UK to launch daily COVID tests in food sector to tackle 'pingdemic'

 

Daily contact testing will be rolled out to workplaces in Britain's food sector so staff who have been 'pinged' by the COVID-19 app can keep working if they test negative rather than isolating, the government said on Thursday.

Some supermarkets are facing shortages of specific products - mainly those in demand in hot weather - and some petrol stations have had to close after the health app told workers to isolate following contact with someone with the virus.

British newspapers carried front-page pictures of empty shelves in supermarkets, declaring a "pingdemic".

With cases rising to nearly 50,000 a day in the United Kingdom, hundreds of thousands of people have been advised - or "pinged" - by the National Health Service's contact-tracing app to isolate for 10 days.

The government said priority testing sites would be set up at the largest supermarket distribution centres this week, and up to 500 sites would start next week.

"As we manage this virus and do everything we can to break chains of transmission, daily contact testing of workers in this vital sector will help to minimise the disruption caused by rising cases in the coming weeks, while ensuring workers are not put at risk," Health Secretary Sajid Javid said.

Contact testing is designed to limit the spread of COVID-19 by identifying people infected by being in proximity to someone with the virus, either via the app or human contact tracers, but who have no symptoms themselves.

WARM WEATHER LINES

The government said supermarket bosses had downplayed fears of shortages, saying problems were not widespread.

Sainsbury's,

 Britain's second largest grocer, said customers may not be able to find the exact product they want.

"Large quantities of products are being delivered to stores daily and our colleagues are focused on getting them onto the shelves as quickly as they can," a spokesperson said.

Asda, the industry's No. 3 player, said although more staff were being forced to self-isolate the level of absences remained well below what it saw at the height of the pandemic last year.

"We're also not in a position where we would have to close any stores," said a spokesperson.

Product availability was "largely OK across the board" though some stores were short of warm weather lines: beers and soft drinks, bottled water, ice cream and salad leaves.

But smaller rival Iceland said it had closed a number of stores due to staff shortages. BP said it had to temporarily close a handful of petrol stations due to a lack of fuel, with a shortage of HGV drivers exacerbated by COVID-19 isolations.

Official data showed the app had told nearly 620,000 people to isolate in England and Wales in the week up to July 14.

Britain has allowed some workers in critical roles to carry on working, even when "pinged".

Companies must apply for authorisation for their staff, and it will only be granted to designated workers in approved workplaces who are fully vaccinated, the government said on Thursday.

Infections had been rising in Britain for several weeks, but a vaccination programme appears to have weakened the link between infections and deaths, with daily fatalities remaining relatively low.

https://www.marketscreener.com/news/latest/UK-to-launch-daily-COVID-tests-in-food-sector-to-tackle-pingdemic--35916929/

Moderna sets up charitable foundation

 Initial up-front endowment of $50 million

Foundation to support charitable organizations and causes that promote public health, healthcare and educational opportunities, particularly in underserved populations

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is establishing a new charitable foundation to promote public health, healthcare and educational opportunities, particularly in underserved populations. The Moderna Board of Directors has approved an initial up-front endowment of $50 million for the Moderna Charitable Foundation.

"Since Moderna’s founding in 2010, our mission has been about making a transformative positive impact on human lives through our medicines. After a decade of pioneering the development of our mRNA bioplatform, we are humbled to be able to have played such a critical role in combatting the COVID-19 pandemic globally with our vaccine," said Noubar Afeyan, Co-founder and Chairman of Moderna. "We view Moderna’s work as only just beginning. On behalf of our growing team, partners and shareholders, we are determined to extend Moderna’s societal impact through the formation of the Moderna Charitable Foundation. Having experienced the positive impact such charitable foundations can have on those in need, I look forward to the contributions that we will make."

"Moderna is committed to making corporate responsibility a critical part of who we are and what we do with a sense of purpose," said Stéphane Bancel, Chief Executive Officer of Moderna. "We need to embed that sense of corporate responsibility as we commercialize the company, to make sure it is part of our DNA, our culture, forever as we scale. We are passionate about being an active contributor to the communities where we live and work, as well as to global communities impacted by COVID-19 and other diseases. Our recent commitment to provide up to half a billion doses of our vaccine to lower- and middle-income countries through COVAX was a key step in this direction. Now, with the establishment of the Moderna Charitable Foundation, we aspire to make a continuing positive impact - in the decades to come - as we work relentlessly to deliver on our mission for patients."

The Company is establishing the Foundation, which will focus on charitable, scientific and educational endeavors, with particular emphasis on advancing scientific education and innovation, supporting local and global communities, promoting public health and access to healthcare, and advocating for inclusion and diversity. The Company is applying to the U.S. Internal Revenue Service for designation of the Foundation as a 501(c)(3). Moderna expects that the Foundation will commence operations once 501(c)(3) status is approved and anticipates providing further information about the Foundation’s activities at that time.

https://finance.yahoo.com/news/moderna-announces-establishment-charitable-foundation-203000589.html

Quest Diagnostics sees ‘faster than expected’ return in base testing

 Though demand for COVID-19 testing this year has receded faster than many diagnostics companies expected, the quick return of patients to the clinic for routine care—such as screenings for heart disease or cancer—may be picking up the slack.

Quest Diagnostics reported “faster than expected recovery” in its base businesses during the second quarter,  the lab testing giant’s CEO, Steve Rusckowski, said Thursday.

The company posted $2.55 billion in net revenues, an increase of 39.5% over the same three months in 2020, when the first wave of the coronavirus pandemic began in earnest in the U.S. and prompted patients to defer trips to the clinic unless absolutely necessary.

But by then, the first authorized diagnostic tests for COVID-19 were coming to the fore, with Quest and its competitor Labcorp launching testing initiatives in pharmacies and online by late April 2020, before expanding their screening programs nationwide later that May.

For Quest, the tempestuous second quarter of 2020 resulted in only a 6.4% revenue drop compared with the year before, amounting to about $1.83 billion as base testing volumes shifted over to coronavirus screenings. 

Now, with both segments on more solid footing, the company is seeing stronger overall growth, posting a 44.4% increase for the first six months of this year for $5.27 billion.

“This was the first quarter since 2019 that organic base testing revenues grew in the quarter, driven by contributions from new hospital lab management contracts as well as people returning to the healthcare system,” Rusckowski said in a statement. 

“We are well-positioned to continue our momentum and support the return to healthcare in the coming months, which is reflected in the outlook we have provided for the remainder of 2021," he added.

The company said it expects its base businesses to fully recover before the end of the year, and it's forecasting between $9.54 billion and $9.79 billion in revenues—slightly above the $9.44 billion Quest brought in for 2020, which in and of itself was a dramatic 22.1% leap over 2019’s $7.72 billion haul. 

At an investor day earlier this year, Rusckowski said Quest is processing about 1.8 million tests per day, and COVID-19 diagnostics will be a permanent part of the company’s menu. This includes antibody blood tests for gauging immune responses as more people aim to return to daily life. 

Meanwhile, Quest is aiming to work more closely with health plans to capture a larger share of in-network diagnostic tests or become the sole preferred provider. It’s also working to provide direct-to-consumer testing through digital platforms, including through collaborations with telehealth providers like 98point6.

https://www.fiercebiotech.com/medtech/quest-diagnostics-sees-faster-than-expected-return-base-testing-business-over-second

Bluebird, with little fanfare, is first to bring a second gene therapy to market

 

• The European Commission on Wednesday approved Bluebird bio's gene therapy Skysona to treat a form of a rare and potentially deadly neurological disorder called adrenoleukodystrophy.
• The EC cleared Skysona for use in children under 18 who have cerebral adrenoleukodystrophy, a genetic disease in which fatty acids build up in the brain and trigger a harmful immune response that leads to disability and an early death. In clinical testing, Skysona helped keep most trial participants alive and free from developing major disability.
• The approval is specifically for CALD patients who have certain genetic mutations and don't have a sibling who is a match for a stem cell transplant. Bluebird hasn't yet disclosed the cost of treatment, though some Wall Street analysts project a price tag of up to $700,000 per patient.

Bluebird is an important company in gene therapy's reemergence. The company's progress developing treatments for rare genetic diseases early last decade helped boost confidence in gene therapy at a time when the field was still recovering from setbacks. Now, gene therapy is a fast-growing field, with many publicly traded companies, a handful of approved products and dozens of startups raising record levels of investment from venture investors.

But Bluebird has had a bumpy ride since debuting as a public company in 2013. Shares swung wildly over the years amid various clinical delays and manufacturing setbacks, while competition from newer gene editing technologies dimmed the outlook for some of its treatments. At less than $30 per share, Bluebird's stock currently trades at levels not recorded for eight years.

The approval of Skysona reflects Bluebird's up-and-down story. It's a scientific achievement, making Bluebird the first company with two marketed gene replacement therapies. (The company also successfully developed an genetically engineered cell therapy called Abecma for the blood cancer multiple myeloma. Others have multiple cell therapies approved.)

Skysona also represents a medical advance for patients with CALD, more than 80% of whom are estimated to not have a matched sibling donor, according to Bluebird. The gene therapy is meant to be as effective as transplants, but safer. In clinical testing, 27 of 32 patients treated with Skysona hadn't experienced major function disabilities after two years of follow up. The company also hasn't observed instances of the potentially deadly immune responses associated with transplants.

Yet Skysona isn't expected to move the needle much for Bluebird's business. CALD is rare: About 80 patients are diagnosed with the disease in the U.S. and Europe combined each year, according to SVB Leerink analyst Mani Foroohar. Identifying those patients will be a challenge for Bluebird, particularly in Europe, as the Netherlands is currently the only country in the EU that screens newborns for the disease.

"The debate around Skysona is largely focused on the market opportunity and that it's commonly perceived as only incremental," Benjamin Burnett, an analyst at Stifel, wrote in June. He predicts $120 million in peak global sales based on an assumed price of $420,000 in Europe and $700,000 in the U.S.

What's more, Bluebird has already had trouble selling its other gene therapy, the beta thalassemia treatment Zynteglo, in Europe. Difficulty convincing EU member states to cover Zynteglo's $1.8 million price tag, combined with manufacturing issues and a temporarily suspended launch, have resulted in very little use of the product.

Bluebird didn't disclose a price for Skysona. A spokesperson told BioPharma Dive via email that the company will "share additional details at a later date."

Bluebird has said it will file for U.S. approval by mid-year, though the company hasn't yet submitted an application.

https://www.biopharmadive.com/news/bluebird-cald-gene-therapy-approval-europe/603683/

Gene editing biotech Caribou Biosciences ups share offering by 26% ahead of $255 million IPO

 Caribou Biosciences, a Phase 1 biotech developing gene edited cell therapies for multiple cancers, raised the proposed deal size for its upcoming IPO on Thursday.

The Berkeley, CA-based company now plans to raise $255 million by offering 17 million shares at a price range of $14 to $16. The company had previously filed to offer 13.5 million shares at the same range. At the revised deal size, Caribou Biosciences will raise 26% more in proceeds than previously anticipated.

Caribou Biosciences is using its novel CRISPR platform, CRISPR hybrid RNA-DNA, or chRDNA (pronounced "chardonnay"), to develop genome-edited allogenic cell therapies. The company is initially targeting cell therapies for the treatment of cancers with cell surface targets for which autologous CAR-T cell therapeutics have previously shown proof of concept, including CD19, BCMA, and new targets. Caribou's lead program, CB-010, is a CAR-T cell therapy with PD-1 removed from the cell surface. CB-010 is currently in a Phase 1 trial for the treatment of relapsed or refractory B cell non-Hodgkin lymphoma and is expected to report initial data in 2022.

Caribou Biosciences was founded in 2011 and booked $12 million in revenue for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol CRBU. BofA Securities, Citi, and SVB Leerink are the joint bookrunners on the deal. It is expected to price during the week of July 19, 2021.

Relevant Profile: CRBU

https://www.renaissancecapital.com/IPO-Center/News/84501/Gene-editing-biotech-Caribou-Biosciences-ups-share-offering-by-26-ahead-of-

Sanofi-Regeneron's COPD Drug Fails In Mid-Stage Trial; Potential Benefit In Subgroup

 Sanofi SA 

SNY 0.02% and Regeneron Pharmaceuticals Inc REGN 1.02% started their collaboration in chronic obstructive pulmonary disorder (COPD) to target all patients, and the data is pointing them towards former smokers.

What Happened: A phase 2a study, published in The Lancet, showed that the companies' itepekimab, a monoclonal antibody lowered acute COPD exacerbations in former smokers. 

Overall, the study did not meet its goal, but the data did reveal some subgroups and different types of inflammation that could potentially benefit from treatment.

Annualized rates of acute exacerbations of COPD were 1·61 in the placebo group and 1·30 in the itepekimab group (relative risk [RR] 0·81.

When the analysis was restricted to former smokers, treatment with itepekimab was associated with nominally significant reductions in acute exacerbations of COPD (RR 0·58). 

Why It Matters: Current smokers treated with itepekimab showed no treatment benefit versus placebo for exacerbations. 

Treatment-emergent adverse events (TEAEs) occurred in 135 (78%) patients in the itepekimab group and 136 (80%) in the placebo group. 

The most common TEAEs were nasopharyngitis (16% vs. 29%), bronchitis (10% vs. 8%), headache (8% vs. 13%), and upper respiratory tract infection (18% vs. 9%).

The study also includes an arm of active smokers to confirm the lack of effect from itepekimab. Meanwhile, itepekimab has already moved into phase 3 clinical trials in the former smoker population.

https://www.benzinga.com/general/biotech/21/07/22107273/sanofi-regenerons-copd-drug-fails-in-mid-stage-trial-but-shows-potential-benefit-in-subgroup-of-f

Endo settles opioid claims by Tennessee counties, cities for $35M

 Endo International Plc has agreed to pay $35 million to settle a lawsuit by Tennessee local governments and on behalf of a child allegedly born addicted to painkillers accusing the drugmaker of fueling the opioid epidemic, the company announced Thursday.

The settlement came just days before the case was set to go to trial to decide damages, in which plaintiffs were expected to seek $2.4 billion. A judge had previously ruled Endo liable as a penalty for failing to hand over evidence.

The deal must still be approved by some of the plaintiffs, Endo said. Gerard Stranch, a lawyer for the plaintiffs, declined to comment.

Endo shares had jumped about 25% on Tuesday after local government officials revealed that the drugmaker had made a settlement offer.

The lawsuit, which was filed in 2017, is being pursued by nine counties, 18 cities and a "Baby Doe" allegedly born with neonatal abstinence syndrome, which is caused by withdrawal after in-utero opioid exposure.

The plaintiffs alleged that Endo downplayed the risks of its painkiller Opana ER, which was pulled from the market in 2017 due to concerns about abuse. OxyContin maker Purdue Pharma and generic opioid maker Mallinckrodt Plc were also named as defendants in the case, but subsequently filed for bankruptcy, leaving Endo as the only active defendant.

Chancellor E.G. Moody of the Circuit Court for Sullivan County, who is overseeing the case, ruled in April that Endo and its lawyers engaged in a "coordinated strategy" to withhold evidence, including about opioid prescribers. He took the unusual step of entering judgment of liability against the company as a sanction, leaving only damages to be decided at trial.

Nearly 500,000 people died from opioid overdoses in the United States from 1999 to 2019, according to the U.S. Centers for Disease Control and Prevention. The CDC last week said provisional data showed that 2020 was a record year for overall drug overdose deaths with 93,331, up 29% from a year earlier.

The Tennessee case is among the more than 3,000 lawsuits, mostly by local governments, accusing drugmakers of falsely promoting opioids as safe and distributors and pharmacies of overlooking red flags that drugs were being diverted to illegal channels. The defendants have denied the claims.

U.S. state attorneys general on Wednesday unveiled a settlement proposal in which leading drug distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp would pay a combined $21 billion, and drugmaker Johnson & Johnson would pay $5 billion, to resolve most claims against them.

Endo is not part of that deal, and is currently defending itself along with other drugmakers at trials in New York and California. The company in 2019 settled opioid claims by two Ohio counties for $10 million.

https://finance.yahoo.com/news/1-drugmaker-endo-settles-opioid-171058892.html