African Pharmaceutical Review

AbbVie’s groundbreaking subcutaneous therapy has gained FDA approval for the treatment of Parkinson’s disease, a neurodegenerative disorder affecting over 10 million people worldwide.

GSK's first in class oral antibiotic with novel mechanism of action in over 20 years has been accepted for priority review by the US Food and Drug Administration, marking a significant advancement in the treatment of uncomplicated urinary tract infections. #clinicaltrials #pharmaceuticals #antibiotics #pharmaceuticalindustry

The South African Health Products Regulatory Authority (SAHPRA) has published a recall notice for a specific batch of Monofer Injection 500mg/5ml. The recall was initiated by Acino, the Marketing Authorization Holder, following a customer complaint from Poland, where a glass fragment was discovered in one of the vials. The affected batch, with the number 230504A-5, was released for sale on May 16, 2024, and is set to expire in May 2026. Monofer, which contains ferric derisomaltose as its active ingredient, is used in the treatment of iron deficiency anaemia. For further details, please refer to the document below ⬇️. #afripharmareview #pharmaceuticals #postmarketingsurveillance

The National Drug Authority (NDA) of Uganda has released a notice outlining a list of medicines and select surgical instruments that are subject to mandatory post-shipment analysis. The NDA emphasized the importance of efficient communication to minimize disruptions in the supply chain. The list includes medicines such as metformin, losartan, and paracetamol suspensions, with sampling conducted at various points in the supply chain, including ports of entry. For more details, please refer to the document below ⬇️ . #afripharmareview #regulatoryaffairs #pharmaceuticals

Lonza's Drug Product Services presence is expanded with a new facility, providing more quality control and bioanalytics capacity to support clinical and commercial projects. #pharmaceuticals #pharmaceuticalindustry

Are you a Marketing Authorization Holder (MAH) with interests in the Tanzanian market? This is important news for you! The Tanzania Medicine and Medical Devices Authority (TMDA) has announced plans to enhance transparency by publishing Public Assessment Reports (PARs) for registered medical devices and in-vitro diagnostic devices (IVDDs) that meet specific selection criteria. Eligible products include devices used in the treatment or diagnosis of infectious diseases of public health significance, reproductive health products, and those required during public health emergencies. What are your thoughts on this initiative? Share in the comments below! For the latest updates, insights, and trends in the pharmaceutical industry, subscribe: https://lnkd.in/dN4be7-U #afripharmareview #medicaldevices #IVD

Roche’s new therapy has received FDA approval, marking a significant advancement in breast cancer treatment. The approval is based on clinical trial findings, which revealed that inavolisib-based combination therapy more than doubled progression-free survival when compared to palbociclib and fulvestrant alone in the first-line treatment of advanced mutated breast cancer. #afripharmareview #cancer #pharmaceuticalindustry

Kenya's national medicines regulator, the Pharmacy and Poisons Board (PPB), has issued a safety alert regarding the prescription and use of aceclofenac and its combination therapies. Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), is commonly used to manage chronic inflammation and pain. However, the PPB has raised concerns about prescription errors, where patients have been exposed to doses exceeding the recommended daily limit of 200 mg. This overexposure puts patients at risk of serious side effects, including gastrointestinal bleeding and ulceration. In response, the PPB has recommended that healthcare professionals strictly adhere to the correct dosage guidelines when prescribing aceclofenac. Patients are also urged to follow the prescribed dosage and administration instructions carefully to avoid potential harm. For more details please refer to the document below. And for the latest updates, insights and developments from the pharmaceutical industry subscribe: https://lnkd.in/dN4be7-U #afripharmareview #pharmacovigilance

Kenya’s national medicines regulator, the Pharmacy and Poisons Board (PPB), has issued a safety alert concerning bupivacaine. Bupivacaine is an anesthetic medicine whose common uses include as an epidural injection into the spinal column to produce numbness during labor, surgery, or certain medical procedures. Following an analysis of individual case safety reports between 2021-2024, the PPB has identified risks of severe drug reactions and potential therapeutic failure associated with the use of bupivacaine. Reported adverse reactions include convulsions, loss of consciousness, and hypotension. In response, the Board has recommended several safety measures, including the development of detailed protocols for the administration of bupivacaine, as well as the close monitoring and management of any adverse events that may occur. For more information, please refer to the document below. And for the latest updates, insights and developments from the pharmaceutical industry subscribe: https://lnkd.in/dN4be7-U #afripharmareview #pharmacovigilance

In a deal that could reach $1.92 billion, AstraZeneca has signed an exclusive licensing agreement with CSPC Pharmaceutical Group Ltd to further develop an innovative early-stage small molecule designed to disrupt Lipoprotein(a). #pharmaceuticals #pharmaceuticalindustry