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

INSIGHTS+

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

VIEWPOINTS

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

VIEWPOINTS

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

THOUGHTSPOT

COVID-19 – Where Does The Pharmaceutical Industry Go From Here?

With the race to develop an effective vaccine becoming intense, how has the coronavirus pandemic changed the pharmaceutical industry, and what can we expect in the long- and short-term? Let's see. The year 2020, and the new decade as a whole, has definitely got off to the worst possible start and we have a pandemic…

BySenior EditorSeptember 28, 2020

INSIGHTS+

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

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, where…

BySenior EditorJune 30, 2020

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

COVID-19 – Where Does The Pharmaceutical Industry Go From Here?

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

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