Generics and Biosimilars Initiative (GaBI)’s Post

Dr. Satyajit Acharya, Consultant, Department of Pulmonary Medicine at SUMUM, emphasizes the importance of thorough treatment and follow-up checks for Tuberculosis. While government medical availability ensures access to pharmaceutical aids, comprehensive care is crucial. At SUMUM, our team of experts prioritize periodic tests and thorough body analysis before declaring a patient TB-free. Choose the best for your health! #WorldTBDay #Tuberculosis #SUMUM

ICYMI: #FDA declines approval of Orexo’s OX124, a high dose #intranasal #naloxone. Collection of additional human factors data was requested in the complete response letter. #overdose #opioid #opioidcrisis #healthcare #harmreduction https://lnkd.in/gmGcVfpV

PN Update: Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin,metformin, Date of authorisation: 15/11/2015, Revision: 22, Status: Authorised

🚀 Continuing Your Pharma Education: Macrolides – A Powerful Class of Antibiotics 🌐 In our latest article, we explore the Macrolides, a vital antibiotic family known for their effectiveness against respiratory, skin, and sexually transmitted infections. Learn about their history, family members, and leading market brands. Essential reading for newcomers in the pharmaceutical industry! #Macrolides #Antibiotics #PharmaEducation #BacterialInfections #MedicalKnowledge #NewToPharma #PharmaceuticalIndustry #AntimicrobialTherapy #RespiratoryInfections #SkinInfections #STIs #Health #MedicalStudent #MedicalRepresentative #PharmaColleagues #Pharmacology #Health #HealthTips Read the full article now and stay tuned for more! 👇 https://lnkd.in/dCv5HE9A

Takeda announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the EU. If approved, rADAMTS13 will be the first and only enzyme replacement therapy in the EU to treat cTTP. Read More: https://lnkd.in/dCx7gBCb “People living with cTTP experience serious, potentially fatal health challenges and have limited treatment options in the European Union,” said Obi Umeh, Vice President, Franchise Global Program Leader at Takeda. #mededgemea #Takeda #ADAMTS13 #cttp #RareDisease #enzymereplacement #BloodDisorders #pharmanews #MedicalBreakthroughs #HealthcareInnovation #thrombocytopenia #europeancommission #LifeSciences

EU Regulators Approve First and Only Adrenaline Nosal Spay for Emergency Treatments The European Commission has approved the first and only no-needle adrenaline-based nosal spray, EURneffy®, to treat severe cases of allergenic reactions commonly known as anaphylaxis. Developed by ARS Pharmaceuticals, Inc., the nosal spray offers EU residents living with severe allergic reactions the first alternative method for adrenaline delivery in over 30 years. The decision announced by the commission on August 22 followed a similar FDA approval of the medication on August 9, 2024, allowing the spray to be commercially available on the US market. Following the approval of EURneffy®e, Richard Lowenthal, Co-Founder and CEO of ARS Pharmaceuticals, said the commission’s decision marks a significant moment for EU residents living with the medical condition. Read more: https://lnkd.in/gCdn5GM6 #HealthcareNews #healthcareinnovation #HealthcareTechnology #Ai #medicaldevice #nextdigitalhealth #vineetagrawal #Wi4

Another on of the BJCP series on European Medicines Agency guidelines. Read this series with academic and regulatory insights in guidelines and hyperlinks to the actual text

In other news, it looks like Humana and other #MedicareAdvantage plans will continue to exclude most generic inhalers from coverage, and list other generics as tier 3, brand drugs. Despite multiple generics on the market now, there is not a single tier 1 or 2 inhaler option for patients with #asthma or #COPD. Patients will continue to fall victim to the perverse incentives driven by the #PBM discount system. How is this still happening? https://lnkd.in/gXeYkeQJ

Hello #infusioncenter friends. Have you seen this? FDA Authorizes New Long-Acting Monoclonal Antibody for Pre-exposure Prevention of COVID-19 in Certain Immunocompromised Individuals. Today, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents. The authorized initial dose of Pemgarda is 4500 mg administered as a single intravenous infusion. If ongoing protection is needed, a repeat 4500mg dose should be administered every three months.  https://lnkd.in/gNGAaC4x

💉 𝐍𝐨𝐯𝐚𝐫𝐭𝐢𝐬 𝐆𝐞𝐭𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐂𝐇𝐌𝐏 𝐎𝐩𝐢𝐧𝐢𝐨𝐧 𝐟𝐨𝐫 𝐢𝐭𝐬 𝐁𝐫𝐞𝐚𝐬𝐭 𝐂𝐚𝐧𝐜𝐞𝐫 𝐃𝐫𝐮𝐠! 💊 𝐈𝐧 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟒, Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting #marketing authorization for Kisqali (ribociclib). The #drug was recommended for the adjuvant #treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early #breastcancer (EBC), at high risk of #disease recurrence, including those with node-negative disease. Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient #population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease. 𝐋𝐨𝐨𝐤 𝐚𝐭 𝐨𝐮𝐫 𝐂𝐨𝐫𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐑𝐞𝐩𝐨𝐫𝐭 👉 https://lnkd.in/dbD5AedJ #Novartis #BreastCancer #DrugDevelopment #MedicinalProducts #Authorization #AdjuvantTreatment