Sanofi, GSK receive nod for Phase 3 trial of Covid-19 vaccine candidate in India

 Sanofi and GSK have received approval for their Phase 3 clinical study in India to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate.

The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America, Sanofi said in a statement on Thursday.
"India is participating in Sanofi Pasteur's pivotal Phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," Sanofi Pasteur India, Country Head, Annapurna Das said.
As the virus continues to evolve," we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program," she added.

The primary endpoint of the study is the prevention of symptomatic Covid-19 in SARSCoV-2 naive adults, with secondary endpoints being the prevention of severe Covid-19 disease and prevention of asymptomatic infection, Sanofi said.
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain, while a second stage will evaluate a second formulation targeting the Beta variant, it added.
The design of the Phase 3 study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants, the statement said.
Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein Covid-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.

https://timesofindia.indiatimes.com/india/sanofi-gsk-receive-nod-for-phase-3-trial-of-covid-19-vaccine-candidate-in-india/articleshow/84232909.cms

Walgreens; VillageMD to Open 500 to 700 Full-Service Doctor Offices in Next 5 Years

 Walgreens Boots Alliance, Inc. (Nasdaq: WBA) and VillageMD announced today that Walgreens will be the first national pharmacy chain to offer full-service doctor offices co-located at its stores at a large scale, following a highly successful trial begun last year.

This expanded partnership will open 500 to 700 “Village Medical at Walgreens” physician-led primary care clinics in more than 30 U.S. markets in the next five years, with the intent to build hundreds more thereafter.

The clinics will uniquely integrate the pharmacist as a critical member of VillageMD’s multi-disciplinary team to deliver the very best healthcare to patients, and will be staffed by more than 3,600 primary care providers, who will be recruited by VillageMD.

The clinics will accept a wide range of health insurance options, and offer comprehensive primary care across a broad range of physician services. Additionally, 24/7 care will be available via telehealth and at-home visits. More than 50 percent will be located in Health Professional Shortage Areas and Medically Underserved Areas/Populations, as designated by the U.S. Department of Health and Human Services.

This rollout follows a trial with five in-store clinics in the Houston, Texas area, which produced very strong results after opening last November including high patient satisfaction, with Net Promoter Scores over 90.

This integrated model has never been more important – six in 10 Americans today live with at least one chronic condition requiring multiple daily medications. Data from current Village Medical clinics shows that an integrated pharmacy and primary care approach increases medication adherence and contributes to improved patient outcomes.

“This rollout is a major advancement of one of Walgreens Boots Alliance’s four key strategic priorities, Creating Neighborhood Health Destinations,” said Stefano Pessina, executive vice chairman and CEO, Walgreens Boots Alliance. “These clinics at our conveniently located stores are a significant step forward in creating the pharmacy of the future, meeting many essential health needs all under one roof as well as through other channels.”

 “In the U.S., we spend $4 trillion per year on healthcare, over 85 percent of that is tied to patients with chronic diseases. To improve our healthcare system and reverse the trajectory of health spending, we must meet the needs of all patients. This partnership allows us to unleash the power of primary care doctors and pharmacists, enabling them to work in a coordinated way to enhance the patient experience,” said Tim Barry, chairman and CEO, VillageMD. “The results of our initial pilot clinics highlight that these outcomes are infinitely achievable.”

Most of the clinics will be approximately 3,330 square feet each, with some as large as 9,000 square feet. They will optimize existing space in the store, which will also still provide a vast range of retail products to customers.

VillageMD and Walgreens also recently announced the availability of Village Medical telehealth providers on Walgreens Find Care™, which is an online platform that connects patients with a wide range of health services.

Under the terms of the new agreement, WBA will invest $1 billion in equity and convertible debt in VillageMD over the next three years, including a $250 million equity investment to be completed today.

Of WBA’s investment, 80 percent will be used by VillageMD to fund the opening of the clinics and build the partnership, including integration with Walgreens digital assets.

It is anticipated, assuming full conversion of the debt, that WBA will hold an approximately 30 percent ownership interest in VillageMD at the completion of the investment.

https://www.villagemd.com/press-releases/walgreens-and-villagemd-to-open-500-to-700-full-service-doctor-offices-within-next-five-years-in-a-major-industry-first-0

COVID-19 infections in England have quadrupled since June

 COVID-19 infections in England have quadrupled in a month since early June, a large prevalence study showed on Thursday, ahead of Prime Minister Boris Johnson’s plan to fully re-open the economy in two weeks’ time.

Johnson said he aimed to end most legal coronavirus restrictions on July 19, even though models suggested cases would rise, saying that he was reconciled to more deaths from COVID-19 but that life needed to return to normal.

According to the research, led by Imperial College London, cases were estimated to be doubling every six days as a new wave fuelled by the Delta coronavirus variant picks up pace. (Graphic on UK cases) https://tmsnrt.rs/3wiUQ5v

The study, one of Britain’s largest with 47,000 people returning tests from June 24 to July 5, found national prevalence was 0.59%, or 1 in 170 people, compared with 0.15% in the last round between late May and early June.

“It’s very difficult to make an argument, based on the type of data that we get, that it’s a good thing to open early,” Steven Riley, Professor of Infectious Disease Dynamics at Imperial College London, told reporters.

He added that the government had to take other, non-epidemiological factors into account when making its decision.

The research found that COVID infection rates were three times lower in people under 65 who had received two doses of vaccine compared with those who were unvaccinated, showing the importance of the vaccine rollout in reducing case numbers. (Graphic on global vaccinations) https://tmsnrt.rs/3tUM8ta

There was no direct evidence that the men’s Euro 2020 soccer championships had fuelled the rise in cases, Riley said, but women were 30% less likely to test positive than men, most likely due to different social mixing patterns.

“The degree to which men and women are socialising is likely to be responsible,” Riley said, adding that specific concerns about London’s Wembley Stadium hosting games might not be as important as an increase in indoor mixing around the nation.

“It could be that watching football is resulting in men having more social activity than usual.”

https://whbl.com/2021/07/07/covid-19-infections-in-england-have-quadrupled-since-june-study-finds/

U.S. will not immediately lift travel restrictions - White House

 The Biden administration will not immediately lift any international travel restrictions, even as it faces growing pressure from U.S. business groups and lawmakers, a White House official told Reuters on Wednesday.

In June, the administration launched interagency working groups with the European Union, United Kingdom, Canada, and Mexico to look at how to lift restrictions and eventually resume travel.

"While these groups have met a number of times, there are further discussions to be had before we can announce any next steps on travel reopening with any country," the White House official told Reuters.

"We have made tremendous progress domestically in our vaccination efforts, as have many of these other countries, but we want to ensure that we move deliberately and are in a position to sustainably reopen international travel when it is safe to do so."

https://finance.yahoo.com/news/u-not-immediately-lift-travel-023653964.html

China’s gene giant harvests data from millions of women

 A Chinese gene company that sells prenatal tests around the world has been harvesting genetic data from millions of women.

The company – BGI Group – worked with the Chinese military to develop the tests.

BGI is using the genetic data for sweeping research on population traits.

The U.S. sees it as a security risk.

Government advisors warn that BGI’s vast bank of genomic data could give China a path to economic and military advantage and potentially lead to engineered pathogens or genetically enhanced soldiers.

"I want to know what is happening with such sensitive data about me, such as my genome and that of my child.”

This is Emilia.

She’s one of the more than 8 million women who have taken the BGI prenatal test.

The 32-year-old office administrator spoke to Reuters on the condition that only her first name be used.

She says she did sign consent stating that her genetic data would be stored and used for research.

What she did not realize, however, was that her information could end up in mainland China: BGI’s headquarters and research are based in Shenzhen, but the form she signed did not make this clear.

It said only that her sample would be sent for analysis to Hong Kong.

“I have to admit that the news that my data could’ve been taken over by the Chinese government is shocking for me. After reading the form, I had the impression that I was well-informed about the test and how the data would be used. There was information that, if I agree to it, can be used for further studies to improve the method. But no, there wasn’t much else.

BGI said it had never been asked by the Chinese government to provide the genetic testing data for research.

The companies prenatal test – branded NIFTY - is one of the most popular in the world.

It’s sold in at least 52 countries – though not in the United States.

Tests like this, taken about 10 weeks into a pregnancy, capture DNA from the placenta in the woman’s bloodstream, to detect fetal abnormalities like Down syndrome.

The tests don’t carry names, but they do capture genetic information about the mother -- which the test’s privacy policy says may be shared, for national security reasons. BGI said it hasn’t been asked to do that.

Online records reviewed by Reuters show that the genetic information of at least 500 women – including some outside of China, are also stored in China’s national genebank.

Each row seen here is a different woman.

Reuters could not determine if Emilia’s data is in the gene bank.

BGI records personal details such as women’s country, height and weight.

Researchers say this genetic Big Data can give clues to genes associated with for example bipolar disease, or schizophrenia, link genes to height and body fat, and track viruses.

While the procedure is private – the data is stored.

Reuters found no evidence that BGI violated patient privacy agreements or regulations.

BGI says it never has access to any identifiable personal data.

The company says it only stores location data on women in mainland China, and destroys foreign samples and data after five years.

BGI's collaboration with the military on prenatal research has not been previously reported.

The gene giant is a pivotal player in a genomics race between China and the U.S.

An expert panel led by former Google chief executive Eric Schmidt said in March that the United States should recognize China’s strides in biotechnology and AI as a new kind of national security threat.

BGI did not respond to questions on its military collaboration or the national security threats that the U.S. says its research poses.

China’s Ministry of Foreign Affairs said the report reflected – quote -“groundless accusations and smears" of U.S. agencies.

Over in Poland, Emilia says that if she had understood the extent of BGI's secondary research, she would have chosen a different test.

"This could be a very important matter when choosing a test. For me it would be.”

https://news.yahoo.com/china-gene-giant-harvests-data-122150812.html

Oncology biotech Nuvalent files for a $100 million IPO

 Nuvalent, a preclinical oncology biotech developing small molecule kinase inhibitors, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering.

Nuvalent focuses on clinically proven kinase targets that have demonstrated efficacy and received FDA approval. It seeks to improve upon the limitations of existing kinase inhibitors, including kinase resistance, selectivity, and limited brain penetrance. The company's lead product, NVL-520, is a brain-penetrant ROS1-selective inhibitor and is expected to begin clinical trials in patients with ROS1-positive non-small cell lung cancer and other advanced solid tumors in the second half of 2021, pending the acceptance of its IND.

The Cambridge, MA-based company was founded in 2017 and plans to list on the Nasdaq under the symbol NUVL. Nuvalent filed confidentially on May 28, 2021. J.P. Morgan, Cowen, and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: NUVL

https://www.renaissancecapital.com/IPO-Center/News/83712/Oncology-biotech-Nuvalent-files-for-a-$100-million-IPO

Mark Wahlberg-backed fitness franchisor F45 Training sets terms for $325 million IPO

 F45 Training, a global tech-enabled fitness franchise offering 45-minute workouts, announced terms for its IPO on Wednesday.

The Austin, TX-based company plans to raise $325 million by offering 20.3 million shares (8% insider) at a price range of $15 to $17. New investor Caledonia has indicated an interest in purchasing up to $100 million worth of shares in the offering (31% of the deal). At the midpoint of the proposed range, F45 Training would command a fully diluted market value of $1.5 billion.

F45 Training offers fun, effective, and community-driven functional workouts that combine elements of high-intensity interval, circuit, and functional training exercises. The company's in-studio experience is powered by a database of over 3,900 unique training movements and a team of instructional trainers. As of March 31, 2021, the company had 2,247 Total Franchises Sold in 63 countries, including 1,487 Total Studios, of which 1,286 had re-opened following temporary COVID-19 closures.

F45 Training was founded in 2013 and booked $76 million in sales for the 12 months ended March 31, 2021. It plans to list on the NYSE under the symbol FXLV. Goldman Sachs, and J.P. Morgan are the joint bookrunners on the deal. It is expected to price during the week of July 12, 2021.

Relevant Profile: FXLV

https://www.renaissancecapital.com/IPO-Center/News/83721/Mark-Wahlberg-backed-fitness-franchisor-F45-Training-sets-terms-for-$325-mi