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AI Drug Discovery Is a $50 Billion Opportunity for Big Pharma
Finding a potential blockbuster medicine typically takes years of extensive analysis in the laboratory, with teams of researchers methodically sifting through data and test results to unearth a promising candidate. But when Japan’s Takeda Pharmaceutical Co. bought an experimental psoriasis drug for $4 billion from a Boston startup in February, it gained a compound selected in only six months by using artificial intelligence.
In the coming months, the drug — picked out of thousands of potential molecules through AI and machine learning algorithms — will progress to the final stages of clinical trials. If successful, it could become one of the first therapies discovered with the help of AI. Analysts at Jefferies estimate it could generate as much as 500 billion yen ($3.7 billion) in annual sales.
USDA Greenlights Lyme Disease Vaccine That Targets Mice Hosts
The U.S. Department of Agriculture (USDA) has conditionally licensed an oral vaccine designed to limit the spread of Borrelia burgdorferi, the bacterium that causes Lyme disease. The vaccine is sprayed onto pellets and distributed in natural settings to be consumed by mice.
In its announcement, Memphis-based U.S. Biologic said field trials by several groups showed a real-world impact and that the product meets all of the USDA’s conditional licensing requirements, including that it uniquely addresses an emergency condition.
The company said it will make the product available for residential settings and public spaces, such as parks, golf courses, and other recreational facilities. It added that it will work closely with federal and state health agencies, pest control management groups, and partners including the Global Lyme Alliance and the Lyme Disease Association.
The vaccine is called Borrelia Burgdorferi Bacterin. The product, called LymeShield, includes a device or “station” that holds and applies the pellets, according to the company’s website.
Will Senate Hearing Expose PBMs’ Unscrupulous Drug Pricing Tactics?
Today, Sen. Bernie Sanders, I-Vt., will haul executives from three insulin manufacturers and three pharmacy benefit managers before the Senate Health, Education, Labor and Pensions Committee for a hearing on “the need to make insulin affordable for all Americans.“
Sen. Sanders is sure to call the pharmaceutical executives — who represent Eli Lilly and Company, Novo Nordisk, and Sanofi — greedy, as he has repeatedly during his tenure atop the HELP Committee. This time, though, PBMs will get some heat, too.
Good. PBMs have unscrupulously created an opaque drug pricing system that has yielded riches for them — at the expense of patients and drug companies.
PBMs act as middlemen between insurers and pharmaceutical firms. Insurers hire them to manage their prescription drug plans — to negotiate with drug companies over whether their medicines will go on a health plan’s formulary or list of covered medicines, and at what cost.
Gilead Sciences Defeats U.S. Government Lawsuit Alleging HIV Drug Patent Violations
A Delaware federal court jury on Tuesday cleared Gilead Sciences of civil claims by the U.S. government that the company violated patents held by the Centers for Disease Control and Prevention for an HIV prevention drug.
The government sued Gilead in 2019, arguing that the company was profiting off CDC patents through the company’s sales of Truvada and Descovy, oral medications taken to prevent HIV infection.
But jurors after a multiday trial found that the government’s patent claims on the HIV prevention regimen called pre-exposure prophylaxis, or PrEP were not valid.
Gilead’s combined worldwide sales of Truvada and Descovy were about $2 billion in 2022, according to company financial statements.
Drugs Like Adderall, Xanax Can Be Prescribed Online Into 2024, U.S. Says
Controlled substances like Adderall will be allowed to be prescribed online into late 2024, U.S. health and drug officials said, reversing their earlier position that restrictions on the drugs would be reinstated as the pandemic eased.
Healthcare providers can prescribe controlled substances online through Nov. 11, according to an advance copy of a rule posted online Tuesday. In addition, practitioners who establish relationships with patients on or prior to that date can continue to prescribe controlled substances for an additional year.
Cancer Vaccine From BioNTech, Roche Shows Potential in Small Study
An experimental vaccine developed by German drug developer BioNTech showed early promise in a small study of people with pancreatic cancer, suggesting that personalized immunotherapy could offer a way to treat one of the deadliest types of tumors.
The results, published in the journal Nature on Wednesday, showed trial participants who responded to treatment with the vaccine went longer without their cancer returning after surgery than those who didn’t respond. The study was primarily designed to assess safety and participants’ immune responses, and “responder” analyses aren’t as rigorous a test as placebo-controlled comparisons.
Still, the data’s publication is the second time this year a drugmaker has detailed trial findings for a personalized cancer vaccine, after years of setbacks in the research field. In April, Moderna and partner Merck & Co. disclosed full results from a mid-stage trial of a cancer vaccine they’re developing for melanoma.
The studies also provide a sign that the biggest names in messenger RNA-based medicines may have a chance to deliver on expectations investors held for them in cancer treatment prior to their success in developing COVID-19 vaccines. Roche paid $310 million seven years ago to collaborate with BioNTech on mRNA cancer vaccines.
Most Antidepressants Ineffective at Treating Chronic Pain
More than 51 million U.S. adults live with chronic pain. Out of that, at least 17.1 million people suffer through high-impact chronic pain on a daily basis, according to the Centers for Disease Control and Prevention. Doctors commonly prescribe antidepressants to people living with chronic pain. But a recent study suggests that might not be the best approach to provide pain relief.
In the U.K.-based study, researchers reviewed and analyzed studies that investigated the efficacy of 25 different antidepressants. They observed that the only antidepressant that might be useful in treating chronic pain is duloxetine. Whereas they highlighted that the “evidence for all other antidepressants was low certainty.”
In a press release, lead author of the study, Tamar Pincus, a professor at the University of Southampton said, “This is a global public health concern. Chronic pain is a problem for millions who are prescribed antidepressants without sufficient scientific proof they help, nor an understanding of the long-term impact on health.”
“Our review found no reliable evidence for the long-term efficacy of any antidepressant and no reliable evidence for their safety for chronic pain at any point. Though we did find that duloxetine provided short-term pain relief for patients we studied, we remain concerned about its possible long-term harm due to the gaps in current evidence,” he further added.
Talcum Powder Settlement Negotiations Ordered by Bankruptcy Judge
A federal bankruptcy judge has ordered Johnson & Johnson and attorneys representing thousands of plaintiffs to engage in additional talcum powder settlement negotiations, while the Court evaluates whether it will reject a second attempt by the manufacturer to force a resolution of the litigation through the U.S. bankruptcy process.
Over the last decade, Johnson & Johnson has faced nearly 40,000 Johnson’s Baby Powder lawsuits and Shower-to-Shower lawsuits, each involving similar allegations that asbestos particles in the talc powder caused users to develop ovarian cancer, mesothelioma and other injuries.
Johnson & Johnson has faced sharp criticism from plaintiffs’ attorneys and consumer advocates for its repeated attempts to pursue a so-called “Texas Two-Step” bankruptcy scheme, solely to avoid paying women settlements that it easily could have absorbed through the U.S. civil justice system.
