Login
$20,000 Monkeys: Inside the Booming Illicit Trade for Lab Animals
In 2019, Jonah Sacha, a researcher at Oregon Health and Science University, received a delivery of 20 monkeys from Mauritius. As part of his research into stem-cell transplants as an HIV treatment, he performs tests on long-tailed macaques.
The captive-bred monkeys were legally imported using an approved vendor and looked healthy. However, when Sacha tested them, one appeared to have latent tuberculosis (TB). None of the monkeys could be used because Sacha needed disease-free animals to produce accurate research. “My feeling was one of utter despair; it set this project back by more than a year and a half,” he says.
Long-tailed macaques are the most heavily traded primate species in the world, according to a paper published in September, and much of this is for laboratory research. The U.S. National Association for Biological Research says non-human primates remain a critical resource for research, with about 70,000 monkeys imported a year to study infectious diseases, the brain and the creation of new drugs.
Difficulty getting monkeys is compromising important research, Sacha says. Before the pandemic, he was paying between $2,000 (£1,600) and $5,000 for an animal. Now, it’s about $20,000. “For a couple of years during lockdown, it was near impossible to get them,” he says.
‘Last Roll of the Dice’ for a Near-Term HIV Vaccine Fails
A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe.
The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa. After multiple other high-profile trials failed, a PrEPVacc investigator described the study this summer as “the last roll of the dice” for an HIV vaccine until the 2030s.
The study has now been halted early after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy, researchers told the International Conference on AIDS and STIs in Africa.
Although disappointing, the news may not surprise many HIV vaccine researchers. PrEPVacc was seen as a pioneering study, both as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP, the daily antiviral pills that can dramatically reduce the risk of HIV infection.
But the trial used older vaccine designs that some scientists doubted would provide adequate protection. With the failure, there are now “no HIV vaccines being trialed for efficacy anywhere in the world,” PrEPVacc investigator Pontiano Kaleebu said in a statement.
The White House Is Threatening the Patents of High-Priced Drugs Developed With Taxpayer Dollars
The Biden administration is putting pharmaceutical companies on notice, warning them that if the price of certain drugs is too high, the government might cancel their patent protection and allow rivals to make their own versions.
Under a plan announced Thursday, the government would consider overriding the patent for high-priced drugs that have been developed with the help of taxpayer money and letting competitors make them in hopes of driving down the cost.
The administration did not immediately release details about how the process would work and how it would deem a drug costly enough to act. White House officials would not name drugs that might potentially be targeted.
There will be a 60-day public comment period. If the plan is enacted, drugmakers are almost certain to challenge it in court.
AbbVie to Buy Drug Developer Cerevel for $8.7 Billion
AbbVie (ABBV.N) said on Wednesday it would buy Cerevel Therapeutics (CERE.O), a developer of drugs for neurological conditions, for about $8.7 billion in a bid to replace revenue as its arthritis drug Humira faces a raft of new competition.
It marks the second large deal for AbbVie in the past week, coming days after it agreed to buy cancer drug developer ImmunoGen (IMGN.O) for $10.1 billion in cash, highlighting its appetite to place big bets on promising new medicines.
Revenue from Humira, once the top-selling drug in the world, is expected to fall precipitously following market entry of over half a dozen biosimilar versions of the drugs this year in the U.S. It already faced competition in Europe. Humira sales, which topped out above $21 billion in 2022, are expected to be below $9 billion next year.
Novartis Hit With FDA Letter Detailing ‘Significant’ Kymriah Manufacturing Shortfalls
In recent months, Novartis has faced FDA scrutiny due to “significant” production flubs tied to its flagship CAR-T medicine Kymriah, a newly posted letter shows.
This past August, the FDA issued an untitled letter after an inspection of Novartis’ Morris Plains, New Jersey, manufacturing facility between Nov. 28 and Dec. 9 of last year. In the wake of the inspection, the agency handed down a Form 483 describing “significant” deviations around Kymriah production.
Novartis responded to Form 483, according to the letter, but the agency subsequently identified “additional significant deviations” related to the Kymriah manufacturing process.
Chief among Novartis’ production problems, the company’s sampling and testing procedures around the freezing of cryobags could not confirm that the specialized Kymriah containers were free of particulate matter, the FDA said in its letter.
Aside from the particulate concern, the FDA flagged issues with possible microbial contamination. Between Oct. 2019 and the date of the inspection, the company logged roughly 100 possible contamination instances in the areas where Kymriah is manufactured, according to the FDA.
Mpox Surge in Congo Raises Concerns World Will Ignore Warnings Again
A surge of mpox in the Democratic Republic of Congo has raised concerns of another global outbreak with more deaths than the one ignited last year, prompting scientists to worry the world will again fail to recognize warnings from Africa.
The Centers for Disease Control and Prevention this week plans to alert health providers and people who have traveled to Congo to be on the lookout for rashes caused by the virus. The World Health Organization released a report in November detailing Congo’s worst surge on record, with nearly 13,000 suspected cases and 581 suspected deaths this year.
While there’s no evidence of another global outbreak starting, health authorities are especially attuned to a virus that was declared an international and U.S. health emergency last year.
The WHO warned that the situation in Congo, if not controlled, poses a significant risk of international outbreaks “with potentially more severe consequences than the one which has been affecting the world since 2022.”
Sanofi Says It Has 12 Blockbusters in Its Back Pocket. Will Investors Believe It?
The top executives at French drug giant Sanofi on Wednesday defended their decision to reduce earnings forecasts for 2024 in order to fund more research studies of new medicines they say could one day generate billions of dollars in annual sales.
CEO Paul Hudson and Houman Ashrafian, Sanofi’s new head of R&D, made their remarks in an exclusive interview with STAT ahead of a full-day meeting with analysts here. When the cuts to earnings were first announced on Oct. 27, along with a plan to spin off the company’s consumer products division, shares dove 18% and have yet to fully recover. The share price is down 5% since the beginning of 2023.
