Insights+: The US FDA New Drug Approvals in June 2023

Shots: The US FDA approved 12 NDAs and 3 BLA in June 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 69 novel products in 2023 In June 2023, the major highlights drugs were Talzenna + Xtandi approval for prostate cancer, Rystiggo for generalized myasthenia gravis PharmaShots…

BySenior EditorJuly 19, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2023

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in December 2022

Shots: The US FDA approved 8 NDAs and 5 BLA in December 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 86 novel products in 2022 In December 2022, the major highlights drugs were Krazati (adagrasib) approval for non-small cell lung cancer with a KRASG12C mutation, Sunlenca…

BySenior EditorJanuary 18, 2023

INSIGHTS+

PharmaShots’ Most Read News of 2022

The year 2022 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, clinical trial results and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2022 1. AVEO Entered into a Clinical Trial Collaboration with Merck KGaA to…

BySenior EditorJanuary 2, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of September 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 September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…

BySenior EditorOctober 6, 2022

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2022

The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4B The third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…

BySenior EditorSeptember 29, 2022

TOP 20

Top 20 Life Sciences Deals of 2021 by Total Deal Value

Shots: The life science industry saw high deal activity in 2021 staying in the range of an even busier 2020. Fourth-quarter 2021 set the tone with Recursion’s development and commercialization deal with Roche and Genentech for a total value of $12.7B, followed by Poseida Therapeutics’ development and commercialization deal with Takeda for $3.73B. This article is based on the 2021…

ByPrince GiriFebruary 10, 2022

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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

TOP 20

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

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+: The US FDA New Drug Approvals in June 2023

Insights+: The US FDA New Drug Approvals in April 2023

Insights+: The US FDA New Drug Approvals in December 2022

PharmaShots’ Most Read News of 2022

Insights+ Key Biosimilars Events of September 2022

PharmaShots’ Key Highlights of Third Quarter 2022

Top 20 Life Sciences Deals of 2021 by Total Deal Value

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

Top 20 Life Sciences Deals of 2020 by Total Deal Value

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

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