Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for the next two weeks, November 22–December 5, 2021. Happy Thanksgiving!

Covid-19

  • The European Medicines Agency (EMA) is holding a virtual public meeting on November 25 on an update on Covid-19 vaccines and treatments in the European Union.
  • The FDA’s Antimicrobial Drugs Advisory Committee will meet virtually on November 30 to consider an oral antiviral to treat mild-to-moderate outpatient Covid-19, Merck MSD and Ridgeback Biotherapeutics’ molnupiravir.

Dermatology: The FDA is expected to make a decision by November 30 on a topical gel for treating skin wounds in patients with epidermolysis bullosa (EB)—Amryt Pharma’s Filsuvez (oleogel-S10).

Endocrinology: The hybrid International Congress of Inborn Errors of Metabolism (ICIEM) is taking place in Australia and virtually through November 24. Among the data to watch are the results of:

  • A Phase I/II trial of Applied Therapeutics’ AT-007, an oral aldose reductase inhibitor, in galactosemia.
  • An interim analysis of the Phase II SynPheny-1 trial of Synlogic’s SYNB-1618, a genetically modified probiotic, in phenylketonuria (PKU).

Hepatology

  • The International Viral Hepatitis Elimination Meeting (IVHEM) will take place virtually December 3-4. IVHEM is a global forum for exchanging practical information on the diagnosis and treatment of viral hepatitis. The program includes practical examples of innovative intervention studies, country elimination programs, and novel funding mechanisms for testing and treatment.
  • The FDA is expected to make a decision by November 30 on a trivalent prophylactic vaccine for hepatitis B virus (HBV), VBI Vaccines’ Sci-B-Vac.

Infectious disease: The FDA is expected to make a decision by November 23 on Takeda’s maribavir (TAK-620), an oral antiviral, to treat refractory cytomegalovirus infections in transplant recipients. In October 2021 the FDA’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend approval.

Neurology: The hybrid American Epilepsy Society (AES) meeting will take place in Chicago and virtually December 3-7. Among the data to watch: The results of the Phase IIb X-TOLE trial of Xenon Pharmaceuticals’ XEN-1101, a potassium channel modulator, in adult focal epilepsy.

Oncology

  • The FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet virtually on December 2 to review the accelerated approvals of Acrotech Biopharma’s Marqibo (vincristine sulfate liposome injection) to treat Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) and Secura Bio’s Farydak (panobinostat) as a ≥3-line treatment for multiple myeloma.
  • The FDA is expected to make a decision on a number of drugs:
    • By November 26 on a new mTOR inhibitor, Aadi Bioscience’s Fyarro (nab-sirolimus, ABI-009), to treat genetically-defined cancers with alterations in mTOR pathway genes.
    • By November 27 on a unique formulation of sodium thiosulfate (Fennec Pharmaceuticals’ Pedmark) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients age <18 with a non-metastatic solid tumor. Last year, the FDA rejected Pedmark, issuing a complete response letter that cited manufacturing issues. The company fixed the issues and resubmitted the drug.
    • By November 30 on: BeyondSpring’s plinabulin, a selective immunomodulating microtubule-binding agent—in combination with granulocyte colony-stimulating factor (G-CSF)—to prevent chemotherapy-induced neutropenia (CIN); CTI BioPharma’s pacritinib, an oral multikinase inhibitor, for treating myelofibrosis patients with severe thrombocytopenia.
    • By December 1 on expanded approval of Roche’s Tecentriq (atezolizumab) to treat early non-small cell lung cancer (NSCLC).
    • By December 4 on expanded approval of Merck MSD’s Keytruda (pembrolizumab) to include treatment of patients age ≥12 with stage IIB or IIC melanoma after removal.

Radiology: The hybrid Radiological Society of North America (RSNA) meeting will take place November 28-December 2 in Chicago and virtually. The theme this year is “Redefining Radiology,” with a focus on artificial intelligence—ethics, applications, and integration into systems—and breakthroughs in medical imaging.

Regulatory

  • Clinical trials. The FDA is holding a three-day virtual symposium November 30-December 2 for sponsors, investigators, and research staff on FDA regulations, guidelines, and best practices for clinical trials.
  • Drug development. The FDA is holding a virtual public workshop on November 30 on bioequivalence assessments of long-acting injectable and implantable drugs.
  • Orthopedics. The FDA is holding a virtual public workshop on December 3 on orthopedic device-related infections.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 935

Topic ID: 78,935,730,105,187,111,935,190,130,192,725,96