Reports of deaths and hospitalization in WA
The deaths follow warnings from the federal Centers for Disease Control and Prevention earlier this month that this could be a severe year for flu. This past week, influenza was reported to be widespread in Washington.
Clinics around Snohomish County have reported an increase in flu cases.
“We’re saying that the flu season has arrived,” said Dr. Yuan-Po Tu, who tracks influenza at The Everett Clinic. The type of flu they’ve seen the most so far this year, called H3N2, tends to be more severe among the elderly and causes more hospitalizations, he said.
At Edmonds Family Medicine, there were as many suspected cases of influenza the first two weeks in December as in the entire month of November, said Marcy Shimada, the clinic’s chief executive.
Providence Regional Medical Center Everett had one case of influenza in November last year and 11 this year
The HAE trial is listed as recruiting on clinical trials site, but I don't see the BCX 4430 trial listed yet. It would be interesting to see the sites and interested parties for the 4430 trial. Like, if I was in a CSH headed to Liberia, I would want to be in that clinical trial.
Downside about 20%, upside 50-80%, see what happened to Pozen
(Reuters) - Pozen Inc said two versions of its experimental heart drug were rejected for the second time by the U.S. Food and Drug Administration, which cited deficiencies in the manufacturing plant of a supplier of an active ingredient.
Pozen's shares fell 19 percent to $7.30 in premarket trading on Wednesday.
The two drugs, PA8140 and PA32540, are being evaluated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
$12-13 before PDUFA, $9-18 after ($18 if Rapivab approved); $20-$30 if NHP and Phase I 4430 positive. Remember Jan 15 is date for response to pandemic MCM RFP's, and the turkeys are chickens are dying just across the border in Canada.
On October 20, 2014, Party B indicated that it was not interested in pursuing a strategic transaction with the Company at that time, in light of its assessment of the risk associated with the regulatory approval of drisapersen and Party B’s appetite for such risk.
Also in late October and early November 2014, the Company and its advisors continued preparations for a potential equity offering if the discussions related to a potential strategic transaction did not result in an announced deal by mid-November 2014 (at which time the Company was prepared to abandon discussions related to a potential strategic transaction and instead pursue the equity offering).
On October 27, 2014, Party E, which was contacted in connection with Citi’s outreach to third parties but had indicated to Citi that it was not interested in pursuing a transaction with the Company at that time, indicated that it had reconsidered and may be interested in pursuing a transaction with the Company. Party E was given access to the electronic data room that had been populated for purposes of providing the other potential transaction counterparties with access to due diligence materials, as well as the initial draft purchase agreement provided to the other parties on October 14, 2014, and conducted an initial due diligence phone call with representatives of the Company regarding clinical and regulatory matters on October 29, 2014.
On November 1, 2014, Party A’s legal advisors contacted Davis Polk to discuss the terms of the draft purchase agreement provided to Party A, with a view to providing comments on the purchase agreement to the Company over the next few days.
On November 5, 2014, representatives of Citi provided Hans Schikan, chief executive officer of the Company, with an update on the strategic transaction process, as well as Citi’s preparations with respect to a potential equity offering, by phone. As part of this update, Citi indicated that it anticipated revised offers from each of Parent and Party A on November 14, 2014 and that Citi had requested an initial indication of interest from Party E on that date as well.
On November 7, 2014, Party A indicated that it was not interested in pursuing a strategic transaction with the Company at that time and that it would not be providing comments on the purchase agreement to the Company, in light of Party A’s assessment of the risk associated with the regulatory approval of drisapersen and Party A’s appetite for such risk.
World Health Organization (WHO) and US Centers for Disease Control and Prevention (CDC) guidelines have suggested that double-dose oral oseltamivir therapy or, where available, parenteral NA inhibitors, may be considered for severe avian influenza disease4
Peramivir is a replacement for tamiflu, whose lesser effectiveness and higher IC50 have contributed to growth of NAI resistance. See discussion of higher plasma concentrations and effect of treatment with 24 and 48 hour lag. If given ASAP, would be highly effective. FDA needs to understand this, use the full treatment, not the half treatment.
Therapeutic Activity of Intramuscular Peramivir in Mice Infected with a Recombinant Influenza A/WSN/33 (H1N1) Virus Containing the H275Y Neuraminidase Mutation
RTT FDA Approval Calendar
12/23/2014 Biocryst Pharmaceuticals Inc BCRX Intravenous (i.v.) Peramivir (NDA) FDA decision on intravenous Peramivir for influenza
12/21/2014 Cubist Pharmaceuticals Inc CBST Ceftolozane/Tazobactam (NDA) FDA decision on Ceftolozane/Tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections
12/05/2014 Incyte Corporation INCY Ruxolitinib (sNDA) FDA decision on Ruxolitinib as a potential treatment in the addnl. indication of polycythemia vera patients who have had an inadequate response to or are intolerant of hydroxyurea
Stockpile 2015 November 21, 2014 RFP: 15-100-SOL-00003
Draft Statement of Work (SOW) Questions and Answers 1. What is the context for issuing an RFI/RFP at this time?
Answer: Allowance for adequate time to solicit, receive offers, evaluate, negotiate, and award contracts before September 1, 2015.
2. When does BARDA anticipate releasing the RFP? Are there any additional important dates to keep in mind?
Answer: RFP Pre-solicitation Notice publication date anticipated: December 5, 2014 RFP publication anticipated: January 12, 2015
Pediatric CMV and transplants specifically mentioned.
Added: Nov 28, 2014 1:06 pm
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) has a requirement for the support/advancement of the development of therapeutic strategies for select rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations.
But having Paramivir/Rapivab available could be a good thing, given the fact that the flu vaccine isn't a good match this season. So a PDUFA decision could produce a positive surprise.
CDC A sampling of flu cases so far this season suggests the current flu vaccine may not be a good match for the seasonal flu strain currently circulating in the United States, the U.S. Centers for Disease Control and Prevention on Wednesday
Probably waiting on results of second higher dose Ebola survival data, and if good, get orphan tropical fast track breakthrough accelerated approval personal congratulations from FDA and WH
Which is why the FDA holdup based on clinical trial toxicity problems with drisa was so much bs-lack of knowledge of molecular biology, PK and MOAs on the part of FDA staffers led to reasoning by faulty analogy, costing a bunch of the DMD boys and mothers time that might never be recovered-unless exon skipping can rebuild muscle.
what do you think of Biomarin picking up RNA - is that wishful or is it platform acqusition and pipeline expansion
Medical Countermeasures for Pandemic Influenza Preparedness and Response
Solicitation Number: 15-100-SOL-00003
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
On Sat 15 Nov 2014, the National Health and Family Planning Commission (NHFPC) of China notified WHO of 3 additional laboratory-confirmed cases of human infection with avian influenza A(H7N9) virus infection, including one death. Details of the cases are as follows:
Safety and Efficacy of Peramivir Hata and Akashi-ueda et all review 11 studies Oct 24
We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose-response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors.
Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.