India Insists On Better Drug Manufacturing Standards; Combination Drug Proves Effective Treating CF
Read recent pharmaceutical developments in KFF Health News' Prescription Drug Watch roundup.
Reuters:
Indian Drugs Regulators Took Action Against 105 Pharma Firms, Minister Says
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)
ScienceDaily:
Triple Combination Therapy Brings Lasting Improvement In Cystic Fibrosis
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)
Reuters:
US FDA Classifies Recall Of J&J's Electrosurgical Tools As Most Serious
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)
FiercePharma:
Takeda Yanks FDA Application For Dengue Vaccine Qdenga
U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. (Liu, 7/11)
FiercePharma:
ADC Pauses Zynlonta Study After 7 Patient Deaths
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)
New England Journal of Medicine:
A Phase 3, Randomized Trial Of Bulevirtide In Chronic Hepatitis D
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)
