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Biogen & Organon
NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…
April 2, 2025

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EchoIq, Sciimage & Medaxiom
NEWS

Echo IQ Enters into Strategic Partnership And Integration Agreements With ScImage And MedAxiom for EchoSolv AS

Shots: This collaboration will broaden the availability of EchoSolv AS, integrating its AI cardiology technology into a wide network of US hospitals and cardiology practices As per the agreement, EchoSolv AS will be deployed across 36 MedAxiom/ScImage-affiliated hospitals and cardiology practices, providing physicians access to AI-driven diagnostics via ScImage's image management and workflow platform. By leveraging…
April 1, 2025

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Alnylam & Sanofi
NEWS

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Shots: The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil Qfitlia published clinical data in the NEJM in 2017, showing…
April 1, 2025

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Ono & Reborna Biosciences 
NEWS

Ono Enters into an Option Agreement with Reborna Biosciences for RNA-Targeting Small Molecule to treat CNS Disorders

Shots: Ono Pharmaceutical entered into an option agreement to obtain exclusive rights for identified small-molecule compounds developed by leveraging Reborna’s proprietary RNA-targeting drug discovery platform Furthermore, the companies will collaborate to discover small molecule drug candidates for mutually selected rare neurological disorders Upon exercising the option, Ono will gain exclusive worldwide rights to develop, manufacture, and…
April 1, 2025

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INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2025

Shots:   Q1’2025 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The talk of the town remained Intra-Cellular Therapies’ acquisition by Johnson & Johnson for ~$14.6B   The quarter highlighted breakthrough results, pivotal clinical data, including Eli Lilly and Incyte's P-III Study Data of Baricitinib to treat Alopecia Areata  PharmaShots brings…
April 1, 2025

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Visby Medical
NEWS

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…
March 31, 2025

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Spirited Paw
NEWS

Spirited Paw Launches Calm Chewable Wafers for Dogs and Cats

Shots: Spirited Paw (Standard Process' Brand) has launched Calm supplement to manage stress-related behaviors like occasional anxiety in cats & dogs Calm consists of scientifically-backed ingredients along with plant-based nutrients like Kalette, ginger & chamomile extracts, grown on Standard Process’ 868-acre USDA-certified organic farm   Calm contains L-Theanine, L-Tryptophan, & marine-derived Magnesium, with L-Theanine tested in…
March 31, 2025

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Astrazeneca
NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL)

Shots: The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regions Opinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…
March 31, 2025

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