The US FDA has approved 3 NDAs and 2 BLAs in Jan 2022, leading to treatments for patients and advances in the health care industry. The CDER and CBER approved 5 novel products in 2022
In Jan 2022, the major highlights were Quviviq's approval for insomnia, Cibinqo for atopic dermatitis, Kimmtrak for unresectable or metastatic…
In an interview with PharmaShots, Dikla Czaczkes Akselbrad, Executive Vice President, Chief Financial Officer at PolyPid shares her views on Q3’21 financial results & P-III (SHIELD I) trial of D-PLEX100 in patients with incisional SSIs in post-abdominal surgery
Shots:
The P-III (SHIELD I) trial evaluates the efficacy and safety of D-PLEX100 in ~500 patients with incisional SSIs in post-abdominal surgery. The trial continues to enroll…
In an interview with PharmaShots, Dr. Jim Woody, MD, Ph.D., Chief Executive Officer at 180 Life Sciences shared his insights on the Phase 2b study of anti-TNF for the treatment of the early Dupuytren's disease.
Shots:
180 Life Sciences used anti-TNF to treat early Dupuytren’s disease and the Phase 2b study is complete.
Additional programs using anti-TNF soon to…
In an interview with PharmaShots, John Meduri, Chief Strategy Officer at Accelerate Diagnostics shared his views on antimicrobial resistance and discuss the epidemiology of AMR cases in the US and worldwide. He also shared his views on Accelerate Pheno system and PhenoTest BC kit.
Shots:
Antibiotic resistance occurs when bacteria develop the ability to defeat…
In an interview with PharmaShots, Todd Cohen, MD, Vice President of Medical Affairs/Medical Director of Urology at Myriad Genetics shares his views on the precision medicine and prognostic tests for Prostate Cancer
Shots:
The company reported the importance of precision medicine and prognostic tests that can help to determine cancer & enables personalized treatment paths. The company highlights the ability of genetic…
In an interview with PharmaShots, Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant shares his views on the P-III (PSOARING 1 & 2) trials of tapinarof for the treatment of Plaque Psoriasis
Shots:
The P-III (PSOARING 1 & 2) trials evaluate the efficacy and safety of tapinarof (1%, qd) vs vehicle-controlled cream in a ratio (2:1) in 1025 patients aged…
In an interview with PharmaShots, Moshe Safran, CEO at RSIP Vision shared his views on the new coronary module in the complete 3D reconstruction of the coronary vasculature during angiography
Shots:
The company reported the 3D reconstruction technology that focused on AI to generate 3D models of patient anatomy from 2D images. The purpose of the technology is to create precise,…
Insights+ Key Biosimilars Events of January 2022
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 January,…
In an interview with PharmaShots, Laura Dix, a Managing Director in Accenture’s Life Sciences Strategy and Consulting practice shares her views on the new research & provides more useful, data-driven information to HCPs
Shots:
The company unveiled new research, titled The “New” Rules of Engagement & which have increased their relevance during COVID-19 through more valuable and meaningful interactions with…
In an interview with PharmaShots, Laurent Levy, Co-Founder & CEO at Nanobiotix shares his views on the first patient enrollment of NBTXR3 in P-III (NANORAY-312) study for the treatment of head and neck squamous cell carcinoma
Shots:
The first patient has been enrolled in P-III (NANORAY-312) study to evaluate the efficacy & safety of NBTXR3 with/out cetuximab vs radiotherapy with/out cetuximab…

