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BIO: Moderna to Test Mpox Vaccine in Humans This Summer
Back in January, Moderna set a planned mpox vaccine on the back burner as the immediate outbreak waned, but now the shot has slid into the priority lane, with entry to the clinic likely a “month or so” away, according to a top vaccine developer and strategist at the company.
Moderna is set to launch a phase 1/2 trial of the shot this summer, Hamilton Bennett, senior director of vaccine access and partnerships at Moderna, said in an interview at the BIO International Convention. The company had previously teased launching human trials sometime this year.
The upcoming trials are just the latest example of the swiftness of Moderna’s mRNA platform. The company announced in May 2022 that preclinical work would begin on an mpox vaccine. But no update had been made on the progress prior to Moderna CEO Stéphane Bancel’s comments at the beginning of the year.
For Bennett, the development of the shot means more than just the potential for a new product; it’s an opportunity to flex her muscles leading the company’s public health portfolio, a position she’s pivoted to since helping lead the development and dissemination of the COVID shot.
Federal Judge Certifies Class Action Lawsuit Against Eli Lilly
A federal judge in California recently certified a class action lawsuit against Indianapolis-based Eli Lilly & Company and Japanese company Takeda Pharmaceuticals, alleging that the pharmaceutical companies engaged in fraud and violated anticorruption legislation by covering up the risk of bladder cancer from a diabetes drug.
The previously-filed lawsuit has been underway for several years. The complaint alleges Takeda and Lilly violated the Racketeer Influenced and Corrupt Organizations Act (RICO), which is designed to fight organized crime. The RICO violation allegation will potentially allow for treble, or triple, damages to be awarded.
The plaintiffs claim Lilly and Takeda had “reason to know” about the dangers of bladder cancer from the diabetes drug Actos, also known as pioglitazone, and falsely marketed the drug to avoid losing money.
According to the complaint when the FDA issued its alert about Actos’ link to increased bladder cancer risk in 2011, sales fell by 80%, a news release from law firm Wisner Baum, who’s representing the plaintiffs, said.
Opioid Deaths Could Hit 165,000 Annually Without Intervention, Biden Official Warns
Biden-nominated drug czar Dr. Rahul Gupta warned of the potential increase in opioid deaths at Politico’s Health Care Summit Wednesday, saying it’s crucial the administration continues to focus on addressing the opioid crisis as “there is almost no other area today (that) affects our public health, national security and economic prosperity.”
Drug overdose deaths have hit record highs in recent years, in large part due to the spread and wider availability of opioids, also known as narcotics. Opioids are widely used as painkillers to treat pain too severe for other drugs to alleviate, but they are highly addictive and can be abused both as a prescription medication and as a street drug. Heroin, morphine, opium, fentanyl, oxycodone (sold under brand names, including OxyContin), hydrocodone (brands include Vicodin), codeine and methadone are all examples of opioids.
While Biden is making progress on some of the strategies outlined in his plan, he hasn’t followed through on all his opioid-related promises. When campaigning in 2020, Biden said he would hire an opioid crisis accountability coordinator who would support states litigating against pharmaceutical companies in spending their money, but Biden has not yet hired one despite settlement money arriving to state and local leaders, NPR reported.
Overdoses are happening all around us, and frequently. At the summit, Gupta said that someone is dying from an overdose every five minutes in America.
Teva to Pay Nevada $193 Million Over Role in Opioid Epidemic
Teva Pharmaceutical Industries (TEVA.TA) on Wednesday agreed to pay Nevada $193 million to settle claims that its marketing practices fueled opioid addiction, the state announced.
Nevada was one of two states, along with New Mexico, that did not join a $4.35 billion nationwide settlement with the Israel-based drugmaker last year. New Mexico has also since settled.
Nevada, along with other states and thousands of local governments, accused Teva and other drugmakers of downplaying the addiction risks of opioid pain drugs.
Teva sells the brand-name fentanyl-based drugs Actiq and Fentora used to treat breakthrough cancer pain, and has sold generic opioid drugs.
Recalled Philips CPAP Machines Linked to Nearly 400 Deaths by FDA Medical Device Reports
The U.S. Food and Drug Administration (FDA) issued an update this week on the widespread Philips CPAP health problems experienced by former users, indicating that the agency is now aware of more than 105,000 medical device reports involving problems caused by exposure to toxic sound abatement foam inside the sleep apnea machines, including 385 deaths.
The agency has been posting regular updates for consumers and the medical community since a massive Philips CPAP recall was issued in 2021, impacting millions of machines sold since 2009, following widespread reports of small black particles being found in the tubing and face masks, which was released by a polyester-based polyurethane (PE-PUR) foam intended to reduce noise and vibrations while the sleep apnea machines were used at night.
While the rate of new FDA complaints has begun to drop, the rate of new Philips CPAP Lawsuits filed is spiking, as many former users expect that the manufacturer may argue that the statute of limitations began running at the time the recall was announced, creating a potential deadline later this month for injuries suffered in certain states.
Cancer Centers Say Drug Shortages Are Impacting Patient Care
U.S. News & World Report reported:
A new survey of cancer centers finds that chemotherapy shortages are affecting most of them, prompting last-minute changes in treatment for numerous types of cancer.
“This is an unacceptable situation. We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Robert Carlson, chief executive officer at National Comprehensive Cancer Network, said in a news release on the widespread shortages.
World’s First Vaccine Against Deadly Swine Fever Nears Approval in Vietnam
Vaccines against African swine fever being tested in Vietnam are close to approval, global and U.S. veterinary officials said, in what would be a major breakthrough to tackle the deadly animal disease that regularly ravages pig farms worldwide.
After decades of failed attempts due to the complexity of the virus, two vaccines co-developed by U.S. scientists being tested in large pilot schemes by Vietnamese companies are showing “very promising” results, Gregorio Torres, head of the Science department at the World Organization for Animal Health (WOAH), told Reuters in a telephone interview.
Both vaccines have received approval in Vietnam for pilot commercial use, now completed. The next step will be nationwide authorization, the first ever for an African swine fever vaccine, and possible sales overseas.
