Stephanie Sutton

This week an interesting report was released about the use of gelatine in medicines. Most of us are comfortable with the use of animal products as ingredients.

Last week, counterfeits of the anti-cancer drug Avastin were discovered in the US and this week fake pharmaceuticals continue to occupy headlines.

Pfizer has signed an agreement with the Chinese biopharmaceutical company Zhejiang Hisun Pharmaceuticals with the objective of establishing a $545-million joint venture to develop and commercialize branded generic medicines in both China and the global market.

Much negative criticism has been directed at the pharmaceutical industry’s perceived lack of innovation in recent years, but one area that has received a lot of attention is neglected diseases.

The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral medicines.

The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.

After its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again.

The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.

The European Commission (EC) has closed an investigation into Servier that accused the company of providing "misleading" and "incorrect" information to the EC?s pharmaceutical sector inquiry.

Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its restructuring initiatives “to drive productivity and support innovation”.

Guidance offered on how to deal with off-label information requests.

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.

How can pharma make use of social media opportunities without running afoul of regulators?

Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost.

As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments.

According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.

Takeda has announced "strategic measures to achieve efficiencies for long-term growth", which includes cutting close to 3000 jobs, 2100 of which will come from Europe.

Earlier this week, Novo Nordisk launched a diabetes initiative in the US that stars the celebrity chef Paula Deen. Usually, it’s the pharma company that gets the sharp end of the stick when it comes to criticism but this time the negative attention has fallen on Deen, with Norvo Nordisk barely getting a mention in many news sources.

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

Sanofi will co-invest in start-up biotech company Warp Drive Bio by providing financial funding and access to its strains library and expertise in natural products.

GlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. The transaction will provide BMS with a potential candidate currently in Phase II development for the treatment of hepatitis C.

First of all, I wish all of you a very happy new year! The pharma industry and its workers have been through a lot of hardships in recent times with huge job losses, eroding profits and drying pipelines. A lot of gloomy predictions have been made about 2012 (including ongoing economic woes and the end of the world) but let’s hope that this year finally brings good times for pharma as it seems that the industry is well overdue for a successful year.

Alexion Pharmaceuticals has signed an agreement to acquire all the capital stock of the biopharmaceutical company Enobia Pharma in a $610-million all-cash transaction.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.

Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis, and is one of leading causes of death in children under the age of five in developing countries.

EMA has unveiled its work program for 2012, which forecasts a slight increase in marketing authorization applications for new medicines compared with 2011. In addition, EMA said that it will, where needed, strengthen the quality, regulatory, and scientific consistency of its assessment process.

After reviewing the "shortcomings in quality assurance" that were recently identified at Ben Venue Laboratories's Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta and Liminity.

The United Kingdom's life-sciences industry this week welcomed a new, multimillion-pound strategy that aims to both support the industry and encourage innovation in the unsettled economic climate.