Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 16 small molecules, 5 biologics, 11 cell & gene therapies, 1 recombinant protein, 1 vaccine, 1 immunotherapy, 1 radiopharmaceutical, 1 antisense oligonucleotide, 3 RNA therapies 1 herbal medicine…
Shots: The EMA granted Positive Opinion to 2 Biologics and 5 New Chemical Entities in July 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Johnson & Johnson’s Yuvanci to treat Pulmonary Arterial Hypertension (PAH) and Astellas’ Vyloy + CT for Gastric & Gastroesophageal Junction Cancer PharmaShots has compiled a list…
Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
Shots: The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH) PharmaShots has compiled a list of 5 drugs that…
Shots: Small cell lung cancer (SCLC) aka Oat cell carcinoma is a rare & fast-growing lung cancer and ~15% of bronchogenic carcinomas are SCLC In this reprise of our Disease of the Month report, we bring an illuminating account of SCLC with a dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…
Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices This…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During May, Teva & Alvotech launched Simlandi injection Treat Multiple Indications. Our…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…

