Porsche, Ferrari's Plan To Save Combustion Engines Involves "eFuels"

 With many automakers transitioning from petrol-powered vehicles to electrified ones, Porsche and Ferrari are pursuing a new strategy by concentrating on the advancement of eFuels to preserve gas-powered engines. This decision follows the European Commission's delay last week of the proposed 2035 ban on new internal combustion engine vehicles as the commission prepares to carve out a role for eFuels after 2035.

"Porsche and Ferrari's status as national icons was enough to move their governments to challenge the EU plan last week just days before a scheduled vote," Bloomberg wrote. 

Germany's Transport Minister Volker Wissing told the European Commission that he would withhold support for the approval of the new engine standards to end the sale of new combustion engine cars unless there were a plan for eFuels post-2035. Italy also threatened to fight the reforms.

European Commission President Ursula von der Leyen met with German Chancellor Olaf Scholz on Sunday, discussing a comprise that would likely involve eFuels. 

Germany and Italy are home to the world's top sportscar manufacturers. There has been growing opposition against Brussels' plan to ban petrol-powered engines. That's because who in their right mind would purchase an all-electric Porsche 911? 

The alternative route, mainly for sportscar brands, is the development of eFuels as a climate-neutral way to preserve combustion engines—just something about the sound of a twin-turbo V-8 or V-6 that captivates motorheads.

While most carmakers are pouring tens of billions into the EV shift, Porsche has also invested in an e-fuel plant in Chile, partly because the manufacturer doesn't plan to make its 911 sports car with a plug. Operating combustion-engine vehicles in a climate-neutral way could also help speed up the decarbonization of the transport sector, according to a Porsche spokesman. Existing vehicle stock should be included in the push to lower CO2 emissions faster, he added. Ferrari has said it's pursuing alternative fuels to keep making combustion-engine cars that preserve its heritage.

Proponents of e-fuels, say they're essentially renewable electricity that's been converted into a combustible, liquid fuel. To make it, scientists combine captured carbon dioxide with hydrogen that was split from water in a process powered by renewable energy, creating a synthetic hydrocarbon fuel. When burned in a combustion engine, the e-fuels create carbon dioxide. But since it was made from previously captured CO2, they argue it's climate neutral.

We've outlined the growing resistance among vehicle brands and motorsport organizations that are firm in their belief the combustion engine will be sticking around for years to come. 

• Mercedes-AMG Boss Says V-8 Engine Will Be In Demand For "Next Ten Years"

• Formula 1 Boss: We "Will Never Switch To Electric"

• Ducati Says 'Battery Technology Not Ready' For E-Bike

It's straightforward, the push for eFuels for sportscars will likely preserve the combustion engine, but the cost per gallon might make the cost to operate the vehicle so expensive that only the rich will only be able to afford it. 

https://www.zerohedge.com/technology/porsche-ferraris-plan-save-combustion-engines-involves-efuels

Biden proposes to raise taxes on high earners to avert Medicare funding crisis

 The White House will propose raising taxes on people earning more than $400,000 and reduce what Medicare pays for prescription drugs in a bid to keep the program stable, the Washington Post reported on Tuesday.

"The president's budget extends the life of the Medicare Trust Fund by at least 25 years," the report said citing the plan.

The White House's proposal would raise the net investment income tax, created by the Affordable Care Act, from 3.8% to 5% for all Americans earning more than $400,000 per year, according to the report.

The White House did not immediately respond to Reuters' request for comment.

https://sports.yahoo.com/biden-proposes-raise-taxes-high-101017246.html

Omission Of Children's COVID-19 Vaccine Deaths In Australia Raises Concerns

 by Victoria Kelly-Clark via The Epoch Times (emphasis ours),

An Australian senator has said he is concerned about the country’s therapeutic authorities’ delayed approach to updating Australia’s Database of Adverse Event Notifications (DAEN) after it was revealed the government body had neglected to include a number of deaths attributed to the vaccine, including that of two children aged 7 and 9.

This comes after a Freedom of Information request by an Australian doctor revealed the Australian pharmaceutical and drug administrator, the Therapeutic Goods Administration (TGA), had not updated its DAEN with the deaths.

Australian Liberal Party senator, Gerard Rennick, told The Epoch Times that he was deeply concerned about the TGA’s failure to update DAEN and is calling for there to be some independent oversight on the TGA, given the conflict of interest.

“A third independent medical party should examine the evidence as the TGA has a conflict of interest because they approved the vaccines and would therefore be held responsible for the deaths of these children due to poor regulatory oversight,” Rennick said.

The senator noted that he was highly concerned that the TGA had soft-pedalled the risks involved with the COVID-19 vaccines, especially those around myocarditis and cardiac arrests.

“They are definitely downplaying the risks. They do not have enough information to rule it out given the known link between the vaccines and myocarditis and myocarditis and cardiac arrests,” Rennick said.

As of March 6, the DAEN states that since the beginning of the vaccination rollout in Australia, 137,576 adverse events have been reported relating to the range of COVID-19 vaccines. Of those, 134,224 are believed to be directly related to the vaccines, while 980 are vaccine-related deaths.

TGA Independent Review Board

The TGA does have a pre-existing independent review vehicle for vaccines called the Vaccine Safety Investigation Group (VSIG).

The group is meant to provide independent specialist immunisation (and other relevant) expertise to assist the TGA in investigating and managing Adverse Event Following Immunisation (AEFI) that require the services of national-level experts.

The group is described as a time-limited working group that can be convened when a single serious AEFI that is unexpected and without an obvious non-vaccine cause occurs. The TGA notes that an AEFI is considered unexpected when it is not listed in the product information document for the vaccine or is listed, but causality has not been established.

https://www.zerohedge.com/geopolitical/omission-childrens-covid-19-vaccine-deaths-australia-raises-concerns

Made in the USA? Proposed rule clarifies grocery meat labels

 Shoppers could soon find it easier to tell if those grocery store steaks or pork chops were really “Made in the USA.”

Federal agriculture officials on Monday released new requirements that would allow labels on meat, poultry or eggs to use that phrase -- or “Product of USA” -- only if they come from animals “born, raised, slaughtered and processed in the United States.” That’s a sharp change from current policy, which allows voluntary use of such labels on products from animals that have been imported from a foreign country and slaughtered in the U.S., but also on meat that’s been imported and repackaged or further processed.

Imports of beef from countries including Australia, Canada and Brazil, for instance, account for about 12% of the total consumed in the U.S. Overall, imports of red meat and poultry account for less than 6%, while imports of eggs account for less than half of 1%.

U.S. Department of Agriculture Secretary Tom Vilsack said the proposed rule would better align the labels with consumers’ views. A survey commissioned by the USDA found that nearly two-thirds of shoppers believed that a “Product of USA” label meant that most or all meat production steps occurred in the U.S.

“There’s obviously a disconnect between what the consumers’ understandings and expectations are and what the label currently is,” Vilsack said in an interview.

About 12% of all meat, poultry and egg products sold in the country carry the U.S.-origin labels, USDA officials said.

The label change was first proposed by President Joe Biden in 2021 and was included last year in a series of steps to bolster the U.S. meat and poultry supply chain.

The USDA survey, conducted last summer, included a nationally representative sample of more than 4,800 American adults who do the grocery shopping for their families and who bought beef or pork in the previous six months. More than 40% of the shoppers said they look for the USA label when buying meat.

The rule was praised by consumer advocates and representatives for U.S. ranchers and farmers, including the U.S. Cattlemen’s Association, which petitioned the USDA for the label change in 2019.

“The proposed rule finally closes this loophole by accurately defining what these voluntary origin claims mean,” said Justin Tupper, the group’s president. “If it says ‘Made in the USA,’ then it should be from cattle that have only known USA soil. Consumers have the right to know where their food comes from, full stop.”

Thomas Gremillion, director of food policy for the Consumer Federation of America, said the change is a “small but important step” that should have been made long ago.

Under the current rule, Gremillion noted, a cow can be raised in Mexico under that country’s regulations for feed and medications, then shipped across the border and slaughtered that same day to make ground beef and steaks that qualify as “Product of USA.”

Carrie Balkcom, executive director of the trade group American Grassfed Association, said the existing rule also penalizes small domestic producers.

It’s expensive to raise grass-raised animals from scratch,” Balkcom said. “And these large producers were importing these animals raised elsewhere and just repackaging them and then kind of coasting on the ‘Made in the USA’ label.”

An official with the North American Meat Institute, which represents large firms that process most of the meat and poultry products sold in the U.S., said she hadn’t seen details of the new rule. But Sarah Little added, the group “opposes overly prescriptive labeling requirements that will raise prices for consumers.”

Another industry group, the National Cattlemen’s Beef Association, has called for eliminating the voluntary USA labels entirely and allowing for strict labeling standards verified by the USDA.

The voluntary labeling rules are different from country-of-origin labels, known as COOL, which required companies to disclose where animals supplying beef and pork are born, raised and slaughtered. That requirement was rolled back in 2015, after international trade disputes and a ruling from the World Trade Organization.

Country-of-origin labels are still required for other foods, including fish, shellfish, fresh and frozen fruits and vegetables and more.

Companies won’t have to prove that their products are American-made before using the labels, but they will have to file documentation. The proposal applies only to meat, poultry and eggs, products overseen by the USDA’s Food Safety and Inspection Service, which can pull the label if companies are found to violate the rule.

The label proposal is open for public comment before it becomes final.

—-

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

https://apnews.com/article/meat-usa-label-usda-290b54baa34844011c71d7ef4b4e046f

FDA removes leash from Lilly Verzenio in early breast cancer

 Eli Lilly’s Verzenio is already one of its fastest-growing products, but could go up another gear following a pair of FDA approvals that expand its eligible patient population – particularly in early-stage breast cancer.

CDK4/6 inhibitor Verzenio (abemaciclib) was the third drug in the class to reach the market, first approved in 2017 as a second-line treatment for post-menopausal patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer after endocrine therapy.

The drug's use expanded into the first-line setting in combination with endocrine therapy in 2020, and the following year it also got a green light as adjuvant (pre-surgery) treatment alongside endocrine therapy for HR+/HER2- early breast cancer, where patients test positive for a biomarker called Ki-67.

Verzenio remains the only drug in the CDK4/6 class to be approved for adjuvant use in early breast cancer, which has helped it to buoyant sales growth, up 84% to nearly $2.5 billion last year.

In the first of the two new approvals, the FDA has cleared use of Verzenio in patients with early-stage breast cancer without the need to test for Ki-67 – something that the company had previously said was holding back growth of the drug as it was not routinely used.

That means the drug can now be prescribed to patients at high risk of recurrence based on other clinical factors like tumour size and grade, or whether their disease has infiltrated the lymph nodes, without a test, lifting the brake on its use in early breast cancer.

The new approval is based on the results of the monarchE study, which found that adding Verzenio added to adjuvant endocrine therapy reduced the risk of recurrence by 35% compared to adjuvant endocrine therapy alone.

In the second approval, the FDA has lifted the restriction to post-menopausal on use of Verzenio in advanced breast cancer, making it an option for all adults including pre- and peri-menopausal women who represent around 17% of the total patient population.

The new approvals are important for Verzenio’s sales growth as it tries to take market share from Pfizer’s first to market CVDK4/6 drug Ibrance (palbociclib), which currently leads the category with sales of $5.1 billion but saw a slight decline last year.

Ibrance failed the PALLAS trial as adjuvant treatment for early breast cancer, giving Verzenio its own territory in the CDK4/6 market.

Pfizer’s drug was also recently approved for use in pre- and peri-menopausal women with advanced breast cancer based on the results of the PALOMA-3 study, but both Ibrance and Verzenio are playing catch-up in the category with Novartis’ Kisqali (ribociclib), which got a green light four years ago following the MONALEESA-7 trial.

Novartis meanwhile is also looking to muscle in on the adjuvant setting with the NATALEE trial of Kisqali, due to generate results later this year. The CDK 4/6 drug made $1.2 billion in sales last year, up 38%.

Lilly is clear that the adjuvant approval will have the most impact on both its drug and patients.

"This expanded approval will allow us to bring Verzenio to many more women and men with HR+, HER2-, high risk early breast cancer in the curative setting – before patients experience recurrence, potentially to incurable metastatic disease," said Jacob Van Naarden, chief executive of the drugmaker's Loxo@Lilly subsidiary.

"The initial adjuvant approval for Verzenio changed the treatment paradigm, and the strength of the monarchE results supporting this approval underscores the role this differentiated CDK4/6 inhibitor can play in reducing the risk of recurrence in early breast cancer."

https://pharmaphorum.com/news/fda-removes-leash-verzenio-early-breast-cancer

WeightWatchers to buy Sequence telehealth, enter obesity drug prescription business

 WW International Inc, known as WeightWatchers, said on Monday it is acquiring subscription telehealth platform Sequence, moving the weight-loss program operator into the obesity drug prescription business.

WeighWatchers said it expects its $132 million acquisition in cash and stock will complement its nutrition and behavior-change program for weight loss at a time when obesity drugs are seen as one of the biggest markets for drugmakers.

Analysts have forecast the global obesity market to be worth around $50 billion in sales in 2030.

"As science advances rapidly, we know there is a significant opportunity to improve outcomes for those using medications," WeightWatchers Chief Executive Officer Sima Sistani said in a statement.

Launched in 2021, Sequence now serves about 24,000 members across the U.S., as of February 2023, and clocks about $25 million in annual revenue on a run-rate basis.

The telehealth platform's website says its clinicians can prescribe medications like Novo Nordisk's Wegovy and Saxenda, and Eli Lilly's Mounjaro.

Currently, Wegovy and Saxenda are approved drugs for obesity in the United States, with tirzepatide also widely expected to be approved for it later this year.

In December, Eli Lilly CEO David Ricks called the drug one of its "generational opportunities". The drug was last year approved for diabetes, for which it is sold under the brand Mounjaro.

https://www.yahoo.com/lifestyle/weightwatchers-buy-sequence-telehealth-enter-002739408.html

Europe will lose out on medical innovation if draft EU reforms pass, Novo Nordisk CEO says

 Europe will lose out to countries like the U.S. and Japan on new medical research, trials and treatments unless draft rules reforming the European pharmaceutical landscape change, the CEO of Danish drugmaker Novo Nordisk warned on Thursday.

The European Commission will present its proposed overhaul of the bloc's pharmaceuticals regulation on March 29, the first major revisions to medicines rules in 20 years. It says drugs need to reach patients more quickly and in all European nations.

Novo's Lars Jorgensen lamented that without changes to the current draft, his company would be forced to research, test and bring products in its pipeline to market in the United States and elsewhere, instead of in Europe.

Novo is the world's biggest producer of diabetes drugs, and Jorgensen said that while the company shares the European Union's wish that patients across Europe have access to the same treatments, Brussels' proposal would delay access for Europe as a whole as companies like his would work elsewhere.

"You're not getting the health benefit and you're not getting the economic activity level from the industry, either. A lose, lose, lose," he said in an interview.

Consumer groups say the changes would make things fairer, for example by shaving off two years of exclusivity on new products unless companies introduce them simultaneously in all 27 member states.

The pharma industry, lobbying hard against parts of the draft, counters that this will introduce uncertainty over whether investment costs will be recouped before generic competition enters, while putting up regulatory hurdles that even the biggest companies will struggle to clear.

EU Health Commissioner Stella Kyriakides told Reuters on Thursday that any changes to the current system would "aim to strike the right balance" between equal access and promoting innovation "and a globally competitive EU industry".

https://www.yahoo.com/lifestyle/europe-lose-medical-innovation-draft-183318708.html