Hayley Shasteen

Taysha Gene Therapies announced that it will focus its efforts on clinical programs targeting Rett Syndrome and giant axonal neuropathy (GAN), resulting in a 35% reduction in its workforce.
FDA
Orchard Therapeutics announced today that it intends to focus its hematopoietic stem cell (HSC) gene therapy platform exclusively on severe neurometabolic diseases and early research programs.
Neuron23 announced today that it closed a $100 million Series C financing round led by SoftBank Vision Fund 2.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.
Although some may be hopeful that the end of the COVID-19 pandemic is nearby, millions still are facing their own lifelong version of the pandemic.
The Phase II trial is evaluating zepzelca as a monotherapy in patients with urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and HRD tumors.
FDA
Pfizer has announced it received Breakthrough Therapy Designation from the FDA for its vaccine candidate intended to prevent infections caused by the respiratory syncytial virus (RSV).
The 4D pharma has shared positive interim results from its Phase I/II study of a combination therapeutic for the treatment of renal cell carcinoma (RCC).
Merck has announced the retirement of Dr. Roy D. Baynes, head of global clinical development and chief medical officer of Merck Research Laboratories.
Moderna is broadening its vaccine horizons once again using mRNA technology and has announced two new vaccine development programs targeting a variety of viruses.
FDA
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Provention Bio has announced that the FDA has accepted its biologics license application resubmission for teplizumab, a drug intended to delay clinical Type I Diabetes (T1D) in at-risk individuals.
BioMarin Pharmaceuticals has published positive results in the New England Journal of Medicine from its Phase III clinical trial of valoctocogene roxaparvovec.
Biopharma is heeding the call and many pharmaceutical companies are working towards including patient communities in their work.