PharmaShots Weekly Snapshots (August 14–18, 2023)

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PharmaShots Weekly Snapshots (August 14–18, 2023)

This week PharmaShots’ news was all about the updates on clinical trials, regulatory, biotech, pharma, M&A and Animal Health. Check out our full report below:

  • The US FDA has cleared an IND application to initiate the P-I trial of Zumutor Biologics’ ZM008 for multiple solid cancers

Read more: Zumutor Biologics

  • The US FDA has granted accelerated approval to Pfizer’s Elrexfio for relapsed or refractory multiple myeloma, based on the clinically meaningful response rates and duration of response from the P-II trial (MagnetisMM-3)

Read more: Pfizer

  • The US FDA has accepted the sNDA and granted priority review of Servier’ Tibsovo (ivosidenib) for r/r myelodysplastic syndromes, based on the P-I open-label study which showed durable remissions

Read more: Servier

  • The NMPA has approved Innovent’s Sintbilo (tafolecimab) for adult patients with primary hypercholesterolemia and mixed dyslipidemia, based on the 2 P-III registrational trials (CREDIT-1/2/4)

Read more: Innovent

  • The EC has approved AbbVie’s Aquipta (atogepant) for the preventive treatment of migraine in adults, based on the 2 P-III studies (PROGRESS) & (ADVANCE) demonstrated significant reduction in mean monthly migraine days

Read more: AbbVie

  • The EMA has accepted the MAA for Iveric Bio’s Avacincaptad Pegol to treat GA secondary to AMD, based on the results from the P-III (GATHER1 & 2) trials 

Read more: Iveric Bio

  • The EMA has accepted the MAA for Regeneron’s Odronextamab to treat r/r FL & r/r DLBCL, based on the P-I study (ELM-1) and P-II trial (ELM-2)

Read more: Regeneron

  • The US FDA has approved Revance Therapeutics’ Daxxify (daxibotulinumtoxinA-lanm) as first therapeutic indication for cervical dystonia, based on the P-III program (ASPEN 1) & (ASPEN OLS)

Read more: Revance Therapeutics

  • The NMPA has accepted AstraZeneca’s Forxiga (dapagliflozin) for adult patients with symptomatic chronic heart failure, based on the P-III trial (DELIVER)

Read more: AstraZeneca

  • The EC granted the approval of Type II variation application for Janssen’s Tecvayli (teclistamab) to treat RRMM based on the P-I/II study (MajesTEC-1) maintained deep & durable responses with the reduced onset of grade ≥3 inf.

Read more: Janssen

  • HebeCell & Logomix collaborated for next gen genomically engineered PSC-NK cells to treat cancer patients

Read more: HebeCell & Logomix

  • Gilead & Tentarix collaborated to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases using Tentarix’s Tentacles platform

Read more: Gilead & Tentarix

  • HDL Therapeutics to go public via Swiftmerge Acquisition Corp. SPAC merger for ~$480M to advance the commercialization of an innovative US FDA-approved cardiovascular disease treatment

Read more: HDL Therapeutics

  • Harmony Biosciences to acquire Zynerba for ~$200M and focussing to expands pipeline and diversifies portfolio to drive long-term growth

Read more: Harmony Biosciences

  • Keystone Dental Holdings & Check-Cap Ltd signed a definitive business combination agreement focusing solutions for tooth replacement procedure

Read more: Keystone Dental Holdings & Check-Cap Ltd

  • Asieris highlighted P-III bridging trial of Hexvix for bladder cancer meeting 1EPs & the results will be submitted to the NMPA for NDA in the coming months

Read more: Asieris

  • BMS highlighted P-I/II study (TRIDENT-1) results of Repotrectinib for locally advanced or metastatic ROS1-positive NSCLC demonstrated high response rates & durable responses

Read more: BMS

  • Reviva completed patient enrolment in the P-III Study for Brilaroxazine to treat Schizophrenia

Read more: Reviva

  • Everest Medicines Partner Calliditas highlighted P-III (NeflgArd) trial results of Nefecon for primary IgA nephropathy, published in The Lancet demonstrated clinical benefit in eGFR

Read more: Everest Medicines

  • Bio-Thera highlighted the P-I study results of BAT8006 for advanced solid tumors demonstrated a manageable safety profile

Read more: Bio-Thera

  • Merck highlighted P-III (LITESPARK-005) trial results of Welireg (belzutifan) for advanced renal cell carcinoma showed significant improvements in PFS over everolimus 

Read more: Merck

  • Formosa & Eyenovia collaborated to commercialize APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for inflammation and pain following ocular surgery

Read more: Formosa & Eyenovia

  • Day One & Sprint Bioscience collaborated for VRK1 program & expands Day One’s portfolio of targeted therapies in oncology

Read more: Day One & Sprint Bioscience

  • The US FDA has approved Boehringer Ingelheim’ Senvelgo (velagliflozin) as the first oral liquid medication to improve glycemic control in cats with diabetes mellitus

Read more: Boehringer Ingelheim

Related Post: PharmaShots Weekly Snapshots (August 07–11, 2023)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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