Health
FDA approves cancer therapy by J&J, partner Legend Biotech
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The U.S. health regulator has approved a therapy developed by Johnson & Johnson and its China-focused partner Legend Biotech Corp to treat a type of white blood cell cancer, the U.S. healthcare company said on Monday.
The Food and Drug Administration‘s decision paves the way for Legend’s first approved product in the United States, at a time when the regulator has stepped up its scrutiny of drug trials conducted in China. The Legend-J&J therapy was tested initially in China, and then in the United States and Japan.
“This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states,” said Ying Huang, Legend’s chief executive officer and chief financial officer.
The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies.
CAR-T drugs work by harvesting a patient’s own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.
Legend and J&J will sell the drug in Greater China at 70-30 split in profit, and in all other countries in a 50-50 split in profit. https://bit.ly/3C1cfnsA decision on the CAR-T therapy was initially expected to come by the end of November after it was given priority review six months earlier, but this was extended by three months to allow sufficient time to review information submitted by J&J following an FDA request.
Legend, which initiated the development, signed an agreement with Janssen Biotech Inc, an arm of J&J, in 2017, to jointly develop and commercialize the drug, with Legend getting $350 million in upfront payment.
Besides the United States, Carvykti/Cilta-cel is also being reviewed by health authorities in Japan and Europe. A Marketing Authorisation Application (MAA) for the therapy in China is yet to be filed.
(This story clarifies in paragraph 6 that Legend and J&J will sell the drug in Greater China at “70-30” split in profit, corrects last paragraph to say an MAA is yet to be filed in China)
(Reporting by Leroy Leo, Shivani Tanna and Sneha Bhowmik in Bengaluru; additional reporting by Bhargav Acharya; Editing by Sriraj Kalluvila, Subhranshu Sahu and Sherry Jacob-Phillips)
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Alberta Health Services (AHS) has confirmed a case of measles in Edmonton, and is advising the public that the individual was out in public while infectious.
Measles is an extremely contagious disease that is spread easily through the air, and can only be prevented through immunization.
AHS says individuals who were in the following locations during the specified dates and times, may have been exposed to measles.
- April 16
- Edmonton International Airport, international arrivals and baggage claim area — between 3:20 p.m. and 6 p.m.
- April 20
- Stollery Children’s Hospital Emergency Department — between 5 a.m. to 3 p.m.
- April 22
- 66th Medical Clinic (13635 66 St NW Edmonton) — between 12:15 p.m. to 3:30 p.m.
- Pharmacy 66 (13637 66 St NW Edmonton) — between 12:15 p.m. to 3:30 p.m.
- April 23
- Stollery Children’s Hospital Emergency Department — between 4:40 a.m. to 9:33 a.m.
AHS says anyone who attended those locations during those times is at risk of developing measles if they’ve not had two documented doses of measles-containing vaccine.
Those who have not had two doses, who are pregnant, under one year of age, or have a weakened immune system are at greatest risk of getting measles and should contact Health Link at 1-877-720-0707.
Symptoms
Symptoms of measles include a fever of 38.3° C or higher, cough, runny nose, and/or red eyes, a red blotchy rash that appears three to seven days after fever starts, beginning behind the ears and on the face and spreading down the body and then to the arms and legs.
If you have any of these symptoms stay home and call Health Link.
In Alberta, measles vaccine is offered, free of charge, through Alberta’s publicly funded immunization program. Children in Alberta typically receive their first dose of measles vaccine at 12 months of age, and their second dose at 18 months of age.
Health
U.S. tightens rules for dairy cows a day after bird flu virus fragments found in pasteurized milk samples – Toronto Star
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Infected cows were already prohibited from being transported out of state, but that was based on the physical characteristics of the milk, which looks curdled when a cow is infected, or a cow has decreased lactation or low appetite, both symptoms of infection.
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