All About Pharmaceuticals

Istradefylline (Nourianz, Kyowa Kirin) tablets have been approved by the US Food and Drug Administration (FDA) as add-on treatment to levodopa/carbidopa in adults who have Parkinson’s disease (PD) experiencing “off” episodes.  Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA’s Centre for Drug Evaluation and Research said “Parkinson’s disease is a debilitating condition that profoundly impacts patients’ lives.” Istradefylline is a selective adenosine A2A receptor antagonist. When treated on ‘off’ episodes in patients with PD taking levodopa/carbidopa its effectiveness was shown in four 12-week, placebo-controlled clinical studies that included a total of 1143 participants. According to all the four studies, it reports that the addition of istradefylline leads to a statistically significant decrease from baseline in daily “off” time relative to placebo add-on, the FDA stated in a news release. Dyskinesia, dizziness, constipation

This section provides information on some of the major concepts within pharmacovigilance related to pharmaceutical products for human use . Pharmacovigilance has been defined by the World Health Organisation as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem” Adverse Events & Adverse Reactions The ICH E2A guideline describes Adverse Events as any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person 1 . This encompasses any signs which are unfavourable and unexpected for the patient or subject, including any abnormal laboratory findings. These could be symptoms or a diseases temporally associated with the use of a medicinal product, and do not have to have been previously associated with that product. Neither do they have to have a known causal relations

Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019) The Federal Circuit applied the constitutional principle under Article III that there must be a case or controversy for a federal court to enter judgment (in this case, of invalidity) in ANDA litigation that can be vitiated by a statutory disclaimer of patent claims prior to judgment.  The Court also applied principles of chemical obviousness and its "lead compound" analysis to affirm the District Court's determination that Defendants had not shown that claims in a related patent-in-suit were obvious. The case arose in ANDA litigation involving Sanofi's Jevtana ®   (cabazitaxel), having the structure: where the methoxy groups at the C7 and C10 positions distinguished cabazitaxel from prior art docetaxel, which had hydroxyl groups at these positions.  At trial, Sanofi initially asserted claims 7, 11, 14-16, 21, 26, and 30 of Orange Book-listed U.S. Patent No.   8,972,592 , which claims met

Few substances on earth have been surrounded by more confusion than marijuana. Harmless plant or illicit drug? Medicinal or recreational? Legal or illegal (or  partially  legal)? And what should we make of all these things associated with marijuana, like hemp and CBD oil? Marijuana has been on a long, tortured march towards legalization across the U.S., but because each state has its own rules, and both state and federal policies can change based on who is in power, the pharmaceutical industry has largely kept its distance. But, with attitudes and laws rapidly changing, some pharma and biotech companies are exploring the possibilities of pot. A big first came in 2018 when, according to Stat News, Novartis became the first major medical company to get into the medical marijuana business when its subsidiary Sandoz partnered with Canadian marijuana company Tilray. It’s a relationship that will enable Sandoz to enter this growing market in dozens of countries where it is

The role of a Certificate of Suitability  is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. Active pharmaceutical ingredients for which a Certificate of Suitability has been granted are suitable for use in medicinal products. CEP What is the Full form of abbreviation, CEP? Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs It is also informally referred to as Certificate of Suitability (COS) What is a CEP? It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.