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

• The EMA’s CHMP has adopted the positive opinion recommending the approval of AstraZeneca and Daiichi Sankyo’s Enhertu for HER2-mutant advanced NSCLC, was based on the P-II trial (DESTINY-Lung02)

Read more: AstraZeneca and Daiichi Sankyo

• The US FDA has approved GSK’ Ojjaara (momelotinib) for Myelofibrosis patients with Anemia, based on the P-III trial (MOMENTUM) & data for a subpopulation from the P-III (SIMPLIFY-1) trial

Read more: GSK

• The EMA’s CHMP recommended Merck’s Keytruda (pembrolizumab) as adjuvant treatment for NSCLC, based on results from the P-III trial (KEYNOTE-091)

Read more: Merck

• NICE has recommended Idorsia’s Quviviq (daridorexant) for adults with Chronic Insomnia

Read more: Idorsia

• The EC has approved Pfizer’s Litfulo (ritlecitinib) for adolescents and adults with severe alopecia areata, based on the (ALLEGRO) trial program incl. P-IIb/III trial (ALLEGRO)

Read more: Pfizer

• The EC has approved ViiV Healthcare’s Apretude (cabotegravir long-acting injectable and tablets) for HIV prevention, based on the results from two P-IIb/III active-controlled studies (HPTN 083 & 84)

Read more: ViiV Healthcare

• The US FDA’s has granted FTD to Kymera Therapeutics’ KT-333 for Cutaneous and Peripheral T-Cell Lymphoma

Read more: Kymera Therapeutics

• The US FDA has accepted the sNDA and granted Priority Review of Merck’s Welireg (belzutifan) for advanced renal cell carcinoma, based on the results from the P-III trial (LITESPARK-005)

Read more: Merck

• The NMPA has recommended a Priority Review for Everest Medicines’ cefepime-taniborbactam to treat Complicated Urinary Tract Infections

Read more: Everest Medicines

• The US FDA has accepted the sBLA and granted priority review for Merck’s Keytruda for newly diagnosed high-risk locally advanced cervical cancer, based on the P-III trial (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Read more: Merck

• The EC has approved Jazz’ Enrylaze for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma, based on the P-II/III trial

Read more: Jazz

• Health Canada granted marketing approval to argenx’s Vyvgart for the treatment of Generalized Myasthenia Gravis (gMG)

Read more: argenx

• Kite highlighted P-II study (ALYCANTE) results of Yescarta (axicabtagene ciloleucel) for Relapsed/Refractory Large B-Cell Lymphoma showed a complete metabolic response

Read more: Kite

• Aclaris reported P-I (ATI-2138-PKPD-102) trial results of ATI-2138 for immuno-inflammatory diseases showed no serious AEs

Read more: Aclaris

• Iveric Bio highlighted 24-month results of Izervay (avacincaptad pegol) for Geographic Atrophy met the primary objective of reducing the rate of GA growth

Read more: Iveric Bio

• Rani Therapeutics reported an initiation of P-I study for RT-111 (biosimilar, ustekinumab) to treat Autoimmune Diseases

Read more: Rani Therapeutics

• Daiichi Sankyo and AstraZeneca highlighted P-III trial (TROPION-Breast01) results of Datopotamab Deruxtecan for Breast Cancer showed an improvement for the 1EPs of PFS

Read more: Daiichi Sankyo and AstraZeneca

• The US FDA granted Feedback to discontinue the development of Taysha Gene Therapies’ TSHA-120 program in giant axonal neuropathy

Read more: Taysha Gene Therapies

• Relmada Therapeutics, Inc reported results from the P-III clinical trial evaluating REL-1017 for major depressive disorders

Read more: Relmada Therapeutics

• Seagen and Astellas highlighted P-III Trial (EV-302) results of Padcev (enfortumab vedotin-ejfv) and Keytruda for advanced bladder cancer met its dual 1EPs of OS and PFS

Read more: Seagen and Astellas

BMS highlighted P-III trial (CheckMate -77T) results of N=neoadjuvant Opdivo (nivolumab) + CT for resectable non-small cell lung cancer met its 1EPs of improved EFS as assessed by BICR

Read more: BMS

• PeptiDream & Genentech collaborated to discover and develop novel peptide-radioisotope drug conjugates

Read more: PeptiDream & Genentech

• Exscientia & Merck KGaA collaborated to discover novel small molecule drug candidates

Read more: Exscientia & Merck KGaA

• The EC has approved Fresenius Kabi’s Tyenne (biosimilar, tocilizumab) for multiple inflammatory and immune mediated conditions

Read more: Fresenius Kabi

• Biocon Biologics’ Yesafili (biosimilar, aflibercept) Receives EC’s Approval for the treatment of patients with age-related macular degeneration and diabetic macular edema

Read more: Biocon Biologics

• Kezar Life Sciences & Everest Medicines collaborated to develop and commercialize Zetomipzomib for Lupus Nephritis 

Read more: Kezar Life Sciences & Everest Medicines

• Inventiva enters into exclusive licensing agreement with Hepalys Pharma to develop and commercialize Lanifibranor in Japan and South Korea

Read more: Inventiva and Hepalys Pharma

• Evaxion Biotech A/S signed a collaboration agreement with Afrigen Biologics (Pty) Ltd to develop novel mRNA vaccines against Gonorrhea

Read more: Evaxion Biotech and Afrigen Biologics

• Orionis Biosciences and Genentech signed a multi-year collaboration to discover and develop molecular glue class medicines for the treatment of disorders including oncology and neurodegeneration

Read more: Orionis Biosciences and Genentech

• Boundless Bio & Taiho Oncology collaborated to evaluate Lytgobi + BBI-355 for FGFR amplified solid tumors

Read more: Boundless Bio & Taiho Oncology

Related Post: PharmaShots Weekly Snapshots (September 11–15, 2023)