Tags : July

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19

Shots: The two companies collaborated to develop a COVID-19 vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. The partners are planning to initiate P-I study in mid-July followed by pre-clinical results that showed combining the two platforms demonstrated a high level of neutralizing Abs following a single dose The study […]Read More

Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First

Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV. The company anticipate initiating the clinical studies in July’2020 The DCGI’s approval is based on preclinical data demonstrating safety and immune response. The SARS-CoV-2 strain was isolated in NIV & transferred to […]Read More

Celltrion Anticipates the Launch of its POCT Kit for COVID-19

Shots: Celltrion has completed the development of a point-of-care antigen testing kit for COVID-19 in collaboration with BBB. The POCT kit is a portable and overly sensitive device for use in rapid POC testing, thus supporting the early detection of COVID-19+ patients in clinical settings Celltrion’s POCT kit demonstrated 95% sensitivity, utilizes lab-on-a-chip technology consisting […]Read More

Moderna to Initiate P-III Study of its mRNA-1273 Against COVID-19

Shots: The P-III study will evaluate mRNA-1273 vs PBO in a ratio (1:1) and is expected to enroll ~30,000 patients in the US, to be conducted in collaboration with NIAID. The 1EP of P-III study will be the prevention of symptomatic COVID-19 while 2EP include prevention of severe COVID-19 The company has finalized 100 μg […]Read More

Johnson & Johnson to Initiate P-I/IIa Clinical Study of its

Shots: Janssen has accelerated the initiation of the P-I/IIa study of its investigational Ad26.COV2-S recombinant vaccine. Earlier, the company had scheduled the clinical trial to begin in Sept’2020, the trial is now expected to commence in the second half of July The P-I/IIa study will evaluate the safety, reactogenicity & immunogenicity Ad26.COV2-S, recombinant in 1045 […]Read More

Insights+ Key Biosimilars Events of July 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” which are biologically like biologics. They possess similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots have […]Read More