Canada added as Health Authority
Here's the list of other countries:
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency
Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
South Korea - Ministry of Health announces 5 new coronavirus MERS cases - cumulative total now equals 30 - June 2, 2015
There is no specific antiviral treatment recommended for MERS-CoV infection.
Is there a vaccine?
A: Currently, there is no vaccine available to protect against MERS.
Ebola this time last year was starting to create concern, by August govts. were scrambling for answers.
30 Mers patients from one traveler, 3 of them are 3rd generation affected. ~700 people quarantined.
BCX4430 about done with safety trial putting it much further along than it was for Ebola.
The new cases included the country's first tertiary infections as two people were found to have contracted the virus from a secondarily-infected patient.
FYI, had this happened in the US it would be a huge story. The ebola quandary exposed the lack of treatments for that disease and forced the US and other govts. to rush early treatments.
A US cluster would further demonstrate the slowness of moving MCM drugs towards approval...
.BCX4430 has been in PH1 since mid December requiring 88 patients to demonstrate safety. This trial should have been completed. HHS has likely seen early safety results since they took the baton from NIAID to further 4430 but BCRX has been kept quiet.
Since 4430 is broad spectrum, and shown invitro efficacy against MERS, it would stand to reason that there have been discussions about it as a candidate. Now where are the NHP trials on 4430 against MERS?
"never thought that oppy had that kind of pull…"
Husky, JPM said this April 3:
"...the firm thinks that BioCryst's stock can rise significantly heading into key catalysts in the second half of the year and kept an Overweight rating on the name."
JPM PT is $18
No longer listed at BCRX website...assume they filled this position (that was quick).
NEW ONE added today:
Department: Clinical Operations
Job Title: Clinical Study Manager
Job Location: Durham, NC
The Clinical Development Manager manages global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, in order to achieve a high quality product for the marketplace and business success for company. This involves participation in all aspects of study design, execution, analysis and reporting, including critical document design (protocol, CRF, data management plan, statistical analysis plan, clinical study report), vendor selection and management, oversight of investigator selection, study conduct and site monitoring, data collection, analysis planning and reporting, managing clinical supplies, quality control, and study budget development and tracking to ensure compliance with regulatory and ICH/FDA GCP guidelines.
13) #1173 - Male, 35, hospitalized May 13 for TB, on same ward as case #1149, re-hospitalized May 27, South Korea WHO
14) #1174 - Male, 35, onset May 24, hospitalized May 25-27, son of previous case, South Korea WHO
15) #1180 - Male, 49, onset May 21, husband of case #1172, South Korea WHO
16) #1181 - MoH confirmed: reportedly a male, 40, on ward with case #1149, South Korea
17) #1182 - MoH confirmed: reportedly a male, 45, son of case on ward with case #1149, South Korea
18) #1183 - MoH confirmed, reportedly a female, 77, on ward with case #1149, South Korea
"BCX4430 is not only active against Ebola virus, but also targets other members of the Filovirus family as well as 8 other RNA virus families. Because of the potent and efficacious effects, BCX4430 is being fast-tracked for clinical trials in humans."
11) #1171 - Hospitalized contact of previous case, announced May 29, South Korea
12) #1172 - Hospitalized contact of previous case, announced May 29, South Korea
A Hong Kong woman was rushed to hospital today showing symptoms of deadly Middle East respiratory syndrome (Mers) after she shared a flight to the city with a Korean man confirmed to have the virus.
and now there was 10 including the one that got away to China:
1) #1149 - IMPORTED CASE/INDEX CASE - Male, 68, onset May 11, hospitalized in South Korea May 15 & May 20, travel history to Gulf, Bahrain/Saudi Arabia/UAE/Qatar WHO
2) #1151 - Female, 63, wife of case #1149, South Korea WHO
3) #1152 - Male, 76, hospital roommate of case #1149, South Korea WHO
4) #1158 - Female, 46, daughter of case #1152 & contact of case #1149, South Korea
5) #1160 - Male, 50, doctor, contact of case #1149 for less than 1 hour, South Korea
6) #1161 - Male, 71, contact with case #1149, hospitalized, South Korea
7) #1162 - Female, 28, contact with case #1149, hospitalized, South Korea
8) #1165 - Medical staff, contact with case #1149, South Korea
9) #1166 - Shared hospital room with case #1149, South Korea
10) #1167 - EXPORTED CASE - Male, 44, brother of case #1158, son of case # 1152, traveled to Guangdong, China via Hong Kong, South Korea
South Korea confirms 6th & 7th coronavirus MERS cases - May 28, 2015
The Health Ministry said the son of the second confirmed victim in the outbreak, who was himself being observed for possible infection, broke voluntary home quarantine and left South Korea on Tuesday for China.
The 44-year-old man expressed discomfort as early as May 21 and reported fever of 38.7 degree celsius on Monday. He landed in Hong Kong on Tuesday and went on to Huizhou city in Guangdong Province via Shenzhen.
Chinese state broadcaster CCTV said that authorities in Guangdong province found the Korean man on Thursday and isolated him in a hospital for treatment. They also isolated 35 people who had come in close contact with him, though none has yet to shown symptoms.
The man had not exhibited symptoms other than a fever and had not been confirmed as a MERS case.
Sept. 30 is the end of their FY:
ASPR’s budget request to Congress for fiscal year
(FY) 2015—which extends from October 1, 2014
through September 30, 2015—supports our mission
and reflects the goals and objectives of our
five-year strategic plan as follows
We help make sure the country has the vaccines,
drugs, and medical supplies our population may
need in a disaster. And, when states ask for assistance,
we are ready with a federal health response
tailored to their needs.
Thanks to the
efforts of BARDA and its partners, a dozen MCMs
were added to the SNS during the last decade and
more than 85 other MCM candidates are in the
pipeline for further development and prospective
The Administration’s goal is to
add 12 new CBRN MCMs to the SNS by the end of
The Pandemic and All-Hazards Preparedness
Reauthorization Act (PAHPRA) authorizes up
to $2.8 billion during FY 2014-2018 for BARDA to
meet this goal.
My note: BCRX is happy to share in the 2.8 billion pie...
JPM" $BCRX Management Meeting Takeaways; Next Up: Ph I Data for Next Gen HAE Asset '7353;Expect data late 3Q,Maintain OW, TP=$18.
4 people caught it from one patient returning from Middle East. Why so easily transferable in this situation and not in M.E.? BCX4430 hasn't been formally discussed for this disease but we know...
"In addition, BCX4430 was shown to be active in vitro against a broad range of other RNA viruses, including the emerging viral pathogen Middle East Respiratory Syndrome Coronavirus (MERS-CoV)."
MERS is like SARS, remember the concern SARS casued? Now we see a large cluster from MERS that was transferred from one person coming back from the M.E.
Details below from flutrackers:
Current South Korea coronavirus MERS cluster:
1) #1149 - Male, 68, onset May 11, hospitalized in South Korea May 15 & May 20, travel history to Gulf: Bahrain/Saudi Arabia/UAE/Qatar WHO
2) #1152 - Female, wife of case #1149, South Korea WHO
3) #1153 - Male, 76, hospital roommate of case #1149, South Korea WHO
4) #1159 - Female, daughter of case #1153 & contact of case #1152, South Korea
5) #1161 - Doctor, contact of previous case, South Korea
Jefferies 2015 Global Healthcare Conference
When: Mon, June 1, 2015, 8am – Thu, June 4, 2015, 5pm
Where: New York City, NY
Tuesday, June 24, and Wednesday, June 25, 2014
The Westin New York Grand Central
From their May 12th ER slide they had this bullet point:
-Interactions with USFDA continue for resolution of Spokane Warning Letter
They discuss normalcy returning to that plant and also received some other drug business that just got approved. Probably not long before they get the WL off their back. Not sure if it affects IV P anymore.