Morning Briefing
Summaries of health policy coverage from major news organizations
Facing Competition, J&J Stops Efforts Toward RSV Vaccine
Bloomberg: J&J Exits RSV Race After Competing Shots Advance Toward Approval
Johnson & Johnson halted development of a vaccine for respiratory syncytial virus infections in adults, leaving a $10 billion market to competitors who are ahead in their efforts. (Muller and Cattan, 3/29)
More pharmaceutical developments —
NBC News: 'We Have Arrived In The Post-Antibiotic Era': WHO Warns Of Too Few New Drugs For Deadly Superbugs
Late last year, one of Dr. Vance Fowler’s patients — a man in his 60s who’d returned to North Carolina from visiting his family in Nepal — died of a bacterial infection. He’d been treated at a top U.S. hospital with access to the strongest antibiotics. But the infection, a drug-resistant strain of E. coli, surged on. (Hopkins, 3/29)
Stat: Monkey Shortage Imperils Early-Stage Drug Development Timelines
A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring. Meanwhile, the cost of these monkeys, when they can be obtained, has jumped to more than $25,000 each, compared with $10,000 or less three years ago. (Silverman and Garde, 3/29)
Reuters: Novo Nordisk Says Stopping Obesity Drug May Cause Full Weight Regain In 5 Years
Patients discontinuing the use of weight-loss drugs such as Wegovy risk regaining their original body weight in about five years, a Novo Nordisk official said on Wednesday. Based on individual profile, patients could gain back about half of the original body weight in two to three years if they stop the treatment, the Danish drugmaker's head of global drug discovery, Karin Conde-Knape, told a health conference organized by CNBC. (3/30)
Bloomberg: Somerville-Based Bluebird Bio Expects Delay On FDA Sickle Cell Drug Application
Bluebird Bio expects to fall short of its goal to seek regulatory approval for its sickle cell gene therapy by the end of March, the latest setback for the struggling biotechnology company. The company may be able to file the application in a few weeks, depending on when the US Food and Drug Administration provides feedback about Bluebird’s drug manufacturing process, Chief Executive Officer Andrew Obenshain said in an interview. He still expects to launch the drug, lovo-cel, next year. (Peebles, 3/29)
Reuters: GSK Licenses Companies To Make Cheap Copies Of HIV Prevention Drug
British drugmaker GSK has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir was approved by regulators in the United States in late 2021. Last July, GSK announced a program with the United Nations-backed healthcare organization, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. (Fick, 3/30)
The Boston Globe: Waltham Biotech’s Vision Loss Drug Helps Slow A Form Of Macular Degeneration
“The rate of slowing is modest, but it’s real,” said Dr. Jeffrey Heier, director of retina research at Ophthalmic Consultants of Boston who led one of the clinical studies of Syfovre. “Patients aren’t going to see visual improvement with this treatment,” he added. “They’re still going to notice vision loss, but hopefully at a much slower rate.” (Cross, 3/29)
KHN: States Try To Obscure Execution Details As Drugmakers Hinder Lethal Injection
In 2011, Jeffrey Motts was executed in South Carolina. More than a decade later, the state hasn’t carried out another execution because officials have struggled to obtain the drugs needed for lethal injection. Now, to resume executions, lawmakers are debating a bill that would further shroud the state’s lethal injection protocols from public scrutiny by shielding the identities of the drug suppliers. (Rayasam, 3/30)
Also —
Stat: Medical Device Makers Must Now Prove Cybersecurity To FDA
Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid, lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan. It also gives the FDA $5 million to see a higher security standard through. Historically, the agency has lacked the resources to keep up with rapidly-evolving security threats, or the authority to force device makers to comply with its draft guidelines. (Lawrence, 3/29)
