Lucira's home test for flu and COVID-19 gets U.S. FDA nod for OTC use

 Lucira Health said on Monday the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for its combination diagnostic test for COVID-19 and the flu, making it the first to be available over-the-counter.

The test — called Lucira COVID-19 & Flu Home Test — is a single-use, at-home rapid test kit that provides results from self-collected nasal swab in about 30 minutes.

Shares of the medical test maker rose more than four-fold to 66 cents in premarket trade.

The FDA's authorization, which came on Friday, allows the test to be purchased without a prescription and performed completely at home by individuals aged 14 years or older or collected by an adult for children two years or older.

The development comes days after Lucira filed for bankruptcy protection in the United States, and said it intended to pursue a sale of its business. "Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through," said CEO Erik Engelson.

The company was hoping to launch the test during autumn last year — in time for the 2022 flu season — but remains confident that the test will play a key role in upcoming periods of severe respiratory disease.

Lucira is also seeking a strategic or financial partner to resume the manufacturing and development of additional home diagnostic tests. 

https://www.yahoo.com/now/1-luciras-home-test-flu-141224241.html

As China's birth rate slumps, political advisor urges egg freezing for single women

 A member of China's top political advisory body said she would propose allowing unmarried women to access egg freezing as a measure to preserve their fertility after the country's population fell last year for the first time in six decades.

Lu Weiying, a member of China's top political advisory body, told the state backed Global Times that she would also propose including infertility treatments in the public health insurance system at the upcoming Chinese People's Political Consultative Conference (CPPCC), which kicks off on March 4.

Lu, a fertility doctor in China's southern Hainan province, said giving single women access to freezing their eggs enables them "to preserve the eggs before they pass their peak reproductive years. The woman still needs to get married if she wants to use her frozen eggs and get pregnant in the future," she told the Global Times.

Currently fertility treatments such as in vitro fertilisation (IVF) and egg freezing in China are banned for unmarried women.

Lu's recommendations come as authorities try to bolster a faltering birth rate with incentives including expanding maternity leave, financial and tax benefits for having children as well as housing subsidies.

Last year, China recorded its lowest ever birth rate, of 6.77 births per 1,000 people.

Some provinces have already made changes to their rules to boost birth rates. Jilin in northeastern China, which has one of the lowest birth rates in the country, modified its rules in 2002 to permit single women to access IVF but it has had little impact with the practise still banned nationally under the country's National Health Commission.

While nine of the 10 most populous nations in the world are experiencing declines in fertility, China's 2022 fertility rate of 1.18 was the lowest and well below the 2.1 OECD standard for a stable population. China has yet to officially release its fertility data for 2022.

Much of China's demographic downturn is the result of China's one-child policy imposed between 1980 and 2015 as well as the high cost of education.

https://www.yahoo.com/lifestyle/chinas-birth-rate-slumps-political-054400612.html

Reuters reporters' online accounts faked to approach China activists

 Two Reuters journalists had their identities faked by an unknown person or people who then used sham social media accounts to engage with Chinese activists on several online platforms over several months.

The false representations of the two journalists, Shanghai bureau chief Brenda Goh and Hong Kong-based correspondent Jessie Pang, starting in late November, appeared on platforms including Instagram and the Telegram message app.

The impersonator or impersonators were seeking information about a group linked to protests the same month against China's strict COVID-19 controls, according to screenshots and several accounts provided to Reuters.

An Australia-based Chinese activist and dissident artist known as Badiucao first disclosed the impersonations on Saturday on Twitter.

A fake account was set up on Instagram and one on Telegram purporting to be Pang, according to screengrabs from Badiucao seen by Reuters. Another activist told Reuters he had conversed with a fake persona of Goh via Telegram for three months.

Badiucao tweeted that he had been approached on Telegram by someone purporting to be Pang, asking for information on a Chinese-language online platform called Citizens Daily that carries protest art.

"Hello everyone," an imposter wrote in a Telegram chatroom, according to screenshots seen by Reuters that were provided by Badiucao. "I am Jessie with Reuters." The imposter then asked two members of the group: "Do you two have any ties to Citizens Daily?"

The imposter sought to gain the group's trust by giving details of Pang's background and recent work, Badiucao said.

Badiucao said he became suspicious at the language and questions posed by the imposter, however, and asked to verify the person's identity through Pang's verified Twitter account.

The imposter said he or she had no control over the Twitter account, as it was "run by a team at Reuters", a screenshot of the conversation provided by Badiucao showed.

https://finance.yahoo.com/news/reuters-reporters-online-accounts-faked-041704072.html

Bayer's 4Q Profit Missed Expectations; Sees Lower 2023 Earnings as Inflation Takes Toll

 Bayer AG on Tuesday reported net profit for the fourth quarter of 2022 that missed consensus expectations despite higher sales, and said it expects earnings for 2023 to be lower than the prior year as inflation remains high.

The German agricultural and pharmaceutical company posted net profit of 611 million euros ($648.3 million) for the final quarter of 2022, down from EUR1.16 billion the year prior, and missing a company-provided consensus that had expected EUR981 million. Earnings before special items were up slightly on year to EUR2.46 billion from EUR2.40 billion the previous year.

Core earnings per share rose to EUR1.35 from EUR1.26 the previous year, though earnings per share dropped to EUR0.62 from EUR1.18, the company said.

Sales rose to EUR12 billion in the quarter from EUR11.12 billion the previous year, a slight miss on a consensus forecast of EUR12.06 billion.

For the year ahead, Bayer said it expects earnings to be lower due to high inflation-driven cost increases, though sales are expected to grow, reaching a range of EUR51 billion to EUR52 billion in the year.

Ebitda before special items is expected to be in the range of EUR12.5 billion to EUR13 billion.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-s-4Q-Profit-Missed-Expectations-Sees-Lower-2023-Earnings-as-Inflation-Takes-Toll-43104650/

Adamis, DMK Pharmaceuticals to Merge

 

• Combined company will have commercial products and a library of development candidates, two of which are clinical stage
  
  

• Will be under the leadership of DMK CEO, Dr. Ebrahim (Eboo) Versi MD, PhD
  
  

• Lead development program will be a clinical stage therapeutic under development for the treatment of opioid use disorder

On February 24, 2023, Adamis entered into the Agreement with DMK and Aardvark Merger Sub (“Merger Sub”), a newly created wholly-owned subsidiary of Adamis, pursuant to which DMK will merge with and into Merger Sub (the “Merger”), with Merger Sub as the surviving corporation of the Merger and a wholly owned subsidiary of Adamis.

Subject to approval by the Adamis stockholders of proposals relating to the transaction and the satisfaction of other closing conditions, in connection with and before the effective time of the Merger (the “Effective Time”), a reverse stock split of Adamis Common Stock will be consummated, pursuant to which a number of outstanding shares of Adamis Common Stock (determined by the Reverse Stock Split Ratio) will be converted into one share of Adamis Common Stock at a ratio to be determined by the Adamis board of directors.

Please see Adamis Report on Form 8-K which will be filed with the Securities and Exchange Commission for additional detail on the proposed transaction.

https://finance.yahoo.com/news/adamis-pharmaceuticals-dmk-pharmaceuticals-announce-210500709.html

Biologics License Application for Lecanemab Designated for Priority Review by China

 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022. Eisai initially submitted a package that includes data from the Phase II clinical trial (Study 201) and the top-line data of the large global Phase III Clarity AD study in mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed Aβ accumulation in the brain. Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

https://finance.yahoo.com/news/biologics-license-application-lecanemab-designated-233000327.html

Moms who give birth in early 20s at higher risk of heart attack, stroke: study

 A recent study found that reproductive factors have a direct link to increasing a woman’s risk of heart attack and stroke.

Researchers from Imperial College London, the University of Cambridge and the Yale School of Public Health led the largest analysis of how reproductive factors can influence women’s heart health.

They studied data from more than 100,000 women that showed a causal link between the genes that predict reproductive factors and the risk of multiple cardiovascular diseases.

Women who started periods early, had their first child while young and who have multiple children are at higher risk of atrial fibrillation, coronary artery disease, heart failure, stroke and other cardiovascular diseases, the study reported.

The research showed that much of the increased risk leading to an earlier first menstrual cycle resulted from this factor being associated with women having a higher body mass index (BMI). 

Heart disease is the leading cause of death for women in the United States, according to the CDC.

Getty Images/iStockphoto

It also noted that an increased risk for earlier first birth could be partly hindered by traditional cardiometabolic risk factors, such as BMI, high cholesterol and high blood pressure.

There was no link between the age of menopause onset and cardiovascular disease.

“While we cannot say exactly how much these factors increase the risk of cardiovascular disease, our study shows that reproductive history is important and it points towards a causal impact,” said Dr. Fu Siong Ng, who is from the National Heart and Lung Institute at Imperial College London and senior author for the study.

“We need to understand more about these factors to make sure that women get the best possible care.”

Heart disease is the leading cause of death for women in the United States as more than 60 million women (44%) in the country are living with some form of heart disease, according to the Centers for Disease Control and Prevention.

Experts suggest doctors should consider these factors alongside other known risks when assessing women’s health and warned that treating heart issues as something that mainly affects men puts women’s lives at risk.

They claimed that women are often mistakenly identified as low risk for cardiovascular disease, potentially leading to delays in diagnosis and a tendency to receive less targeted treatment than men, which can lead to poorer outcomes.

“The misconception that cardiovascular disease mostly affects men is costing women their health, and even their lives,” said Dr. Sonya Babu-Narayan, consultant cardiologist and an associate medical director at the British Heart Foundation.

https://nypost.com/2023/02/27/moms-who-give-birth-in-early-20s-at-higher-risk-of-heart-attack-stroke-study/