LabAnalysis’ Post

🌟 EMA Drug Approvals in 2024! 🌟 The EMA has had a significant year so far in 2024, with numerous new drug approvals that promise to make a big impact on patient care and treatment options across the EU. 🌍💊 Notably, the Committee for Medicinal Products for Human Use (CHMP) recently recommended 10 new medicines for approval, including: 💊 Winrevair: A first-in-class treatment for pulmonary arterial hypertension supported through the PRIority Medicines (PRIME) scheme. 💊 Eurneffy (epinephrine): The first nasal adrenaline spray for emergency treatment against allergic reactions, offering a convenient alternative to injectable formulations. 🏢 Key companies securing approvals – #Idorsia, #Takeda, #AstraZeneca, #Sobi, #Biogen, #Novartis, #TravereTherapeutics, #Pfizer, #BeiGene, #GSK, #UCB, #Merck, #Johnson, #Roche, #Regeneron 🏢 These advancements underscore the EMA's commitment to facilitating the development and accessibility of innovative medicines that address critical health needs. Stay updated on the recent drug approvals with ➡ AdametNext #Pharmaceuticals #Healthcare #EMA #DrugApprovals #Innovation #PatientCare

“Skinny Labeling” allows drug manufacturers to bring more affordable, generic medicines to patients quicker. For example, if a brand-name drug is approved for treating four different diseases, only one of which is covered by a patent, generic drug manufacturers can “carve-out” that patented method and gain FDA approval for the remaining three diseases. Skinny labeling protects timely patient access to affordable #generic and #biosimilar medicines. Learn more: https://lnkd.in/eNZ4H37S

An addition to the ongoing discussion: According to drug act section 12, the Federal Govt has to fix the minimum price of medicine or may entrust it to any authority. But in the DRAP Act 2012 price regulation is under the jurisdiction of DRAP, for this purpose DRAP have issued a pricing Policy for therapeutic goods and biologicals in 2018. So, there is an overlap in DRAP act 2012 and Drug Act 1967. So the ministry of law has been advised to propose amendments for removal of inconsistencies which arises after the cabinet approved the proposal contained in the summary submitted by the federal ministry of Health. Interestingly, there is also confusion as to how the federal government can amend the drug act or the DRAP Act as it is a provincial subject after the 18th amendment.

According to the notification, the Drug Act, 1976 has been amended to be said to remove the role of the Drug Regulatory Authority of #Pakistan (DRAP) and empower pharmaceutical companies to fix medicine prices. This decision of the #government will apply to 'non-essential medicines' i.e. daily use #medicines. Medicines in Pakistan are divided into two categories essential and daily use. Under the said legislation, allegedly now it will not be under the jurisdiction of the government to #control the #prices of daily use medicines i.e. medicine for fever, headache, blood pressure, antibiotics, anti-allergic and multivitamins, while the authority to increase the prices of essential medicines i.e. life-saving medicines will be possible only with the approval of the #cabinet. Another blunder tantamount to letting people fully looted by these capitalists butchers.

🔬📚 Discover the Crucial Role of Bioequivalence Studies in ANDA Approval! 🏥💊 Are you curious about how generic medications gain FDA approval? 🤔 The answer lies in bioequivalence studies! 🧪🔬 These scientific investigations play a vital role in demonstrating the safety and efficacy of generic drugs, making them reliable substitutes for brand-name medications. 💯✅ Read our latest article to explore the significance of bioequivalence studies in ANDA approval, ensuring patient safety and medication effectiveness. 🚀🌟 👉 https://lnkd.in/duPYE35P #GenericDrugs #ANDA #FDA #Bioequivalence #Healthcare #Patent

Ever wondered how drugs make their way through the rigorous vetting process of the Food and Drug Administration (FDA)? In this article, we delve into the TLDR (Too Long; Didn't Read) version of how drugs become FDA-approved. Susan Egbert, PharmD writes. https://lnkd.in/eFmaAZeR #medicine #healthcare #pharmacy #FDA #FDAapproval #medications #innovation #research #researchanddevelopment #meded #healthliteracy

#AmylyxPharmaceuticals shares fell Friday after its ALS (amyotrophic lateral sclerosis) drug was denied marketing authorization by European Union regulators for the second time.  The repeat rebuff comes after Amylyx asked in June for a formal re-examination of the original denial adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Shares of the company eased 1.8% to $17.31.  Going forward, Amylyx said it intends to prioritize completing the late-stage study of the drug, at which point it will seek approval once again from the EU. Data from that study is expected in mid-2024.  Notably, Amylyx’s drug has already been approved by the US Food and Drug Administration and has received conditional approval in Canada.  More at #Proactive #ProactiveInvestors http://ow.ly/uJvz104XIIp

Half of new #treatments for #rarediseases don't reach patients in Belgium Only 24 (39%) of the 61 #orphandrugs registered by the European Medicines Agency (#EMA) between 2018 and 2021 were reimbursed in #Belgium on January 5, 2023. Only 53% of the 19 orphan drug records analysed by the Refund Committee in 2023 resulted in #reimbursement approval by the Belgian government. These drugs intended for (ultra) #rare conditions have therefore been developed but patients do not (yet) have access to them. Read the pharma.be press release https://lnkd.in/gBXBf6Gh “Through perseverance and investment in research, the innovative #pharmaceutical sector has been able to make considerable progress to help patients and citizens. However, it faces many uncertainties, long development paths and increasingly personalized needs, for which #access to #healthdata is crucial. pharma.be is convinced that together we can meet these challenges, if we are ready to listen to each other and constructively build a future whose top priority is #publichealth” Caroline Ven CEO pharma.be