Author Archive

The Truth Behind China Bribery Scandals

VLUU L110  / Samsung L110The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China. Big names were engulfed in the scandal, including GSK, AstraZeneca, Sanofi, Novartis, Eli Lilly, Novo Nordisk and UCB amongst others.

Last month, four GSK executives were put under investigation for allegedly paying up to $480 million to doctors, hospital administrators, government officials and medical groups to promote the use of its medications. The limelight then shifted to Sanofi when some of its employees were accused of paying bribes totaling up to $280,000 to more than 500 Chinese doctors across 79 hospitals six years ago. The newspapers also alleged that Sanofi paid doctors 80 yuan each time a patient bought its products, with the largest payment said to be 11,200 yuan.

Novartis has also fallen prey to bribery allegations in China. The Swiss drug maker was accused of paying doctors $8000 to prescribe its cancer drug, Sandostatin LAR. Sales figures were expected to increase in June and July this year as a result. Eli Lilly is now the latest being investigated after a former employee alleged in a report that the company spent more than $490,000 to bribe doctors in China. The former sales manager said that Eli Lilly offered kickbacks to ensure doctors used its drugs, including its insulin brand. Read more »

Falsified Medicines Directive Enforced in the UK

Craig Stobie from Domino Printing Sciences shares on how to prepare for FMD and other emerging legislation.

The Falsified Medicines Directive (FMD) has finally been transposed into UK legislation. The FMD came into force on 20 August 2013. “It is now time for pharmaceutical manufacturers to walk the talk,” said Craig Stobie, global life sciences sector manager at Domino Printing Sciences. Read more »

Myriad Ruling Will Undermine Global Biotech investment But All Is Not Lost

Guest blog written by Adrian Tombling, partner and patent attorney at Withers & Rogers LLP.

The US Supreme Court ruling in the so-called ‘Myriad case’ regarding the patentability of human genes will undermine global biotech investment but all is not lost. Judge Thomas, in Association for Molecular Pathology v. Myriad Genetics, effectively tightened the rules on the patentability of human genes, finding that all naturally occurring gene sequences, even when isolated in the laboratory, are not patentable. In future, only non-naturally occurring gene sequences (e.g., sequences that have been modified or entirely created in the laboratory), will be patentable, and therefore, attract investment from biotech companies. Read more »

Drug Development: To Sue or Not to sue?

Guest blog written by Dr Nicholas Jones, partner and patent attorney at Withers & Rogers LLP.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world. Read more »

Advertising of Prescription Drugs – Keeping it Honest and Balanced

It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals. In the US, a significant amount is also spent on direct advertising to consumers. In a report by the FDA on Keeping Drug Advertising Honest and Balanced, Thomas Abrams, director of the Office of Prescription Drug Promotion (OPDP), shares on how the agency “protects consumers from false and misleading ads for prescription drugs that appear on TV, radio, online and in print publications.” Read more »

Inadequate Access to Medicines Puts EU at Risk

The issue of patients not receiving essential medicines because they cannot afford them is becoming a serious problem in the EU as the region battles through its economic crisis. In a briefing by the European Public Health Alliance (EPHA) on Access to Medicines in Europe in Times of Austerity, it was highlighted that the three factors that will determine whether or not a patient gets his/her medicine are “affordability and availability, in terms of access to medicines, and innovation in terms of developing new methods of assuring best possible health outcomes.” Read more »

Global Biosimilars Market to Reach $2.445 Billion in 2013

VLUU L110  / Samsung L110The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the global biosimilars market is expected to experience a steady growth over the next 10 years, driven by worldwide launches of such products, particularly in the EU and US. Read more »

Adapting to Change

Evidence of health outcomes is what payers want to see. As a result, biotech companies are now focussing more on demonstrating economic value, for example, by showing survival benefit of a cancer drug or superiority to branded or generic competitors. Read more »

AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways

Guest blog written by Chris Watson, product manager of Exco InTouch.

AstraZeneca and Exco InTouch have announced a program to develop and launch interactive mobile phone and internet-based health tools that will help patients in the UK and their healthcare providers to track and manage chronic conditions. AstraZeneca’s R&D organisation and Exco InTouch are developing the tool with an initial focus on chronic obstructive pulmonary disease (COPD). Read more »

Biotech Needs to Focus on Demonstrating Product Value

VLUU L110  / Samsung L110Ernst & Young recently released its annual biotechnology industry report, Beyond Borders: Matters of Evidence, stating that while the major players are performing well, it is essential that small- to mid-size biotech companies focus on demonstrating the value of products in their pipelines instead of just creating a drug that works. If not, they will lose out in a challenging environment, especially now that there is a global shift towards evidence-based healthcare. Read more »

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