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Henlius and Intas
NEWS

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC 

     Shots:    The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same  Henlius partnered with Intas in 2023 to develop & commercialize…
September 21, 2024

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Pfizer
NEWS

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B 

      Shots:    The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively   The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…
September 20, 2024

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NEWS

AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer 

      Shots:    The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway  The opinion was based on P-III (MIRASOL) study assessing Elahere…
September 20, 2024

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Viewpoints_Jacqueline Nielsen_Tahi Ahmadi
VIEWPOINTS

Unlocking Approval: Jacqueline Nielsen from AbbVie & Tahi Ahmadi from Genmab in a Riveting Conversation with PharmaShots

Shots:  Recently, the EMA’s CHMP adopted a positive opinion by recommending conditional marketing authorization for AbbVie and Genmab’s Tepkinly for the treatment of R/R Follicular Lymphoma  Today at PharmaShots, we have Jacqueline Nielsen, Head of Hematologic Oncology Affairs at AbbVie, and Tahi Ahmadi, EVP and CMO at Genmab, shedding light on this conditional marketing authorization…
September 18, 2024

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Exclusive_Ahsan Arozullah_2024
EXCLUSIVE

Advancing Urothelial Carcinoma Care: Ahsan Arozullah from Astellas Pharma in an Exclusive Interview with PharmaShots

Shots:  Recently, the CHMP of the EMA adopted a positive opinion for Astellas’ Padcev + Keytruda combination therapy as the first-line treatment of patients with unresectable or metastatic urothelial cancer  Today, in an exclusive coverage, we bring an enlightening conversation with Ahsan Arozullah from Astellas Pharma, sharing insights from the P-III EV-302 study  Astellas looks…
September 4, 2024

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New Drug Designations - July 2024
INSIGHTS+

New Drug Designations – July 2024

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…
August 27, 2024

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Roche
NEWS

Roche’s PiaSky Receives the EC’s Approval to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH) 

Shots:    The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve  Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients…
August 27, 2024

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ARS Pharma
NEWS

ARS Pharmaceuticals Reports the EC’s Approval of Eurneffy (Adrenaline Nasal Spray) to Treat Type I Allergic Reactions 

Shots:    Following the US FDA approval, the EC has approved Eurneffy (2mg) for type I allergic reactions (anaphylaxis) in adults & children (≥30kg). It will be available in Q4’24 through undisclosed pharmaceutical partner  The approval was supported by the results from a study, involving ~1200 administrations among >700 subjects, along with studies and peer-reviewed literature…
August 26, 2024

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NEWS

SIFI and Avanzanite Bioscience’s Akantior (Polihexanide) Gains the EC’s Approval to Treat Acanthamoeba Keratitis (AK) 

      Shots:    Following recommendations from the EMA’s CHMP & COMP, the EC has approved Akantior to treat AK among adults & adolescents (≥12yrs.)   Approval was based on the data from P-III (ODAK) study in AK patients (n=135), published in Ophthalmology, demonstrating that the disease cured in 84.8%, full vision restoration was found in 66.7% with…
August 26, 2024

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