Philips recalls ventilators, sleep apnea machines due to health risks

 Dutch medical equipment company Philips has recalled some breathing devices and ventilators because of a foam part that might degrade and become toxic, potentially causing cancer, it said on Monday.

Foam used to dampen the machines' sound can degrade and emit small particles that irritate airways, the group said as it announced the recall. Gases released by the degrading foam may also be toxic or carry cancer risks.

Philips Chief Executive Frans van Houten said the company was one of the largest makers of sleep apnea machines and ventilators. Between 3 million and 4 million would be targeted in the recall, he said.

The group took a 250 million euro ($303 million) charge for the issue after announcing an identical provision in its first quarter-earnings report in April, bringing the total cost of the problem to 500 million euros to date.

Shares in the group were down 4.2% to 44.42 euros by 0850 GMT in Amsterdam.

"We're going to put all our capacity to focus entirely on replacing and repairing these units," Van Houten said in a call, a process he said would likely take a year.

That "has a consequence that we will not be able to serve new customers, so there's going to be a shortage in the field".

Company spokesman Steve Klink said about 80% of the affected devices were machines used to help people with sleep apnea, known as Continuous Positive Airway Pressure (CPAP) machines. Users of those machines were advised to halt usage. Around two-thirds of Philips CPAP machine sales are in the United States.

The other 20% of affected devices were ventilators. Doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks, the company said.

"Philips has received reports of possible patient impact due to foam degradation," the company said in a statement. "To date, there have been no reports of death as a result of these issues."

Spokesman Klink said Philips had received some complaints about the devices, representing 0.03% of those sold in 2020.

The company said the matter would cause "revenue headwinds" in the division making the devices but that would be compensated by strength in other businesses.

It left its full-year financial guidance of "low-to-mid-single-digit" comparable sales growth unchanged.

Philips said it was working with health authorities on a safe replacement for the foam, but that it must first clear testing and regulatory hurdles.

In April, Philips said first-quarter core earnings surged 74% to 362 million euros compared with the same period a year earlier, on a 9% rise in comparable sales.

https://finance.yahoo.com/news/philips-recalls-3-4-million-055353068.html

FDA Declines to Approve Avenue's Non-Opioid Painkiller Again

 Avenue Therapeutics Inc said on Monday the U.S. Food and Drug Administration had once again declined to approve its non-opioid painkiller tramadol, sending its shares about 5% lower in premarket trading.

The FDA has been pushing drugmakers to develop alternatives to opioid-based painkillers, as the United States grapples with the menace of opioid addiction.

The health regulator had previously declined to approve the painkiller in October, stating that it was not safe for the intended population.

The agency said the delayed and the unpredictable onset of analgesia - relief from pain - with intravenous (IV) tramadol does not support its benefit as a monotherapy to treat patients with acute pain.

There is also insufficient data to support that IV tramadol is safe and effective in combination with other drugs, FDA said in its decision that came more than two months after the scheduled target date of April 12.

The FDA did not mention any "Chemistry, Manufacturing and Controls (CMC)" issues in the complete response letter, Avenue said, adding that it disagreed with the health regulator's decision and would continue to seek regulatory approval for IV tramadol.

IV tramadol is being developed by the drugmaker as a potential alternative to conventional opioids for people with acute pain in the United States.

https://www.usnews.com/news/top-news/articles/2021-06-14/us-fda-declines-to-approve-avenues-non-opioid-painkiller-again-shares-drop

Virus outbreaks at Thai factories threaten export sector, recovery

 

A series of coronavirus outbreaks in Thai factories is raising concerns that the export sector could be hit hard, threatening to further undermine an economy as it struggles to recover from the pandemic's crippling blow to the crucial tourism industry.

The virus has swept through over 130 factories, including those supplying international brands, with more than 7,100 cases across 11 provinces, making manufacturing one of the top sources of infections along with prisons and construction camps.

The affected plants are just a fraction of about 63,000 factories in Thailand that employ 3.4 million, government data shows, but officials worry about the impact on exports that have kept the struggling economy moving as income from tourism has collapsed.

In 2020, exports accounted for 45% of gross domestic product. The tourism-reliant economy, a global trade hub, suffered a steep 6.1% contraction last year, and last month the government trimmed GDP growth forecast for this year to 1.5%-2.5% from 2.5%-3.5% previously.

Electronics, rubber gloves, and food are among the export sectors hit by infections, Federation of Thai Industries vice chairman Kriengkrai Thiennukul told Reuters, but he said it was too early to assess the overall impact.

"If it continues the damage will increase so factories have to be fully vaccinated," he said.

Already, some of the manufacturers affected by the outbreak have had to curtail production.

Charoen Pokphand foods Pcl, which exports to 40 countries from Thailand, said a factory that was closed due to infections accounted for 10% broiler chicken production.

Instant noodle maker, Thai President Foods Pcl closed a factory that produces rice vermicelli and rice noodle. Overseas sales accounted for about a third of the company's semi-finished food sales.

Some factories continued partial operations while others have temporarily closed and quarantined their workers. The outbreak has sent industry sentiment tumbling to an 11-month low.

Thailand has recorded a total of 199,264 COVID-19 infections and 1,466 deaths so far, with over 80% of the new cases and 90% of the fatalities reported after April. As of now, only 1.6 million people out of a population of over 66 million have been fully vaccinated.

BUBBLE-AND-SEAL IMPACT

The government has been trying to contain the outbreak with a "bubble and seal" policy, which takes effect when 10% of factory workers are infected. The confirmed cases are then sent for treatment while the remainder are kept at the factory for 28 days.

Workers at factories and in construction camps who live on site - many of them low-wage migrant workers - have been unable to leave their workplace, even if they are not infected. The policy differs from other workplaces affected by the coronavirus.

"It's not appropriate," said Suthasinee Kaewleklai, Migrant Workers Rights Network (MWRN) coordinator in Thailand, adding that authorities should be doing more tests.

Suthasinee said that companies should improve conditions, give more space for social distancing and increase training for workers so those who were healthy could avoid infection and move freely.

The Industry Ministry has given factories until the end of June to upgrade conditions including providing mandatory face masks and administering temperature checks.

A government official defended the bubble and seal policy, saying it allows businesses to continue operations and limits the outbreak.

"Those with symptoms will be sent for treatment, others will be in the bubble, if it spreads it will spread in there and not outside," health official Taweesap Siraprapasiri told Reuters.

"This limits the outbreak and allows business to continue."

https://www.marketscreener.com/quote/stock/CHAROEN-POKPHAND-FOODS-10859580/news/Charoen-Pokphand-Foods-nbsp-Virus-outbreaks-at-Thai-factories-threaten-export-sector-recovery-35595524/

El Salvador bitcoin transfers soar, but still a fraction of dollar remittances

 Small transfers of bitcoin to El Salvador jumped over four-fold in May from a year ago but still represent a small amount when compared to remittances sent in dollars, data shared with Reuters showed.

The Central American country last week became the first country to adopt bitcoin as legal tender, with President Nayib Bukele touting the cryptocurrency's potential as a remittance currency for Salvadorans overseas.

Monthly bitcoin transfers of under $1,000 - a proxy for money sent to the country from Salvadorans working abroad - totalled $1.7 million in May compared to $424,000 year earlier, U.S. crypto researcher Chainalysis found.

Such transfers hit a peak of $2.5 million in March, though a comparison with the previous year was unavailable.

El Salvador is heavily reliant on remittances. In 2019, transfers using traditional money totalled nearly $6 billion - around a fifth of GDP - one of the highest ratios in the world, according to the World Bank.

The sharp increase in bitcoin transfers mirrors trends across Central America, the data showed, one of the first glimpses of crypto use in El Salvador. Yet its minute use versus traditional remittances suggests the cryptocurrency is still a niche tool for Salvadorans.

Chainalysis, which tracks crypto flows for financial firms and U.S. law enforcement, compiles geographical data by analysing web traffic and trading patterns, though the location of transactions can be obscured by virtual private networks.

El Salvador data for October-January was not available.

Bitcoin transfers in Central America https://graphics.reuters.com/ELSALVADOR-BITCOIN/oakpebybzvr/chart.png

REMITTANCE RELIANCE

In its latest report, the World Bank found that for the first three months of 2021, remittances to El Salvador jumped a third year-on-year. Some 95% come from Salvadorans working in the United States, it said.

Bitcoin, in theory, offers a quick and cheap way to send money across borders without relying on traditional and often costly remittance channels. Yet its relative complexity and lack of infrastructure for converting to dollars is widely seen as hampering its use.

While El Salvador sees bitcoin as a useful way for citizens overseas to send funds home, major remittance firms are cautious about offering cryptocurrency services.

Separately, ratings agency Moody's said on Friday that El Salvador's bitcoin law may imperil a deal on a funding programme with the International Monetary Fund (IMF).

The move "carries risks for the financial system, the stability of the country's monetary regime and signals a lack of a coherent economic framework," Moody's said.

The IMF warned on Thursday it had economic and legal concerns over El Salvador's law, widening spreads on the country's bonds.

https://www.yahoo.com/news/exclusive-el-salvador-bitcoin-transfers-142406953.html

Hims & Hers To Expand UK Footprint, Acquire London-Based Honest Health

 Acquisition will further support Company’s mission of making access to personalized health available to everyone; lay the foundation for future expansion into UK & Europe; add best in class distribution capabilities, including pharmaceutical compounding

Hims & Hers Health, Inc., the multi-specialty telehealth platform focused on providing modern personalized health and wellness experiences to all consumers, today announced plans to expand their UK footprint and acquire London-based vertical health platform, Honest Health. Honest Health offers consumers hair loss-related products, including access to compounded products, such as a topical Finasteride with Minoxidil solution when appropriate, through an exclusive relationship with the first UK compounding pharmacy and fulfillment center. The proposed transaction provides Hims & Hers with best-in-class operational capability and infrastructure to support the beginnings of the Company’s long-term plans for expansion across the United Kingdom and Western Europe. Financial details of the transaction will not be disclosed at this time.

https://www.businesswire.com/news/home/20210614005241/en/Hims-Hers-To-Expand-UK-Footprint-Acquire-London-Based-Honest-Health

Glaxo, iTeos to develop cancer drug in up to $2 bln deal

 Britain's GlaxoSmithKline Plc has agreed to pay up to $2 billion to iTeos Therapeutics Inc to develop and sell a potential cancer treatment together, the companies said on Monday.

Boston-based iTeos, whose shares jumped 52% in premarket trading, will receive a $625 million upfront payment and is eligible to get up to $1.45 billion more if the programme meets certain development and commercial milestones.

GlaxoSmithKline is under pressure to shore up its drug pipeline after a report that U.S. activist investor Elliott built up a significant stake in the company. The British drugmaker is also preparing to outline plans to split its consumer products business from its drug operations.

The iTeos deal is to develop EOS-448, a monoclonal antibody that acts as an anti-TIGIT agent, which showed promise in early studies.

Anti-TIGIT treatments are new experimental immunotherapies against certain cancer types. These treatments, including Roche's tiragolumab and Merck & Co vibostolimab, are designed to deactivate a tumour's ability to evade the immune system.

GSK's chief scientific officer Hal Barron, said immuno-oncology had "transformed cancer care" but that less than 30% of patients respond to treatment with the current leading immune checkpoint inhibitors.

The deal with iTeos will make GSK the only company with antibodies targeting the three known checkpoints, which sometimes keep the immune system from fighting cancer cells, GSK said.

EOS-448 is currently being tested in an early-stage study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with GSK's recently approved cancer drug dostarlimab in 2022.

ITeos is eligible to get milestones and royalty payments on sales outside the United States, and the two companies will share both costs of the development and profits in the United States.

https://finance.yahoo.com/news/1-gsk-iteos-develop-cancer-115310429.html

RAPT Therapeutics: Positive Topline Results in Phase 1b Atopic Dermatitis Trial

 Improvements demonstrated in all key exploratory efficacy endpoints - percent change in EASI, EASI-50, vIGA and pruritis NRS - at four weeks following once-daily oral treatment with RPT193

• Further improvement in percent change in EASI, EASI-50 and vIGA observed with RPT193 two weeks after end of treatment
• RPT193 was well tolerated with no serious adverse events
• RAPT plans to advance RPT193 to Phase 2b clinical trial in atopic dermatitis
• Management to host webcast conference call today at 8:30 a.m. ET

Conference call and webcast details
RAPT hosedt a conference call accompanied by a slide presentation today, Monday, June 14, 2021, at 8:30 a.m. ET. The live webcast and audio archive of the presentation is available on the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations. The call can be accessed by dialing (833) 672-0665 (domestic) or (929) 517-0344 (international) and referring to conference ID 4696044. The webcast replay will be available for 30 days.

https://finance.yahoo.com/news/rapt-therapeutics-reports-positive-topline-120000507.html