PharmaShots Weekly Snapshots (August 21 – 25, 2023)

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PharmaShots Weekly Snapshots (August 21 – 25, 2023)

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


  • The US FDA has approved Neurocrine Biosciences’ Ingrezza (valbenazine) capsules for chorea associated with huntington's disease, based on the 2 studies incl. the P-III study (KINECT-HD) & (KINECT-HD2) OLE trial

Read more: Neurocrine Biosciences

  • The US FDA has approved Regeneron’s Eylea HD (aflibercept) for serious retinal disease, based on the 48wk. results from the (PULSAR) in wAMD & (PHOTON) trials in DME

Read more: Regeneron

  • The US FDA has accepted the sNDA and granted priority review of Calliditas Therapeutics’ Nefecon for the treatment of IgA Nephropathy, based on the P-III study (NefIgArd) showed a significant benefit of Nefecon in eGFR

Read more: Calliditas Therapeutics

  • The US FDA has approved Pfizer’s Abrysvo (bivalent RSV prefusion F vaccine) for the prevention of respiratory syncytial virus in infants, based on the P-III trial (MATISSE)

Read more: Pfizer

  • The EC has granted conditional marketing authorization to Janssen’s Talvey (talquetamab) for the treatment relapsed and refractory multiple myeloma, based on the P-I/II study (MonumenTAL-1)

Read more: Janssen

  • The EC has approved BMS’ Opdivo (nivolumab) as an adjuvant treatment for completely resected stage IIB or IIC melanoma, based on the results from the P-III trial (CheckMate -76K) showed reduction in risk of recurrence or death

Read more: BMS

  • The MHLW has approved Daiichi Sankyo’s Enhertu as first HER2 directed therapy for HER2 mutant metastatic non-small cell lung cancer, based on the P-II trial (DESTINY-Lung02)

Read more: Daiichi Sankyo

  • The NMPA has approved Dizal's Sunvozertinib for non-small cell lung cancer with EGFR exon20ins mutations, based on the (WU-KONG6) study showed a superior cORR

Read more: Dizal

  • AstraZeneca’ Soliris Receives the MHLW Approval for Generalised Myasthenia Gravis which showed a clinical benefit in paediatric patients

Read more: AstraZeneca

  • The EMA accepted the MAA for Novaliq’s CyclASol (ciclosporin ophthalmic solution) to treat dry eye disease, based on the 6 clinical studies

Read more: Novaliq

  • The EC has granted marketing authorization of Pfizer’s Abrysvo to protect infants through maternal immunization and older adults from RSV, based on the P-III studies (RENOIR) & (MATISSE)

Read more: Pfizer

  • The US FDA has granted Fast Track Designation to Taysha Gene Therapies’ TSHA-102 for Rett Syndrome which is being studied in the P-I/II study (REVEAL) in Canada

Read more: Taysha Gene Therapies

  • HUTCHMED highlighted P-III (ESLIM-01) trial results of Sovleplenib for primary immune thrombocytopenia in China showed a statistically significant increase in durable response rate

Read more: HUTCHMED

  • Akeso dosed the first patient in the head-to-head P-III trial for Ivonescimab as 1L treatment of squamous non-small cell lung cancer

Read more: Akeso

  • The US FDA pauses Gilead’s magrolimab studies in acute myeloid leukaemia, follows the previously announced discontinuation of the P-III trial (ENHANCE)

Read more: Gilead

  • Eli Lilly highlighted P-III (LIBRETTO-531) study results of Retevmo (selpercatinib) for RET-mutant medullary thyroid cancer showed a significant and clinical improvement in PFS

Read more: Eli Lilly

  • GSK highlighted P-IV trial (ZOSTER-076) results of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles in adults aged ≥50yrs. in China showed the vaccine efficacy of 97% over a follow-up period of ~4yrs.

Read more: GSK

  • Lynk Pharmaceuticals highlighted P-II clinical trial results of LNK01001 for the treatment of ankylosing spondylitis showed a rapid onset of action with response rates for various efficacy EPs

Read more: Lynk Pharmaceuticals

  • Tarsier Pharma reported P-III (TRS4VISION) trial results of TRS01showed clear anti-inflammatory activity in noninfectious anterior uveitis

Read more: Tarsier Pharma

  • Immunomic Therapeutics doses the first patient in P-I clinical trial of ITI-1001 for the treatment of glioblastoma multiforme

Read more: Immunomic Therapeutics

  • Amneal highlighted P-III study results of IPX203 for Parkinson’s Disease showed significant improvement in daily “Good On” time over-optimized IR CD/LD

Read more: Amneal

  • The US FDA has accepted the NDA of Geron’s Imetelstat to treat transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes

Read more: Geron

  • Genentech highlighted second interim analysis results from the P-III (SKYSCRAPER-01) study of Tiragolumab + Tecentriq for PD-L1-high metastatic non-small cell lung cancer

Read more: Genentech

  • Leo Pharma acquires US biotech Timber Pharmaceuticals for ~$36M. The transaction will add an attractive late-stage asset to LEO Pharma’s pipeline in medical dermatology

Read more: Leo Pharma

  • CARsgen to partner with Moderna for CT041 + mRNA Cancer Vaccine

Read more: CARsgen and Moderna

  • Tarsus reported the commercial availability of Xdemvy (lotilaner ophthalmic solution) for demodex blepharitis at pharmacies nationwide for prescription

Read more: Tarsus

  • BaroPace highlighted the enrolment of first patient in FIH clinical trial (RelieveHFpEF-II) for PressurePace in non-pharmacologic hypertension and heart failure

Read more: BaroPace

  • Magenta Medical reported the patient enrolment completion in early feasibility study of Elevate Percutaneous Left Ventricular Assist Device & provide temporary mechanical circulatory support during HR-PCI procedures

Read more: Magenta Medical

Related Post: PharmaShots Weekly Snapshots (August 14–18, 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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