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Wednesday, November 30, 2022

Federal Court Blocks Joe Biden’s Mandate Trying to Force Christian Doctors to Do Abortions

 A federal appeals court has blocked Joe Biden’s controversial mandate attempting to force Christian doctors to kill babies in abortions.

Christian medical leaders raised the alarm about a new pro-abortion mandate from the Biden administration that could shut down Christian health care throughout the U.S. The U.S. Department of Health and Human Services officials planned to revoke a Trump administration rule that protected pro-life medical workers from being forced to kill unborn babies in elective abortions.

Alliance Defending Freedom attorneys filed suit presenting Christian doctors challenging two Biden administration mandates. They say the mandate forces religious nonprofit and for-profit employers to pay for and perform surgeries, procedures, counseling, and treatments that seek to alter one’s biological sex and to do abortions — actions that violate their religious beliefs.

The Fifth Circuit Court of Appeals struck down the Biden abortion mandate on August 26, ruling that religious doctors could not be required to perform procedures like abortion that violate their beliefs.

The Biden administration had until November 25th to appeal the ruling and failed to do so — meaning the mandate is now blocked by the appellate court.

The Christian Medical & Dental Associations told LifeNews that the end of the Biden mandate is a major victory for pro-life physicians to protect the religious beliefs of healthcare professionals from being forced to perform gender-transition procedures or abortions against their conscience and best medical judgment.

“This key legal battle is a hard-fought victory that impacts and protects the rights of healthcare professionals across this country,” said CMDA CEO Mike Chupp, MD, FACS.

“CMDA’s national polling proves that healthcare professionals of faith are committed to caring for all patients with dignity and respect,” said CMDA Senior Vice President of Bioethics and Public Policy Jeffrey Barrows, DO, MA (Ethics), who is an OBGYN.

“No one should be forced to violate their conscience or sincere religious beliefs,” said Dr. Barrows. “Most importantly, each patient we treat is better off when healthcare professionals who are motivated by their convictions are free to provide quality care without being forced to check those convictions at the door.”

ADF Legal Counsel Jacob Reed said “All employers, including those in the Christian Employers Alliance, have the constitutional right to conduct their business in a manner consistent with their deeply held religious beliefs.”

“The employers we represent believe that God purposefully created humans as either male or female, and so it would violate their religious beliefs to pay for or perform life-altering medical procedures or surgeries that seek to change one’s biological sex. We urge the court to immediately halt enforcement of these unlawful mandates that disrespect people of faith,” he added.

The lawsuit explains that the Equal Employment Opportunity Commission is misinterpreting and improperly enforcing discrimination based on sex in Title VII to force religious employers to pay for and provide health insurance coverage for such surgeries and procedures. Additionally, the lawsuit challenges the U.S. Department of Health and Human Services’ reinterpretation of “sex” in federal law to include gender identity, thereby forcing religious healthcare providers to physically perform or facilitate surgeries and procedures that conflict with their deeply held beliefs.

The HHS mandate also compels religious healthcare providers to speak positively about these procedures even if they disagree with them and prohibits them from sharing their medical opinions or objections. Neither the EEOC nor HHS provide religious exemptions to these mandates. If CEA members fail to comply with these mandates, they face loss of federal funds, the prospect of expensive and burdensome litigation, and in some cases fines, criminal penalties, and attorneys’ fees and costs.

Responding to the news, pro-life leaders criticized the Biden administration for wanting to force hardworking Americans to choose between exercising their beliefs and being able to feed their families.

“Doctors, nurses, and other medical providers should enjoy this same constitutional protection, free to live and work in a manner consistent with their faith,” Alliance Defending Freedom senior counsel Matt Bowman said in a statement. “Yet the Biden administration’s proposed rule would abandon health care professionals to being forced to perform medical procedures that directly violate their religious beliefs or risk losing their jobs.”

Abortion advocates loved the Biden mandate.

Jacqueline Ayers, the senior vice president of policy, organizing and campaigns for Planned Parenthood, told Politico that they are excited about the new Biden administration rule. Twisting the issue, she slammed conscience protections as “discriminatory.”

“As state politicians continue to strip people of their sexual and reproductive rights and freedoms, it’s imperative that the Biden-Harris administration revoke this discriminatory policy and help ensure people can access the health care and information they need when they need it,” Ayers said. “We look forward to seeing the details of the new rule and are excited about this step forward.”

Forcing doctors and nurses to abort unborn babies or lose their jobs is the real discrimination, and pro-life advocates are urging the president to withdraw his plan.

“This is an illegal and gross overreach of executive power, and we urge the administration to withdraw this harmful proposal immediately,” Bowman said.

Pro-life leaders feared Biden would work to dismantle religious freedom for pro-life medical workers after his administration dropped a lawsuit last year defending a pro-life nurse who allegedly was forced into aborting an unborn baby. The Vermont nurse said she was tricked into helping with an elective abortion even though the doctors knew her objections; she said they told her she would be helping with a miscarriage.

https://www.lifenews.com/2022/11/30/federal-court-blocks-joe-bidens-mandate-trying-to-force-christian-doctors-to-do-abortions/

Does the U.S. have at-home flu tests?

 Flu season is underway. RSV is putting record numbers of children in hospitals. And health professionals are gearing up for another Covid winter.

With so many potential viruses in play, it would be helpful if Americans had a way to distinguish between different ailments at home. And when it comes to the flu in particular, at-home testing could help telehealth doctors decide when it makes sense to prescribe treatments like Tamiflu, which need to be started within two days of onset of symptoms.

“Home flu testing would ensure that those who do need and receive antiviral medication for influenza are the ones who need it the most,” said Christina Yen, an infectious diseases doctor at the University of Texas Southwestern Medical Center, as well as ensure “that we are making our treatment decisions based on data.”

Yet no at-home flu tests are available for purchase in the U.S. That’s not for lack of technology — the rapid antigen flu tests at the doctor’s office are “virtually identical” to the Covid tests already in people’s homes, according to ZoĆ« McLaren, associate professor of public policy at the University of Maryland Baltimore County who studies health policies for infectious disease epidemics.

Rather, the issue comes down to historical hangups — and the need to find digital fixes to address them.

“It’s really rare, and it’s really new, that people are allowed to know about what’s happening inside their body without a physician in the middle,” said Michael Mina, a former assistant professor of epidemiology at Harvard.

The Food and Drug Administration has been historically slow to approve over-the-counter tests, Mina said, citing pregnancy tests as an example. Although a 26-year-old female product designer made a prototype of an at-home version of a lab pregnancy test in 1967, at-home pregnancy tests were not approved in the U.S. until 1977. “The general thinking was, ‘How could a woman possibly know what to do if she found out she was pregnant on her own without a doctor in the room?’ That is a ridiculous concern because women have been doing that for millions of years,” said Mina.

The FDA was similarly cautious with respect to at-home testing for HIV, which became the only over-the-counter test for an infectious disease when it received approval in 2012.

A 2016 FDA advisory panel, meanwhile, was split on whether the benefits of over-the-counter influenza tests outweighed the risks. Meeting transcripts show that as experts debated whether at-home tests would actually be effective at keeping people at home if they knew they or their children had the flu, one panelist joked that daycare centers might make the decision for parents if over-the-counter tests were available.

“The woman is going to want to go to work, and she wants to drop her kids off at daycare,” the panelist said. “The daycare, when they sign their contract, [could say] ‘If your kid has symptoms, we’re going to test him,’” and send the child home if they tested positive.

The room laughed at the idea.

This scenario is not so laughable in the wake of the pandemic. During the height of the Omicron wave, nearly 1 in 4 symptomatic people were testing themselves at home. Many Americans have clearly gotten accustomed to the idea of at-home testing, and to the fact that they may have to adjust their plans if they get a positive result.me

But regulators and clinicians still have concerns. At-home tests can be less accurate than tests administered by a health care worker because people may not obtain enough sample to get a valid result, or might have trouble reading the result correctly. And whereas home users generally take a positive or negative result at face value, clinicians have more context with which to interpret false positives or false negatives. They might order a more sensitive test, act with more caution for people they know are high-risk, or decide to treat a patient anyway because they suspect a false negative.

There’s also a historical concern about rapid influenza tests having low accuracy and varying in sensitivity from year to year. Before 2009, measuring viruses by cell culture was the decades-old standard — but cell culture numbers could vary widely depending on how good the lab was at cultivating cells.

During the 2009 H1N1 pandemic, nucleic acid amplification tests such as PCR — which were much more consistent — became the new standard. When compared against PCR methods, rapid-antigen flu tests now seemed much less reliable than they had been when their cell-culture-based trials were first approved.

Based on outcry from the medical community against rapid flu tests so inaccurate that some were only able to detect H1N1 in 11% of samples, the FDA in 2017 reclassified antigen influenza tests from Class I devices to Class II, which are considered to present more risk. The FDA began requiring manufacturers to certify their tests against eight influenza strains, which change from year to year depending on circulating variants. These year-to-year fluctuations can become a concern if people keep flu tests in their medicine cabinets and pull them out months or years later.

There may be ways to address concerns about patients inaccurately administering and interpreting at-home tests. eMed, where Mina is currently chief scientific officer, is trying to address such issues by having a telehealth professional proctor each at-home test the company sells.

But while the eMed tests are marketed as at-home flu and Covid tests, the kits only contain a FlowFlex rapid Covid test. Because there isn’t an approved at-home flu test, clinicians can’t ask the patient to test for flu like they would if they were in person. Instead, they follow the Centers for Disease Control and Prevention guidance for diagnosing flu through telehealth. If the patient is Covid-negative during flu season, for example, they probably have the flu, and clinicians might then decide to prescribe Tamiflu. But this set-up can prompt telehealth clinicians to over-prescribe antivirals, as Yen at UT Southwestern pointed out.

This situation is particularly frustrating because there are rapid flu tests that are Clinical Laboratory Improvement Amendments-waived, meaning they are approved for use in point-of-care testing sites like pharmacies and health clinics—just not at home.

“It’s kind of like [the FDA] still lives in a world where the internet and telehealth doesn’t exist,” said Mina. “There are ways to get people testing at home that don’t require the person to be in charge of interpreting the results all on their own.” He imagines a scenario in which the FDA could broaden access to diagnostic tests by making telehealth appointments a CLIA-waived setting, so that patients could swab their own noses under the guidance of a health-care provider.

Whether the FDA would support that kind of change is unclear, though a senior FDA official said that the agency is currently trying to find a better way to bridge point-of-care and at-home approvals.

The senior official also said that the administration “strongly supports” at-home tests for respiratory viruses and has since before the pandemic. But companies developing these tests have gotten a different impression from their interactions with the FDA. “I’m glad to hear they said that,” said Wade Stevenson, a senior vice president of marketing at rapid-PCR test manufacturer Visby Medical.

Stevenson acknowledged that the FDA has a hard job — they’re trying to safeguard the products available to the American medical system without stifling innovation. “When you put a new idea in front of the FDA, generally, they’re excited about it,” said Stevenson. “They like to see new ideas. And they do not want to play the role of, ‘No, this is never going to work.’ They want to encourage development and people pushing boundaries.”

But manufacturers are frustrated about what they say is a lack of clarity surrounding the pathways to approval for over-the-counter tests and constantly shifting goalposts.

One obstacle manufacturers like Visby face is the question of what the FDA is looking for in the at-home tests. The FDA has strongly emphasized they want test manufacturers to engage with them by submitting pre-submissions for feedback. But Stevenson said that the FDA’s guidance for their pre-submissions came back too late to be useful for developing their clinical trials. Clinical trials take a long time to complete because the prevalence of flu, especially low-incidence influenza B, has been so fickle the last few years.

Stevenson thinks a Visby at-home PCR test is “a long ways away,” partially because the latest suggestions the company received from the FDA specified that the administration would like public health reporting to be built into at-home tests. This would help address the problem facing Covid tests today, where the reported case counts don’t include unreported at-home tests. But including this feature is “not trivial” because each state has its own reporting standards and different ways they collect that data.

“The FDA saying ‘Think about this’ is nice and has good intentions,” said Stevenson, “but the reality is coming up with one product that does that today in an at-home setting? I don’t know how to do that.”

Beyond getting tests approved, it’s hard for test makers to transition into the at-home market because insurance reimbursements don’t typically cover at-home tests, whereas lab diagnostics are usually covered. In 2020, Congress required insurers to cover Covid tests at no cost, but that stipulation only lasts while the national public health emergency is in place. And while at-home tests are ostensibly meant to help lower barriers to access medical care, CDC research shows that the people most likely to use an at-home Covid test are highly educated, in higher income brackets, and white — meaning that if and when at-home flu tests are approved, there’s more work to be done in ensuring they actually reach all populations.

Currently, the only test available for differentiating flu, Covid, and RSV at home is the Labcorp Pixel test, where users swab themselves at home and send the sample in for lab testing. However, this test’s turnaround time of one to two days wouldn’t be able to compete with an at-home test that gave results in 15-30 minutes.

Some Covid test manufacturers are now pivoting to include flu in their analytes. Cue Health and Lucira Health have both filed emergency use authorizations for their Covid and flu at-home tests, both of which are molecular-based amplification tests and thus might sidestep some of the sensitivity concerns of antigen tests. Both companies also have a companion app that can help connect patients to treatment options like Paxlovid or, if approved for flu, Tamiflu. However, neither have yet been approved by the FDA. Lucira’s test, which has been authorized in Canada and Europe, was submitted for authorization in May, while Cue Health’s request was submitted at the end of September.

“We are in constant communication with the FDA,” said Debkishore Mitra, founder and CTO of Lucira. “We are really hoping that we can make some impact in this current flu season.”

https://www.statnews.com/2022/11/22/why-doesnt-the-u-s-have-at-home-flu-tests/

US officials say 2 more places will test sewage for polio

 Philadelphia and Oakland County, Michigan, are joining the small list of U.S. localities that are looking for signs of polio infections in sewage, U.S. health officials said Wednesday.

The Centers for Disease Control and Prevention said the communities will test for polio in sewage for at least four months. Communities in New York state began testing earlier this year after a man was diagnosed with paralytic polio outside New York City.

CDC officials say they have been talking with other communities about also starting polio wastewater testing. They are focused on cities and counties with low polio vaccination coverage and those in which travelers had visited the New York communities where polio was found.

Officials say identifying the virus in sewage can help a city or county accelerate and target vaccination campaigns.

Health officials around the world have used wastewater to track COVID-19 outbreaks. The CDC currently is receiving wastewater sampling data for the coronavirus from all 50 states. This year, commercial laboratories began testing wastewater for mpox, previously known as monkeypox.

Next year, health officials in Houston and Colorado plan to begin testing sewage for several other health threats, including germs with antibiotic resistance, influenza, respiratory syncytial virus, norovirus and other bugs. If the pilot goes well, the wider testing will be rolled out to other parts of the country, CDC officials said.

https://apnews.com/article/science-health-new-york-city-covid-4ca5cf5320d40093ef6eac2ee054f891

SARS-CoV-2 spike protein binds and modulates estrogen receptors

 DompĆ© farmaceutici announced new data revealing a novel function of the SARS-CoV-2 spike (S) protein interaction with the human Estrogen Receptor Alpha (ERĪ±) that may lead to the severe coagulopathy observed in patients with COVID-19 and a minority of subjects receiving the SARS-CoV-2 vaccine.

The data published today in Science Advances is a collaboration between researchers from DompĆ© farmaceutici, the National Institute on Drug Abuse, part of the U.S. National Institutes of Health, Johns Hopkins University, The Scripps Institute, Stanford School of Medicine, and the University of L'Aquila, in Italy.

It is well understood that the SARS-CoV-2 virus can cause severe vasculopathy, which may, in turn, result in fatal thrombosis. The team's findings are consistent with the sex-specific differences in thrombosis observed in hospitalized patients with COVID-19, and in a minority of subjects receiving the SARS-CoV-2 vaccine, as reported earlier this year in the American Journal of Cardiology by an unrelated team.

The initial finding leading to the study emerged from the results of the Exscalate4CoV (E4C) project, a group composed of 30 public and private institutions from seven countries aimed at fighting Coronavirus with the latest European supercomputing resources and experimental facilities. The project leveraged the computational power of Exscalate, DompƩ's supercomputing platform exploiting a database of 500 billion molecules to find those capable of targeting clinically relevant coronavirus variants.

Due to its processing capacity of more than 3 million molecules per second, Exscalate is currently the most powerful intelligent supercomputing drug design platform running on Leonardo, the 4th most powerful supercomputer in the world. This processing power allowed the E4C researchers to rapidly select and repurpose a generic molecule (raloxifene) with known efficacy and tolerability as an estrogen modulator for treating osteoporosis. Using the Exscalate platform to identify spike protein binding partners beyond the canonical ACE2 receptor, researchers identified prominent interactions between two human estrogen receptors (ERĪ±, ERĪ²) and SARS-CoV-2 spike protein.

After an unbiased primary screen to profile the binding of full-length spike protein against more than 9,000 human proteins, researchers found a consistent interaction with the human estrogen receptor alpha (ERĪ±). Similarly, high ERĪ± levels were measured in the damaged lungs of infected hamsters, as well as in human postmortem lung samples. The researchers suggest that, given the role of ERĪ± in the coagulation cascade, S-protein could increase the pro-coagulation activity of endothelial cells leading to an enhanced risk of thrombosis.

While circulating estrogens play a protective role by regulating the  to infection, it may be possible that the modulation of ER signaling in SARS-CoV-2-infected lung tissue can stimulate proinflammatory signals leading to hypertrophy, vasoconstriction, and vessel obstruction. This concept has been validated by a further set of experimental findings, which are currently released in a pre-print and submitted to a peer-reviewed publication, demonstrating that the interaction between the  and ERĪ± leads to an increase in tissue factor (TF) and overall pro-coagulation activity in a human endothelial cell line, a result further confirmed by overexpressing S-protein in mice.

These findings are consistent with the researchers' demonstration that deletion of the appropriate point mutations in the spike sequence abolished the binding of ERĪ± and its effects without compromising its immunogenicity and pointing at a way to mitigate the rare side effects observed with the currently available vaccines.

More information: Oscar Solis et al, The SARS-CoV-2 spike protein binds and modulates estrogen receptors, Science Advances (2022). DOI: 10.1126/sciadv.add4150www.science.org/doi/10.1126/sciadv.add4150
https://medicalxpress.com/news/2022-11-sars-cov-spike-protein-modulates-estrogen.html

New therapeutic target for the prevention of heart failure due to aortic stenosis

 Scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) have identified a new therapeutic target for the prevention of heart failure linked to aortic stenosis. The study was led by Dr. Borja IbƔƱez, Clinical Research Director at the CNIC, cardiologist at Hospital Universitario FundaciĆ³n JimĆ©nez DĆ­az, and member of the Spanish cardiovascular research network (CiberCV).

The study shows that overexpression in  cells of beta-3 , a member of the beta adrenergic system, can prevent or even reverse heart failure in a mouse model of , a condition that currently has few therapeutic options.

In the study, published in Basic Research in Cardiology, the CNIC team adopted an innovative  approach to boost the expression of this receptor in the heart and thus reinforce its beneficial action.

"Gene therapy has an enormous potential for the treatment of cardiac diseases. The next step will be to investigate this approach in animals with a heart more similar to that of humans, such as pigs, and then design a pilot clinical trial to translate these promising results to patients," explained study co-author and CNIC General Director Dr. ValentĆ­n Fuster.

Aortic stenosis is a progressive narrowing of the aortic valve, a "floodgate" through which blood flows from the heart to the rest of the body. The progressive obstruction of the aortic valve impedes the supply of blood to the body organs and causes pressure to build within the heart. The extra force required to expel blood with each heartbeat generates a physical stress that deteriorates the . The condition is currently treated by replacing the damaged valve with a prosthesis.

While valve replacement technology has become much less invasive and successfully recovers valve function, Dr. IbƔƱez explained that the cardiac muscle, after years of being subject to stress, does not recover. Unfortunately, there is a lack of treatments able to improve cardiac muscle function and thereby alleviate heart failure resulting from a long history of aortic stenosis.

In addition to the CNIC team led by Dr. IbƔƱez's team, the study had input from groups based in Italy and the U.S.. The study exploited the beneficial properties of stimulating the beta-3 adrenergic receptor, which is abundant in adipose tissue and the bladder but weakly expressed in the heart. Previous research had shown that stimulation of this receptor, despite its low expression in the heart, has potentially beneficial effects on cardiac diseases.

Using rat heart muscle cells (cardiomyocytes) grown in culture, the researchers found that forced expression of beta-3 adrenergic receptor inhibited the hypertrophic growth of these cells when they were exposed to a hormonal stimulus.

Through a collaboration with the CNIC Intercellular Signaling in Cardiovascular Development and Disease group, led by Dr. Jose Luis de la Pompa, transgenic mice were generated that overexpress the beta-3 adrenergic receptor in cardiomyocytes.

"When these mice were subjected to supravalvular aortic stenosis, they developed less  and fibrosis than mice with normal levels of expression. The transgenic mice were also free of heart failure, and their hearts were metabolically more efficient and consumed less glucose," explained Dr. AndrĆ©s Pun, first author on the study.

These results prompted the scientists to study the cardiomyocytes' mitochondria, the energy production hubs in cells. "Because heart muscle has such high energy requirements, any damage to its mitochondria can have catastrophic consequences, as frequently occurs in heart failure," said Dr. Pun.

In healthy hearts, mitochondria mainly burn fatty acids, which provide a highly efficient generation of abundant amounts of energy. Nevertheless, said Dr. Pun, "the failing heart often switches to the use of glucose, a much less efficient energy source, and this contributes to the progression of the disease."

In addition, the mitochondria of the failing heart are unable to fuse efficiently and are therefore smaller and more prone to accumulating injuries. The investigators found that the cardiomyocyte mitochondria in the transgenic mice were much larger and healthier.

Since the transgenic technology used to develop these mice is not applicable in patients, the investigators developed a gene therapy approach, whereby an innocuous virus was injected into mice to deliver the beta-3 adrenergic receptor gene specifically to cardiomyocytes, resulting in safe and efficient production of the receptor.

Working in partnership with the CNIC Viral Vectors Unit, the team designed an innocuous virus able to enter cardiomyocytes and drive elevated expression of beta-3 adrenergic receptor in the hearts of non-transgenic adult mice. When these mice were subjected to aortic stenosis, they were as equally protected against heart failure as transgenic mice overexpressing the receptor from before birth.

In a final test, the team injected the virus into non- with long-lasting aortic stenosis and established . In these mice, gene-therapy–induced overexpression of beta-3 adrenergic receptor recovered heart function, reduced cardiomyocyte hypertrophy, restored normal mitochondrial size and normal expression of mitochondrial fusion proteins in the heart, and increased animal survival.

More information: AndrĆ©s Pun-GarcĆ­a et al, Beta-3 adrenergic receptor overexpression reverses aortic stenosis–induced heart failure and restores balanced mitochondrial dynamics, Basic Research in Cardiology (2022). DOI: 10.1007/s00395-022-00966-z
https://medicalxpress.com/news/2022-11-therapeutic-heart-failure-due-aortic.html

Viatris Completes Biosimilars Transaction with Biocon Biologics

 Receives a $2 Billion Cash Payment and $1 Billion of Convertible Preferred Equity Representing a Stake of at Least 12.9% (on a Fully Diluted Basis) in Biocon Biologics

Marks the First in a Series of Expected Initiatives to Reshape and Rebase Viatris, Aimed at Setting it Up for Long-term Growth

Viatris Inc. (NASDAQ: VTRS) today announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain other transition services for an expected two-year period intended to ensure business continuity for patients, customers and colleagues. Upon the completion of the transition services, Biocon Biologics will assume responsibility of commercial, regulatory and other related services.

Under the terms of the transaction agreement, Viatris received $3 billion in consideration in the form of a $2 billion cash payment and $1 billion of convertible preferred equity representing a stake of at least 12.9 % (on a fully diluted basis) in Biocon Biologics. Viatris also is entitled to $335 million of additional cash payments in 2024.

Financial Impact of Completion of the Biosimilars Transaction 
As previously stated, the Company's financial guidance ranges for total revenues, adjusted EBITDA and free cash flows for the year ending December 31, 2022, do not include the impact of the closing of the transaction with Biocon Biologics.  The Company expects its reported results for the year ending December 31, 2022, to be impacted by the closing of the transaction as follows:

  • The Company expects its reported total revenues and adjusted EBITDA for the year to be lower by approximately $80 million and $20 million, respectively.

  • The Company expects to report the $2 billion of cash proceeds, offset by the impact of certain deal related adjustments, as cash flows from investing activities. Additionally, the Company expects to incur approximately $400 million of certain deal related expenses, primarily taxes and associated transactions costs. As a result, the Company expects these deal related expenses to lead to lower reported cash flows from operating activities, and consequently free cash flow, for the year.

Capital Allocation 
The Company expects to use the net divestiture cash from the biosimilars transaction to:

  • Pay down additional short-term debt and accelerate its progress towards $6.5 billion of Phase 1 debt reduction

  • And, in combination with cash on hand, to:


  • Fund the previously announced ophthalmology acquisitions totaling approximately $700 to $750 million, anticipated to close in the first quarter of 2023, and
    Begin to execute on the previously announced share buyback authorization in 2023.

    https://finance.yahoo.com/news/viatris-completes-biosimilars-transaction-biocon-130000791.html

Fosun Pharma considers $3.8B sale of Indian drugmaker Gland Pharma

 Fosun Pharmaceutical Group may be considering the sale of a company it took a stake in just a few years ago.


According to a report from Bloomberg News on Tuesday, Fosun is considering the sale of the Indian-based injectable CDMO Gland Pharma Ltd. after it had reportedly received interest from potential buyers.


Bloomberg said in its report that Fosun has been working with an adviser as it informally “gauges interest” in its controlling stake in Gland. Other companies and buyout firms are in the beginning stages of looking at Gland, but no details have emerged on any potential buyers, the report says. The publication lists the market value of Gland at around $3.8 billion.


Fosun bought its controlling stake in Gland in 2017, buying a 74% stake in the company for $1.1 billion. The Chinese pharma had originally wanted an 86% stake but was cut back after the Indian government wanted to veto the original plan.


The news has perked up the ears of investors as Fosun and Gland have seen a rise in their stock prices today by 3% and 7% respectively.


However, despite the reported interest in Gland, it is coming as a bit of a surprise to the manufacturer.


In a letter to the Bombay Stock Exchange on Tuesday, Gland clarified that it is “not aware of any such information” that Fosun is considering the sale of shares of Gland.


“The Company is not in receipt of any communication in this regard from its Promoter(s) and is unable to comment on the same,” Gland’s letter said.


Endpoints News has reached out to both Fosun and Gland for further information but has not received any by press time.


Meanwhile, Gland is making moves of its own. According to Reuters, Gland will buy the French injectable drug manufacturer Cenexi for the price of €120 million ($123.9 million).


With Covid-19 vaccine in limbo, China's Fosun inks $628M deal for a Prevnar 13 rival

Fosun is no stranger to the acquisition game, as last year it bought a majority stake in Chengdu Antejin Biotech, which is developing a shot against 13 strains of pneumonia-causing bacteria, making it a subsidiary. The deal saw Fosun paying shareholders $173.9 million in cash to grab 32.5% of the company with Fosun merging its vaccine business, Dalian Aleph Biomedical, into the company.

https://endpts.com/fosun-pharma-considers-3-8b-sale-of-indian-drugmaker-gland-pharma-report/