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 ~$4BThe third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…
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…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012The 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…
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 2020Artios 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…
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…
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…
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…
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…
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…
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…

