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

The US FDA has approved 4 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 29 novel products in 2021. Additionally, last year in 2020, the US FDA…

BySenior EditorJune 17, 2021

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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

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

The US FDA has approved 7 NDAs in Mar 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 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…

BySenior EditorApril 15, 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

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Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A- licensing- and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal…

ByPrince GiriJanuary 22, 2021

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PharmaShots Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC

In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Shots: Janssen reported the BLA submission to the US FDA seeking approval of Amivantamab for the…

BySenior EditorJanuary 13, 2021

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PharmaShots Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen's commitment to advance research in rheumatic disease. Shots: Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program Sixteen abstracts focus on Tremfya in adults…

BySenior EditorJanuary 11, 2021

INSIGHTS+

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

The US FDA has approved multiple NDAs and BLAs in May 2020, leading to the 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 43 novel products so far in 2020, including 12 in May 2020…

BySenior EditorJune 19, 2020

INSIGHTS+

Insights+: Breakthrough Therapy Designation by the US FDA in 2019

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 13, 2020

INSIGHTS+

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

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named 'SARS-CoV-2'(severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named 'Coronavirus Disease 2019'(COVID-19). The outbreak of the respiratory disease was first detected in Wuhan…

BySenior EditorFebruary 28, 2020

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

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

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

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

Top 20 Life Sciences Deals of 2020 by Total Deal Value

PharmaShots Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC

PharmaShots Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

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

Insights+: Breakthrough Therapy Designation by the US FDA in 2019

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

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