The US FDA has approved 6 NDAs and 1 BLAs in 2021, 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 68 novel products in 2021
Additionally, last year in 2020, the US FDA…
In an interview with PharmaShots, Dr. Dale Christensen, Ph.D., Director of Clinical Development at TFF Pharmaceuticals shared his views on the preliminary data from the P-I trial of inhalable tacrolimus powder formulation for Lung Transplant & its TFF technology
Shots:
TFF has developed an inhalable tacrolimus powder formulation that can be delivered directly to the lung via an inhaler bypassing…
In an interview with PharmaShots, James Graham, CEO of Recce Pharmaceuticals shared his views on the multiple patient dosing in P-I/II clinical trial of RECCE 327 (R327) for the treatment of infected burn wounds.
Shots:
The multiple patients have been dosed in P-I/II trial evaluates the effectiveness & safety of RECCE 327 in 30 patients (10 will receive RECCE 327…
In an interview with PharmaShots, Dr. Ian Walters, CEO of Portage Biotech shared his views on the interim data from the P-II IT-01 trial evaluates the safety and efficacy of INT230-6 as both a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors
Shots:
The P-II IT-01 trial evaluates the safety & efficacy of INT230-6 as monothx. & in…
In an exclusive interview with PharmaShots, Kelly Pokuta, Vice President of Pharmaceutical Trade Relations, and April Kunze, Senior Director, Clinical Formulary Development & Trend Management Strategy at Prime therapeutics share their views on the MedDrive as a first-of-its-kind medical drug management program uniquely aligned with its Blue Plan clients.
Shots:
Prime introduced the first-of-its-kind medical drug management solution with…
In an interview with PharmaShots, Paula Ragan, Ph.D., President, and Chief Executive Officer at X4 Pharmaceuticals shared her views on preliminary efficacy and safety data of Mavorixafor + Ibrutinib in an ongoing P-Ib study to treat waldenström's macroglobulinemia
Shots:
The ongoing P-Ib clinical trial evaluates the safety & efficacy of mavorixafor + ibrutinib in patients with WM with both MYD88 &…
In an interview with PharmaShots, Michael Dale, Senior Vice President of the Structural Heart division at Abbott shared his views on the Navitor's approval in the EU for patients with severe aortic stenosis who are at high or extreme surgical risk for open-heart surgery.
Shots:
Abbott has received CE Mark approval for its latest-generation transcatheter aortic…
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
During the month of August, Samsung Bioepis Byooviz (biosimilar, ranibizumab) received EC's…
In an interview with PharmaShots, Rami Levin, Chief Executive Officer at Saniona shared his views on the US FDA's Orphan Drug Designation (ODD) to Tesomet for the treatment of hypothalamic obesity (HO) and discuss its role in the company's continued pipeline progress.
Shots:
Saniona reported that the FDA has granted orphan drug designation to Tesomet for the…
Introduction:
'Over-prescription' is defined as the action of prescribing a drug or treatment in greater amount or on more occasions than necessary. Overprescribing, in general in health care, has been a subject of frequent study. For instance, research published in 2018 found that 46% of a half-million outpatient antibiotic prescriptions were written by clinicians without diagnoses of…

