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FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Azteca Linda Corp. Expands Recall of Queso Fresco Because of Possible Health Risk
Contact:
Azteca Linda Corp.
(718) 418-7459
FOR IMMEDIATE RELEASE – September 1, 2010 – Azteca Linda Corp. of Brooklyn, NY, is expanding the 8/24/10 recall of QUESO FRESCO (FRESH WHITE CHEESE (exp. SEP 11 2010)to include expiration date SEP 12 2010. In addition, the firm is recalling Queso El Azteca brand REQUESON (RICOTTA CHEESE) with expiration date SEP 19 2010 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
QUESO FRESCO (FRESH WHITE CHEESE) with expiration date SEP 12 2010 was sold to retail stores in the New York City area. QUESO REQUESON (RICOTTA CHEESE) with expiration date SEP 19 2010 was sold to retail stores in the New York City area and to Providence, Rhode Island.
QUESO FRESCO (FRESH WHITE CHEESE) is packaged in a hard plastic (clam shell) container labeled with the brand name Queso El Azteca, NET WT. 14 OZ. (396g), UPC 0 23986 92692 8, and expiration dateSEP 12 2010. REQUESON (RICOTTA CHEESE) is packaged in a hard plastic (clam shell) container labeled with the brand name Queso El Azteca, NET WT. 14 OZ. (396g), no UPC coding, and with expiration dateSEP 19 2010.
No illnesses have been reported to date.
The recall was the result of sampling by the Rhode Island Department of Health which revealed the presence of Listeria monocytogenesin QUESO FRESCO (FRESH WHITE CHEESE) with expiration date SEP 12 2010, and REQUESON (RICOTTA CHEESE) with expiration date SEP 19 2010. The company has temporarily stopped production.
Consumers who have purchased the above listed expiration dates of QUESO FRESCO (FRESH WHITE CHEESE) and/or REQUESON (RICOTTA CHEESE) are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Azteca Linda Corp. at 718-418-7459, Monday – Friday, 9 am – 4 pm EDT.
FOR IMMEDIATE RELEASE
Wednesday, September 1, 2010
Contact: HHS Press Office
(202) 690-6343
BARDA funds development of new way to treat illness from acute radiation
Treatment could be used for other blood disorders and complications of cancer
The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) today awarded a $153 million contract to Cellerant Therapeutics, Inc. of San Carlos, Calif., to continue developing a new way to treat an illness caused by exposure to high levels of ionizing radiation which can damage the body’s cells – the type of radiation that would come from a nuclear blast.
Under the contract, the company will continue development of a medication called CLT-008 that uses a special kind of cells called myeloid progenitor cells. The medicine potentially could be used to treat the illness known as neutropenia, an abnormally low number of white blood cells. In addition, the treatment potentially could be used for other blood disorders and complications of cancer in which blood cells and platelets need to be replenished.
The body has progenitor cells that can grow into any kind of blood cell the body needs. CLT-008 is being developed to support and add to the patient’s own progenitor cells.
The contract to Cellerant is for approximately $63.2 million in the first two years. The contract can be extended annually for up to three years for an additional $89.9 million.
Today’s contract is a follow on from a previous contract between BARDA and Cellerant which supported advanced research and development of this cell-based treatment. Under the new contract, the company will conduct additional studies and validate their manufacturing process in order to apply for U.S. Food and Drug Administration licensure of this method of treating neutropenia.
The contract uses the federal government’s new approach to producing medical countermeasures – the medications, vaccines, medical equipment and supplies needed for a health emergency. On Aug. 19, HHS Secretary Kathleen Sebelius released a review of the federal government’s system to produce medical countermeasures, along with recommendations for a better approach. The recommendations included developing drugs that can be used for bioterrorism as well as common illnesses.
To learn more about BARDA and medical countermeasures, including The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs, visit www.phe.gov.
NEW YORK (Reuters Health) – “Some thirty years after authorities doled out the last dose of smallpox vaccine, the world faces another multiplying menace: monkeypox.
A new study suggests that the monkeypox virus, which the smallpox vaccine also grants immunity against, is now at least 20 times as common as it was shortly after victory over smallpox had been declared.
“The eradication of smallpox was one of the greatest achievements known to man,” lead researcher Anne Rimoin of the University of California, Los Angeles School of Public Health told Reuters Health. “But a consequence of ceasing smallpox vaccinations is that now the world’s population is vulnerable to other (related viruses) such as monkeypox.”……..”
Atlantic Tropical Storm FIONA Advisory Number 11 Thu, 02 Sep 2010 03:36:27 -0500
000
WTNT33 KNHC 020836
TCPAT3
BULLETIN
TROPICAL STORM FIONA ADVISORY NUMBER 11
NWS TPC/NATIONAL HURRICANE CENTER MIAMI FL AL082010
500 AM AST THU SEP 02 2010
…FIONA MOVING NORTHWESTWARD…TROPICAL STORM WATCH ISSUED
FOR BERMUDA…
SUMMARY OF 500 AM AST…0900 UTC…INFORMATION
———————————————-
LOCATION…22.6N 65.4W
ABOUT 295 MI…475 KM N OF SAN JUAN PUERTO RICO
ABOUT 670 MI…1080 KM S OF BERMUDA
MAXIMUM SUSTAINED WINDS…50 MPH…85 KM/HR
PRESENT MOVEMENT…NW OR 320 DEGREES AT 17 MPH…28 KM/HR
MINIMUM CENTRAL PRESSURE…1000 MB…29.53 INCHES
WATCHES AND WARNINGS
——————–
CHANGES WITH THIS ADVISORY…
THE BERMUDA WEATHER SERVICE HAS ISSUED A TROPICAL STORM WATCH
FOR BERMUDA.
SUMMARY OF WATCHES AND WARNINGS IN EFFECT…
A TROPICAL STORM WATCH IS IN EFFECT FOR…
* BERMUDA.
A TROPICAL STORM WATCH MEANS THAT TROPICAL STORM CONDITIONS ARE
POSSIBLE ON BERMUDA…GENERALLY WITHIN 48 HOURS.
FOR STORM INFORMATION SPECIFIC TO YOUR AREA IN THE UNITED
STATES…INCLUDING POSSIBLE INLAND WATCHES AND WARNINGS…PLEASE
MONITOR PRODUCTS ISSUED BY YOUR LOCAL NATIONAL WEATHER SERVICE
FORECAST OFFICE. FOR STORM INFORMATION SPECIFIC TO YOUR AREA OUTSIDE
THE UNITED STATES…PLEASE MONITOR PRODUCTS ISSUED BY YOUR NATIONAL
METEOROLOGICAL SERVICE.
DISCUSSION AND 48-HOUR OUTLOOK
——————————
AT 500 AM AST…0900 UTC…THE CENTER OF TROPICAL STORM FIONA WAS
LOCATED NEAR LATITUDE 22.6 NORTH…LONGITUDE 65.4 WEST. FIONA IS
MOVING TOWARD THE NORTHWEST NEAR 17 MPH…28 KM/HR. THIS GENERAL
MOTION WITH A DECREASE IN FORWARD SPEED IS EXPECTED TODAY…
FOLLOWED BY A TURN TOWARD THE NORTH LATER TONIGHT…AND A TURN
TOWARD THE NORTHEAST ON FRIDAY. ON THE FORECAST TRACK…FIONA IS
EXPECTED PASS NEAR BERMUDA SATURDAY MORNING.
MAXIMUM SUSTAINED WINDS ARE NEAR 50 MPH…85 KM/HR…WITH HIGHER
GUSTS. LITTLE CHANGE IN STRENGTH IS FORECAST DURING THE NEXT 48
HOURS.
TROPICAL STORM FORCE WINDS EXTEND OUTWARD UP TO 115 MILES…
185 KM…NORTHEAST THROUGH SOUTHEAST OF THE CENTER.
ESTIMATED MINIMUM CENTRAL PRESSURE IS 1000 MB…29.53 INCHES.
HAZARDS AFFECTING LAND
———————-
NONE.
NEXT ADVISORY
————-
NEXT INTERMEDIATE ADVISORY…800 AM AST.
NEXT COMPLETE ADVISORY…1100 AM AST.
$$
FORECASTER STEWART
This service is provided by NOAA’s National Weather Service.
CNN, 9/2/10: “Three people died and dozens were injured in riots over
increases in the price of bread, water, energy and other
critical goods in Mozambique, the southern African nation’s
official news agency reported Wednesday.”
CNN, 9/2/10: “Two Yemeni men arrested as possible terror suspects at Schiphol
International Airport in the Netherlands have been cleared of
wrongdoing and freed, Dutch authorities said.”
CNN, 9/2/10: “The death toll from a trio of suicide attacks during a Shiite
processions in Lahore, Pakistan, grew to 31 Thursday,
authorities said Thursday…….340 people are wounded, with 7 in very critical condition, officials say……Three blasts strike a Shiite procession in 30-minute span……..2,500 police officers were assigned to procession after attack warning……”
000
WTNT32 KNHC 020855
TCPAT2
BULLETIN
HURRICANE EARL ADVISORY NUMBER 32
NWS TPC/NATIONAL HURRICANE CENTER MIAMI FL AL072010
500 AM EDT THU SEP 02 2010
…EARL STRENGTHENS A LITTLE MORE…NEW WARNINGS AND WATCHES
ISSUED…
SUMMARY OF 500 AM EDT…0900 UTC…INFORMATION
———————————————-
LOCATION…29.3N 74.7W
ABOUT 410 MI…660 KM S OF CAPE HATTERAS NORTH CAROLINA
ABOUT 870 MI…1400 KM SSW OF NANTUCKET MASSACHUSETTS
MAXIMUM SUSTAINED WINDS…145 MPH…230 KM/HR
PRESENT MOVEMENT…NNW OR 330 DEGREES AT 18 MPH…30 KM/HR
MINIMUM CENTRAL PRESSURE…928 MB…27.40 INCHES
WATCHES AND WARNINGS
——————–
CHANGES WITH THIS ADVISORY…
A HURRICANE WATCH HAS BEEN ISSUED NORTH OF SAGAMORE BEACH
MASSACHUSETTS TO PLYMOUTH MASSACHUSETTS…AND WEST OF WOODS HOLE
MASSACHUSETTS TO WESTPORT MASSACHUSETTS.
A TROPICAL STORM WARNING HAS BEEN ISSUED FOR THE COAST OF LONG
ISLAND NEW YORK FROM FIRE ISLAND INLET NORTHWARD AND EASTWARD TO
PORT JEFFERSON HARBOR.
A TROPICAL STORM WATCH HAS BEEN ISSUED NORTH OF PLYMOUTH
MASSACHUSETTS TO EASTPORT MAINE.
ENVIRONMENT CANADA HAS ISSUED A TROPICAL STORM WATCH FOR THE COAST
OF NOVA SCOTIA FROM PORT MAITLAND TO MEDWAY HARBOUR.
SUMMARY OF WATCHES AND WARNINGS IN EFFECT…
A HURRICANE WARNING IS IN EFFECT FOR…
* BOGUE INLET NORTH CAROLINA NORTHEASTWARD TO THE NORTH
CAROLINA/VIRGINIA BORDER INCLUDING THE PAMLICO AND ALBEMARLE
SOUNDS.
A HURRICANE WATCH IS IN EFFECT FOR…
* NORTH OF THE NORTH CAROLINA/VIRGINIA BORDER TO CAPE HENLOPEN
DELAWARE.
* WESTPORT TO PLYMOUTH MASSACHUSETTS…INCLUDING MARTHAS
VINEYARD AND NANTUCKET.
A TROPICAL STORM WARNING IS IN EFFECT FOR…
* CAPE FEAR TO WEST OF BOGUE INLET NORTH CAROLINA.
* NORTH OF THE NORTH CAROLINA/VIRGINIA BORDER TO SANDY HOOK NEW
JERSEY…INCLUDING DELAWARE BAY SOUTH OF SLAUGHTER BEACH AND THE
CHESAPEAKE BAY SOUTH OF NEW POINT COMFORT.
* THE COAST OF LONG ISLAND NEW YORK FROM FIRE ISLAND INLET NORTHWARD
AND EASTWARD TO PORT JEFFERSON HARBOR.
A TROPICAL STORM WATCH IS IN EFFECT FOR…
* SANDY HOOK NEW JERSEY TO WOODS HOLE MASSACHUSETTS…INCLUDING
BLOCK ISLAND AND LONG ISLAND SOUND.
* THE COAST OF LONG ISLAND NEW YORK WEST OF FIRE ISLAND INLET AND
PORT JEFFERSON HARBOR.
* NORTH OF PLYMOUTH MASSACHUSETTS TO EASTPORT MAINE.
* THE COAST OF NOVA SCOTIA FROM PORT MAITLAND TO MEDWAY HARBOUR.
A HURRICANE WARNING MEANS THAT HURRICANE CONDITIONS ARE EXPECTED
SOMEWHERE WITHIN THE WARNING AREA.
A HURRICANE WATCH MEANS THAT HURRICANE CONDITIONS ARE POSSIBLE
WITHIN THE WATCH AREA.
A TROPICAL STORM WARNING MEANS THAT TROPICAL STORM CONDITIONS ARE
EXPECTED SOMEWHERE WITHIN THE WARNING AREA WITHIN 36 HOURS.
A TROPICAL STORM WATCH MEANS THAT TROPICAL STORM CONDITIONS ARE
POSSIBLE WITHIN THE WATCH AREA…GENERALLY WITHIN 48 HOURS.
INTERESTS ELSEWHERE IN NORTHERN NEW ENGLAND AND SOUTHEASTERN CANADA
SHOULD MONITOR THE PROGRESS OF EARL.
FOR STORM INFORMATION SPECIFIC TO YOUR AREA IN THE UNITED
STATES…INCLUDING POSSIBLE INLAND WATCHES AND WARNINGS…PLEASE
MONITOR PRODUCTS ISSUED BY YOUR LOCAL NATIONAL WEATHER SERVICE
FORECAST OFFICE. FOR STORM INFORMATION SPECIFIC TO YOUR AREA OUTSIDE
THE UNITED STATES…PLEASE MONITOR PRODUCTS ISSUED BY YOUR NATIONAL
METEOROLOGICAL SERVICE.
DISCUSSION AND 48-HOUR OUTLOOK
——————————
AT 500 AM EDT…0900 UTC…THE CENTER OF HURRICANE EARL WAS LOCATED
NEAR LATITUDE 29.3 NORTH…LONGITUDE 74.7 WEST. EARL IS MOVING
TOWARD THE NORTH-NORTHWEST NEAR 18 MPH…30 KM/HR. A TURN TOWARD
THE NORTH IS EXPECTED LATER TODAY…WITH A TURN TOWARD THE
NORTH-NORTHEAST AND A FASTER FORWARD SPEED EXPECTED ON FRIDAY. ON
THE FORECAST TRACK…THE CENTER OF EARL WILL PASS NEAR THE NORTH
CAROLINA OUTER BANKS TONIGHT…AND APPROACH SOUTHEASTERN NEW
ENGLAND FRIDAY NIGHT.
REPORTS FROM AN AIR FORCE RESERVE HURRICANE HUNTER AIRCRAFT INDICATE
THAT MAXIMUM SUSTAINED WINDS ARE NOW NEAR 145 MPH…230 KM/HR…
WITH HIGHER GUSTS. EARL IS A CATEGORY FOUR HURRICANE ON THE
SAFFIR-SIMPSON HURRICANE WIND SCALE. A GRADUAL WEAKENING IS
EXPECTED TO START LATER TODAY.
HURRICANE-FORCE WINDS EXTEND OUTWARD UP TO 90 MILES…150 KM…FROM
THE CENTER…AND TROPICAL-STORM-FORCE WINDS EXTEND OUTWARD UP TO 230
MILES…370 KM.
THE MINIMUM CENTRAL PRESSURE ESTIMATED FROM THE HURRICANE HUNTER
DATA IS 928 MB…27.40 INCHES.
HAZARDS AFFECTING LAND
———————-
WINDS…TROPICAL-STORM-FORCE WINDS ARE EXPECTED TO REACH THE NORTH
CAROLINA COAST WITHIN THE WARNING AREA BY THIS AFTERNOON WITH
HURRICANE FORCE WINDS OCCURRING BY THURSDAY NIGHT. TROPICAL-STORM-
FORCE WINDS WILL LIKELY REACH THE COAST FROM VIRGINIA NORTHWARD TO
NEW JERSEY BY LATE THURSDAY NIGHT OR EARLY FRIDAY.
STORM SURGE…A DANGEROUS STORM SURGE WILL RAISE WATER LEVELS BY AS
MUCH AS 3 TO 5 FEET ABOVE GROUND LEVEL WITHIN THE HURRICANE WARNING
AREA AND THE LOWER CHESAPEAKE BAY. ELSEWHERE WITHIN THE TROPICAL
STORM WARNING AREA…STORM SURGE WILL RAISE WATER LEVELS BY AS MUCH
AS 1 TO 3 FEET ABOVE GROUND LEVEL. NEAR THE COAST…THE SURGE WILL
BE ACCOMPANIED BY LARGE AND DESTRUCTIVE WAVES.
RAINFALL…ACCUMULATIONS OF 2 TO 4 INCHES…WITH ISOLATED
MAXIMUM AMOUNTS OF 6 INCHES…ARE EXPECTED OVER PORTIONS OF EASTERN
NORTH CAROLINA INCLUDING THE OUTER BANKS. ACCUMULATIONS OF 1 TO 2
INCHES ARE POSSIBLE FARTHER TO THE NORTH ALONG THE IMMEDIATE
MID-ATLANTIC COAST.
SURF…LARGE SWELLS FROM EARL WILL CONTINUE TO AFFECT THE BAHAMAS
AND THE EAST COAST OF THE UNITED STATES THROUGH FRIDAY. THESE
SWELLS WILL LIKELY CAUSE DANGEROUS SURF CONDITIONS AND RIP
CURRENTS.
NEXT ADVISORY
————-
NEXT INTERMEDIATE ADVISORY…800 AM EDT.
NEXT COMPLETE ADVISORY…1100 AM EDT.
Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine
New Contract Valued at up to $28.7 Million for Phase II Clinical Trial
ROCKVILLE, Md., Sep 01, 2010 (BUSINESS WIRE) –
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmuneTM).
“Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”
This four-year development contract consists of a two-year base, valued at $9.1 million, and milestone-based options that if exercised, would increase the total contract value to up to $28.7 million. The base contract will fund activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The milestone-based options include continued stability testing of Phase II clinical trial lots and a clinical study to evaluate safety and immunogenicity of the product candidate. The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.
This new contract was awarded to expand the development efforts being conducted under a Biomedical Advanced Research and Development Authority (BARDA)/NIAID contract awarded in September 2008, which provides for funding of up to $29.7 million. Thus, with this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to over $58 million.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE: Emergent BioSolutions Inc.
Emergent BioSolutions Inc.
Investors:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt, 301-795-1800
Vice President, Corporate Communications
SchmittT@ebsi.com
Taipei, Sept. 1 “(CNA) The Centers for Disease Control (CDC) began a nationwide program to provide free vaccinations against influenza A virus subtype H5N1, also known as bird flu, that is scheduled to last until Sept. 30, the centers said Wednesday……”
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