Covid-19 symposium, PD congress, ESMO, pending FDA decisions, and more

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

Covid-19: The American Society of Gene + Cell Therapy (ASGCT) will hold a two-day virtual Covid-19 Symposium on Sept. 15-16 that will highlight the advances in understanding SARS-CoV-2 and treating Covid-19.

Endocrinology: The American Society for Bone and Mineral Research (ASBMR) virtual meeting is continuing through Sept. 15. Among the sessions to watch on the last two days are: Bone Therapeutics – Now and the Future, Novel Molecular Approaches to Skeletal Therapeutics, and Dilemmas in Metabolic Bone Diseases.

Neurology: The International Parkinson and Movement Disorder Society’s MDS Virtual Congress is continuing through Sept. 16. Among the data to watch are the details on Sept. 15 of a phase II trial of prasinezumab (Prothena and Roche, PRX-002), a humanized IgG1 antibody against aggregated α-synuclein, in Parkinson’s disease. Remember — Part 1 of this trial failed.

Oncology: The European Society for Medical Oncology (ESMO) virtual science session will start Sept. 19. The education session will be in October. There is a wealth of data, ranging from early phase I trials in ovarian and non-small cell lung cancer to pivotal phase III trials.

Ophthalmology: The FDA is expected to make a decision by Sept. 15 on Bausch Health/Eton Pharmaceuticals’ EM-100, a preservative-free eye drop for treating ocular itching associated with allergic conjunctivitis. The original PDUFA date of Aug. 10 was extended by the FDA. This is the second attempt to get FDA approval for this eye drop.

Pediatrics: The FDA’s Pediatric Advisory Committee will hold a virtual meeting on Sept. 15 to discuss acute dystonia associated with attention-deficit/hyperactivity disorder (ADHD) medications and to discuss acute hyperkinetic movement disorder associated with the combined use of ADHD stimulants and antipsychotics. The six specific products to be discussed are:

  • 1 biologic: Grifols’ Gamunex-C (caprylate/chromatography, purified).
  • 1 device: a humanitarian device exemption for Cook Medical’s Flourish, a pediatric esophageal atresia device.
  • 4 drugs: Neos Therapeutics’ Adzenys ER (amphetamine extended-release oral suspension), Takeda’s Mydayis (an extended-release oral amphetamine) and Vyvanse (lisdexamfetamine dimesylate, capsule and chewable), and Bristol-Myers Squibb’s Orencia (abatacept).

Regulatory

  • The FDA and the Parenteral Drug Association will jointly hold a virtual conference Sept. 14-16 on “The Future is Now: Effective Quality Management and Robust Manufacturing.” The meeting will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms.
  • On Sept. 17-18 the FDA will hold a virtual public workshop on the use of real-world evidence to assess the effectiveness of preventive vaccines.

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

Cat ID: 190

Topic ID: 79,190,543,697,190,37,136,725,240