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Morning Briefing

Summaries of health policy coverage from major news organizations

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Wednesday, Jul 12 2023

Full Issue

India Insists On Better Drug Manufacturing Standards; Combination Drug Proves Effective Treating CF

Read recent pharmaceutical developments in Ñî¹óåú´«Ã½Ò•îl Health News' Prescription Drug Watch roundup.

Indian drugs regulators have taken action against 105 pharmaceutical companies after a risk-based inspection and audit of manufacturing plants, the health minister said on Tuesday. The action by national and state regulators comes after Indian-made cough syrups were linked to the deaths of dozens of children overseas. The minister said production has been stopped at 31 companies while product license cancellations or suspensions have been issued against a further 50 companies. (7/11)

Two years ago, a research group headed by Charité showed that combination therapy involving three drugs -- elexacaftor, tezacaftor, and ivacaftor -- is effective in a large portion of patients with cystic fibrosis, a hereditary disease, meaning that the treatment noticeably improves both lung function and quality of life. (Charite - Universitatsmedizin Berlin, 7/7)

The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit (JNJ.N) as "most serious", saying their use could lead to injuries or death. The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them. (7/11)

U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. (Liu, 7/11)

ADC Therapeutics has slammed the brakes on enrollment in a phase 2 combination trial for Zynlonta as it investigates seven patient deaths and five other severe respiratory events among patients who received the drug. (Becker, 7/11)

Coinfection with hepatitis D virus (HDV) accelerates the progression of liver disease associated with chronic hepatitis B. Bulevirtide inhibits the entry of HDV into hepatocytes. (Wedemeyer, M.D., et al, 7/6)

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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