The year 2018 saw a number of significant triumphs in the biopharma industry – increased numbers of drug approvals and near record-shattering IPOs, but the industry also saw its share of blemishes and black eyes from various corners of the globe.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Whatever comes out of Congress on the “repeal and replace” of the Affordable Care Act (ACA or Obamacare) matters because it will affect the bottom line of the life sciences industry as well as all of its industry partners.
The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.
Biopharma executives were asked to predict what the next year might reveal.
Denali announced a collaborative deal with Sanofi to develop potential treatments for neurological and systemic inflammatory diseases that could be worth more than $1 billion.
Novo Nordisk is in advanced talks to acquire assets to bolster the company’s struggling biopharma business after the drugmaker announced the hiring of an AstraZeneca executive to head the unit.
Forbes’ 2018 ranking of the “World’s Best Employers” includes a number of global biopharmaceutical companies.
A Cuban-developed lung cancer treatment combined with Bristol-Myers Squibb’s anti-PDL1 Opdivo shows promise in treating patients who would not likely benefit from immune checkpoint inhibition.
Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review
Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).
Incidence of Alzheimer’s disease is projected to double in the next 40 years unless a cure or preventive measures are found.
Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.