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Wednesday, June 8, 2022

New versions of omicron variant gaining ground in US

 Omicron COVID-19 subvariants BA.4 and BA.5 represent an increasing number of new infections in the country, according to the Centers for Disease Control and Prevention (CDC), though it’s unclear what the impact will be.

New estimates from the CDC show that for the week ending June 4, the two subvariants combined accounted for 13 percent of all new U.S. cases. That’s an increase from the combined 7.5 percent estimated for the week ending May 28.

During the week ending June 4, BA.5 accounted for an estimated 7.6 percent of cases and BA.4 accounted for 5.4 percent of cases, up from 4.2 percent and 3.3 percent, respectively, the previous week.

There are also regional differences in the rise of the new subvariants. In the southern region comprising Louisiana, Texas, Arkansas, Oklahoma and New Mexico, BA.4 and BA. 5 account for about 22 percent of all infections.

Data on BA.4 and BA.5 is limited, though early evidence suggests they are more infectious and may be able to evade some of the immunity people have acquired from being infected with other variants. There isn’t evidence to show they cause more severe disease.

It’s still unclear what the rise in the new variants means for the trajectory of the U.S. pandemic, though some public health experts think BA.4 and BA.5 will soon become the dominant subvariants and prolong the current wave of infections. The majority of cases right now are being driven by the omicron subvariants BA.2.12.1 and BA.2.

COVID-19 cases have risen in the U.S. to around 100,000 per day, though the real number could be as much as five times higher given that many cases go unreported.

https://thehill.com/news/3516176-new-versions-of-omicron-variant-gaining-ground-in-us/

Biden’s push to undermine IP rights harms the US and helps Communist China

 The Biden administration is partnering with global organizations and foreign countries on an agreement that will undermine the intellectual property (IP) of American businesses. This will both damage American workers and businesses and will be a giveaway to geopolitical rivals like Communist China and Russia.

Intellectual property is important to the American economy. It includes patents on inventions, copyrighted books and movies and computer software. The value added to new products is largely intellectual property and millions of jobs rely on it, so allowing other nations to steal it is economic suicide.

The World Trade Organization (WTO) will soon consider a proposal to “waive” or remove IP protections for COVID-19 vaccines that exist under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). If adopted, foreign countries would be permitted to seize the patents and clinical data belonging to American businesses.

This would set a dangerous precedent across the world that foreign countries can steal IP from Americans with the support of the United States government. This would threaten American innovation and the millions of high-paying jobs that depend on this manufacturing and would certainly undermine the development of vaccines and treatments for future deadly pandemics.

Thanks to American medical innovation, several highly effective COVID-19 vaccines were quickly developed and distributed. One key reason for this success is the existence of strong IP rights which incentivize manufacturers to innovate, ensure medicines are safe and effective and invest in the next generation of cures. 

Developing new medicines is a costly, risky, and time-consuming process. A manufacturer must invest an average of $2.6 billion, according to the Tufts Center for the Study of Drug Development. In all, just 10 to 20 percent of medicines that begin clinical trials are approved.

Surrendering the IP rights of American manufacturers will undermine this system and threaten the next generation of vaccines. There is no reason for this proposal. There is no shortage of vaccines thanks to the extensive investment in production, increased competition and slowing demand. In India, manufacturers have slowed down the manufacture of new vaccines because they created an overproduction of  200 million doses  — far more than was needed.

IP supports millions of high-paying jobs across the country. According to the United States Patent and Trademark Office (USPTO), IP-intensive industries accounted for $7.8 trillion in GDP in 2019; 41 percent of the economy. These industries accounted for 47.2 million jobs or 33 percent of total U.S. employment.

Medical innovation is no exception — it directly or indirectly accounts for over 4 million jobs across the U.S and in every state, according to research by TEconomy Partners, LLC. The average annual wage of a pharmaceutical worker in 2017 was $126,587, which is more than double the average private-sector wage of $60,705. 

While this will harm U.S. workers and businesses, it will help America’s rivals like Communist China who could use this proposal to seize IP and trade secrets. China has an extensive record of violating property rights, costing the U.S. $225 billion to $600 billion each year in counterfeit goods, pirated software, and theft of trade secrets. 

There is nothing in the WTO proposal to stop further IP theft — although the draft proposal “encourages” countries like China to opt out of the waiver if they do not need vaccines, every country would be eligible to participate in the waiver if they so choose. Even if a more geographically restricted waiver were implemented, China would still acquire U.S. trade secrets and technology via other countries.

Given that this proposal harms American businesses and workers and helps foreign rivals, it should be alarming that the Biden administration has been rushing it through. In fact, the administration has even failed to properly consult Congress as noted by a bipartisan group of senators including Senate Finance Committee Chairman Ron Wyden (D-Ore.), Ranking Member Mike Crapo (R-Idaho), and Sens. Bob Menendez (D-N.J), Chuck Grassley (R-Iowa), Catherine Cortez Masto (D-Nev.), and Ben Sasse (R-Neb.).

They recently sent a letter to the U.S. Trade Representatives (USTR) urging the office to improve transparency and consultation with Congress on pending trade negotiations including the proposed WTO IP waiver.

The Biden administration should withdraw its support for the proposal to undermine IP rights of COVID-19 vaccines. This would undermine the efforts of American innovation and high-paying jobs that rely on IP. Instead, it would help foreign governments like China and serve as an implicit endorsement of the rampant theft of American IP.

Grover Norquist is the president of Americans for Tax Reform.

https://thehill.com/opinion/finance/3515851-bidens-push-to-undermine-ip-rights-harms-the-us-and-helps-communist-china/

ASCO22: New data backs BMS’ investment in Eisai’s first cancer ADC

 Eisai’s first-ever attempt at developing an antibody-drug conjugate for cancer was rewarded with a $3.1 billion licensing deal from Bristol-Myers Squibb, and new data reported at ASCO has given a glimpse into its potential.

Farletuzumab ecteribulin – also known as MORAb-202 – is being developed to treat tumours that overexpress folate receptor alpha (FRα), and combines an antibody targeting the antigen with the cell-killing drug eribulin.

In a small trial reported at ASCO involving patients with FRα-positive ovarian cancer, the ADC achieved an overall response rate (ORR) of 25% at a dose of 0.9 mg/kg and 52% at a dose of 1.2 mg/kg.

In a subgroup of patients with high-grade serous ovarian cancer (HGSOC) – the most common type of ovarian cancer, which tends to spread before it can be detected – MORAb-202 achieved an ORR of 31.6% and 50% at the two dose levels, respectively.

The drug also seemed to retain its efficacy across a range of FRα levels, according to Eisai, which says the ADC seems to target tumour cells that express the antigen on their surfaces, but also kills neighbouring cells in what is known as a ‘bystander effect’.

FRα is considered as a marker of tumour aggressiveness and is associated with poorer response rates to treatment, said the Japanese drugmaker.

The results are an early endorsement of BMS’s sizeable investment in the programme, including an upfront payment of $650 million.

Under the terms of the deal, BMS will share development and commercial rights to MORAb-202 with Eisai in the US and Canada, Europe, China, Japan, and Russia, with exclusive rights elsewhere, and Eisai will be responsible for manufacturing the drug globally.

BMS and Eisai are playing catch-up with Immunogen in the FRα category, as the US biotech already has an ADC in phase 3 testing for platinum-resistant ovarian cancer.

That drug – called mirvetuximab soravtansine – also had new data reported at ASCO from the phase 3 SORAYA trial, which involves patients with FRα-positive ovarian cancer who have previously been previously treated with one to three prior therapies including Roche’s VEGF-targeting antibody Avastin (bevacizumab).

After 120 days’ follow-up, 71.4% of patients saw their tumours reduced with the drug and treatment was associated with a median overall survival of 13.8 months.

Lead investigator Ursula Matulonis of the Dana-Farber Cancer Institute said the data are “impressive” and support mirvetuximab soravtansine’s potential “to become the first biomarker-directed agent indicated for patients with platinum-resistant ovarian cancer”.

https://pharmaphorum.com/news/asco22-new-data-backs-bms-investment-in-eisais-first-cancer-adc/

Abbott makes progress with wearable for diabetic ketoacidosis

 Abbott is already a big player in the wearable glucose-monitoring sector, and has started working on a new device that will measure both glucose and ketones, potentially serving as a warning system for a life-threatening complication of diabetes known as ketoacidosis.

The system – which already has a breakthrough device designation from the FDA – will take the form of a small patch-like device similar to Abbott’s FreeStyle Libre 3 device (pictured above), and a prototype version is already in clinical testing.

Diabetic ketoacidosis (DKA) is a build-up of substances called ketones in the blood that can happen if a patient’s blood glucose levels are too high for too long and is caused by a lack of insulin, which results in body fat being broken down for energy.

If ketone levels rise too far, patients can pass out, go into a coma, and even die if levels of ketones aren’t quickly reduced. In the US alone, there are hundreds of thousands of emergency room visits and hospitalisations for DKA each year.

According to Abbott, there is a pressing need for a continuous glucose-ketone monitor for individuals who are at higher risk of developing ketoacidosis.

That includes children and young adults with type 1 diabetes, as well as patients with type 1 or 2 diabetes who have other health issues – such as infections – that can contribute to elevations in blood glucose levels. With continuous monitoring, rising ketone levels can be detected early.

At the moment, however, few people with diabetes are regularly monitoring their ketones because the current methods of testing using blood or urine samples can be costly and burdensome, said the company in a statement on the new development.

Abbott’s programme comes amid calls for continuous ketone monitoring from a number of diabetes specialists, including clinicians on a panel organised by the Diabetes Technology Society, who drew up a checklist of recommendations for glucose and ketone monitoring devices last year.

The Juvenile Diabetes Research Foundation (JDRF) organisation meanwhile has welcomed Abbott’s programme, saying that continuous glucose-ketone monitoring will be the key to bringing the incidence of DKA down.

JDRF CEO Aaron Kowalski said the devices would also enable broader use of SGLT2 inhibitors, a class of medicines that “improve blood glucose and are expected to improve heart and kidney outcomes for people with type 1 diabetes but have been held back because they increase the risk of DKA.”

The new wearable is scheduled to start pivotal trials next year, said Abbott.

It has been designed to slot into the company’s digital platform for patient monitoring – which also includes mobile apps for patients and caregivers and cloud-based data management software for healthcare workers – and pair with insulin pumps.

https://pharmaphorum.com/news/abbott-makes-progress-with-wearable-for-diabetic-ketoacidosis/

Apple adds medication tracking to iPhone and Apple Watch

 Owners of an iPhone or Apple Watch have a new health feature, an app called Medications, that will help them manage and track their use of medicines.

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Users can also use the built-in health records feature on the Health app to download current medications, said Ricky Bloomfield, a former director of mobile strategy at Duke University who joined Apple as clinical and health informatics lead in 2016 in a tweet.

Medications will issue a reminder when it is time to take one, with the user indicating whether they have taken or skipped a dose, and will keep a record of usage. A customised picture and background can be assigned to each medicine to help avoid errors.

In the US, it will also be able to alert users if there are any interactions between drugs they have added to the Health app that could make them less effective or cause unexpected side effects, said Apple. For example, it can warn of possible issues like mixing drugs like metronidazole or cetirizine with alcohol.

Other features include compatibility with Apple’s health data sharing facility, which allows information to be shared securely with healthcare staff or carers, and the ability to export a medications list into a PDF.

New atrial fibrillation feature

Medications was just one of the health-focused updates released as Apple previewed its new iOS 16 and watchOS 9 operation systems at its Worldwide Developers Conference this week. Another was a new feature for the Apple Watch, which has a built-in ECG that can already be used to identify signs of atrial fibrillation (AFib), a potentially serious heart condition.

Now, users who are diagnosed with AFib can turn on an FDA-cleared AFib History feature that provides another layer of information, including an estimate of how frequently a user’s heart rhythm shows signs of AFib.

They will receive weekly notifications to understand frequency and view their AFib history in the Health app, including lifestyle factors that may influence the condition, like sleep, alcohol consumption, and exercise.

A similar documenting approach has been applied to the Sleep app, which is used to maintain healthy sleep habits and track sleep patterns.

The update expands the information available by using the Apple Watch’s accelerometer and heart rate sensor to detect sleep stages – i.e. REM, core and deep sleep – using machine learning techniques.

https://pharmaphorum.com/news/apple-adds-medication-tracking-to-iphone-and-apple-watch/

Nutex Health Acquires 55,755 SF Hospital in North San Antonio

 Nutex Health, a Houston-based provider that owns and operators 21 facilities across eight states, has acquired a 55,755-square-foot facility in north San Antonio. According to LoopNet Inc., the 65-bed facility was built on 4.1 acres in 1971. Zach Leger of NAI Partners represented Nutex Health in the transaction. Chad Gunter of Transwestern represented the seller.

https://rebusinessonline.com/nutex-health-acquires-55755-sf-hospital-in-north-san-antonio/

Iveric started at Buy by Guggenheim, B of A

 Targets $30 and $18, respectively

https://finviz.com/quote.ashx?t=ISEE&ty=c&ta=1&p=d