Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

China and India will become the world leaders in innovation during the next decade, according to an 

The survey comprised 6000 respondents across six countries (China, India, Japan, Sweden, the UK and the US), with the overall consensus being that China will be the most innovative by 2020, followed by India. The two current leaders in innovation, the US and Japan, will be relegated to third and fourth respectively by 2020. 

 According to AstraZeneca, there is a strong sense of optimism amongst respondents in the developing nations of China and India about the ability of their nations to prosper through innovation. “People in both India and China strongly believe that their country will be the most innovative in 2020. This is most striking in India, where respondents have shown a remarkable self-confidence for their innovative climate, both now and in the future,” said the survey. In India, 16% of respondents already believe that their country is the most innovative in the world and 56% believe this will be the case by 2020.

This optimism is a stark contrast to the views of respondents in developed western economies; in the UK for example, two-thirds of respondents believe that the country is not as innovative as it used to be, and only 5% believe that the UK will be the most innovative country by 2020. Respondents in Japan and the US also believe that their country is not as innovative as it once was.

Respondents were also asked about the importance of specific innovations over the past century. In general, respondents rated the internet, computers and electricity as the most important innovations, but people in Sweden, the UK and the US also placed equal importance on innovation in vaccines and antibiotics. 

According to David Brennan, Chief Executive of AstraZeneca, the survey offers a “fascinating perspective into what innovation means to people from different parts of the world”. He also added: “I am convinced that it’s combining the best skills and talents from around the world that drives the greatest innovations – I see much stronger results coming from those countries and organizations that make strong connections across boundaries, and share the best ideas, breaking new ground along the way.”

Articles

China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.

China and India to be world leaders of innovation

 its application to the European Medicines Agency (EMA) for a centralized marketing authorization for its pandemic influenza vaccine Emerflu. 

The vaccine was intended to be used to help prevent influenza during an officially declared pandemic. A core pandemic dossier was submitted in the context of preventing influenza in an officially declared pandemic, according to the mock-up vaccine procedure. According to the EMA, Sanofi Pasteur withdrew the application because the EMA’s Committee for Medicinal Products for Human Use (CHMP) said that the data did not allow the committee to conclude a positive benefit/risk balance. 

The application for marketing authorization was submitted in April 2007. However, the CHMP issued a negative opinion for the drug in March 2009 because of concerns about the vaccine’s ability to trigger the production of enough antibodies against the flu virus. 

“According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable,” stated a 

 from the EMA concerning Emerflu. “Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.”

Similar results were also seen in people who received the drug containing a different strain of flu virus and there were also contradictory results in the studies looking at the effects of a third dose, raising concerns about the vaccine’s low immunogenicity, regardless of the strain of virus included. 

More information about the withdrawal, including the withdrawal letter from the company, will be published on the EMA website after the next CHMP meeting on 13–16 December 2010. 

Sanofi Pasteur has formally withdrawn its application to the European Medicines Agency (EMA) for a centralized marketing authorization for its pandemic influenza vaccine Emerflu.

Sanofi withdraws Emerflu application

 its application to the European Medicines Agency (EMA) for a centralized marketing authorization for its pandemic influenza vaccine Emerflu. The vaccine was intended to  help prevent influenza during an officially declared pandemic. A core pandemic dossier was submitted in the context of preventing influenza in an officially declared pandemic, according to the mock-up vaccine procedure.  Sanofi Pasteur withdrew the application because the EMA’s Committee for Medicinal Products for Human Use (CHMP) said that the data did not allow the committee to conclude a positive benefit–risk balance, according to the EMA. 

Sanofi submitted the application for marketing authorization  in April 2007. However, the CHMP issued a negative opinion for the drug in March 2009 because of concerns about the vaccine’s ability to trigger the production of enough antibodies against the flu virus. 

 concerning Emerflu. “Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.”

Similar results were also seen in people who received the drug containing a different strain of flu virus, and studies looking at the effects of a third dose produced contradictory results, thus raising concerns about the vaccine’s low immunogenicity, regardless of the strain of virus included.

More information about the withdrawal, including the withdrawal letter from the company, will be published on the EMA website after the next CHMP meeting on  December 13–16, 2010. 

Sanofi Withdraws Emerflu Application

 released by AstraZeneca (London). The survey results comprised 6000 respondents from six countries (i.e., China, India, Japan, Sweden, the United Kingdom, and the United States), and the overall consensus was that China will be the most innovative country by 2020, followed by India. Survey respondents said that the two current leaders in innovation, the US and Japan, will be relegated to third place and fourth place, respectively, by 2020. 

According to AstraZeneca, respondents in the developing nations of China and India have a strong sense of optimism about the ability of their nations to prosper through innovation. “People in both India and China strongly believe that their country will be the most innovative in 2020. This is most striking in India, where respondents have shown a remarkable self confidence for their innovative climate, both now and in the future,” said the survey. In India, 16% of respondents already believe that their country is the most innovative in the world, and 56% believe that this will be the case by 2020.

This optimism is a stark contrast to the views of respondents in developed Western economies; in the UK, for example, two-thirds of respondents believe that the country is not as innovative as it used to be, and only 5% believe that the UK will be the most innovative country by 2020. Respondents in Japan and the US also believe that their country is not as innovative as it once was.

Respondents  also were asked about the importance of specific innovations over the past century. In general, respondents rated the Internet, computers, and electricity as the most important innovations, but people in Sweden, the UK, and the US also placed equal importance on innovation in vaccines and antibiotics. 

According to David Brennan, chief executive officer of AstraZeneca, the survey offers a “fascinating perspective into what innovation means to people from different parts of the world.” He  added, “I am convinced that it’s combining the best skills and talents from around the world that drives the greatest innovations—I see much stronger results coming from those countries and organizations that make strong connections across boundaries, and share the best ideas, breaking new ground along the way.”

China and India to Be World Leaders of Innovation

Roche has announced implementation plans for its Operational Excellence Program, announced in September, which include eliminating 4800 positions worldwide over the next 2 years — 6% of its current workforce. The largest reductions are planned in the company’s Pharmaceuticals Division, particularly in sales and marketing, as well as manufacturing, according to a 

In addition to the planned reductions, the company also anticipates transfers of about 800 jobs internally and approximately 700 positions to be outsourced to third parties. Overall, the combination of reductions and transfers will affect 6300 positions overall. More than half of the total positions affected (3550) will be in the US.  

Worldwide, Roche says it plans to reduce its sales and marketing workforce by 2650 positions. The main reasons for the cuts are the setbacks in its diabetes medicine taspoglutide, with the drug showing 

 in Phase III studies, and structural adjustments in its primary care sales organizations.

On the manufacturing side, some technical operations activities will be reorganized in California (USA), Mannhein (Germany) and various other sites, resulting in 750 job losses. Additionally, the company is planning to seek buyers for certain US sites, affecting a further 600 positions.

The company also expects to discontinue or transfer certain product development activities, mostly in the US, to improve overall activity. Certain activities in research and early development will also be discontinued, including RNA interference research in Kulmbach (Germany), and in New Jersey and Wisconsin in the US. Plans also include reorganising some internal functions to free up resources for upcoming Phase II studies of new molecular entities.  

According to Roche, the actions enable sustained investment in research and product development, and will result in annual cost savings of 2.4 billion Swiss francs (approximately $2.4 billion) from 2012 onwards. 

Roche has announced implementation plans for its Operational Excellence Program, announced in September, which include eliminating 4800 positions worldwide over the next 2 years &#151; 6% of its current workforce.

Roche To Cut 6% Of Workforce

Following new clinical data and a request from the FDA, Xanodyne Pharmaceuticals has agreed to withdraw its prescription pain products Darvon and Darvocet (propoxyphene) from the US market. The FDA has also requested generic manufacturers of propoxyphene-containing medicines to voluntarily withdraw their products too. 

The actions were taken because of the release of clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As such, the FDA concluded that the benefits of the medication do not outweigh the risks and has advised healthcare professionals to stop prescribing it. 

The FDA had previously examined the efficacy and safety of the medication in January 2009 where an advisory committee voted 14 to 12 against the continued marketing of propoxyphene-containing products. However, the committee also believed that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits. In July 2009, the FDA decided to permit continued marketing, but required a new boxed warning to be added to the drug. Additionally, the FDA requested Xanodyne to conduct a new safety study. 

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology at the FDA’s CDER, said in a 

. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

In the EU, a phased withdrawal of propoxyphene is already underway. The European Medicines Agency (EMA) recommended in June 2009 that marketing authorizations for the medication be withdrawn across the EU. 

Following new clinical data and a request from the FDA, Xanodyne Pharmaceuticals has agreed to withdraw its prescription pain products Darvon and Darvocet (propoxyphene) from the US market.