INSIGHTS+ Archives - Page 6 of 37

New Drug Designations – October 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices. Significant trends this month…

November 26, 2024

AOP Health’s Rapiblyk (landiolol) Receives the US FDA’s Approval for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

Shots: The US FDA has granted approval to Rapiblyk for treating severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter) in critical care setting Approval was supported by 5 clinical trials assessing the safety & efficacy of Rapiblyk (9.3 to 74.6 mcg/kg/min) vs PBO in adults (n=317) with supraventricular tachycardia, showing 40-90% vs 0-11%…

November 22, 2024

EMA Marketing Authorization of New Drugs in October 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis PharmaShots has…

November 21, 2024

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)

Shots: The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends…

November 20, 2024

Disease of the Month – Gastroparesis

Shots: Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying, leading to symptoms such as nausea, vomiting, bloating, and early satiety. This condition significantly affects patients' quality of life, posing challenges for diagnosis and treatment. Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the…

November 19, 2024

The US FDA New Drug Approvals in October 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of October 2024 The US FDA has approved a total of 4 new drugs including 2 new molecular entities and 2 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drugs were Pfizer’s Hympavzi for…

November 12, 2024

Know Your Investor: Catalio Capital Management (November’24 Edition)

Shots: A New York-based venture capital fund, Catalio Capital Management invests in breakthrough MedTech and innovative healthcare companies globally In 2023, Catalio Capital participated in eight funding rounds and invested approximately $1.82B to add 22 companies to its portfolio For a curated report on a specific investor or venture capital firm, reach out to us…

November 7, 2024

Key Biosimilars Events of October 2024

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 Dong-A ST’s Imuldosa…

November 5, 2024

New Drug Designations – September 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA, Health Canada and EMA. The September 2024 report covers regulatory designations for 42 drugs and 1 device, including 16 small molecules, 6 biologics, 12 cell and gene therapies, and 1 device, among others. Significant trends this month…

October 29, 2024

EMA Marketing Authorization of New Drugs in September 2024

Shots: The EMA’s CHMP has granted positive opinion to 4 Biologics and 1 New Chemical Entity in September 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of 3 drugs that have been…

October 24, 2024

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