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)