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Mifepristone, the first drug in a medical abortion, is prepared for a patient April 20, 2023 at the Alamo Women’s Clinic in Carbondale, Illinois.

Evelyn Hockstein Reuters

A federal appeals court Wednesday afternoon will hear arguments in a closely watched lawsuit aimed at removing the abortion pill mifepristone from the US market.

The hearing in the US 5th Circuit Court of Appeals in New Orleans comes 11 months after the Supreme Court ruled that abortion was no longer constitutional.

Justice Department attorneys representing the Food and Drug Administration and attorneys from an anti-abortion group called the Alliance for Hippocratic Medicine each have 40 minutes to present their case before the three-judge panel.

The outcome of the hearing, scheduled to begin at 2 p.m. ET, could determine whether women continue to have access to the now-standard method of abortion in the United States. The arguments will be broadcast live.

Mifepristone, used in combination with another drug, misoprostol, is responsible for about half of all abortions domestically.

The judges who will hear the arguments were all nominated by Republican presidents.

Justices James Ho and Cory Wilson were appointed by Donald Trump. Judge Jennifer Elrod was appointed by George W. Bush.

The panel’s decision could be made at any time after the arguments. But regardless of what the verdict says, the losing side is sure to petition the Supreme Court to appeal the decision.

If the Supreme Court accepts the case for appeal, mifepristone will remain widely available until the Supreme Court makes a final decision on the case.

However, if it refuses to listen to an appeal, the 5th Circuit’s decision will be the final say on the fate of the drug.

challenge for mifepristone

The Alliance for Hippocratic Medicine sued the FDA in November in the US District Court for the Northern District of Texas, challenging the agency’s 2000 approval of mifepristone.

The group argued the agency failed to follow the correct process in approving mifepristone, claimed the drug was unsafe and asked a judge to order the drug’s withdrawal from the market.

These claims have been fiercely disputed by the FDA, leading medical associations, nearly half of US states and more than 200 members of Congress.

These companies argued in court filings that the FDA duly approved mifepristone and that the approval was based on extensive data demonstrating the drug’s safety and efficacy.

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But US Judge Matthew Kacsmaryk ruled in favor of the anti-abortion group’s claims and suspended FDA approval of mifepristone. His order would have halted sales of the drug nationwide pending the appeals process.

Days later, the DOJ appealed Kacsmaryk’s decision to the 5th District, which handles cases from the Northern District of Texas.

In April, a three-district judge panel ruled that the FDA’s approval of mifepristone stands pending the outcome of the DOJ’s appeal.

That panel said challenging the permit was likely precluded by the federal statute of limitations, though the judges made it clear their decision was based on “abridged scrutiny.”

But this body also blocked the mail delivery of the drug and imposed strict restrictions on the use of the drug.

Shortly thereafter, at the request of the Biden administration, the Supreme Court ordered that mifepristone be allowed to remain on the market without restrictions while the lawsuit was being fought in the 5th Circuit.

When the anti-abortion group wins

The Alliance Defending Freedom, an anti-abortion rights organization that represents the doctors group, is asking the three judges who will hear arguments on Wednesday to uphold in full Kacsmaryk’s order and halt sales of mifepristone nationwide.

The trio of judges differs from the 5th Circuit panel that issued the order last month that put some restrictions on the availability of mifepristone but kept the drug on the market.

Glenn Cohen, a former DOJ attorney, said the current three-judge panel is not bound by the April panel’s decision.

The new panel could issue an order that goes further or less far than the restrictions imposed in April, said Cohen, who is now a professor at Harvard Law School. Or the panel could take an entirely different direction, he said.

Cohen, along with other drug law experts, filed a brief with the 5th Circuit in support of the FDA’s position.

He said the Supreme Court will likely agree to take the case if the 5th Circuit panel votes to remove mifepristone from the US market.

Cohen argued that Supreme Court justices would take this position because a majority of them approved the DOJ’s request to keep mifepristone available without restrictions while litigation played out in the lower courts.

If the FDA wins

The DOJ is asking the 5th Circuit to reverse Kacsmaryk’s sweeping order and keep mifepristone available under current FDA regulations. The FDA now allows women to receive mifepristone without having to see a doctor in person and can receive the prescription drug in the mail.

The previous 5th Circuit panel blocked mail delivery of mifepristone in April, reinstated the requirement that women see a doctor to get a prescription for the pill, and shortened the length of time women can take the drug from the 10th week. up to the seventh week of pregnancy.

The panel said in its ruling last month that the FDA’s earlier decision to relax its regulations on mifepristone would result in more women seeking emergency care due to serious complications from the drug.

The Justice Department said in its appeal that the panel misunderstood data showing the drug was safe.

DOJ attorneys noted in a court filing that sepsis and bleeding occur in only 0.2% of patients taking the drug, and the rate of blood transfusions or hospitalizations is 0.7% or less.

“And study after study has shown that when mifepristone is taken in accordance with approved conditions of use, serious adverse events are ‘exceedingly rare,'” the DOJ said in its letter to the panel that will hear the arguments Wednesday.

“Furthermore, pregnancy itself carries a significantly higher risk of serious adverse events, including a 14 times higher mortality rate than legal abortion,” the DOJ said.

Cohen believes the Supreme Court is less likely to accept the case if the 5th Circuit government wins and the anti-abortion group appeals the verdict.

He said the fact that the majority of judges have opted to keep mifepristone available while a lawsuit is pending in a lower court suggests they are not particularly sympathetic to the anti-abortion case.

And while the lawsuit raises questions the Supreme Court may eventually be interested in, he said the case against the FDA is a technical case that judges might prefer not to consider.

A person walks next to the Google Cloud logo at the Mobile World Congress (MWC) in Barcelona, ​​Spain, on February 27, 2023.

Sweet Nacho | Reuters

Google Cloud on Tuesday launched two new AI-powered tools designed to help biotech and pharmaceutical companies accelerate drug discovery and advance precision medicine.

A tool called the Target and Lead Identification Suite aims to help companies predict and understand the structure of proteins, a fundamental part of drug development. Another solution, the Multiomics Suite, will help researchers ingest, store, analyze and share large amounts of genomic data.

The new developments mark Google’s latest advance in the red-hot AI arms race, with tech companies competing for dominance in a market that analysts believe could one day be worth trillions. Since the release of OpenAI’s ChatGPT late last year, the company has been under pressure to showcase its generative artificial intelligence technology.

Google announced its generative chatbot Bard in February. Shares of parent company Alphabet rose 4.3% last week after Google unveiled several AI advances at its annual developer conference.

The two new Google Cloud suites help address a long-standing problem in the biopharmaceutical industry: the lengthy and costly process of bringing a new drug to the US market.

Pharmaceutical companies can invest anywhere from a few hundred million to more than two billion US dollars to bring a single drug to market. according to a recent Deloitte report. Their efforts are not always successful. According to another Deloitte report, drugs that go through clinical trials have a 16% chance of being approved in the US.

This high cost and dismal success rate comes with an extensive and lengthy research process, typically lasting around 10 to 15 years.

The new suites will save companies a “statistically significant” amount of time and money throughout the drug development process, said Shweta Maniar, global director of life sciences strategy and solutions at Google Cloud. Google CNBC did not give specific figures.

“We help organizations get medicines to the right people faster,” Maniar said in an interview with CNBC. “I’m personally very excited, it’s something I and the team have been working on for a number of years.”

Both suites will be available to customers across the board from Tuesday. According to Google, costs vary by company. Several companies including Big Pharma Pfizer and biotech companies Cerevel Therapeutics and Colossal Biosciences are already using the products.

Target and lead identification suite

According to Maniar, the Target and Lead Identification Suite aims to streamline the first critical step in drug development, identifying a biological target for researchers to focus on and develop a treatment.

A biological target is most commonly a protein, an essential building block for disease and all other parts of life. Finding this target requires identifying a protein’s structure, which determines its function, or the role it plays in a disease.

“If you can understand the role, the protein structure, the role, you can start developing drugs on it now,” Maniar said.

However, this process is time-consuming and often unsuccessful.

According to a widely used guide for drugmakers published in a database maintained by the Federal National Library of Medicine, it can take scientists about 12 months to identify a biological target. The two techniques that researchers traditionally use to determine protein structures also have a high failure rate, according to Maniar.

She also said that it is difficult for traditional technologies to increase or decrease the amount of work as needed.

Google Cloud’s suite takes a three-pronged approach to make this process more efficient.

The suite enables scientists to ingest, share and manage molecular data on a protein using Google Cloud’s Analytics Hub, a platform that allows users to securely share data between organizations.

Researchers can then use this data to predict a protein’s structure using AlphaFold2, a machine learning model developed by a Google subsidiary.

AlphaFold2 runs on Google’s Vertex AI pipeline, a platform that enables researchers to build and deploy machine learning models faster.

In minutes, AlphaFold2 can predict the 3D structure of a protein, more accurately than traditional technologies and at the scale researchers need. Predicting this structure is crucial because it can help researchers understand a protein’s function in a disease.

The final component of Google Cloud’s suite helps researchers figure out how the protein’s structure interacts with different molecules. A molecule can become the basis for a new drug if it changes the function of that protein and ultimately shows the ability to treat the disease.

Researchers can use Google Cloud’s high-performance computing resources to find “the most promising” molecules that could lead to the development of a new drug, according to a press release accompanying the new tools. These services provide the infrastructure businesses need to accelerate, automate, and scale their work.

According to John Renger, Chief Scientific Officer, Cerevel, which focuses on developing treatments for neuroscientific diseases, typically has to sift through a large library of 3 million different molecules to find one that has a beneficial effect against a disease. He called this process “complicated, time-consuming and expensive”.

But Renger said that with Google Cloud’s suite, the company will be able to sort out molecules faster. Computers will take care of screening molecules and help Cerevel “get an answer really fast,” he said.

Renger estimates that Cerevel will save an average of at least three years by using the suite to discover a new drug. He said it’s difficult to estimate how much money the company will save, but stressed that the suite saves the resources and manual labor typically required to screen molecules.

“That means we can get to where we need to be quicker and cheaper, and we can get the drugs to patients much faster and without as many failures,” he told CNBC.

Cerevel has been working with Google for more than a month to better understand the suite and determine how the company will use it. But Renger hopes Cerevel will be “at a point where we’re getting some results” next month.

Multiomics suite

Google Cloud’s second solution, the Multiomics Suite, aims to help researchers solve another daunting challenge: analyzing genomic data.

Colossal Biosciences, a biotechnology company aiming to use DNA and genetic engineering to reverse extinctions, used the Multiomics Suite in their research.

As a startup, Colossal didn’t have the internal infrastructure needed to organize or decode massive amounts of genomic data. A human genome sequence alone requires more than 200 gigabytes of storage, and researchers predict they will need 40 exabytes by 2025 to store the world’s genome data, according to the National Human Genome Research Institute.

The institute estimates that every word ever spoken by humans could be stored in five exabytes, so building the technology to support genomic data analysis is no easy task.

Therefore, the Multiomics Suite aims to provide companies like Colossal with the infrastructure they need to make sense of big data so they can focus more on new scientific discoveries.

“If we had to do everything from scratch, that’s the power of Google Cloud, right?” Alexander Titus, vice president of strategy and computer science at Colossal, told CNBC in an interview. “We don’t have to build this from scratch, it definitely saves us time and money.”

Researchers’ ability to sequence DNA has historically exceeded their ability to decode and analyze it. However, as technology has improved in recent years, genomic data have provided new insights into areas such as the genetic variations associated with diseases.

Google Cloud’s Maniar said it could ultimately help develop more personalized medicines and treatments. In 2021 alone, two-thirds of the drugs approved by the Food and Drug Administration were supported by human genetics research, according to an article published in the journal Nature.

Maniar believes the Multiomics Suite will help drive further innovation.

Colossal CEO Ben Lamm said the Multiomics Suite is what gives the company the ability to conduct research “in any reasonable timeframe.” Colossal began piloting Google’s technology late last year. As a result, Lamm says the company is on track to produce a woolly mammoth by 2028.

According to Lamm, without the Multiomics Suite the company would have been set back by more than a decade.

“We wouldn’t be anywhere near where we are today,” he said.

Prior to using Google Cloud’s suite, much of Colossal’s data management was done manually using spreadsheets, Lamm said.

He said it would have been a “massive drain” on the company trying to create the more complex tools it needed for research.

“When it comes to biology, we’re not stuck in small amounts of data anymore,” said Titus of Colossal. “We think on the scale: How do we get insights into 10,000, 20,000, 10 million years of evolutionary history? And these questions simply cannot be answered without scalable computing infrastructure and tools like cloud computing and multiomics.”

Correction: It can take scientists about 12 months to identify a biological target, according to a widely used guide for drugmakers published in a database maintained by the Federal National Library of Medicine. In an earlier version, the attribution was incorrect.

A woman receives a booster dose of Moderna coronavirus vaccine (COVID-19) at a vaccination center in Antwerp, Belgium, February 1, 2022.

Johanna Geron | Reuters

The National Institutes of Health announced Monday that patients are now enrolling in an early clinical trial to test a universal influenza vaccine based on messenger RNA technology.

Scientists hope the vaccine will protect against a wide range of influenza strains and provide long-term immunity so people don’t need to be vaccinated every year.

Messenger RNA or mRNA is the technology behind it Modern‘s and PfizerThe widely used Covid vaccines are widely available. NIH played a critical role in developing the mRNA platform used by Moderna.

“A universal influenza vaccine could serve as an important line of defense against the spread of a future influenza pandemic,” said Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases, in a statement Monday.

According to the NIH, the universal flu vaccine trial will enroll up to 50 healthy people, ages 18 to 49, to test whether the experimental vaccine is safe and will elicit an immune response.

The study will also include participants receiving a quadrivalent influenza vaccine that protects against four strains of the virus to compare the experimental universal vaccine with those currently on the market.

The universal syringe was developed by researchers at the National Institute of Allergy and Infectious Diseases. For the clinical study, volunteers will be recruited at Duke University in Durham, North Carolina.

The current generation of influenza vaccines offer important protection against hospitalization, but the effectiveness of vaccinations can vary greatly from year to year.

Scientists currently have to predict months in advance which influenza strains will dominate, to give vaccine makers time to produce the vaccines ahead of the respiratory virus season.

The predominant influenza strains can change between the time experts select strains and the time manufacturers introduce vaccines. In some seasons, vaccinations are not well matched to the circulating loads and are therefore less effective.

According to the Centers for Disease Control and Prevention, flu vaccines reduce disease risk by 40 to 60% when well matched to circulating strains. However, in some years the effectiveness of the vaccines was only 19% because the vaccination was not well coordinated.

According to the CDC, between 2010 and 2020, between 12,000 and 52,000 people died from the flu annually in the United States, depending on the strains circulating and the timing of vaccinations.