Category: NEWS
Milestone Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s response to the Complete Response Letter (CRL) for cardamyst (etripamil) nasal spray, an investigational therapy for paroxysmal supraventricular tachycardia (PSVT). The FDA has set a new Prescription Drug User …
Bayer announced that the U.S. Food and Drug Administration (FDA) has approved finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. Finerenone (10 mg, 20 mg, 40 mg) …
Pre-formulation studies are a critical step in formulation development, focusing on understanding the physical and chemical properties of a drug substance. Goals: 1. Characterize Drug Substance: Determine properties like solubility, stability, and particle size. 2. Identify Potential Issues: Detect potential formulation challenges early on. 3. Inform …
Becton, Dickinson and Company, popularly known as BD, and Waters Corporation recently announced a strategic collaboration to combine BD’s Biosciences Diagnostic Solutions business with Waters’ expertise in analytical technologies. This joint venture aims to create a new life sciences and diagnostics entity focused on regulated, high-throughput …
Eli Lilly and Company (India), in collaboration with the Association of Physicians of India (API), has launched ‘API – Obesity Gurukul’, a Continuing Medical Education (CME) program aimed at helping physicians better manage obesity, which is becoming one of India’s major public health challenges. Taking inspiration …
There are several routes of drug administration, each with its own advantages and disadvantages. Common Routes: 1. Oral: Taken by mouth, absorbed through the gastrointestinal tract. 2. Parenteral: Injected into the body, either intravenously, intramuscularly, or subcutaneously. 3. Topical: Applied directly to the skin or mucous …
Role of the Technology Transfer Department in the Pharmaceutical Industry The Technology Transfer (TT) department is essential in moving pharmaceutical products from development to full-scale manufacturing. Their primary role is to ensure a seamless transfer of manufacturing processes, analytical methods, and technical knowledge from R&D to production, ensuring …
Lyophilization, also known as freeze-drying, is a process that removes water from a frozen product by sublimation, resulting in a dry, stable product. How Lyophilization Works: 1. Freezing: The product is frozen to a temperature that makes the water molecules form a solid crystal structure. 2. …
Panacea Biotec Limited had earlier received a notification dated October 04, 2023 from the International Court of Arbitration, Paris (ICC) intimating that an Arbitration proceeding has commenced with respect to the Request for Arbitration filed by Apotex, an entity based out in Canada for arbitration of …
Merck today announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP). The EXPrESSIVE-11 trial will evaluate the safety and efficacy of MK-8527 among …
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