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EMA Marketing Authorization of New Drugs in November 2024
EMA Marketing Authorization of New Drugs in November 2024
Shots:    The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 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…
December 19, 2024
The US FDA New Drug Approvals in November 2024
The US FDA New Drug Approvals in November 2024
Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024      The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…
December 10, 2024
Know Your Investor- Surveyor Capital (December’24 Edition) 
Know Your Investor: Surveyor Capital (December’24 Edition) 
Shots:   A longstanding equities business within Citadel, Surveyor Capital invests in the consumer, financials, healthcare, industrials, and Technology, Media & Telecom sectors  In 2023, Surveyor participated in four funding rounds, investing approximately $2.35B and adding 17 companies to its portfolio  For a curated report on a specific investor or venture capital firm, reach out to…
December 5, 2024
Key Biosimilars Events of November 2024
Key Biosimilars Events of November 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        A major highlight was the EC’s approval of Sandoz’ Afqlir for treating…
December 3, 2024
New Drug Designations - October 2024
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
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
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
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
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
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
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