Author Archive

Pharma’s Efforts in Hurricane Aid

Stephanie Sutton Pharm Tech EuropeThe end of October saw chaos in the Caribbean and then on the east coast of the US, particularly in New York and New Jersey (the location of some of PharmTech’s offices) after hurricane Sandy hit.

The pharmaceutical industry has also been affected by the storm, with several big companies delaying the announcements of their third-quarter financial results. On a consumer and patient-level, medicinal supplies have been affected in the US by looting and power outages affecting the filling of prescriptions. 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 »

Will Pharma Embrace Open Innovation?

Stephanie Sutton Pharm Tech EuropeRecent years of low approvals of new blockbuster products have given rise to the perception that pharmaceutical drug development, in its current format, no longer works. Recent late-stage failures of clinical trials have also served to emphasise the risky nature of drug development. So what’s the alternative?

At the end of last week, GlaxoSmithKline placed its bets on open innovation as a new way forward for developing medicines. Read more »

Concerns Raised Over the Comparability of Branded/Generic-Drugs

Stephanie Sutton Pharm Tech EuropeLast week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product. The drug in question, Budeprion XL 300 mg, was approved in the US in December 2006 as a generic form of GlaxoSmithKline’s antidepressent drug, Wellbutrin XL 300 mg. Read more »

Biopharma Industry Set to See New Technologies and New Therapies

Stephanie Sutton Pharm Tech EuropeA new report has forecast that the global biopharmaceutical market will be worth more than $320 billion by 2020, up from just $138 billion in 2011. According to global business intelligence firm GBI Research, annual revenues for biopharmaceuticals have been rising year on year since 2001. In 2011, biopharmaceuticals accounted for 15.6% of the total pharmaceutical market. Read more »

ISPE Annual Meeting Seeks to Foster Global Change

Guest blog written by Nancy Berg, President and CEO, ISPE.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry. She put the onus on industry and regulators to find ways to work together more effectively, to engage in productive conversations, and to dissolve roadblocks to QbD and the issues that lead to counterfeiting, shortages, and other threats to safe, high-quality medicines. Read more »

Why Sanofi’s Recent Job Cuts Could be Worse

Stephanie Sutton Pharm Tech EuropeYesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement here.

Read more »

Advancing Pharma’s Social Media Listening Analytics

Guest blog by Ben Comer of Pharmaceutical Executive.

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies. Read more »

Colored Brain Sparks FDA Warning Letter

Stephanie Sutton Pharm Tech EuropeWarning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them. Not only are warning letters issued by FDA for cGMP deficiencies, letters can also be initiated by marketing or advertising blunders, including the misuse of social media and product websites.

Last week, Eli Lilly received an FDA Warning Letter after the agency’s routine monitoring and surveillance program spotted an image of a colored brain on the website for Amyvid, a diagnostic PET tracer used by healthcare professionals when evaluating Alzheimer’s Disease and other causes of cognitive decline. According to FDA, the brain classifies as misbranding because Amyvid’s product labeling states that images must be displayed and reviewed in black and white. Read more »

FDA Eyes More Foreign Inspections

Stephanie Sutton Pharm Tech EuropeIt’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to. For a start, FDA only has a limited ability to require foreign establishments to allow inspectors into the facilities and logistical problems also mean that inspections cannot be performed unannounced.  In addition, the cost of overseas inspections can be a huge burden and regulators, like the rest of the pharmaceutical industry, are being squeezed by today’s unsettled economic environment. However, I was still surprised this week to learn at how infrequently these inspections are performed. Because of limited resources, FDA can only inspect generic-drug manufacturers outside of the US every 7 to 13 years. Read more »

« Previous PageNext Page »