Tags : Allergan

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

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. In 2018, the FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a […]Read More

Top 20 BioPharma Companies based on 2019 Total Revenue

The global biopharma companies are developing novel therapies & devices which is, in turn, enhancing their portfolio and encouraging them in this undergoing competition to stay in the topmost position. The top 20 companies’ chartbusters changed their 2019 ranking, but the history of Johnson and Johnson did not change and it continued being at the […]Read More

PharmaShots Weekly Snapshot (March 02-06, 2020)

1. Mount Sinai Signs a Multi-Year Collaboration with Harbour BioMed to Develop Novel Biotherapies for Multiple Cancer Indications and COVID-19 Published: Mar 06, 2020 | Tags: Mount Sinai, Signs, Multi-Year, Collaboration, Harbour BioMed, Develop, Novel Biotherapies, Multiple Cancer Indications, COVID-19 2. AstraZeneca Reports Results of Imfinzi and Tremelimumab in P-III DANUBE Study for Unresectable Stage IV […]Read More

Allergan and Editas Report First Patient Dosing in P-I/II BRILLIANCE

Shots: The P-I/II study will assess the safety & efficacy of AGN-151587 (subretinal injection) in ~18 patients with Leber congenital amaurosis 10. The patients enrolled are both adult & pediatric patients (aged 3-17yrs.) The first patients dosing in BRILLIANCE study marks a significant milestone toward delivering the CRISPR medicines, treating the devastating LCA10 AGN-151587 (EDIT-101) […]Read More

AbbVie to Divest Allergan’s Brazikumab and Zenpep (pancrelipase) to Gain

Shots: Allergan will divest its brazikumab to AstraZeneca including its global development and commercialization rights while Nestle to acquire complete ownership of Zenpep and will be acquiring Viokace as a part of the same transaction The divestiture of two therapies is in conjunction with the ongoing US FTC’s and EC’s approval. The transactions are expected […]Read More

PharmaShots’ Key Highlights of Fourth Quarter 2019

1. Pfizer Launched its Zirabev (biosimilar, bevacizumab) in the US by the year end 2019 Date – Oct 01, 2019 Product – Zirabev (biosimilar, bevacizumab) The biosimilar was launched in the US on Dec 31, 2019 following the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept […]Read More

PharmaShots Weekly Snapshot (December 23-27, 2019)

1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005 Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US 2. Immunomedics Reports the US FDA’s Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer Published: Dec 26, 2019 | Tags: Acceptance, BLA, FDA, Immunomedics, […]Read More

Allergan’s Ubrelvy (ubrogepant) Receives the US FDA’s Approval for Acute

Shots: The US FDA’s approval is based on four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002), which demonstrated efficacy, safety and tolerability of Ubrelvy (50, 100mg) for the acute treatment of migraine with/-out aura in adults The studies resulted in meeting its 1EPs i.e, elimination in migraine pain and the most bothersome symptom […]Read More