Helixgate

Helixgate

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Opinion: Check-in and intake at the doctor’s office are perfect for AI

I was the only person seated in the waiting room of an internal medicine specialty clinic for blood pressure issues. The day before the appointment I had completed the online registration, including demographics, past medical history, medications, allergies, etc. 

Upon arrival I was directed, as I am at the airport, to check in at a kiosk. However, instead of a person nearby to assist me to complete the process like at the airport, I then needed to go to the front desk, where the receptionist confirmed, again, the correct spelling of my name, my date of birth, insurance information, and queried about recent international travel. I was advised to sit in an adjacent room and wait.

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I was the only person seated in the waiting room of an internal medicine specialty clinic for blood pressure issues. The day before the appointment I had completed the online registration, including demographics, past medical history, medications, allergies, etc. 

Upon arrival I was directed, as I am at the airport, to check in at a kiosk. However, instead of a person nearby to assist me to complete the process like at the airport, I then needed to go to the front desk, where the receptionist confirmed, again, the correct spelling of my name, my date of birth, insurance information, and queried about recent international travel. I was advised to sit in an adjacent room and wait.

Read the rest…

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FDA imposes import alert on Indian plant after inspectors flag GMP failings

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Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.

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STAT+: Pharmalittle: We’re reading about a discontinued cancer drug, a Novo security breach, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

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Amgen shores up Tavneos’ FDA defense with Duke data analysis

Amgen shores up Tavneos’ FDA defense with Duke data analysis

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After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.​ ​Read More

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