12th Summit on Biosimilars & Innovator Biologics

June 22 ' 23, 2021 (EDT) | Virtual Conference The 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

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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

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Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…

BySenior EditorMarch 11, 2021

INSIGHTS+

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

The US FDA has approved 4 NDAs in Jan 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 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…

BySenior EditorFebruary 18, 2021

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PharmaShots Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

In a recent interview with PharmaShots, Laura Yecies, CEO of BoneHealth Technologies shared her views on OsteoBoost Vibration Belt that has been granted 'Breakthrough Device' designation by the US FDA Shots: OsteoBoost receives the US FDA's BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at…

BySenior EditorFebruary 2, 2021

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PharmaShots Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US. Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with…

BySenior EditorJanuary 6, 2021

INSIGHTS+

Insights+: COVID-19 Healthcare News Monthly Updates – January 2020

Shots: Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019 PharmaShots is keeping a track of all of the important updates in the Lifesciences sector…

BySenior EditorDecember 31, 2020

INSIGHTS+

Insights+ Key Biosimilars Events of November 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…

BySenior EditorDecember 3, 2020

INSIGHTS+

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

The US FDA has approved 4 NDAs and 1 BLA in Oct 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 90 novel products so far in 2020, including 5 in Oct 2020.…

BySenior EditorNovember 19, 2020

12th Summit on Biosimilars & Innovator Biologics

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

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

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

PharmaShots Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

PharmaShots Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

Insights+: COVID-19 Healthcare News Monthly Updates – January 2020

Insights+ Key Biosimilars Events of November 2020

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

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