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Big Pharma Is Warming to the Potential of AI
Artificial Intelligence is not new in drug making. Biotech firms have been tinkering with it for years. Now interest from big pharma is growing.
Last year Emma Walmsley, chief executive of GSK, said it could improve the productivity of research and development, the industry’s most profound challenge. Moderna recently described itself as “laser-focused” on AI. Sanofi is “all in.” Morgan Stanley, an investment bank, reckons that within a decade the pharmaceutical industry may be spending $50 billion a year on AI to speed up drug development.
Most of the buzz revolves around AIs trained on biological data that could improve the hit-and-miss process of drug discovery. Drugs can take a decade to emerge, cost billions of dollars and succeed only 10% of the time. Even a small improvement in speed and efficiency would be hugely valuable. But scientists have struggled to tame biological big data with conventional statistical tools.
Machine learning makes it possible to sift through piles of information, from clinical patient data and genome sequences to images of body scans. Last year DeepMind, an AI lab that is part of Google, made a breakthrough using its AlphaFold system to predict the structure of almost all proteins, which may one day help identify which molecules have therapeutic potential.
U.S. FDA Classifies Recall of J&J’s Electrosurgical Tools as Most Serious
The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit (JNJ.N) as “most serious”, saying their use could lead to injuries or death.
The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them.
The tools are soft pads that conduct an electric current through the patient’s body during electrosurgical procedures to heat or cut tissue or stop bleeding. The tools were recalled by Megadyne Medical Products, which was acquired in 2017 by Ethicon Endo-Surgery, a unit of J&J MedTech.
Megadyne received reports of 63 injuries and no deaths related to the use of the devices and is continuing to evaluate the root cause for patient burns, the FDA said in a statement.
EU Expands Wegovy, Ozempic Probe Over Suicide Risks to Include Other Weight Loss, Diabetes Drugs
The European Union’s drug regulator on Tuesday said it has broadened an investigation into the risk of suicidal thoughts and self-injury among patients taking Novo Nordisk’s Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes medications.
The European Medicines Agency didn’t specify which additional drugs are now included in the investigation, but it could potentially include Eli Lilly’s diabetes drug Mounjaro, which is approved in the EU. Other companies such as Pfizer and Amgen are developing similar products.
The EMA said it is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight loss and diabetes drugs. It’s still unclear if the medicines caused the events or whether they are linked to patients’ underlying conditions or other factors, the statement said.
On Monday, the agency told CNBC it launched an investigation into the matter after the Icelandic Medicines Agency flagged three cases of suicidal thoughts and self-injury in patients taking drugs containing liraglutide and semaglutide.
Gardasil HPV Vaccination Caused Seizures, Fainting and Other Side Effects for Teen: Lawsuit
The side effects from Gardasil HPV vaccination caused a New York woman to experience syncope and non-epileptic seizures as a teen, according to a lawsuit recently filed against the manufacturer for failing to adequately warn patients and the medical community about the potential risks.
The complaint was brought by Elaina Bouw in the U.S. District Court for the Western District of North Carolina on June 28, naming the Gardasil vaccine manufacturer Merck & Co., Inc. as the defendant.
Although families and medical providers were led to believe Gardasil was safe and that there were few serious HPV vaccination side effects, a number of problems have been reported in recent years, and Merck now faces nearly 100 Gardasil lawsuits alleging that users were left with severe and debilitating autoimmune problems, including POTS (postural orthostatic tachycardia syndrome), premature ovarian failure, seizures and other debilitating complications, which have emerged shortly after receiving the injection.
Plaintiffs claim that these injuries could have been avoided if the drug maker had adequately researched the HPV vaccine and disclosed the potential risks.
$130 per Shot COVID Vaccines? Manufacturers Warned Against Price Gouging
The Biden administration is calling on COVID-19 vaccine makers to ensure the updated shots for the fall are priced affordably.
“Updated COVID-19 vaccines entering the market this fall should be priced at a reasonable rate, reflective of the value that you have obtained through U.S. government investment,” Health and Human Services Secretary Xavier Becerra said in a Thursday letter to the CEOs of Pfizer, Moderna and Novavax.
The federal government is no longer paying for COVID-19 vaccines with the end of the public health emergency related to the pandemic. That means the vaccines are now only available on the commercial market.
Merck Applies More Pressure Against IRA, Asking for Decision Without Trial in Fight With U.S. Government
Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday in federal court in Washington, DC, for a decision without a trial.
In its request for summary judgment in its case against the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS), Merck reiterated its claim from five weeks ago that the drug price negotiation program violates the First and Fifth Amendments of the Constitution.
Under the IRA, the federal government is set to begin negotiating prices on certain drugs in 2026. The new law also enables the government to dish out penalties for price hikes that outpace inflation.
Superbugs, Antibiotic Resistance Get Renewed Scrutiny in Congress
“The discovery of antibiotics revolutionized modern medicine,” increasing the average human lifespan by 23 years, said the subcommittee’s chairman Sen. Ed Markey (D-Mass.) in his opening statement. “But the rise of antimicrobial resistance threatens to undo 100 years of medical progress.”
Around the world, AMR has been linked to 5 million deaths per year, and this number is estimated to skyrocket to 10 million annual deaths by 2050. In the U.S, resistance to antibiotics caused an estimated 2.8 million infections and 35,000 deaths annually, according to data released by the Centers for Disease Control and Prevention in 2019.
There may be a renewed eagerness in Congress to address AMR. In April, the House Energy & Commerce Committee convened a parallel hearing on “Antimicrobial Resistance: Examining an Emerging Public Health Threat” that similarly touched on the Pasteur Act.
And during Tuesday’s hearing, the Senators all seemed to be fairly supportive of reform, with Sen. Mike Braun (R-Ind.) articulating the need to shore up the antibiotics pipeline for the sake of preparedness and Sen. Tina Smith (D-Minn.) saying that the U.S. needed to invest in the development and manufacturing of antibiotics, while also fixing the broken market. However, the subcommittee offered no specific action items regarding how Congress should respond.
Inappropriate Dental Antibiotics Cost U.S. Healthcare System Millions, Study Finds
Inappropriate dental antibiotic prescriptions to prevent infective endocarditis cost the U.S. healthcare system nearly $31 million a year, according to a modeling study published today on Infection Control & Hospital Epidemiology.
Although guidelines from the American Heart Association and the American Dental Association limit the use of prophylactic antibiotics to prevent infective endocarditis to those with cardiac conditions at the highest risk, research has shown that 83.1% of dental antibiotics prescribed for that reason are inappropriate.
