Month: December 2021

Celularity Inc NK Cell Therapy CYNK-001 Receives US FDA Fast Track Designation for AML Treatment

Celularity Inc Celularity Inc. (CELU) announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001 created for the treatment of acute myeloid leukemia (AML). Headquartered in Florham Park, N.J., Celularity is a clinical . . . This content is for paid subscribers. Please click here to subscribe …

The FDA Authorized Emergency Use of Pfizer Paxlovid Pills Against COVID-19

Pfizer Received Emergency Use Authorization from the FDA for Paxlovid Pills for COVID-19 Good news for Pfizer (PFE), the U.S. FDA announced it has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 (the virus that cause COVID-19) viral testing …

Comprehensive Prohost Letter #448

Comprehensive Prohost Letter Issues Coronavirus Variant Omicron A lot has happened since the coronavirus variant Omicron was discovered in South Africa. After having been responsible for a severe plummeting of the stock market, Omicron boosted the market after being described by many scientists as fast spreading with different yet milder symptoms when compared to those caused by SARS-CoV-1, SARS-CoV-2 (the virus that causes COVID-19) and …

The FDA Cleared the IND for Erasca Inc Product ERAS-801 for Recurrent Glioblastoma

Erasca Inc Product ERAS-801 IND Cleared by FDA Erasca Inc (ERAS) announced that the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ERAS-801, an orally available small molecule epidermal growth factor receptor (EGFR) inhibitor specifically designed to have high central nervous system (CNS) penetration for the treatment of recurrent glioblastoma multiforme (rGBM). In the meantime, the company entered into …

Arcturus Therapeutics Additional Updates from ARCT-154 and ARCT-165 Clinical Trials and More

Arcturus Therapeutics Holdings Arcturus Therapeutics Holdings (ARCT) is a clinical-stage mRNA medicines company of enabling technologies with an interesting pipeline of treatments and vaccines as well as other products for diseases that have yet to find treatments. Arcturus Therapeutics’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense . . . This …

Devastated and Resurrected Good Biotech Firms: Theravance Biopharma

The Market Devastation and Resurrection of Good Biotech Firms Due to the market’s instability that we have been experiencing for a while now, we decided to look back at some biotech firms whose values tumbled and stocks tanked as a result of both internal and external bad circumstances and other reasons. The decision to retackle these firms is in our conviction that they will rebound …

AstraZeneca Granted FDA EUA for Long Acting Antibody Evusheld for Pre-Exposure Prophylaxis of Covid-19

AstraZeneca Long Acting Antibody Granted FDA EUA for COVID-19 Prevention AstraZeneca (AZN) product Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with the first doses expected to become available very soon. The EUA for Evusheld was granted for . . . This content is for paid subscribers. Please click here …

Celldex Therapeutics Dosed the First Patient in a Phase 1 Study of CDX-0159 for Prurigo Nodularis

Celldex Therapeutics Dosed the First Patient with CDX-0159 for Prurigo Nodularis Celldex Therapeutics (CLDX) announced that the first patient in a Phase 1 study of CDX-0159 for prurigo nodularis (PN) has been already dosed.  From Celldex Therapeutics Diane C. Young, MD, Senior Vice President and Chief Medical Officer of . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Amgen: Positive Results from Otezla® Phase 3 DISCREET Study in Moderate to Severe Genital Psoriasis

Amgen Announces Positive Results from Otezla Study for Psoriasis Amgen (AMGN) announced positive top-line results from the DISCREET trial - a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study demonstrated that oral Otezla 30 mg twice daily achieved a . . . This content …

Great News: Vertex Pharmaceuticals Announced Successful Phase 2 Study Results of VX-147

Vertex Pharmaceuticals Phase 2 Results of VX-147 Vertex Pharmaceuticals (VRTX) announced today that, in a Phase 2 proof-of-concept (POC) study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147, on top of standard of care, achieved a statistically significant, substantial and clinically meaningful . . . This content is for paid subscribers. Please click here to subscribe or here to log in.