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+

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+

PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B. Apart from…

BySenior EditorOctober 29, 2020

INSIGHTS+

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

The US FDA has approved 6 NDAs in Sept 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 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year…

BySenior EditorOctober 15, 2020

VIEWPOINTS

PharmaShots Interview: Genentech’s Dr. Neil Collinson Shares Insights on Xofluza

In a recent interview with PharmaShots, Dr. Neil Collinson, the Senior Principal Clinical Development Scientist at Genentech / Roche shares his insights and highlights on Xofluza. Shots: The P-III BLOCKSTONE study demonstrated that the proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza…

BySenior EditorSeptember 22, 2020

VIEWPOINTS

PharmaShots Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications. In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration. Shots: A decision on…

BySenior EditorSeptember 7, 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+

Insights+: COVID-19 Healthcare News Monthly Updates – March 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 EditorJanuary 31, 2020

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

Insights+ Key Biosimilars Events of November 2020

PharmaShots’ Key Highlights of Third Quarter 2020

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

PharmaShots Interview: Genentech’s Dr. Neil Collinson Shares Insights on Xofluza

PharmaShots Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

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

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

Contact US

FOLLOW US