Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

FDA Issues Draft Guidance on Electronic Submissions

 Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning,

 which is one in a series of documents intended to assist sponsors and applicants making certain regulatory submissions to FDA in electronic format.  

US Supreme Court to Hear Pay-for-Delay Case

The US Supreme Court agreed to hear a case that will decide whether brand-name drug companies may pay generic drug-companies to delay introduction of lower-cost generic drugs. The Supreme Court is to review a federal appeals court ruling that upheld a "pay-for-delay" arrangement.  

Ranbaxy Recalls Atorvastatin Due to Quality Issues

Ranbaxy Pharmaceuticals is recalling certain lots of its atorvastatin tablets because of possible contamination with small glass particles (less than 1 mm in size). Ranbaxy has ceased atorvastatin manufacturing until it has thoroughly investigated the problem. 

Valeant Pharmaceuticals International has completed its acquisition of Medicis Pharmaceutical. 

Isochem has expanded its range of intermediates by acquiring the British fine-chemicals company, Wychem.

French contract manufacturing firm Synerlab has acquired lyophilization specialist company Lyofal.

Amgen has agreed to buy Icelandic-based Decode Genetics for $415 million in an all-cash transaction.

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Pharma Conversation & Community

The management board of the European Medicines Agency (EMA) has endorsed the agency’s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012. 

The EMA’s primary goals for the year are to continue to conduct assessment activities to the highest scientific levels, boosting the efficiency of its activities and to develop initiatives for greater transparency and communication with its stakeholders. In addition, the EMA will focus on the continued implementation of Europe’s pharmacovigilance legislation and the new falsified medicines legislation. Revisions are also planned to veterinary medicines legislation.

Several initiatives are taking place at the EMA to increase support to scientific committees, and to assure the quality and consistency of the agency’s outputs. The EMA will be reviewing and optimising scientific processes, such as coordination among committees and continuing to implement policies for conflicts of interest.

The EMA’s management board has endorsed several activities relating to implementing Europe’s new pharmacovigilance legislation. These activities take into account budget constraints because pharmacovigilance fees to aid in implementation are not expected before 2015. Activities to be implemented in 2013 include collecting key information on medicines, such as: 

guidance preparation for patient reporting

better analysis and understanding of data and information

regulatory action to safeguard public health, including coordination of pharmacovigilance inspections. 

January 2013 will also see the implementation of the falsified medicines legislation. EMA will be working on developing a database that contains certificates of good manufacturing practice and good distribution practice from all member states.

, the EMA explains that it expects approximately 100 applications for human medicines in 2013, including around 54 applications for new medicinal products, 20 new orphan medicines and 2o generic applications (compared with 52, 13 and 39, respectively, in 2012). 

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

EMA Reveals Work Programme for 2013

GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa. 

Initially, the project will focus on Mozambique for a one-year pilot project examining whether mobile technology solutions can help encourage mothers to take up vaccination services, support health workers, and enable better management of vaccine stock. According to a 

, the pilot will seek to boost vaccination in the country by 5–10%.

“Innovative technologies – whether mobile devices, medicines or vaccines – are helping to transform global health. Organizations such as UNICEF and GAVI have played a key role in making vaccines much more accessible in Africa but barriers still exist which stop children from benefiting from basic immunization,” Sir Andrew Witty, CEO of GSK, said in a statement.

Mothers and caregivers will be registered on a database and alerted by SMS about the availability of vaccinations. Appointments can also be scheduled by SMS and notifications will help to ensure that children complete the full schedule of vaccinations. Health workers will be given smartphones with software that allows them to contact mothers, view and record vaccination histories, schedule vaccinations and report on follow-up visits. 

For supply-chain management, healthcare facilities will be prompted to report on vaccine stock levels by SMS.

The project will be supported by the Save the Children organization and the Mozambique Ministry of Health.  Up to 100 clinics will be included and the project will be independently tested to prove its impact, effectiveness and cost benefits.

Witty added, “This new partnership combines GSK’s expertise, knowledge and resources with those of Vodafone with the potential to deliver life-saving vaccines to tens of thousands more children in Mozambique. Our hope is that together we will create a sustainable and scalable model which could ultimately be replicated to help more children live healthy lives across developing countries.”

GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa.

GSK Partners with Vodafone for Vaccinations

Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialize in vaccines and antibodies. 

Vivalis currently specializes in cell-based solutions for the biotechnology and pharmaceutical industry. Intercell is a vaccine company seeking to develop and commercialize immunomodulatory biologicals. Together, the companies are seeking to create a “leading” biotechnology company with greater scale and diversification, and a strengthened financial portfolio, with a combined cash balance of EUR 94 million ($124 million) as of Sept. 30, 2012. 

The combined companies’ portfolio will comprise a range of partnered product candidates, including a pandemic influenza vaccine in Phase III, a 

 vaccine in Phase II–III and a Tuberculosis vaccine in Phase II, as well as several validated and commercialized technology platforms, including the EB66 cell line for human and veterinary product development.

Vivalis is acquiring Intercell for an undisclosed amount. Upon completion of the merger, Intercell shareholders will receive 13 new Vivalis ordinary shares and 13 new preferred shares for every 40 Intercell shares they own. According to a 

, the merger consideration implies a 31.7% premium for Intercell shareholders based on the average share prices in the last three months. 

Following the completion of the merger, which is expected in May 2013, Valneva intends to launch a EUR 40-million ($52 million) rights issue. Shareholders will have the right to subscribe on a 

Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialize in vaccines and antibodies.

Vivalis and Intercell to Create New Biotechnology Company

Once upon a time in the world of healthcare, the only competition for a pharmaceutical company was other pharmaceutical companies.

		Times have changed. Pharma companies are now competing with many nontraditional players in the healthcare arena, including electronic and mobile health firms, retailers, financial services companies and IT firms. Healthcare is no longer about just making a new medicine, but about creating greater value for patients, providers and payers, and encouraging a more active and healthy lifestyle.

		In PharmTech, we often talk about manufacturing innovations, such as new dosage forms or more efficient manufacturing techniques, but today I’m going to look at some of the innovations that have been made in the healthcare industry as a whole.

 explained that microchips are being developed that will enable doctors to tell whether patients are taking their prescribed medicines. Nonadherence is a serious issue because it increases healthcare costs, increases patient deaths and belittles pharma manufacturers and scientists who have spent years developing a new drug or treatment.

		Earlier this year, biomedical company Proteus Biomedical partnered with Lloyds Pharmacy to launch edible microchips. Data from the chips could be sent to phones (such as those belonging to doctors or a patient’s relatives) using Bluetooth technology.

		Other companies are also pursuing similar technologies. PricewaterhouseCoopers further added that other implants in the pipeline include devices capable of injecting drugs at prespecified times.

		A 2012 study has shown that 75% of the world’s population have access to a mobile phone, which means there is an enormous market for remote diagnostic tools and healthcare related apps. Indeed, many pharmaceutical companies (and other nontraditional companies) have launched apps designed to aid disease management or to enable remote monitoring.

		According to PricewaterhouseCoopers, the app store Heppatique has launched a pilot programme that enables doctors to prescribe certain apps as part of a healthcare package.

		Interestingly, mobile phones are also being used by pharmaceutical manufacturers, for example, to easily access protocols or guidelines, or to remotely monitor certain systems and equipment.

		I was an eighties child when video games were about plumbers jumping on turtles and blue hedgehogs running as fast as recklessly possible. Now, video games are being developed to encourage people to live more healthy lives, such as games that involve physical exercise. These games don’t just target patients, but everyone, and are blurring the boundary between healthcare and entertainment, as titles about keeping fit and exercise continue to emerge and top the gaming charts. Nintendo’s popular exercise game Wii Fit has even been incorporated into hospital physiotherapy programmes.

		Video games are also being used in other ways. According to PricewaterhouseCoopers, HopeLab, a nonprofit organisation that aims to use technology to improve the health of children, has launched a video game designed to foster a positive attitude in young cancer patients. In the game, Re-Mission, players pilot a nanobot that travels through the body, destroying cancer cells, fighting infection and managing side effects from cancer treatments. HopeLab is also working on a new project targeting obesity. The project involves rewarding children for physical activity.

		Pharmaceutical companies are also acknowledging the power and influence of video games. In 2010, Bayer unveiled a blood glucose meter in the US that connected to Nintendo DS and DS Lite consoles. Players receive points for testing blood sugar levels and meeting blood-glucose targets, which can then be used to unlock different levels in video games online.

		New medicines are always going to be in demand, but while pharma companies are focusing efforts on drugs to treat lifestyle diseases, such as diabetes, obesity and high-blood pressure, and with drug development taking around 10 years, could companies find themselves outdone by other competitors seeking to make consumers healthy enough to avoid medication?

Microchips and Video Games: Innovations in Healthcare

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace. The court has upheld the decision and the fine of EUR 52.50 million ($68.7 million-EUR 40.25 million and EUR 12.25 million for AstraZeneca plc (UK) and AstraZeneca AB (Sweden), respectively).

AstraZeneca companies AstraZeneca plc and AstraZeneca AB were 

 to have committed two abuses of a dominant position.

AstraZeneca made “deliberately misleading representations” to the patent offices of certain member states, with the intention of obtaining or maintaining additional, unwarranted patent protection for the ulcer medicine, Losec.

AstraZeneca submitted requests for deregistration of the marketing authorizations for Losec capsules in Sweden, Denmark and Norway to delay or hinder the marketing of generic ulcer medicines and to prevent parallel imports of Losec. 

The fine originally imposed in 2005 by the European Commission amounted to EUR 60 million ($78.5 million). However, during an appeal in 2010, the fine was lowered by the General Court. Although the EC had proven that the deregistration in Denmark, Sweden, and Norway was made to hinder generic competition and to prevent parallel imports in Sweden, it had not proven the latter effect in Denmark and Sweden. 

AstraZeneca later lodged an appeal before the Court of Justice to have the judgement of the General Court set aside. 

“...in the absence of mitigating circumstances or special circumstances, the abuses must be characterized as serious infringements, and consequently the amount of the fine cannot be reduced,” explained the Court of Justice of the European Union in a 

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.