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Relyvrio, an Amylyx Pharmaceuticals drug approved for treating ALS, failed a post-marketing Phase 3 clinical trial. Amylyx set an eight-week timeline for evaluating its next steps, which could include voluntarily withdrawing the drug from the market. https://ow.ly/khAT50QRtJj #ALS #Relyvrio

We are excited to announce that our regional partner in China, Hasten Biopharmaceutical Co., Ltd., has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Hasten will begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy. LIB Therapeutics is preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.  Lerodalcibep has a potential best in class LDL-C lowering profile and will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel. #lerodalcibep #PCSK9 #cardiovasculardisease

Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s understanding that Oncopeptides does not currently market Pepaxto in the U.S Refer the official announcement on FDA website for more details https://lnkd.in/dRWq26FP .

The Canadian Biosimilars Forum applauds Ontario for its ongoing efforts to improve access to biosimilars. As of July 31, 2024, Ontario’s Biosimilar Policy includes biosimilar versions of the following four originator biologics: Lucentis (ranibizumab), Stelara (ustekinumab), Lovenox (enoxaparin), and Neupogen (filgrastim).   The Forum looks forward to continued efforts to enhance pan-Canadian access to biosimilars.   https://lnkd.in/gdy-gE9z  

The US FDA New Drug Approvals in August 2024  PharmaShots, your go-to media platform for life science news, brings a condensed report highlighting new drug approvals in August 2024 by the US FDA.  Stay Tuned for more updates!   Servier Pharmaceuticals Citius Pharmaceuticals, Inc. Ascendis Pharma Galderma Gilead Sciences Incyte Johnson & Johnson #regulatory #usfda #pharma #healthcareindustry #approvals #newmolecularentities #biologic #pharmashots 

Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) has finalized the acquisition of its NP-120 (Ifenprodil) research program by US-based Seyltx Inc in a deal valued at US$2 million in cash along with a 20% equity stake in Seyltx. Ifenprodil is a potential first-in-class treatment for chronic cough, targeting the NMDA receptor to suppress the urge to cough. Seyltx plans to initiate a Phase 2b clinical trial for chronic cough treatment in 2024, building on positive Phase 2a study data that demonstrated significant reductions in cough counts. Algernon's decision to advance to the Phase 2b trial was based on encouraging results from previous trials and positive feedback from the US Food and Drug Administration. More at #Proactive #ProactiveInvestors #CSE #OTCQB #AGN #AGNPF http://ow.ly/Y8TR105nvLt

What is Product Specific Guidance (PSG)? PSGs describe FDA's current thinking and expectations to develop #genericdrugs therapeutically equivalent to specific RLDs. To facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support #anda approval, the FDA just published updated list of PSG. Here is how you find the searchable database: https://lnkd.in/dBpZN4P Also, check out this: https://lnkd.in/eFyNFV4 Sponsors and investigators of any investigational new drug (#ind)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct, including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring. Today’s batch of 32 PSGs includes:   --26 new PSGs, including 10 for new chemical entities (NCEs), and 6 revised PSGs --25 PSGs for products with no approved ANDAs (including 11 complex products)  --13 PSGs for complex products (8 new and 5 revised PSGs)  --PSGs for products used for treatment of paroxysmal nocturnal hemoglobinuria, Parkinson’s disease, Friedreich's ataxia, mantle cell lymphoma, and other conditions  --PSGs that were developed or revised based on improved scientific understanding resulting from GDUFA-funded research. These PSGs reference products used for treatment of opioid overdose, cystic fibrosis, and other conditions. #precaution, #contraindication

📢 Pulse Newsletter: Your Go-To Source for PBM and Drug Safety Updates Catch up on the latest in clinical pharmacy, drug safety, and pharmaceutical advancements—all in just a few minutes. 🔬 Clinical Pharmacy Update FDA approves Hympavzi™ for hemophilia A and B ⚠️ Drug Safety Bionpharma recalls one batch of Atovaquone Oral 💉 Pharmaceutical News The FDA authorizes Healgen Rapid Check COVID-19/Flu A&B Antigen Test 🆕 FDA Approvals Itovebi™ joins the breast cancer treatment landscape 📈 New Generics Roxybond® (oxycodone) now available as a generic, supporting severe pain management. 🔗 Read the full newsletter: https://bit.ly/3As2C51 #PharmacyNews #DrugSafety #FDAApprovals #PBMIndustry #HealthcareUpdates #PulseNewsletter

PD-1 and PD-L1 Inhibitors Commpetitive Assessment, 2024 Updates | In-depth Insights into the Emerging Drugs, Latest FDA, EMA, and PMDA Approvals, Clinical Trials, and Treatment Outlook | Compass #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

Cardiol Therapeutics Inc. (TSX:CRDL, NASDAQ:CRDL), the #pharmaceutical company, has been awarded Orphan Drug Designation for its lead #drug candidate. The US Food and Drug Administration (FDA) awarded Cardiol the orphan status for the drug due to its potential use in helping treat both one-time and recurrent pericarditis, the inflammation of the lining around the heart. This regulatory milestone was reached following the evaluation of pre-clinical and initial Phase II clinical data from the MAvERIC-Pilot study Andrew Hamer, Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL)' chief medical officer, said: “This designation reinforces the potential of CardiolRx to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity." More at #Proactive #ProactiveInvestors http://ow.ly/8ezf105h2ls #TSX #NASDAQ #CRDL