Hung Trinh’s Post

https://lnkd.in/g3KxvY-M Copied and Pasted: FDA publishes new product-specific guidances to facilitate generic drug development Dear Medical Products Stakeholder, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan. Today’s batch of 60 PSGs (29 new and 31 revised) contains: 38 PSGs for products with no approved ANDAs (including 22 complex products) 31 PSGs for complex products (12 new and 19 revised PSGs) PSGs for products used for treatment of pulmonary hypertension, ovarian cancer, urothelial cancer, vaginal atrophy, and other conditions Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for treatment of schizophrenia, atopic dermatitis, and other conditions. When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs.

https://lnkd.in/gfbyAhrt Copied and Pasted: FDA publishes new product-specific guidances to facilitate generic drug development Dear Medical Products Stakeholder, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.  Today’s batch of 60 PSGs (29 new and 31 revised) contains: 38 PSGs for products with no approved ANDAs (including 22 complex products) 31 PSGs for complex products (12 new and 19 revised PSGs) PSGs for products used for treatment of pulmonary hypertension, ovarian cancer, urothelial cancer, vaginal atrophy, and other conditions Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for treatment of schizophrenia, atopic dermatitis, and other conditions. When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs. 

Is it a good idea for government to get into the business of pharmaceutical development? Read my latest article for why I think it would be more efficient for public drug plans to simply negotiate reimbursement for commercially available biopharmaceuticals. The article titled: "Government development of ‘made-in-Canada’ CAR-T cell immunotherapies: assessing cost, risk, access, and alternatives", examines this question with regard to a novel treatment for cancer.  https://lnkd.in/gsU8tKCf Summary: Chimeric Antigen Receptor T, or CAR-T cell immunotherapy, is a novel treatment that genetically engineers a patient’s own T-cells to recognize and attack cancer cells. CAR-T therapeutics have been available in the United States since May 2017, and in Canada since September 2018. As of July 1, 2024, six CAR-T products had been authorized for marketing by both the U.S. Food and Drug Administration (FDA) and Health Canada. One drug was later withdrawn from the Canadian market. Health technology assessment (HTA) is a prerequisite of the public reimbursement process in Canada and is conducted by the Canadian Drug Agency (CDA), formally known as the Canadian Agency for Drugs and Technologies in Health (CADTH). The five commercially available CAR-T products were recommended for public reimbursement by CDA. However, the prices for these therapies exceeded the cost effectiveness threshold used by CDA and therefore its recommendations were conditional on pricing adjustment. CAR-T has been eligible for public funding under US Medicare since 2017. By contrast, as of July 1, 2024, only six of the 10 Canadian provinces have authorized CAR-T products for public reimbursement. Lack of public funding is a significant barrier to accessing CAR-T immunotherapy, in addition to several other obstacles to treatment affecting patient access. Federal and provincial governments have been reluctant to extend funding eligibility for commercial products, preferring instead to invest in public development of a made-in-Canada capacity for manufacturing CAR-T therapies. Alternative funding models could more efficiently and more immediately improve access using commercially available CAR-T therapies in Canada.

FDA publishes new product-specific guidances to facilitate generic drug development Nov 19, 2024 Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.  Today’s batch of 60 PSGs (29 new and 31 revised) contains: 38 PSGs for products with no approved ANDAs (including 22 complex products) 31 PSGs for complex products (12 new and 19 revised PSGs) PSGs for products used for treatment of pulmonary hypertension, ovarian cancer, urothelial cancer, vaginal atrophy, and other conditions Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for treatment of schizophrenia, atopic dermatitis, and other conditions. When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs. https://lnkd.in/eiMChGAc https://lnkd.in/enWknvsX #FDA #GenericDrugDevelopment

Faster Drug Approvals and Improved Consensus with FDA: Impact of Project Orbis on Swissmedic A recent study published in The Lancet highlights the significant impact of Project Orbis, involving Swissmedic, on drug approval processes between 2020 and 2022. Project Orbis, initiated by the FDA in 2019, aims to expedite cancer drug approvals through collaborative parallel reviews while maintaining independent decision-making. Results showed that Orbis MAAs had a significantly reduced median submission gap and shorter review times compared to non-Orbis MAAs. Approval rates were nearly identical, and consensus decisions between Swissmedic and the FDA were slightly higher for Orbis MAAs. The study underscores the effectiveness of Project Orbis in enhancing the speed and efficiency of Swissmedic's oncology drug approvals, emphasizing the benefits of international regulatory collaboration in providing timely access to innovative cancer treatments. For more details please click the link! https://lnkd.in/eNUifhQ4 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

“The proposed new EU pharmaceutical package includes a provision to overcome obstacles related to the patenting and commercialisation of repurposed drugs.” #ScienceCommunications specialist Sophie Fessl writes about how the proposed revision to the EU’s current pharmaceutical regulation could help unleash new strategies for #DrugRepurposing 💊 Full story on CancerWorld magazine, a publication by SPCC (Sharing Progress in Cancer Care) 👇 https://lnkd.in/d_zbi-nq #PharmaInnovation #DrugResearch #EURegulation #FutureOfMedicine

Patients who are genetically predisposed to high levels of LP(a) have a higher risk of atherosclerosis, coronary heart disease, stroke, thrombosis, and aortic stenosis. Roughly 20-25 % of the world’s population is deemed to have high LP(a) levels. How do you know your levels and, consequently, your risk? LP(a) blood tests can determine levels. Although LP(a) levels should be regularly checked, the American College of Cardiology and the American Heart Association do not have LP (a) screening guidelines. Suppose there is a strong family history of premature atherosclerotic cardiovascular disease (ASCVD) in immediate relatives, a personal history of ASCVD, or severe hyperlipidemia; then LP(a) testing is warranted and strongly recommended in that case. The European Atherosclerosis Society goes even further to recommend LP(a) testing not only for the above categories but also for patients with persistent cardiovascular disease while on statin therapy, patients with >10% ten-year risk of cardiovascular disease, and a general LP(a) screen at least once per lifetime for everyone.

Shanghai MicuRx Pharmaceuticals, Inc. successfully completed the Phase I clinical trial of its self-developed new injectable polymyxin antibacterial drug MRX-8 in China, achieving the expected goals. MRX-8 is primarily used to treat infections caused by multidrug-resistant Gram-negative bacteria. This significant milestone marks a crucial step towards MRX-8 becoming a safe and effective new antibacterial drug. MRX-8 is a novel injectable polymyxin antibacterial drug independently developed by MicuRx Pharmaceuticals, primarily used to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxin drugs have limited clinical use due to their high risk of nephrotoxicity and neurotoxicity. MRX-8, through meticulous structural design, not only maintains or improves therapeutic efficacy, but also significantly reduces these toxic risks. Results from the Phase I clinical trial completed in the United States in 2022 showed that MRX-8 achieves ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii.