An recent article on Pharmaceutical Business Review states that MedImmune, the global biologics unit of AstraZeneca, has submitted a Marketing Authorisation Application (MAA) for its nasal spray live-attenuated seasonal influenza vaccine (LAIV) with the European Medicines Agency (EMEA). The vaccine is already marketed in the US under the brand name FluMist. The proposed indication in the MAA is for prevention of seasonal influenza and is based on data from 73 global clinical and US post-marketing studies of more than 141,000 subjects ranging in age from seven weeks to 97 years and conducted in 38 countries. However, MedImmune has not communicated the age range it is seeking approval for with the EMEA.
LAIV is a trivalent seasonal influenza vaccine which was first approved in the US in 2003 for use in individuals aged five to 49 years of age. In September 2007, the age range of the vaccine was extended by the FDA for use in children aged two to five years. However, this still only represents a small proportion of the key target population for seasonal influenza vaccination. The lack of approval in the elderly, the target group showing the highest seasonal flu vaccine coverage rates, has restricted the overall commercial potential of the vaccine, which only achieved sales of $53m in 2007.
The seasonal influenza vaccine market is a highly competitive field which is becoming increasingly commoditized as a result of the increasing number of available vaccines. Due to its intranasal mode of administration and very good efficacy in this age group, FluMist’s largest opportunity lies in the infant segment. However, it is questionable whether the cost-conscious European payers will opt to introduce FluMist readily following its European approval, if AstraZeneca decides to pursue a similar strategy as in the US, where the vaccine is marketed at a premium price compared to conventional seasonal influenza drugs.
In addition, seasonal flu vaccination in most European countries is currently largely restricted to the elderly population and does not cover the age group of two to 49 year olds, for which LAIV is approved in the US. Unless LAIV is approved for a wider age group than in the US, Datamonitor expects the overall commercial opportunity for the product in Europe to be limited.
Pharmaceutical Process Equipment
Monday, 18 May 2009
NEW - PROCESS MACHINE RENTAL
Do you need process equipment, but your budget doesn’t allow for it? Perhaps Hanningfield Process Systems can help.
Many businesses today find that renting equipment and machinery is often more affordable than purchasing, especially if they are not in need of the equipment for long periods of time. There are occasions in which a company may only need the equipment for a short time, such as to fulfill an urgent order or as temporary back-up for an existing system. If either is the case, there is no need to buy, especially when the cost of renting may never reach the cost of buying.
It also means that you can free up working capital for use in other areas of your business and you don’t need to take out large loans to pay for it.
We offer a comprehensive range of process equipment for rental which will perform at optimum efficiency and provide valuable benefits;
Uni-Mill, Cone Mill with a range of screens for milling a wide variety of products
Uni-Vac, Vacuum Transfer System which is a safe, practical and dust free method of conveying powder, granules and flakes without waste.
Uni-Dust, Product Recovery Cyclone, which offers the ultimate solution to the containment of waste powders from many powder filling processes.
Sure-Press, Single Punch Tablet Press for small scale tablet production.
Since 1987 Hanningfield Process Systems has built a high level of customer trust and satisfaction through the quality of our equipment, reliability, premium service, and unparalleled value.
So the next time you need process equipment, but are unsure about committing to buying, please contact us and we will be pleased to discuss the options available.
Many businesses today find that renting equipment and machinery is often more affordable than purchasing, especially if they are not in need of the equipment for long periods of time. There are occasions in which a company may only need the equipment for a short time, such as to fulfill an urgent order or as temporary back-up for an existing system. If either is the case, there is no need to buy, especially when the cost of renting may never reach the cost of buying.
It also means that you can free up working capital for use in other areas of your business and you don’t need to take out large loans to pay for it.
We offer a comprehensive range of process equipment for rental which will perform at optimum efficiency and provide valuable benefits;
Uni-Mill, Cone Mill with a range of screens for milling a wide variety of products
Uni-Vac, Vacuum Transfer System which is a safe, practical and dust free method of conveying powder, granules and flakes without waste.
Uni-Dust, Product Recovery Cyclone, which offers the ultimate solution to the containment of waste powders from many powder filling processes.
Sure-Press, Single Punch Tablet Press for small scale tablet production.
Since 1987 Hanningfield Process Systems has built a high level of customer trust and satisfaction through the quality of our equipment, reliability, premium service, and unparalleled value.
So the next time you need process equipment, but are unsure about committing to buying, please contact us and we will be pleased to discuss the options available.
Tuesday, 12 May 2009
Drug-Makers Leaking Pharmaceuticals Into Water Supply
Government scientists say that they have detected significantly elevated levels of pharmaceutical residues in the water downstream from treatment facilities in charge of disposing waste from drug manufacturers.
Preliminary results from two important federal studies compared the wastewater flowing from sewage plants that handle waste from drug companies and compared them with others that do not. The studies examined only a handful of the 1,886 U.S. drug manufacturing plants recorded by the 2006 Census report.
redorbit
Preliminary results from two important federal studies compared the wastewater flowing from sewage plants that handle waste from drug companies and compared them with others that do not. The studies examined only a handful of the 1,886 U.S. drug manufacturing plants recorded by the 2006 Census report.
redorbit
Swine Flu
This week, pharmaceutical industry regulators and manufacturers moved quickly to address public health concerns regarding the outbreak and spread of the H1N1 virus infection (swine flu). The following is an overview of key developments.
RxResponse, a network partnership established by the Pharmaceutical Research and Manufacturers of America (PhRMA) and serves as a single-point of contact for the pharmaceutical supply system, declared it was on “Alert Status.”
The announcement means that partnership members are closely monitoring developing information regarding influenza cases in the United States and will collaborate with other health agencies to ensure an efficient supply chain. “Americans need to know that the medicines they rely on will be available even in an emergency. RxResponse provided federal and state crisis managers with the critical information they need about the pharmaceutical supply chain to help communities affected by an emergency return to normal as quickly as possible,” said Billy Tauzin, president and CEO of PhRMA in a prepared statement.
http://pharmtech.findpharma.com
RxResponse, a network partnership established by the Pharmaceutical Research and Manufacturers of America (PhRMA) and serves as a single-point of contact for the pharmaceutical supply system, declared it was on “Alert Status.”
The announcement means that partnership members are closely monitoring developing information regarding influenza cases in the United States and will collaborate with other health agencies to ensure an efficient supply chain. “Americans need to know that the medicines they rely on will be available even in an emergency. RxResponse provided federal and state crisis managers with the critical information they need about the pharmaceutical supply chain to help communities affected by an emergency return to normal as quickly as possible,” said Billy Tauzin, president and CEO of PhRMA in a prepared statement.
http://pharmtech.findpharma.com
Ghana needs more pharmaceutical products
Dr Daniel Ganu, a Lecturer at Valley View University has stressed the need to increase allocation of pharmaceutical products and equipments in Northern Ghana.
He therefore, appealed to management of Partnership for Quality Medical Equipment Donations (PQMD) an international charity organisation responsible for donating medical equipments worldwide to embark on a programme to increase allocation of pharmaceuticals and medical equipments to the area.
Dr Ganu made the call in an interview with Ghana News Agency at VVU campus at Oyibi in the Greater Accra Region. He said a research sponsored by management of PQMD revealed that most donations of pharmaceutical products and medical equipments were done in the southern part of the country making provision of efficient and effective health care delivery in northern Ghana difficult.
Dr Ganu noted that about 20 per cent of medical equipment donated to health institutions broke down after few months for lack of repairs and stressed the need for efforts to remedy the situation.
http://www.citifmonline.com/2009/05/09/northern-ghana-needs-more-pharmaceutical-products-lecturer/
He therefore, appealed to management of Partnership for Quality Medical Equipment Donations (PQMD) an international charity organisation responsible for donating medical equipments worldwide to embark on a programme to increase allocation of pharmaceuticals and medical equipments to the area.
Dr Ganu made the call in an interview with Ghana News Agency at VVU campus at Oyibi in the Greater Accra Region. He said a research sponsored by management of PQMD revealed that most donations of pharmaceutical products and medical equipments were done in the southern part of the country making provision of efficient and effective health care delivery in northern Ghana difficult.
Dr Ganu noted that about 20 per cent of medical equipment donated to health institutions broke down after few months for lack of repairs and stressed the need for efforts to remedy the situation.
http://www.citifmonline.com/2009/05/09/northern-ghana-needs-more-pharmaceutical-products-lecturer/
Friday, 1 May 2009
When more than a pinch of salt is needed….
When the highly successful Maldon Crystal Salt Company in Essex needed to fulfil an order from a Norwegian snack food company, they approached Hanningfield Process Systems Ltd.
The dilemma Maldon faced for its famous soft white flaky crystals was they were too large to apply to the crisps. Maldon needed to find a way of milling the flakes down so that they would stick to the crisps. Two flavours were to be created using Maldon sea salt on these luxury hand cooked gourmet crisps.
The Maldon Crystal Salt Company produces one of our greatest table salts. Maldon sea salt is pure and unique. It has been hand harvested from the River Blackwater in Essex for over 150 years and still uses the traditional methods handed down through generations. World renowned for its quality, texture and delicate flavour, Maldon sea salt is a sought after essential ingredient for the health conscious and gourmet alike. Exported to over 40 countries and championed by top chefs around the world, Maldon sea salt is prevalent in renowned restaurants and homes alike by discerning connoisseurs who appreciate the finest ingredients for their food.
After some trials at Hanningfield’s factory in Rochford, the Uni-Mill proved to be the successful solution in order to process the quantity Maldon needed. Colin Ellis, Managing Director of Hanningfield Process Systems said, “We were delighted to be able to respond to Maldons request immediately and organized a ‘next-day’ trial. We used a variety of screen sizes in the Uni-Mill, until one produced the correct size of salt–flake for the hand-cooked crisps and were very confident that the Uni-Mill could easily handle the quantities required.”
To date the crisps have been launched nationwide in the Norwegian supermarkets and are proving to be a great success!
Steve Osborne, Managing Director of the Maldon Crystal Salt Company said “There is no way we would have ever met the salt volumes our customer required without the Uni-Mill. Thanks to Colin and his team at Hanningfield for their quick response in helping us to get this project off the ground.”
The Maldon Crystal Salt Company.
w www.maldonsalt.co.uk
t 01621 853 315
e info@maldonsalt.co.uk
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