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)