In an interview with PharmaShots, Mike Crichton, Senior Vice President, Global Therapy Area Head, Specialty & Primary Care at GSK shares his views on the European Commission's approval of Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).
Shots:
The European Commission approved the expanded use of GSK's…
In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company's near-term goals in the coming years.
Shots:
The EC approval is based…
Shots:
In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval.
Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…
The US FDA has approved 7 NDAs and 2 BLA in Dec 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 105 novel products so far in 2020, including 9 in Dec 2020.
Additionally, last year in 2019, the US FDA has approved…
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…
The US FDA has approved 5 NDAs and 1 BLA in Nov 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 96 novel products so far in 2020, including 6 in Nov 2020.…
The first quarter of 2019 has marked with major events in the pharma & biotech industries. We have gathered the key highlights of the quarter, which was starting with the blockbuster news, where Celgene had acquired BMS for $74B. Moving to the next news, acquisition of Loxo Oncology for $8B, in addition to Spark Therapeutics…
In the last 20 years the global Biopharma space has changed a lot with ups and downs of companies and their growth. This analysis has found the multiple acquisitions and mergers along with the launch of several blockbusters leading to jump in growth and revenue of numerous companies. Pfizer acquired Warner-Lambert in 2000 to gain…

