Roche on Continuous Manufacturing at the PDA/EMA Joint Conference

Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »

Roche Under EMA Investigation

Stephanie Sutton Pharm Tech EuropeEarlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions. Included in the reports were approximately 15161 deaths, although the European Medicines Agency explained at the time that the actual number of reports could be lower once verified. EMA also added that the deaths may not have a casual link to the medicine. Either way, it’s still a huge number of reports that should have been assessed.

Today, the case accelerated as the European Medicines Agency launched an infringement procedure against Roche to investigate the alleged pharmacovigilance deficiencies. Read more »

Another Loss for New Jersey Life Sciences

Amy RitterRoche’s recent announcement that it will be closing its venerable Nutlley, NJ R&D site is the latest in a string of mergers and reorganizations that have resulted in the loss of thousands of life-sciences jobs from New Jersey, and an exodus of both R&D and manufacturing from a state known as the home of big Pharma. Read more »

Deficiencies in Roche Safety Reporting

Stephanie Sutton Pharm Tech EuropeA coordinated European programme was recently carried out involving routine inspections of pharmaceutical companies’ safety reporting systems. Whether regulators suspected deficiencies or not is unknown, but they certainly found them when the UK’s Medicines and Healthcare products Regulatory Agency inspected one of Roche’s UK sites. During the inspection, the company identified around 80000 reports, including 15161 deaths, connected to Roche medicines marketed in the US that had not been evaluated to determine whether they should be reported as adverse drug reactions. The reports were collected through a Roche-sponsored patient programme. Read more »

Cheap Drugs Versus Expensive Drugs

Stephanie Sutton Pharm Tech EuropeThe pricetag of pharmaceuticals are coming under increasing scrutiny in today’s age of cost constraints. Drug development is expensive and high prices are necessary, but governments and healthcare payers are not always willing to pay the price that pharmaceutical companies are asking.

In the UK, the National Health System (NHS) has taken the controversial step of cutting the cost of treating wet age-related macular degeneration (AMD) by prescribing a cheaper drug over a more expensive one. The controversial element? The cheaper drug isn’t licensed for wet AMD. Read more »

Illumina Continues to Reject Roche

Stephanie Sutton Pharm Tech EuropeIn February, I wrote that Roche could be in for a lengthy battle if it wants to acquire the gene-sequencing specialist Illumina. And indeed, the battle is still raging on. Here’s an update on some of the latest developments. Read more »

Roche and Illumina Ready the Trenches

Stephanie Sutton Pharm Tech EuropeAfter its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again. This time, the Swiss pharma giant has its eyes on the DNA sequencing company Illumina, which is based in San Diego in the US. However, both companies are digging their trenches in preparation for a potentially lengthy battle. Read more »

Live at CPhI: And so it begins!

Rich WhitworthThe day started with a 5 o’clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year’s CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start. Read more »

Roche Takes a Step Forward with Personalized Medicine

Patricia Van Arnum PharmTech editor Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines. Read more »

Stanford versus Roche: The Winners and Losers

Patricia Van Arnum PharmTech editor In a ruling issued this week concerning the patent rights of research universities, the US Supreme Court ruled in favor of Roche in a long-standing patent dispute the company had with Stanford University regarding patent rights to technology to detect HIV blood levels using polymerase chain reaction (PCR) technology. The ruling is significant in that it provides clarity in this particular case to technology transfer and related rights between universities using federal funding and private companies. Read more »

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