Tag Archives: Roche Holding AG

Drug regulators in China, US and Europe out of the gates in 2020 with a whole month’s worth of action.

Slowly at first, then accelerating recently in its domestic and global footprint in drug research and regulation, China and its National Medical Products Administration (NMPA) has been on a tear…. Read more »

In a seeming role-reversal, FDA steps up action over Thanksgiving week while EMA goes on holiday.

Although usually thought of as a well-deserved respite from governmental rulings, the US Food and Drug Administration seized on Thanksgiving week as a demonstration of its zeal to pump out… Read more »

Brexit referendum slowing the European Medicines Agency’s operations to a crawl.

The News: The European Medicines Agency (EMA) recently addressed its concerns for ensuring business continuity and staff retention which had become huge challenges caused by the Brexit referendum. The EMA… Read more »

Doctors reliance on pharmas increasing, while general public trusts supermarkets more. What’s wrong with this picture?

The News: When it comes to pharma partners, doctors prefer quality digital content, according to a new report. While that comes as no surprise and makes sense, new research shows… Read more »

Boomer Alert: Aging immune cells increase risk for macular degeneration, blindness. Apellis, Ophthotech to the rescue?

The News: As people age, so do their immune systems. And new research at Washington University School of Medicine in St. Louis suggests that aging immune cells increase the risk… Read more »

South Korea’s Celltrion Inc. (Incheon) gets EU green light for Herceptin biosimilar

The News: Celltrion Inc. said on February 14, 2018 that it has received approval to sell its replica version of Roche Holding AG’s (Basel CHE) breast-cancer blockbuster Herceptin in Europe…. Read more »

Ablynx soars 60% on Novo’s latest hostile bid; grab a piece of this Belgian biotech because the real action’s just starting.

The News: Denmark’s Novo Nordisk A/S (Copenhagen), the world’s biggest insulin maker, went public Monday (January 8, 2018) with a €2.6-billion ($3.1 billion) bid for Belgian biotech group Ablynx NV… Read more »

Alarming study concludes most new, pricey cancer drugs don’t work; why are we just hearing about this?

The News: Researchers said only half of the cancer drugs approved by European regulators in the past few years have shown to help patients. Many of the drugs were approved… Read more »

Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.

The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »

ASCO, aka The Oncology Super Bowl for Biotechs, sends stocks in every direction

Steve’s Take: As another jam-packed annual meeting of the American Society of Clinical Oncology in Chicago wrapped up on Tuesday (June 6, 2017), with some 38,000 oncologists gathering together at… Read more »