GSK & 3 leading institutions form EU consortium

A new European consortium has been formed including GSK and three leading research institutions, University of Oxford, Centre Hospitalier Universitaire Vaudois in Lausanne and the Bernhard-Nocht Institute, to help further advance development of a candidate vaccine against Ebola, which is being co-developed by GSK and the US National Institutes of Health (NIH).

The consortium is backed by funding of €15.1 million from the European Commission Directorate General for Research and Innovation as part of its dedicated Horizon 2020 programme supporting research into treatments and vaccines for Ebola. The consortium also expects to receive an additional €1.4 million from the Swiss government.

The funding is already helping to implement an ongoing trial of an Ebola candidate vaccine being carried out in 120 healthy adult volunteers in Lausanne, Switzerland. If the safety and immunogenicity data from this and other ongoing phase 1 trials are encouraging, the EC funding will enable the consortium to begin larger phase 2 trials in Africa, which could start as early as January 2015.

Cerus' Intercept Blood System for plasma receives US FDA approval

The US Food and Drug Administration (FDA) has approved Cerus Corporation's Intercept Blood System for plasma. The Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.

The Intercept Blood System inactivates a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.

While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in plasma components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.

"We believe this approval to be a pivotal step toward giving US blood centres a proactive approach for protecting the plasma supply," said William ‘Obi' Greenman, Cerus’ president and chief executive officer. "Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the US approval for Intercept plasma, and our continued work with FDA on reaching an approval decision for the Intercept Blood System for platelets."

PYRIDINES

PYRIDINES

1. 2-AMINO-5-BROMO PYRIDINE [CASNO: 1072-97-5]
2. 2-AMINO-3, 5-DIBROMO PYRIDINE [CASNO: 35486-42-1]
3. 2-AMINO-5-NITRO PYRIDINE [CASNO: 3073-77-6]
4. 2-HYDROXY-5-NITRO PYRIDINE [CASNO: 5418-51-9]
5. 4-NITRO-2-PICOLINE N-OXIDE [CASNO: 5470-66-6]
6. 4-CYANO-2-PICOLINE
7. 3-CYANO-2-CHLORO-4-PICOLINE
8. 4-NITRO-3-PICOLINE
9. 2-BROMO PYRIDINE [CASNO: 109-04-6]
10. 2-HYDROXY-5-AMINO PYRIDINE [
11. 3-NITRO-4-PICOLINE
12. 4-BROMO-2-PICOLINE [CASNO: 22282-99-1]
13. 2-HYDROXY PYRIDINE [CASNO: 142-08-5]
14. 2-METHOXY PYRIDINE [CASNO: 1628-89-3]
15. 3-AMINO PYRIDINE [CASNO: 462-08-8]
16. 4-AMINO PYRIDINE CASNO: 504-24-5]
17. 3-CYANO PYRIDINE [CASNO: 100-54-9]
18. 4-CYANO PYRIDINE [CASNO: 100-48-1]
19. 2-HYDROXY-3, 5-DIBROMO PYRIDINE [CASNO: 13472-81-6]
20. 5-AMINO-3-PICOLINE
21. 2-CHLORO-5-NITRO PYRIDINE [CASNO: 4548-45-2]
22. 2, 5-DI BROMO PYRIDINE [CASNO: 624-28-2]
23. 2-CHLORO-3-NITRO-4-PICOLINE
24. 2, 6-DICLORO-3-NITRO PYRIDINE [CASNO: 16013-85-7]
25. 2-AMINO-6-METHOXY-3-NITRO PYRIDINE [CASNO: 
26. 2-CHLORO-6-METHOXY-3-NITRO PYRIDINE [CASNO: 38533-61-8]
27. 2-CHLORO-6-AMINO PYRIDINE 
28. 2-BROMO-6-CYANO PYRIDINE
29. 6-CYANO-2-PICOLINE
30. 2.AMINO-5-BORMO-3-NITRO PYRIDINE [CASNO: 6945-68-2]
31. 2, 3-DI AMINO PYRIDINE [CASNO: 452-58-4]
32. 3-NITRO-2-PICOLINE
33. 2-METHOXY-5-AMINOPYRIDINE [CASNO: 6628-77-9]
34. 3-BROMO PYRIDINE [CASNO: 626-55-1]
35. 3-HYDROXY PYRIDINE [CASNO: 109-00-2]
36. 2-PICOLINE N-OXIDE [CASNO: 931-19-1]
37. 4-PICOLINE N-OXIDE [CASNO: 1003-67-4]
38. 3-PICOLINE N-OXIDE [CASNO: 1003-73-2]
39. 4-NITRO PYRIDINE N-OXIDE [CASNO: 1124-33-0]
40. PYRIDINE N-OXIDE [CASNO: 694-59-7]

Merck Millipore hosts seminar on regulations and quality control

To apprise Indian pharmaceutical industry about the latest trends and developments concerning regulations in the pharmaceutical industry worldwide, Merck Millipore, the life science division of Merck, organised the third edition of ‘EMPROVE Seminar Series’ in Hyderabad. The theme of the seminar was ‘Risk Mitigation’, which addresses the current challenges faced by the industry.

Attended by over 200 invitees, topics in the seminar ranged from quality by design, Risk-based CMC development solutions presented by Ranjit Barshikar and FDA Inspectional Observations and Warning Letter Citations relating to quality control and assurance by Dr Hemant Mondkar.

The seminar was inaugurated by Tapan Ray, Former President- OPPI. In his inaugural address, he emphasised that it was high time for the industry to “walk the talk” in ethics, values and compliance. Merck Millipore’s panel of speakers addressed various facets of the current issues concerning regulations and shared their expertise with the audience.

This initiative, a service to the industry started by Merck Millipore in 2012, has drawn an ever increasing number of participants, because of its relevance and insights offered by the experts. The idea is to provide a platform for all its stakeholders to enhance their knowledge and keep abreast of latest trends and evolving regulatory agency compliance demands.

Vetter opens new representative office in Singapore

Vetter,  a premier contract development and manufacturing organization (CDMO), opens a new representative office in Singapore. The announcement was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

The new office will allow Vetter to take better advantage of the rapidly growing Asian healthcare market by increasing the presence of the company in this market. It will be staffed by Chervee Ho, Director Key Account Management Asia Pacific. Prior, the company’s Asian customers were handled by the German-based departments of key account management, project management and customer service. Ho will be responsible for supporting the German departments to better serve the existing customer base due to geographic and time proximity as well as the development of new markets.

DENGUE & EBOLA

Dengue fever and Ebola virus disease are two major epidemics that are  threatening millions of people in the world today with no effective remedies available to treat the patients. Dengue fever, the fastest growing tropical illness, currently affects at least 100 million people, according to the World Health Organization, although many doctors believe that because the disease is often misdiagnosed, the actual number of people affected could be three times more than what is estimated. Though most people survive the excruciatingly painful disease, more than 20,000 people do die from the disease every year with children the most affected. Dengue virus can cause flu-like symptoms, as well as bleeding gums, vomiting and severe abdominal pain.

The disease is transmitted by the bite of an Aedes mosquito infected with a dengue virus. The mosquito becomes infected when it bites a person with dengue virus in their blood. It can’t be spread directly from one person to another person. The Ebola virus disease, started in Guinea,  has since spread to Liberia and Sierra Leone in West Africa.

The ongoing epidemic is the most widespread in history and has caused significant mortality, with a reported fatality rate of 71%.  As of November 2014, the WHO and the governments of the affected countries have reported a total of 14,098 suspected cases and 5,489 deaths, though the WHO believes that this substantially understates the magnitude of the outbreak with true figures numbering three times as many cases as have been reported. The assistant director-general of the WHO warned in mid-October that there could be as many as 10,000 new EVD cases per week by December 2014. Almost all of the cases have occurred in the three initial countries.

Atmel introduces high-precision digital temperature sensors

Atmel Corporation, a global leader in microcontroller (MCU) and touch technology solutions, has launched the industry's first family of high-precision digital temperature sensors with the widest Vcc range from 1.7V to 5.5V. The new family delivers higher temperature accuracy and faster I2C bus communication speeds, and are available with integrated nonvolatile registers and serial EEPROM memory making them ideal for consumer, industrial, computer, and medical applications.

With the widest Vcc range in the industry, the new temperature sensor family allows customers to purchase one device to cover all their Vcc requirements in a variety of applications. Currently, digital temperature sensors on the market are available with a very limited Vcc range requiring customers to purchase multiple temperature sensors in their overall bill of materials (BOM) and utilizing multiple devices to cover the different voltage ranges across various applications. Atmel's new family of digital temperature sensors allows customers to select just one device to cover all Vcc requirements in various applications, reducing their overall BOM. The new family also delivers a higher accuracy rate at +/-0.5°C accuracy (typical) across the 0°C to +85°C temperature range across the entire wide voltage range (1.7V to 5.5V). The low voltage operation of the devices also reduce the overall power consumption in applications such as portable handheld consumer devices, enabling longer battery life.