Moderna Inc said on Wednesday its Japanese distribution partner, Takeda Pharmaceutical Co Ltd , planned to initiate the recall of three lots of its COVID-19 vaccine that were suspended due to contamination.
Japan's health ministry said particles of stainless steel were found in suspended Moderna COVID-19 vaccines, but it did not expect they would pose an additional health risk.
Many firms reported logistical troubles, product shortages and a labour crunch which have made it a sellers' market of the goods factories need, driving up prices.
While factory activity remained strong in the euro zone, IHS Markit's final manufacturing Purchasing Managers' Index (PMI) fell to 61.4 in August from July's 62.8, below an initial 61.5 "flash" estimate.
"Despite the strong PMI figures, we think that lingering supply-side issues and related producer price pressures might take longer to resolve than previously expected, increasing the downside risk to our forecast," said Mateusz Urban at Oxford Economics.
In Britain, where factories also faced disruptions, manufacturing output grew in August at the weakest rate for six months. The United States likely suffered a similar slowdown, data is expected to show later on Wednesday. [GB/PMIM]
Canada's economy unexpectedly shrank last quarter and in July, official data showed on Tuesday - hurt by decreases in manufacturing, construction and retail trade - and Australia reported slower growth in the second quarter on Wednesday.
CHINA BRAKES
Meanwhile, Southeast Asia - a low-cost manufacturing hub for many global companies - was hit particularly hard with factory activity shrinking in Vietnam, Indonesia and Malaysia because of virus outbreaks and output suspensions.
And in a worrying sign for the global economy, China's factory activity slipped into contraction in August for the first time in nearly 1-1/2 years as COVID-19 curbs, supply bottlenecks and high raw material prices weighed on output.
China's Caixin/Markit Manufacturing PMI fell to 49.2 in August, from 50.3 in July, breaching the 50-mark separating growth from contraction.
The result was well below market expectations, underscoring the fragile nature of China's recovery that had helped the global economy emerge from pandemic-induced doldrums.
The private survey followed an official PMI on Tuesday, which showed the index falling in August but staying above the 50 mark.
"The elephant in the room for the long North Asia, short ASEAN view is China. This morning, the Caixin Manufacturing PMI followed yesterday's official number South, falling under 50," said Jeffrey Halley at OANDA.
"That rounds out a grim week for China's PMIs as COVID-19 lockdowns and the same supply chain challenges the rest of the world is experiencing erode economic performance."
Export power-houses Japan, South Korea and Taiwan also saw manufacturing activity expand at a slower pace in August, a sign chip shortages and factory shutdowns in the region could delay a sustained recovery from the pandemic-induced slump.
The surveys highlight the pandemic's broadening damage in Southeast Asia, where soaring infections and subsequent lockdown measures have hurt both the service and manufacturing sectors.
Delta variant outbreaks in the region have caused supply chain headaches for the world's largest manufacturers, many of which rely on auto parts and semiconductors made in low-cost bases such as Thailand, Vietnam and Malaysia.
"If the strict lockdown measures continue, Southeast Asia may find it hard to remain a global production hub," said Makoto Saito, an economist at NLI Research Institute.
Japan's PMI eased and new export orders posted their first contraction since January. South Korea's index fell to 51.2.
In Vietnam and Malaysia, activity was hurt by lockdown measures and rising infections that forced some factories to suspend operations. Vietnam saw factory activity shrink while Malaysia's PMI stood at 43.4 in August.
Once seen as a driver of global growth, Asia's emerging economies are lagging advanced economies in recovering from the pandemic's pain as delays in vaccine rollouts and a spike in Delta variant cases hurt consumption and factory production.
Growth in India's factory sector activity slowed as persistent pandemic-related weakness weighed on demand and output, forcing firms to cut jobs again following a brief recovery in July.
Rigel Pharmaceuticals Inc. (RIGL) said that data from NIH/NHLBI-Sponsored phase 2 trial of fostamatinib in hospitalized COVID-19 patients were published in clinical infectious diseases, an official publication of the Infectious Disease Society of America.
The company noted that the results from the 59 patient Phase 2 trial demonstrated that the addition of fostamatinib to standard of care, which included the antiviral remdesivir and the steroid dexamethasone, was well tolerated and associated with clinically meaningful improvement in clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen. Patients treated with fostamatinib had less severe adverse events.
The company noted that the study was not powered to test clinical efficacy, but numerous prespecified secondary endpoints consistently favored fostamatinib, including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU. The study date suggested that fostamatinib may provide an additional therapeutic benefit compared to current standard of care alone.
"Additional studies are needed to confirm the efficacy findings and show how fostamatinib may address the dysregulated immune response observed in COVID-19 patients," said Jeffrey Strich, principal investigator of the study and a physician at the NIH Clinical Center.
The study met the primary endpoint showing fostamatinib did not increase the incidence of serious adverse events compared with placebo.
The overall incidence of serious adverse events by Day 29 was approximately 50% less in the fostamatinib group compared with the placebo group. The most frequent serious adverse event reported by Day 29 was hypoxia, occurring in 1 patient receiving fostamatinib and 3 patients receiving placebo.
At Day 29, in the overall population there were zero deaths in the fostamatinib group compared to 3 in the placebo group.
There were 4 intubated patients in the trial on mechanical ventilation upon enrollment with 2 patients randomized to each treatment group. Both patients in the fostamatinib group were extubated and discharged from the hospital, while both patients in the placebo group deceased.
The company noted that its phase 3 clinical trial in COVID-19, which it expects to complete later this year, will provide the company with further understanding of the safety and efficacy of fostamatinib and its potential as a new therapy for these patients.
In Mid-August, Rigel Pharmaceuticals said that the U.S. Food and Drug Administration did not issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults, due to insufficient clinical data.
Amid reports that the Apple Watch Series 7 is facing production delays and won’t feature any new health sensor technology, a new report today reiterates that the Apple Watch is still “at the center of Apple’s health ambitions.” Apple is exploring a variety of new health features for the Apple Watch for the coming years, the Wall Street Journal says today.
While a report yesterday erroneously suggested the Apple Watch Series 7 could feature blood pressure monitoring capabilities, Bloomberg’s Mark Gurman refuted that possibility in a post on Twitter. As such, the Apple Watch Series 7 is not expected to feature any new health sensors, with the focus instead being on a new design and faster processor.
The Wall Street Journal reports today, however, that Apple still has long-term health ambitions for the wearable, including blood pressure monitoring — but without specific numbers. Again, this feature is not expected to make the cut for the Apple Watch Series 7 this year.
The version of the feature under discussion at Apple would try to show users how their blood pressure is trending, but without providing a baseline measure of systolic and diastolic blood pressure, according to people familiar with these plans. Some employees have raised questions to managers about how useful such a feature would be, the people said, though they cautioned that the feature is still in development and could change.
Long term, Apple is also reportedly studying a “cuffless blood-pressure device, which is theorized as a device that could give a blood-pressure reading without inflating.”
For the Apple Watch Series 8, Apple is said to be investing new sleep tracking features, including the ability to detect advanced sleep patterns and sleep apnea. These features would help the Apple Watch better compete with the latest wearables from companies like Fitbit.
One challenge for Apple in terms of expanding sleep tracking capabilities, however, is battery life. Apple is said to be investigating ways to read data from sensors overnight with as big of an effect on battery life.
Apple is also studying a watch feature that might detect diabetes, the report says. The company is said to be “struggling” with this process, however, and has not made much progress on the efforts over recent years.
This isn’t the first time it has been reported that Apple is studying ways to monitor blood glucose with Apple Watch. Various reports over the years have suggested that Apple is developing a non-invasive glucose monitoring technology, with one report in 2017 indicating that Tim Cook has been seen actively wearing a glucose tracker prototype on his body around Apple’s campus.
Today’s report also adds that Apple is working with the National University of Singapore on a research project to offer “lifestyle coaching for pre-diabetics who wear more invasive blood-glucose monitoring devices from other companies.”
As previously reported by Bloomberg, the Apple Watch Series 8 could feature support for taking a person’s temperature. This would require a new sensor to be added to the Apple Watch. “A planned use for the sensor in 2022 would be for fertility planning, the people said, giving women clues about where they are in their ovulation cycle,” the WSJ report explains.
In the future, Apple reportedly hopes that this. feature could be used to detect fevers, but it’s unclear if that would be available from the start.
Finally, the Wall Street Journal reports that Apple is pushing the FDA to approve updates to existing capabilities of the Apple Watch.
Separately, Apple wants the FDA to sign off on updates to existing watch features. One such update would allow people diagnosed with the irregular heart rhythm known as atrial fibrillation, or AFib, to use the watch feature designed to track that condition, according to the documents and people familiar with the plans. Another would allow the company to alert users if their blood-oxygen level drops, people familiar with the issue said. Today the blood-oxygen sensor provides a reading, but doesn’t alert users, and the AFib feature can only be used by people who say they don’t have that condition.
https://9to5mac.com/2021/09/01/apple-watch-blood-pressure-temperature-more/
Merck & Co Inc MRK.N and partner Ridgeback Biotherapeutics said on Wednesday they had begun enrolling patients in a late-stage trial of their experimental drug molnupiravir for prevention of COVID-19 infection.
The oral antiviral drug will be studied in over 1,300 volunteers to see if it can prevent the spread of the coronavirus.
Merck said in June the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in a separate, ongoing large trial and authorized by U.S. regulators.
The new late-stage study is enrolling participants who are at least 18 years of age and stay in the same household as someone infected with symptomatic COVID-19.
By Emel Akan of The Epoch Times
As the world watches events in Afghanistan unfold, many have started to wonder what the Taliban rule means for the future of the country’s opium production.
Afghanistan is the world’s largest producer of the opium poppy, which is the raw material for heroin, one of the world’s deadliest drugs. The country accounted for nearly 83 percent of global opium production between 2015 and 2020, according to estimates of the U.N. Office on Drugs and Crime (UNODC). And it’s a key supplier for heroin markets across Europe and Asia.
The U.S. military presence failed to curtail opium production throughout the Afghan countryside. For two decades, opiate economy, which includes cultivation of the poppy, processing into heroin, and trafficking, has been a major source of cash for Afghanistan.
Despite its anti-heroin rhetoric, the Taliban has benefited greatly from this opium poppy economy and become a major player in the world’s drug trade.
In its first official press conference in Kabul, the Taliban pledged to end opium cultivation in Afghanistan, in an effort to gain acceptance from the international community.
“Today, when we entered Kabul, we saw a large number of our youth who was sitting under the bridges or next to the walls and they were using narcotics. This was so unfortunate,” Taliban spokesman Zabihullah Mujahid told reporters on Aug. 17.
“From now on, Afghanistan will be a narcotics-free country, but it needs international assistance,” he said, adding that foreign aid is needed to help Afghan farmers switch to alternative crops.
Afghanistan is noted for its high-quality fruits including pomegranates, grapes, and melons. Various international organizations in the past have helped Afghan families grow pomegranates, for example, as an important alternative to opium.
Despite its agriculture sector and rich mineral resources, the country has been critically dependent on foreign aid, which has dried up with the Taliban takeover.
International donors had been providing 75 percent of the Afghan government’s operating budget, Vanda Felbab-Brown, director of the Initiative on Nonstate Armed Actors at the Brookings Institution, wrote in a Chatham House report.
The Biden administration froze nearly $9 billion in Afghan government reserves that were held in the United States. The International Monetary Fund also blocked Afghanistan from receiving nearly $440 million in funds that were scheduled to be sent earlier. And the German government announced a suspension of $300 million in development aid budgeted for this year.
Financial sanctions will also make it difficult for international organizations to provide humanitarian aid to Afghan families.
Hence, the country is expected to drift into a humanitarian and financial crisis soon, according to experts, which may lead the new regime to increase illicit activities, including drug trafficking.
“The immediate effects of the financial squeeze in place is that cash liquidity in Afghanistan may drop, which will drive up inflation—including food prices—while disadvantaging Afghanistan’s poorest and the hundreds of thousands of internally displaced people,” Felbab-Brown wrote.
As in the past, she noted, those who attempt to ban poppy cultivation in rural areas can “find themselves facing significant losses of political capital and violent opposition.”
Gretchen Peters, executive director at the Center on Illicit Networks and Transnational Organized Crime, believes the Taliban shouldn’t be trusted when it comes to its promises to eradicate the poppy trade.
“They pulled a maneuver like that back in the ’90s. They did actually succeed in banning farmers from growing poppy for a year,” she told NPR.
“But the secret was the Taliban were actually sitting on these huge, vast stores of opium. The price of opium went through the roof, and they sold it and made a lot more money than they had the year previous.”
According to Peters, the Taliban will now have full access to the capacities and institutions of state, including its banking system, airlines, and border crossings, which would make its drug trafficking a lot easier.
Recently, poppy cultivation has expanded in most regions of the country, soaring 37 percent in the past year alone, according to UNODC.
https://www.zerohedge.com/markets/amid-sanctions-taliban-expected-double-down-drug-trafficking
Royal Philips (NYSE: PHG; AEX: PHIA) today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the US. The vast majority (>80%) of the registered affected devices in the US to date are in the first-generation DreamStation product family.
Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US [2].
Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.
