Top Performing Drug of 2021 – Opdivo (December Edition)

Active Ingredient: Nivolumab Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial Dosage Form: Injection Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1) First Approval: US (22 Dec 2014), EU (19 Jun 2015)  Revenue Analysis of OpdivoBMS’ Opdivo gives tough competition to other drugs in the…

BySenior EditorDecember 22, 2022

INSIGHTS+

Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV” -Theme of the year 2022 Introduction:HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system.HIV, a type of retrovirus that isn't…

BySenior EditorDecember 20, 2022

INSIGHTS+

Insights+: The US FDA New Drug Approvals in September 2021

The US FDA has approved 5 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industryThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 55 novel products in 2021Additionally, last year in 2020, the US FDA…

BySenior EditorOctober 21, 2021

VIEWPOINTS

PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology

In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company's collaborations with BMS and its Xtend XmAb technology. He also shed light on the EUA of Sotrovimab for COVID-19.Shots:The FDA has granted EUA to Vir and GSK's sotrovimab, which was engineered with Xencor's XmAb…

BySenior EditorAugust 3, 2021

VIEWPOINTS

PharmaShots Interview: BD’s Tony Ezell Shares Insights on the Collaboration with USATF to Provide COVID – 19 Testing for US Athletes

In an interview with PharmaShots, Tony Ezell, President, North America and Chief Marketing Officer, BD shares its agreement with the USA Track and Field team for COVID-19 testing for the Olympic Trials.Shots:BD's partnership with USATF is part of the company's commitment to helping get people back to their normal livesThe BD Veritor…

BySenior EditorJuly 21, 2021

VIEWPOINTS

PharmaShots Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA's approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids.Shots:The US FDA has approved Myovant & Pfizer's Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily treatment for the…

BySenior EditorJuly 20, 2021

VIEWPOINTS

PharmaShots Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US

In an interview with PharmaShots, Dr. Allitia DiBernardo, Global Head of Medical Affairs for Neurology at the Janssen share her views on the availability of Ponvory in the US for MS patients.Shots:Ponvory offers patients superior efficacy in reducing annualized relapses and brain lesions over established oral therapy teriflunomide (Aubagio), with a safe and generally well-tolerated profile…

BySenior EditorMay 24, 2021

EVENTS

12th Summit on Biosimilars & Innovator Biologics

June 22 ' 23, 2021 (EDT) | Virtual ConferenceThe American Conference Institute invites you to attend the Virtual 12th Summit on Biosimilars & Innovator Biologics on June 22-23, 2021! Gain government and industry insights on the Innovator and Biosimilars Marketplace from the U.S. FTC, U.S. FDA, USPTO, and leading In-House Counsel.As the number…

BySenior EditorApril 30, 2021

VIEWPOINTS

PharmaShots Interview: Dr. Sezer, Peter C. Adamson and Israel Lowy Share Insight on the US FDA’s Approval of Libtayo (cemiplimab) in Patients with NSCLC with High PD-L1 Expression

Shots:In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval.Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…

BySenior EditorMarch 30, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 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 12 novel products in 2021.Additionally, last year in 2020, the US…

BySenior EditorMarch 18, 2021

Top Performing Drug of 2021 – Opdivo (December Edition)

Disease of the Month: AIDS

Insights+: The US FDA New Drug Approvals in September 2021

PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology

PharmaShots Interview: BD’s Tony Ezell Shares Insights on the Collaboration with USATF to Provide COVID – 19 Testing for US Athletes

PharmaShots Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

PharmaShots Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US

12th Summit on Biosimilars & Innovator Biologics

Insights+: The US FDA New Drug Approvals in February 2021

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