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%…

ByDipanshu DixitNovember 22, 2024

INSIGHTS+

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…

ByDipanshu DixitNovember 21, 2024

NEWS

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Shots: The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway Approval was based on pivotal P-III (BASIS) study of Hympavzi…

ByDipanshu DixitNovember 20, 2024

INSIGHTS+

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…

ByDipanshu DixitNovember 20, 2024

INSIGHTS+

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…

ByDipanshu DixitNovember 19, 2024

NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Shots: Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…

ByDipanshu DixitNovember 19, 2024

NEWS

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of Ahzantive/Baiama/FYB203 (Biosimilar, Eylea)

Shots: The CHMP has recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25 The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024 FYB203…

ByDipanshu DixitNovember 18, 2024

NEWS

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Shots: The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP…

ByDipanshu DixitNovember 18, 2024

NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots: The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal…

ByDipanshu DixitNovember 18, 2024

NEWS

Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD)

Shots: The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25 Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine Aflibercept is a…

ByDipanshu DixitNovember 15, 2024

Dipanshu Dixit

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

EMA Marketing Authorization of New Drugs in October 2024

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

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

Disease of the Month – Gastroparesis

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer

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