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The Berke Report: Clinical and Commercial Updates

Updated: Jul 12, 2023


Commercial:

  • FDA grants accelerated approval to Sarepta’s Duchenne muscular dystrophy gene therapy. The disease occurs in up to one in every 5,000 newborn males worldwide (pmlive)

  • FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata, LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12 (PR)

  • FDA approves Argenx's drug for muscle-weakening disease. The drug, branded as Vyvgart Hytrulo, is expected to be available in the U.S. next month and will come at a list price of $15,773, the company told Reuters. (reuters)

  • Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval. TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration resistant prostate cancer (PR)

  • FDA approves Eli Lilly-Boehringer's diabetes drugs for children. The approvals were based on a study that showed patients aged between 10 years and 17 years recorded lower average blood sugar compared with placebo when treated with empagliflozin - the active ingredient in the two drugs (reuters)

  • Zealand Pharma Submits Marketing Authorization Application for Dasiglucagon for Treatment of Severe Hypoglycemia in Diabetes to the European Medicines Agency (PR)

  • ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® for the Treatment of Allergic Reactions, Including Anaphylaxis (biospace)

  • CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of obstructive HCM. VALOR-HCM is the second Phase 3 trial in which CAMZYOS demonstrated significant improvement in symptoms of obstructive HCM (PR)

  • Roche has secured approval for Columvi, a treatment for certain people with diffuse large B-cell lymphoma. Columvi is one of a new class of emerging therapies, antibodies which contain two antigen-binding sites and which can therefore simultaneously target two different epitopes (thepharmaletter)

  • U.S. FDA Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to Bristol Myers’s CAMZYOS® Label (PR)

  • Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection Receives FDA Approval for Moderate to Severe Opioid Use Disorder (PR)

Clinical:

  • Synlogic Announces Initiation of Synpheny-3 Global, Pivotal Phase 3 Study Evaluating SYNB1934 for Treatment of Phenylketonuria (PR)

  • FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease (PR)

  • Praxis Precision Medicines Announces Plans to Begin Ulixacaltamide Phase 3 in Essential Tremor by Year End After Completing End of Phase 2 Meeting with FDA (PR)

  • Rain Oncology Announces Topline Results from Phase 3 MANTRA Trial of Milademetan for the Treatment of Dedifferentiated Liposarcoma (PR)

  • Galecto Completes Dosing in 52-Week Phase 2b GALACTIC-1 Trial of GB0139 in Idiopathic Pulmonary Fibrosis (PR)

  • Biomea Fusion (BMEA) Presents Positive Clinical Data from Initial Cohorts of Ongoing Phase II Study of BMF-219 in Patients with Type 2 Diabetes Mellitus (streetinsider)

  • MAIA Biotechnology Announces Updates in Enrollment in Phase II Clinical Trial: THIO-101 Has Enrolled 29 Patients (PR)

  • Rallybio Announces Proof-of-Concept Results and Development Updates for RLYB212, a Novel Monoclonal anti-HPA-1a Antibody to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia (PR)

  • Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial (medtechalert)

  • Another of Mersana's ADCs slapped with FDA hold, this time over bleeding events that include 5 deaths (fiercebiotech)

Designations:

  • Avenge Bio Receives FDA Orphan Drug Designation for AVB-001 for the Treatment of Mesothelioma (PR)

  • Cidara Therapeutics Receives U.S. FDA Fast Track Designation for CD388, a Novel Drug-Fc Conjugate Targeting Influenza A and B (PR)

  • Aardvark Therapeutics Announces FDA Orphan Drug Designation Granted to ARD-101, a Novel Drug Candidate for Prader-Willi Syndrome (PR)

  • Teikoku Pharma granted FDA Fast Track Designation for TPU-006, a Novel 4-day Dexmedetomidine Transdermal System for Post Operative Pain Management (PR)

  • AceLink Therapeutics Receives FDA Clearance to Initiate a Phase 2 Study of AL1211 in Patients with Fabry Disease (PR)

  • Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation (PR)

  • Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review (PR)

  • Aardvark Therapeutics Announces FDA Orphan Drug Designation Granted to ARD-101, a Novel Drug Candidate for Prader-Willi Syndrome (PR)

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