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Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge
When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized. But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”
Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking a resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.
The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.
Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.
A study released last month in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.
Some Patients Suffered Psychiatric Issues After Ozempic Initiation — Two Case Reports Detailed Suicidal Ideation, Mania in Weeks Following Semaglutide Initiation
Some patients who newly started a GLP-1 receptor agonist quickly developed psychiatric symptoms, a few case reports detailed here. One case involved a female, age 42, with a history of bipolar I disorder, post-traumatic stress disorder (PTSD), morbid obesity, and type 2 diabetes. Because of her psychiatric history, she was deemed not a candidate for bariatric surgery and was started on semaglutide (Ozempic).
Just 3 weeks into semaglutide treatment, the patient suddenly developed behavioral disruptions, protracted nihilistic delusion, and then attempted to self-strangulate, reported Shahan Syed, MD, of Bergen New Bridge Medical Center in Paramus, New Jersey, at the American Psychiatric Association (APA) annual meeting. But after the patient stopped semaglutide, the suicidal ideation and behavior slowly reversed.
“I suspect that we’re going to see much more of these sorts of cases, unfortunately, just because of how commonplace the prescribing is of these medications,” Syed told MedPage Today. “Even those patients who are prescribed [GLP’s] who may not have a [psychiatric] history should be evaluated once a week just to check in on their mood, their sleep, their appetite, and especially their anxiety.”
“This is becoming such a popular medication and it has a lot of great effects,” he continued. “It works on fat cells primarily, but it also works on muscles. And the brain is essentially all that. Would this be affecting the brain? We don’t know.”
A slew of reports just like this case have been reported, prompting the FDA and European Medicines Agency (EMA) to look into the link between GLP’s and suicidality. But just last month, the EMA issued its final conclusion following a 9-month review of reports and data, clearing this popular class of agents of having a causal link with suicidal thoughts. The FDA is still currently reviewing the issue but released its preliminary evaluation in January saying these drugs “likely” don’t cause suicidality.
Ex-CNN Host Chris Cuomo Reveals COVID Vaccine Injury: ‘I’m Sick Myself’
Former CNN host Chris Cuomo said in a recent news segment that he is suffering from a health condition after he received a COVID-19 vaccine. Mr. Cuomo made the revelation during his NewsNation program when he was interviewing a nurse practitioner, Shaun Barcavage, a nurse practitioner who said he suffered vaccine injuries and has received little help or recognition.
“We know that vaccines can have unintended consequences, AKA side effects, but nobody’s really talking about it because they’re too afraid of blame, and they just want it to go away,” Mr. Cuomo said. “But the problem is people like Shaun — and me — and millions of others who still have weird stuff with their bloodwork and their lives and their feelings — you know, physically — are not going away,” he added.
Mr. Cuomo, 53, did not go into the details about his symptoms or the brand of COVID-19 vaccine he received. But during the interview, Mr. Cuomo offered to share his doctor’s information with Mr. Barcavage.
Mr. Barcavage told the program that he has received little support from federal health agencies such as the Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC).
Drugmaker Amneal Agrees to $270 Million U.S. Opioid Settlement
Amneal Pharmaceuticals (AMRX.O) said on Friday it had reached a deal valued at more than $270 million to resolve claims it helped fuel the deadly U.S. opioid epidemic, becoming the latest drug company to settle lawsuits over the addiction crisis brought by states and local governments.
Amneal reached an agreement in principle to pay $92.5 million in cash and provide $180 million worth of naloxone nasal spray, an overdose treatment medication, to resolve lawsuits by U.S. states, local governments and Native American tribes.
The settlement, which is payable over 10 years, would if finalized resolve nearly all of the more than 900 opioid-related lawsuits against Amneal, the company said. It did not admit wrongdoing as part of the nationwide settlement. The settlement added to the more than $51 billion that drug manufacturers, distributors, pharmacy operators and consultants have agreed to pay to resolve lawsuits and investigations over their roles in the drug addiction and overdose crisis.
Nearly 645,000 people died in the United States from overdoses involving opioids, both prescription and illicit, from 1999 to 2021, according to the U.S. Centers for Disease Control and Prevention.
Amgen Shares Soar as Executives Outline Obesity Drug Push
Amgen’s market capitalization swelled $20 billion following the announcement, a surge that reflects intense investor interest in emerging weight loss medicines.
The biotech’s lead drug, called maridebart cafraglutide or MariTide, acts on the same targets that Zepbound does, hormones called GLP-1 and GIP. But unlike Zepbound, MariTide blocks, rather than stimulates, GIP. Amgen also aims to show the drug can effectively cut weight with a once-monthly shot, instead of the weekly injections required for Zepbound and Wegovy. But there’s little known publicly about the drug’s potential.
Amgen, though, is now expressing enough confidence to warrant making a substantial investment in late-stage studies. During the conference call Thursday, executives didn’t disclose specific data but said all 11 study arms of the two-stage, placebo-controlled trial remain active. They also said there “has not been an issue” with patients stopping treatment due to side effects.
Should MariTide advance into Phase 3, it would likely need to be tested in a trial lasting more than a year, just as Wegovy and Zepbound were. To be competitive, Amgen will also need to run the type of large, multiyear trial that can prove whether MariTide protects heart health.
In the meantime, Novo and Lilly will be able to further entrench their drugs on the market. Already, they’ve made significant inroads, with Wegovy recording $1.3 billion in sales in the first quarter and Zepbound $517 million. Both are also seeing prescription numbers climb and are investing heavily in manufacturing.
Generative AI Will Be Designing New Drugs All on Its Own in the Near Future
Eli Lilly chief information and digital officer Diogo Rau was recently involved in some experiments in the office, but not the typical drug research work that you might expect to be among the lab tinkering inside a major pharmaceutical company.
Lilly has been using generative AI to search through millions of molecules. With AI able to move at a speed of discovery which in five minutes can generate as many molecules as Lilly could synthesize in an entire year in traditional wet labs, it makes sense to test the limits of artificial intelligence in medicine. But there’s no way to know if the abundance of AI-generated designs will work in the real world, and that’s something skeptical company executives wanted to learn more about.
The top AI-generated biological designs, molecules that Rau described as having “weird-looking structures” that could not be matched to much in the company’s existing molecular database, but that looked like potentially strong drug candidates, were taken to Lilly research scientists. Executives, including Rau, expected scientists to dismiss the AI results.
According to executives working at the intersection of AI and healthcare, the field is on a trajectory that will see medicines completely generated by AI in the near future; according to some, within a few years at most, it will become a norm in drug discovery. Generative AI is rapidly accelerating its applicability to the development and discovery of new medications, in a move that will reshape not only the pharmaceutical industry but ground-level ideas that have been built into the scientific method for centuries.
At Milken Institute Conference, CDC Director Mandy Cohen Talks Public Health Preparedness
In the spring of 2020, as COVID-19 took hold around the world, Centers for Disease Control and Prevention director Mandy Cohen was the head of North Carolina’s Department of Health and Human Services. Among the challenges she and her team had to face was the antiquated state of data pervasive in public health and medicine. “One of our first things that we had to do was stop receiving lab data by fax machine,” Cohen shared at the Milken Institute 2024 Global Conference, where she spoke on Monday with the institute’s chairman Michael Milken.
“Yup. Embarrassing,” she continued, as the audience murmured in surprise. Early in the pandemic, Cohen acknowledged the lack of comprehensive data in her state as a major barrier to the response, as well as the lack of data interoperability. On stage at Milken, she pointed to that experience as she discussed her intention to improve the CDC’s data capabilities as director, a position she has held since July 2023.
“There’s been a lot of investment, but we have to keep going. So we’re really focused this year on getting more electronic case reporting,” said Cohen. “This allows for faster identification of those health threats. And we can do it. The technology exists. We just need to use it.”
That perspective is especially relevant as Cohen leads the CDC in the face of another potential public health threat, a widespread domestic outbreak of bird flu in cows. “I spent a lot of my time these past few weeks on avian flu,” said Cohen. “We need core capacity to respond to those health threats.”
GAO Report Shows Strategic National Stockpile Challenges During COVID, Mpox
In a new report on the U.S. Strategic National Stockpile (SNS), the Government Accountability Office (GAO) noted that during recent public health crises such as COVID-19 and mpox, local officials weren’t clear on how and from whom to request supplies, and some tribal officials cited a lack of the facilities to receive and store delivered supplies.
The report is based on surveys conducted with health officials from 62 jurisdictions in the United States.
The SNS is supposed to help guarantee health and safety in the face of infectious disease outbreaks and crises, but both the COVID-19 pandemic and the global mpox outbreak showed that accessing the national inventory of medical countermeasures, vaccines, and medical supplies is often confusing and inefficient.
As Rival Merck Monopolizes BCG Supply, ImmunityBio Taps Serum Institute for New Combo’s Manufacturing
ImmunityBio last week won the FDA’s approval for its immunotherapy Anktiva to be used alongside the Bacillus Calmette-Guérin (BCG) vaccine to treat certain patients with bladder cancer. The problem is that there is an ongoing global shortage of BCG.
Now, the California biotech has partnered with the Serum Institute of India in an exclusive deal to manufacture BCG globally.
The arrangement aims to create “a long-term solution to chronic BCG supply shortage issues” and produce BCG “at large scale” for use in combination with Anktiva in non-muscle invasive bladder cancer (NMIBC), ImmunityBio said Thursday.
BCG, originally developed as a tuberculosis vaccine, is also a standard treatment for NMIBC, which accounts for about 80% of around 80,000 new bladder cancer diagnoses each year in the U.S.
Vaccine Partners Turn Rivals With First Shot for Advancing Virus
Two European partners will soon be vying for dominance in a new battleground: vaccines to protect travelers against a painful viral illness transmitted by mosquitoes.
Valneva SE became the first company to win clearance late last year to sell a shot for chikungunya, a disease that can cause fever and severe joint pain. Bavarian Nordic A/S is some months behind, awaiting approval in the European Union and starting a submission in the U.S.
The companies have marketed and distributed each other’s products since 2020, a collaboration due to wind down next year — just as the two start competing to carve a new market for their rival chikungunya shots.
