results from a phase 1/2 trial of its lead candidate BNT-211 for solid tumours, which consists of a CAR-T directed at the antigen Claudin-6 on cancer cells, coupled with an mRNA vaccine (CARVac) designed to amplify the activity of the CAR-T.

The vaccine works by stimulating the expression of Claudin-6 on dendritic cells, which present antigens to T cells to encourage them to mount an immune response.

BioNTech hopes this dual approach could unlock the potential of CAR-Ts in solid tumours, a category which so far has proved resistant to this type of cell therapy. Based on that promise BNT-211 was recently awarded Priority Medicines (PRIME) status by the EMA, which could accelerate its passage through regulatory review if it reaches that stage.

The biotech reported preliminary data with BNT-211 in a range of relapsed or refractory advanced solid tumours at the AACR meeting in April, and at ESMO has now brought those results up to date.

The new data comes from 22 patients with relapsed, claudin-6-positive solid tumours – including 13 with testicular cancer and four with ovarian cancer – who were treated with a range of doses with the CAR-T, given either alone or in combination with CARVac.

Of 21 patients who were evaluable, the overall response rate was 33%, with a disease control rate of 67%. One patient had a complete response, another six had partial responses, while seven showed stabilisation of their disease.

BioNTech said the results were particularly encouraging in seven patients with testicular cancer treated with a higher dose level  (1×10⁸ CAR-T cells), with one complete response, three partial responses, and two patients seeing stable disease.

With a target enrolment of 96 patients, there is still a long way to go before the phase 1/2 trial will complete, and give a clearer idea whether BioNTech’s double-headed strategy for CAR-T is able to extend the use of this type of cell therapy from blood cancers into solid tumours.

“This new dataset further supports the encouraging results we have seen for BNT211 to date,” commented Prof Özlem Türeci, BioNTech’s chief medical officer.

“Together with the recently granted PRIME designation for BNT211 in testicular cancer it also reinforces our strategy to combine two of our key technology platforms in hard-to-treat tumour indications,” she added.

https://pharmaphorum.com/news/esmo-evidence-builds-for-biontechs-amplified-car-t-therapy/

Amgen Says Lumakras Cuts Risk of Lung Cancer Progression by 34%

 Amgen Inc's Lumakras pill reduced the risk of disease progression in patients with advanced lung cancer by 34% compared with chemotherapy in a clinical trial, the company said on Sunday.

There was no significant difference in overall survival between the two treatments in the confirmatory study required by U.S. regulators as a condition of accelerated approval for Lumakras. But Amgen said the trial was not designed to detect a survival difference.

The company is also testing whether the drug could be effective against lung cancer earlier in the disease, and said last month a small study of Lumakras combined with immunotherapy found high rates of liver toxicity and that further study was needed.

More detailed results from the 345-patient study, including median progression-free survival - the length of time until the cancer begins to worsen - will be presented on Monday at the annual meeting of the European Society for Medical Oncology (ESMO) in Paris.

Wall Street analysts, such as Michael Yee at Jefferies, have said investors expect a modest benefit of around two months for the Amgen drug over chemotherapy.

Amgen said 33% of Lumakras trial patients experienced serious side effects such as diarrhea and elevated liver enzymes, compared with 40% of chemotherapy patients.

The medication is designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.

"We are offering the choice of a pill ... versus chemotherapy that means going to the hospital," Amgen oncology head Jean-Charles Soria told Reuters.

Lumakras was approved by the U.S. Food and Drug Administration last year under an accelerated pathway for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines.

The agency also asked Amgen to study a lower dose of Lumakras, known chemically as sotorasib. The company said those results are expected in the fourth quarter of this year.

The FDA is slated to make an approval decision on a potential rival KRAS-targeting drug, Mirati Therapeutics Inc's adagrasib, by mid-December.

Mirati in May said adagrasib shrank tumors in 44% of advanced lung cancer patients in clinical trials, but also caused serious side effects in 43% of them.

At the ESMO meeting this week, Amgen is also presenting early data from a trial of Lumakras in combination with other cancer drugs for patients with colorectal cancer.

https://www.usnews.com/news/top-news/articles/2022-09-11/amgen-says-lumakras-cuts-risk-of-lung-cancer-progression-by-34

IDEAYA: Positive Interim Phase 2 Results in Metastatic Uveal Melanoma Combo

 

• Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patients
• Tumor shrinkage observed in 31 of 35 (89%) Any-Line MUM patients
• Median PFS not yet reached and >5 months in evaluable First-Line MUM patients; observed median PFS of ~5 months in evaluable Any-Line MUM patients
• Historical % ORR and median PFS by other therapies in MUM have been low, ranging from ~0% to 5% ORR and ~2 to 3 months median PFS
• Proof-of-concept for use in (neo)adjuvant UM with tumor shrinkage in 5 of 5 ocular lesions, including reductions of ~-74% and -67%, each with improved visual symptoms
• Total UM and MUM annual incidence in US/EU28 projected at over 13,000 patients, and total UM and MUM prevalence in US/EU28 projected at over 110,000 patients
• Targeting to initiate potential registrational trial for Daro + Crizo in First-Line MUM in Q1 2023 and company-sponsored trial for Daro monotherapy in (neo)adjuvant UM in Q4 2022
• ­Investor webcast and call scheduled for Monday, September 12, 2022, at 8:00am ET

IDEAYA Investor Webcast and Conference Call
IDEAYA will host an investor webcast and conference tomorrow morning, September 12, 2022 at 8:00 am ET, to present darovasertib and crizotinib Phase 2 interim clinical efficacy and tolerability data, as well as clinical landscape, potential registrational strategies and expansion opportunities. 

Presenters at the investor webcast and conference call will include Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health, and Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre in Toronto, Canada, and Ocular Melanoma Physician Task Force of Canada Co-Lead, each of whom are key opinion leaders and clinical investigators.   Yujiro S. Hata, President and Chief Executive Officer, and other members of the IDEAYA management team will also present. 

IDEAYA's darovasertib investor webcast presentation, as well as an updated corporate presentation, will be available on the company's website, at its Investor Relations portal (https://ir.ideayabio.com/) in advance of the investor webcast presentation at approximately 6:00 am ET.

https://www.marketscreener.com/quote/stock/IDEAYA-BIOSCIENCES-INC-58457878/news/IDEAYA-Reports-Positive-Interim-Phase-2-Clinical-Results-for-Darovasertib-and-Crizotinib-Synthetic-L-41747774/

Why does NY Legislature allow Hochul’s pay-to-play COVID corruption?

 In the year she’s been in office, Gov. Kathy Hochul has shown she can learn the ropes quickly — the ropes, that is, of New York’s corrupt pay-to-play culture. She’s proven adept at raising tens of thousands of dollars from major real-estate developers coveting special tax breaks, ho hum. But she’s surpassing even her predecessor, Andrew Cuomo, in corrupting that supposedly sacred space: COVID-19 science.

Last week, Albany’s Times Union revealed that Hochul’s administration paid nearly $650 million to a middleman, Digital Gadgets, over the winter for tens of millions of at-home COVID tests at twice the market price. 

It just so happens that Digital Gadgets’ founder and CEO, Charlie Tebele, is a big supporter of the governor. He and his family members have donated nearly $300,000 to her campaign.  

In April, literally weeks after cashing the last multimillion-dollar check from state taxpayers, Tebele kindly hosted a fundraiser for Hochul, at a cost of $4,700. He, his family and his business partners poured more than $150,000 into Hochul coffers that week. 

And a Tebele family member, James, a recent New York University grad, even has a paid job with the Hochul campaign. Young Tebele’s job is . . . fundraising. 

The appearance of corruption is always bad enough. Why didn’t the state long ago forbid any vendors connected with COVID-19 supplies from making political donations? 

In an acute state of emergency, after all, when lives are at stake, we shouldn’t have to even consider whether state officials might be making COVID-related decisions on anything other than your and your family’s health.   

Why did New York pay Digital more than $12 per test when other vendors were selling them to the state at between $5 and $8 at the time?

There are lots of questions here. Maybe Digital’s tests would be cheaper if the manufacturer, AccessBio, cut out the middleman and its undisclosed profit. What value is Digital adding to this supply chain, besides lots of cash for Hochul? 

And why does the Legislature keep allowing Hochul to procure all these tests on an “emergency” basis, thus allowing these shenanigans to go on? 

Digital doesn’t want to answer these questions, so, under a little public scrutiny, it instantly preyed on the public’s fears. It’s trying to distract us from all the donations its principals made to Hochul’s campaign, by using . . . science.

That is, Digital insists it charged so much because the tests it bought, and then resold, were more accurate, as they are made in New Jersey, not China.  

“Because of the reliability of the tests themselves . . . comparing U.S.-made AccessBio tests to inferior-quality tests that were manufactured in China is not valid,” a company spokesperson told the Times Union. The company should know, thanks to its pre-COVID experience as . . . a hoverboard wholesaler. 

No, it’s not nonsense that American manufacturers probably make a better product. But New York could have set exacting accuracy and inspection requirements that only Western-country manufacturing could meet.

The state didn’t do that, says a major supplier. That’s the real scandal.  

As kids go back to school and people (theoretically) go back to work, we’re all supposed to be diligently testing ourselves whenever we feel a tiny bit sick. Test, test, test, they tell us.  

Now, though, a major test seller has told the public that millions of the rest of the tests New York bought — and that many people still have in their homes — are trash. You literally can’t even compare the price of the two, Digital says, because the competitor quality is so “inferior.” 

I’ve got four boxes of tests from Digital’s competitor iHealth — eight tests total — sitting in my bathroom drawer, courtesy of New York state. They do, indeed, say “Made in China” on the box. Shouldn’t I throw them away?

Or, really, shouldn’t Hochul quickly recall the “inferior-quality” iHealth tests, if what Digital says is true?  

It’s the expert. Hochul bought the product it offers at an above-market price because of its expertise and that alone, not because of hundreds of thousands of dollars in cash changing hands.  

More hiding behind the science.  

https://nypost.com/2022/09/11/why-does-the-legislature-allow-hochuls-pay-to-play-covid-corruption/

New private venture tackles riddle of Long Covid, aims to test treatments quickly

 A new, privately funded venture announced today it has recruited more than 20 top scientists and is pouring $15 million raised so far into Long Covid research, with plans to launch clinical trials of treatments as soon as possible. The scientist who spearheaded the Long Covid Research Initiative (LCRI), microbiologist Amy Proal at the Washington state–based nonprofit PolyBio Research Foundation, says the goal is to bring in $100 million. Half would be dedicated to trials, which have thus far been sparse in the field.

When it comes to available funds, LCRI pales in comparison with the behemoth RECOVER initiative at the National Institutes of Health (NIH), which has more than $1 billion to fund Long Covid projects. But RECOVER has also come under fire for its sluggish pace and slow recruitment into its current flagship program, an observational study slated to enroll up to 40,000 people. Proal and others say different, quicker strategies are desperately needed, including more rapid distribution of funds and an embrace of higher risk, higher payoff research.

“We need a spark, we need a philanthropic organization that has a risk tolerance much greater than NIH,” says E. John Wherry, an immunologist at the University of Pennsylvania who is part of LCRI and has been an adviser on some RECOVER grants. Wherry compares NIH money to the bonds in an investor’s portfolio—“lumbering, slow-changing things that give you the core of what you need.” But, “Sometimes to make a rapid change or to pivot in your investment strategy, bonds are not going to be the tool you use,” he says.

NIH said in a statement that the agency welcomes the private initiative because “the public can only benefit from multiple research efforts.” However, the statement called RECOVER “unprecedented” in scale and aim, and said the giant effort will be crucial to giving researchers “a fighting chance at identifying the underlying mechanisms of Long COVID.”

LCRI was born after several patient advocates with Long Covid and a professional background in technology startups approached Proal early this year. “They were like, ‘We want to get better, we want to get better soon,’” Proal says. The advocates considered how to apply their startup mentality to the overwhelming challenge of Long Covid.

“The enormity of the problem really outweighs the size of the response,” says one advocate, LCRI co-founder Henry Scott-Green, a Google product manager. He contracted COVID-19 in August 2020 and subsequently developed Long Covid but has since improved.

The Centers for Disease Control and Prevention estimates more than 40% of U.S. adults have reported contracting COVID-19; of those, nearly one in five may have persistent symptoms. In the months after an infection with the SARS-CoV-2 coronavirus, Long Covid patients can experience crushing fatigue; difficulty thinking; shortness of breath, especially on exertion; and assorted other symptoms. Although Long Covid clinics have popped up in hospitals around the world, they have little to offer in the way of proven therapies. Pharmaceutical companies have been hesitant to invest in research on the syndrome, in part because there are no easy objective methods, such as blood tests, to gauge a treatment’s performance, Proal says.

After talking with the patient advocates, Proal and other Long Covid researchers began contacting additional scientists and initiated weekly meetings. The venture received $15 million from an investment fund led by Vitalik Buterin and from the Chan Soon-Shiong Family Foundation, led by Patrick Soon-Shiong, a billionaire scientist and businessperson. Additional commitments are expected soon, Proal says.

The first $15 million is committed for basic research and will be spread among participating scientists. It will focus on one key issue: whether SARS-CoV-2 persists in Long Covid patients and drives their symptoms. That, Proal says, is “the trend we see the most evidence for,” and she hopes multiple overlapping projects supported by LCRI can tackle the question. Studies will hunt for virus in intestinal, nerve, vascular, and other tissues, including from those procured from autopsies. In imaging studies, researchers will inject antibodies bound to radiotracers that can, in turn, bind to the SARS-CoV-2 spike protein and light up if virus is present in the body. Researchers will also dig deep into immune cell behavior that may reflect viral persistence.

If virus is lingering in the body, antiviral therapies might reduce symptoms. Proal hopes the collaborative can soon begin clinical trials of such therapies, and that its scientists can nail down the kind of biomarkers drug companies crave. “We really think there are tangible outcome measures” that will make assessing therapies more straightforward, Proal says. These could include certain immune signatures or other measures in blood. A working group is considering which drugs or supplements might be tested first.

NIH has said that it, too, expects to launch several Long Covid trials this fall that will include treatments aimed at viral persistence. Those involved in LCRI—and often RECOVER, too—stress that they want to complement each other, not work at cross-purposes. “Most of the people in the collective have a connection to RECOVER, so have an inside track on what’s happening,” says David Putrino, a neurophysiologist and rehabilitation medicine specialist at the Icahn School of Medicine at Mount Sinai. He is part of LCRI and also sits on a RECOVER subcommittee. Knowing what RECOVER is pursuing—and which proposals it’s rejecting—will likely prove useful, he says. “We can chase the things that people are saying ‘no’ to, that hold promise,” he says.

For Wherry, who studies how T cell behavior can be used as a proxy for viral persistence, the collaborative has appeal. He plans to apply to NIH for Long Covid funding but hasn’t yet, partly because grant applications are time-consuming and often rejected, and there can be a lengthy lag to learn the outcome. With LCRI, “in some ways you’re betting on the individual, the idea is so early you know you’ll have to pivot and adjust,” he says.

Putrino cares for Long Covid patients and has been critical of RECOVER in the past, but says he hopes at least for détente, if not friendly cooperation. “No matter what is happening and what’s gone before,” he says, “we need to swallow our pride and work together.”

https://www.science.org/content/article/new-private-venture-tackles-riddle-long-covid-and-aims-test-treatments-quickly