AstraZeneca, Daiichi's Drug Wins Wider Use in Breast Cancer Patients
AstraZeneca Plc and Daiichi Sankyo Co. 's drug was cleared by US regulators for broader use in late-state breast cancer patients.
The Food and Drug Administration approved Enhertu to be used among metastatic, hormone-positive breast cancer patients with a small number of HER2 receptors, the companies said in a statement Tuesday.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Health Line
a day ago
- Health Line
LifeMD Review: Membership, Pricing, and Plans
Key takeaways LifeMD is a membership-based telehealth platform. It's popular for its Weight Management Program with GLP-1 access. LifeMD Plus membership costs $19 monthly, while its Weight Management Program starts from $79 monthly. LifeMD accepts Medicare and some insurance plans but has limited coverage. LifeMD Pros and Cons Pros 24/7 urgent and primary care same-day prescriptions local pharmacy collection lab testing options lower cost appointments and medications member-only offers no insurance required Cons requires a monthly subscription limited insurance coverage online only unsuitable for emergencies LifeMD Weight Management Program LifeMD's leading service is its Weight Management Program. It allows members to access the following Food and Drug Administration (FDA)-approved GLP-1 medications: On signup, you complete a questionnaire on your health and medical history. Within a week, you are matched with a healthcare professional who will assess your submission and determine if Wegovy is suitable for you. If you are eligible, you'll undergo lab tests, including a metabolic test. Your provider will then review the results to create a personalized weight loss plan and write a GLP-1 prescription. As a member of the Weight Management Program, you will receive support from a medical professional and can undergo regular metabolic testing. The LifeMD Weight Management Program starts from $79 monthly. The cost varies depending on the type of medication. If members don't experience at least a 10% weight reduction after 1 year, they can receive a refund. LifeMD Plus services LifeMD Plus costs $19 monthly and provides access to general healthcare services, including 24/7 primary and urgent care via video visits or chat messaging. It also provides same-day prescriptions. With LifeMD Plus, members can access services for many health concerns, such as: urinary tract infections (UTIs) acne erectile dysfunction (ED) premature ejaculation sexually transmitted infections (STIs) insomnia and sleep disturbances allergies and hayfever arthritis contraception migraine LifeMD also offers routine and specialty lab testing with partner companies Quest Diagnostics or LabCorp. These tests may come as at-home kits or require an in-person visit to a lab. Results are viewable online. LifeMD pricing and coverage LifeMD is a membership-based platform, meaning only paying members can access LifeMD services. The monthly membership costs are: LifeMD Plus: $19 monthly. Weight Management Program (GLP-1 injections): from $79 monthly Weight Management Program (oral medication): $129 monthly Virtual consultations, prescriptions, and lab work may come at an additional cost and can vary depending on insurance coverage. The costs without insurance are: video appointment: $50 message-based consults: $20 lab testing: variable The LifeMD Weight Management Program is not eligible for insurance coverage or Medicare. Frequently asked questions about LifeMD Is LifeMD a real company? Yes, LifeMD is a real and legitimate company. It provides various telehealth services, including same-day medication prescriptions, general and urgent healthcare consultations via video or chat, and health testing. Its most popular service is its Weight Management Program with GLP-1 medications. Yes, LifeMD is a real and legitimate company. It provides various telehealth services, including same-day medication prescriptions, general and urgent healthcare consultations via video or chat, and health testing. Its most popular service is its Weight Management Program with GLP-1 medications. Does LifeMD cost include medication? LifeMD prescriptions are an additional cost to its membership and offers low cost prescription options. LifeMD does accept some insurance plans for medication, though this varies depending on the provider and medication. The LifeMD Weight Management Program does not include the cost of medication. This is an additional payment and is not covered by insurance. LifeMD prescriptions are an additional cost to its membership and offers low cost prescription options. LifeMD does accept some insurance plans for medication, though this varies depending on the provider and medication. The LifeMD Weight Management Program does not include the cost of medication. This is an additional payment and is not covered by insurance.
Business Wire
a day ago
- Business Wire
OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it received positive written feedback from the US Food & Drug Administration ('FDA') Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines. 'We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ,' said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting.' OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale occurred in June 2025, valued at $160 million. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on PBS' website. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Yahoo
a day ago
- Yahoo
OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
Company has requested End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) based upon the positive FDA Meeting feedback NEW YORK, June 24, 2025--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it received positive written feedback from the US Food & Drug Administration ("FDA") Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines. "We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting." OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale occurred in June 2025, valued at $160 million. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on PBS' website. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. View source version on Contacts OS Therapies Contact Information: Jack Doll410-297-7793Irpr@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
