Another BIG pop coming!!
House passes biohazard preparation bill, sends to Obama
By Pete Kasperowicz - 03/04/13 06:53 PM ET
The House on Monday evening passed legislation that would reauthorize several programs meant to help develop medical countermeasures and take other steps to prepare for public health emergencies and biohazards, including possible terrorist attacks.
Members approved H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act, in a 370-28 vote. All of of the "no" votes came from Republicans.
The House had approved nearly identical legislation in early February. Last week, the Senate approved it with what Rep. Joe Pitts (R-Pa.) called "minor changes."
House passage sends the bill to the White House for President Obama's signature.
Sentiment: Strong Buy
Monkeypox virus (MPXV) is endemic within Africa where it sporadically is reported to cause outbreaks of human disease. In 2003, an outbreak of human MPXV occurred in the US after the importation of infected African rodents. Since the eradication of smallpox (caused by an orthopoxvirus (OPXV) related to MPXV) and cessation of routine smallpox vaccination (with the live OPXV vaccinia), there is an increasing population of people susceptible to OPXV diseases. Previous studies have shown that the prairie dog MPXV model is a functional animal model for the study of systemic human OPXV illness. Studies with this model have demonstrated that infected animals are able to transmit the virus to naive animals through multiple routes of exposure causing subsequent infection, but were not able to prove that infected animals could transmit the virus exclusively via the respiratory route. Herein we used the model system to evaluate the hypothesis that the Congo Basin clade of MPXV is more easily transmitted, via respiratory route, than the West African clade. Using a small number of test animals, we show that transmission of viruses from each of the MPXV clade was minimal via respiratory transmission. However, transmissibility of the Congo Basin clade was slightly greater than West African MXPV clade (16.7% and 0% respectively). Based on these findings, respiratory transmission appears to be less efficient than those of previous studies assessing contact as a mechanism of transmission within the prairie dog MPXV animal model.
PLoS One. 2013;8(2):e55488. doi: 10.1371/journal.pone.0055488. Epub 2013 Feb 7.
Transmissibility of the Monkeypox Virus Clades via Respiratory Transmission: Investigation Using the Prairie Dog-Monkeypox Virus Challenge System.
Hutson CL, Gallardo-Romero N, Carroll DS, Clemmons C, Salzer JS, Nagy T, Hughes CM, Olson VA, Karem KL, Damon IK.
Division of High-Consequence Pathogens and Pathology, Poxvirus and Rabies Branch, Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Diseases, Atlanta, Georgia, United States of America ; Department of Pathology, College of Veterinary Medicine, The University of Georgia, Athens, Georgia, United States of America.
WASHINGTON, MARCH 4, 2013 — /PRNewswire-USNewswire/ -- TFAH applauds the passage of the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) (H.R. 307), which will help address ongoing and emerging challenges in public health preparedness – and ensure public health has the resources and support necessary to prepare for and respond to disease outbreaks, severe weather events, acts of terrorism or other public health emergencies.
Mar 4, 2013, 2:32pm EST
Sarepta reports positive pre-clinical data on Marburg virus candidate
Sarepta Therapeutics Inc. (Nasdaq: SRPT) says that in animal studies the drug it’s developing to fight a potential bioterrorism agent called Marburg virus has been shown to be as effective when injected into muscles as it is into the bloodstream.
Marburg hemorrhagic fever has no effective treatments, and has been classified as a Category A bioterrorism agent by the Centers for Disease Control and Prevention (CDC).
Sarepta, which specializes in gene-based drugs, received a $3.9 million contract from the Department of Defense in August 2012 for pre-clinical tests of AVI-7288 as administered intravenously. The contract is expected to be completed by the second half of this year, and the DoD has the option to extend it.
While the company intended to develop and commercialize its DMD drug candidate, eteplirsen, on its own, the Marburg program is being done in conjunction with the government and, if successful, would be stockpiled in case of an outbreak, the company said.
Sarepta’s stock has shot up from a low of $2.60 a year ago to $29.82 as of Monday at 2 p.m.
Sentiment: Strong Buy
Billions for Siga
The Biotechnology Industry Organization (BIO) lauds the Senate for passing H.R. 307 the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) yesterday by a unanimous vote.
BIO commends Chairman Tom Harkin (D-IA) Sen. Richard M. Burr (R-NC) Sen. Mike Enzi (R-WY) Sen. Bob Casey (D-PA) and Ranking Member Lamar Alexander (R-TN) for their leadership on this important issue.
Below is a statement from BIO’s President and CEO Jim Greenwood:
“We applaud the Senate for its commitment to improving our nation’s capacity to prepare and respond to natural disasters bioterrorist attacks and outbreaks of infectious disease. PAHPRA enables the frontline response of the public health and healthcare systems rather than funding on an emergency-by-emergency basis.
“The bipartisan legislation provides needed clarity for the regulatory process for medical countermeasures at the Food and Drug Administration and strongly encourages the Agency to work with product sponsors to develop regulatory management plans provide technical assistance and help solve regulatory and scientific issues.
“These provisions will help provide transparency and consistency to accelerate the development and approval of medical countermeasures (MCM).
“The reauthorization of PAHPA signifies the solid commitment of government attention and funding which will allow the biotech industry to do even more to help protect our nation.
“Biotech companies are willing and active partners in the national security endeavor. Our industry plays a central role in ensuring the effective development of MCMs to protect our nation’s citizens against chemical biological radiological and nuclear threats whether naturally occurring or man-made.
“Strengthening the pipeline of medical products drugs and devices that will safeguard the nation during an emergency or pandemic is vital to our national security.”
"BIO strongly encourages the House of Representatives to consider this important measure in the near future."
A similar version of this bill was previously passed by the House of Representatives and the Senate bill will now go to the House for a final vote.
Sentiment: Strong Buy
Alexander Praises Senate Passage of Burr-Harkin Bill to Prepare Nation for Medical Emergencies and Bioterror Attacks
“I thank Senator Burr for his leadership on this issue and I urge our colleagues in the House to pass this important legislation”
Thursday, February 28, 2013
Washington, D.C., February 28 –Senator Lamar Alexander (R-Tenn.), Ranking Member on the Senate Health, Education, Labor and Pensions Committee, today praised passage by the Senate of a bill to improve the nation’s ability to prepare for, and respond to, pandemics and bioterror attacks.
“The threat of a bioterror attack or flu outbreak is real, and this bill helps ensure we’re prepared for that threat and that our state and federal governments and local entities are working together to be as ready as possible,” Alexander said. “I thank Senator Burr for his leadership on this issue, and I urge our colleagues in the House to pass this important legislation.”
Committee chairman Tom Harkin (D-Iowa), Senators Enzi (R-Wyo.), Casey (D-Penn.), Mikulski (D-Md.), Isakson (R-Ga.), Roberts (R-Kan.), Chambliss (R-Ga.) are also original cosponsors of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.
This reauthorization strengthens preparedness for and ability to respond to medical and public health emergencies, optimizes state and local all-hazards preparedness and response efforts and collaboration, enhances medical countermeasure activities, and reauthorizes key medical and public health programs, including the BioShield Special Reserve Fund. Additional information regarding this bill can be found here.
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