Page 26 - Project Orbis News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Mar 4, 2021 10:54am The FDA has expanded Pfizer's Lorbrena approval to include front-line ALK-positive non-small cell lung cancer. Pfizer’s Lorbrena has finally broken into front-line non-small cell lung cancer, where Novartis, Roche and Takeda are already jockeying for a niche market. The FDA expanded Lorbrena’s use into newly diagnosed patients with ALK-positive NSCLC, Pfizer said Wednesday. With that front-line nod, the agency converted Lorbrena's conditional green light for previously treated cases into a full approval. How does Pfizer expect to compete in such a crowded field? As a t...

Why governments need to rethink their regulatory framework in 2021 - Magazine Article - PharmaTimes

UK approval for Seagen’s oral HER2 inhibitor Tukysa MHRA has authorised drug for HER2-positive advanced breast cancer Seagen’s oral HER2 drug Tukysa has been granted authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of HER2-positive advanced breast cancer. The MHRA has cleared Tukysa (tucatinib) as an add-on therapy to Roche’s anti-HER2 antibody Herceptin (trastuzumb) plus Xeloda (capecitabine) for adults patients with HER2-positive locally-advanced or metastatic breast cancer who have previously received at least two anti-HER2 tre...

Operator Good morning to those joining from the U.K. and the U.S. Good afternoon to those in Central Europe. Welcome, ladies and gentlemen, to AstraZeneca's full-year 2020 results conference call and webcast for investors and analysts. Before I hand it over to AstraZeneca, I'd like to read the safe harbor statement. The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca. Although we belie...

In the fall of 2016, Alnylam Pharmaceuticals was looking to expand. The Cambridge, Massachusetts–based company had therapies based on RNA interference (RNAi) technology in late-stage clinical testing for a handful of rare diseases, and wanted to establish a presence in Europe to better serve patients there. By the end of the following year, the company had opened offices in Maidenhead, UK; Zug, Switzerland; and Amsterdam, the Netherlands, to serve as its three European hubs. Scouting for new locations in Europe, the company found Amsterdam particularly appealing, says Marco Fossatelli, Alny...