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A group of University of Alberta researchers who have discovered why the drug remdesivir is effective in treating the coronaviruses that cause Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) expect it might also be effective for treating patients infected with the new COVID-19 strain. [...]
Thu, Feb 27, 2020
Source WorldPharmaNews
Several of the industry's top players turned in a strong performance in the fourth quarter, growing revenues at high single digits. Others? Not so much. And no company grew revenues as much as Vertex, which is riding a hot new launch for cystic fibrosis combination med Trikafta. [...]
Thu, Feb 27, 2020
Source FiercePharma
With the board appointments of former leaders at Pfizer and Mylan, generics megamerger Viatris has already indicated its predecessors would play an outsized leadership role. Now, with nine more Pfizer and Mylan board members moving over––and a Pfizer CFO, to boot––the past is definitively the future at Viatris. [...]
Thu, Feb 27, 2020
Source FiercePharma
FDA advisers voted 6-5 in favor of approving Eli Lilly's Cyramza plus Roche's Tarceva in the first-line treatment of EGFR-positive non-small cell lung cancer, in a less-than-ringing endorsement that could foreshadow the challenges Lilly will face in the lung cancer market. The approval would pit Lilly against AstraZeneca's Tagrisso, which [...]
Thu, Feb 27, 2020
Source FiercePharma
Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects, a $55 million expansion of its manufacturing facility in North Carolina. [...]
Thu, Feb 27, 2020
Source FiercePharma
The pharma industry is launching into deals “ill-prepared”, Scotwork claims. [...]
Thu, Feb 27, 2020
Source PharmaTimes
TrakCel was created in 2012 in order to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. [...]
Thu, Feb 27, 2020
Source PharmaTimes
The decision brings a new option to the market for around 900 patients. [...]
Thu, Feb 27, 2020
Source PharmaTimes
When completed, the planned company will allegedly rank as the world's second largest API company with approximately €1 billion in expected sales by 2022. [...]
Thu, Feb 27, 2020
Source PharmaTimes
Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, [...]
Thu, Feb 27, 2020
Source WorldPharmaNews
A team of academic and industry researchers is reporting new findings about how exactly an investigational antiviral drug stops coronaviruses. Their paper was published the same day that the National Institutes of Health announced that the drug in question, remdesivir, is being used in the nation's first clinical trial of [...]
Thu, Feb 27, 2020
Source WorldPharmaNews
Amgen
Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis, which included consideration of pre-specified criteria for futility and superiority. [...]
Wed, Feb 26, 2020
Source WorldPharmaNews
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. [...]
Fri, Jan 16, 2015
Source FDANews