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Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
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 …
FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
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) …
What are Pre-Formulation Studies in Formulation Development
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 …
BD biosciences unit agree to $17.5 billion merger
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 …
Lilly partners with API to launch ‘Obesity Gurukul’ in India
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 …
Understanding the Various Routes of Drug Administration
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 …
A Key Pillar in Pharmaceutical Manufacturing
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 …
What is Lyophilization?
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 reaches settlement with Apotex
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 …
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