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Morning Briefing

Summaries of health policy coverage from major news organizations

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Thursday, Mar 30 2023

Full Issue

Facing Competition, J&J Stops Efforts Toward RSV Vaccine

Bloomberg says Johnson & Johnson's exit from the race to make a respiratory syncytial virus vaccine for adults leaves open a $10 billion market. Separately, the WHO warned that the world has "arrived in the post-antibiotic era" over a lack of development of new drugs capable of tackling deadly superbugs.

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 鈥

Late last year, one of Dr. Vance Fowler鈥檚 patients 鈥 a man in his 60s who鈥檇 returned to North Carolina from visiting his family in Nepal 鈥 died of a bacterial infection. He鈥檇 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.聽(Hopkins, 3/29)

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 鈥 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)

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)

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鈥檚 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)

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)

鈥淭he rate of slowing is modest, but it鈥檚 real,鈥 said Dr. Jeffrey Heier, director of retina research at Ophthalmic Consultants of Boston who led one of the clinical studies of Syfovre. 鈥淧atients aren鈥檛 going to see visual improvement with this treatment,鈥 he added. 鈥淭hey鈥檙e still going to notice vision loss, but hopefully at a much slower rate.鈥 (Cross, 3/29)

KHN: States Try To Obscure Execution Details As Drugmakers Hinder Lethal Injection聽

In 2011, Jeffrey Motts was executed in South Carolina. More than a decade later, the state hasn鈥檛 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鈥檚 lethal injection protocols from public scrutiny by shielding the identities of the drug suppliers. (Rayasam, 3/30)

Also 鈥

Hidden in this year鈥檚 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)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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