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It already is. ;~)
$AVNR Japan’s Otsuka to buy U.S. drug maker Avanir for $3.5 billion Japanese drugmaker Otsuka Holdings has agreed to buy U.S.-based Avanir Pharmaceuticals for about $3.5 billion, the company announced Tuesday.
The purchase will help expand Otsuka’s neurologic drug lineup ahead of the patent expiration for one of its top drugs Abilify, a treatment for schizophrenia. Once its exclusivity rights end in April 2015, the company will have to fend off generic competition for a drug that brought in $5 billion last year — about 40% of Otsuka’s total sales.
Otsuka will pay $17 a share in cash for Avanir AVNR 0.54% , a 13.3% premium to the drugmaker’s Monday closing price. The deal is expected to close in the first quarter next year.
http://for.tn/1B97G74
$POZN J. Napodano http://bit.ly/1vK8QBr
$MEIP interim data leak? I don't know but that would be my guess.
$AVNR 4:57 pm Avanir Pharmaceuticals receives Complete Response Letter from FDA on AVP-825
(AVNR) : Co announced that the FDA has issued a Complete Response letter to its New Drug Application (:NDA) for AVP-825. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology.
In the Complete Response letter, and consistent with the preliminary feedback announced on November 7, 2014, the FDA requested that Avanir assess the root cause(s) of device use errors observed in the previously conducted human factors testing. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. A new human factors validation study will be required to assess usability of the device following improvements. The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval.
"We believe the concerns raised by the FDA are fully addressable," said Joao Siffert, MD, chief medical officer of Avanir. "Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015."
http://yhoo.it/1AU8axT
http://yhoo.it/1xU8J8D
$BCRX 11.19 up over 5%. PDUFA in December.
$ELOS 10.18 up again today.
$ELOS none that I know of. I like the chart and they just beat earnings. Also FDA clearance for one of their devices.
WAYLAND, Mass., Nov. 3, 2014 /PRNewswire/ -- Syneron Medical Ltd. (ELOS), a leading global aesthetic device company, announced today the US Food and Drug Administration (FDA) clearance of the new PicoWay picosecond device. PicoWay is a state-of-the-art dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay TechnologyTM to generate picosecond pulses for the removal of tattoos. The FDA clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. The US launch of PicoWay will begin immediately, following the launch of the product in the international market in October.
http://yhoo.it/1A4clru
$ELOS $ 9.99 is my only stock in the green .
$LJPC up 10%.
$CERS Should hear soon on announced submission of their protocol to apply INTERCEPT to the treatment of Ebola convalescent plasma. The 30 day mark to hear from FDA on IDE is Nov 21st from Oct 21st notification.
"For Ebola, we recently announced submission of our protocol to apply INTERCEPT to the treatment of Ebola convalescent plasma. Plasma collected from individuals who have recovered from Ebola virus disease contain antibodies against the virus, these antibodies that can help fight Ebola infections in the recipient of the transfused plasma. Convalescent plasma has demonstrated benefit in prior disease outbreaks, and is one of the few therapies immediately available for Ebola virus disease. It is of note that each of the surviving patients treated in the U.S. received convalescent plasma during the active phase of their disease. A concern associated with collection of convalescent plasma from recovered patients is that they may carry undetected pathogens due to prior exposure, and their history of travel to Africa make these individuals temporarily ineligible to donate blood under U.S. regulatory guidelines. We believe that INTERCEPT pathogen inactivation can provide a critical risk mitigation strategy by inactivating harmful organisms that may be present without impacting the anti-Ebola antibodies that the patient needs."
$OXGN Good DD read. http://bit.ly/1z381Es
$AVNR Likely targets, investors and bankers said, are companies with one or two promising new products, such as Avanir Pharmaceuticals Inc (AVNR.O), which has an Alzheimer's drug under patent; San Diego-based Neurocrine Biosciences Inc (NBIX.O), which has partnered with Abbvie on an endometriosis treatment; and Puma Biotechnology Inc (PBYI.N), which is developing a breast cancer drug.
All three companies are rumored to be the object of takeover deals in the next few months. None responded to requests for comment.
http://reut.rs/1GufGRc
$OXGN Good DD read. http://bit.ly/1z381Es
$OXGN The person who wrote the SA article only has 23 followers. I wouldn't give much weight to the article. He obviously has his own agenda.
$OXGN negative SA article out this morning. http://bit.ly/1xcBQmR
$RMTI Adam F article.
$POZN need to see a close above 200 day MA then close above 8.50
http://seekingalpha.com/article/2574445-the-truth-about-ibios-role-in-ebola-drug-production
Oct. 20, 2014 8:24 AM ET | 2 comments | About: iBio, Inc. (IBIO)
Disclosure: The author has no positions in any stocks mentioned, but may initiate a short position in IBIO over the next 72 hours. (More...)
Summary
iBio NEVER confirmed in a straight-forward fashion that it's involved in the Ebola drug production.
The license agreement with Caliber is for an "oncology indication".
iBio plays no role in Ebola drug ZMAPP's production.
iBIO (NYSEMKT:IBIO) spiked nearly 70% after the "U.S. requests production plans for Ebola drug ZMapp" news broke in the early afternoon on Friday. The news reported that government officials have asked "three advanced biology laboratories to submit plans for producing the experimental Ebola drug ZMapp." These three labs are: Texas A&M Health Science Center, Emergent Biosolutions in Baltimore, and another center in Holly Springs, North Carolina, led by Swiss drug company Novartis AG. iBio was never mentioned as one of the production centers, or a partner of the centers. You may wonder why iBIO shares are up so much. It turns out that iBio is only remotely related to a subcontractor of one of the three centers, the Texas center. If Texas center wins the government contract, said Dr. Brett Giroir, chief executive officer of Texas A&M Health Science Center, it would likely tap Caliber Biotherapeutics as a subcontractor. (click to enlarge)
iBio entered into a license agreement with Caliber in Feb 2013. So the question is, is iBio directly involved in the Ebola drug production? On last Thursday, iBio issued an ambiguous press release responding to inquiries about its role in emergency response to Ebola virus. All iBio said in the press release can be summarized into below three points:
1). iBio has an on-going relationship with Caliber;
2). iBio reiterated its self-claim that plant-based production may be superior to animal-based antibody production;
3). iBio "offered" to help US government.
iBio NEVER confirmed in a straightforward fashion that it's involved in the Ebola drug production. Why? It's because iBIO has never been involved. Based on the company's 10-K, the license to Caliber is for use of the iBioLaunch in connection with the development of an antibbody-based protein for an "oncology indication":
(click to enlarge)
If the story gets convoluted for the readers, the below diagram should help sort out all the relationship.
(click to enlarge)
If iBio management has any dignity, it should just tell investors what Protalix (another plant-based therapeutic proteins producer) CEO Dr. David Aviezer said, "We have no information about the drug, no connection with the manufacturers. We also have no genetic information about the drug or the rights to use it."
I sold $MEIP yesterday @ 8.19 from 7.08. Good call Bob. Thx.
ottoman I feel your pain. I took about a 20% loss myself.
$ARWR i did. Ouch. Took a big haircut on this one. On to the next.
$ARWR trading halted.
$PGNX resumes trading at 6:00 pm.
$PGNX halted.
$PSDV ditto Bob.
$PSDV trading halted!
$CPRX I'm holding through data. GLTY
OXiGENE (OXGN) Begins Phase 2 Study of Fosbretabulin in GI-NETs
September 17, 2014 4:03 PM EDT
OXiGENE, Inc. (Nasdaq: OXGN), a biopharmaceutical company developing novel cancer therapeutics, today announced that the first patient has been enrolled in a Phase 2 study to evaluate the safety and activity of fosbretabulin monotherapy in patients with locally advanced, recurrent or metastatic gastrointestinal neuroendocrine tumors, or GI-NETs, with elevated biomarkers. GI-NETs are slow-growing, often invasive tumors that produce excessive amounts of hormones and other peptides which enter the blood stream and cause debilitating symptoms.
"Based on our preclinical NET study which showed a statistically significant decrease in a relevant biomarker when treated with fosbretabulin, this study of fosbretabulin in GI-NETs is a potentially meaningful advance, as these tumors are increasing in incidence and very few treatment options exist beyond surgery or radiation," said Steven K. Libutti, MD, FACS, Professor of Surgery and Genetics, Albert Einstein College of Medicine, and Montefiore Medical Center. "Fosbretabulin's unique mechanism of action specifically targets the tumor vasculature in order to cut off the blood supply at the tumor's core, which may result in reduction in biomarkers and symptoms for these patients. We are hopeful that this novel approach may be effective in reducing the debilitating symptomatology of this cancer."
The Phase 2 study will evaluate the safety and activity of fosbretabulin monotherapy in approximately 20 GI-NET patients with increased biomarkers and/or clinical symptoms. The study will evaluate the impact of fosbretabulin on certain biological mediators over time, following the patient's baseline measurements at the study start. The primary endpoint of the trial is the reduction of biomarkers, and secondary endpoints include improvement in symptoms and quality of life as assessed by validated measures. The study will be conducted at five sites in the U.S.
"We are pleased to add GI-NET as a new tumor type that may benefit from treatment with fosbretabulin given the significant need for alternative new treatment options in patients with these tumors," said Dai Chaplin, president and chief executive officer at OXiGENE. "We hope to build on the growing body of evidence suggesting fosbretabulin's meaningful biological activity in various indications. We look forward to enrolling this important study and obtaining the data to evaluate the potential of this novel treatment approach for patients with GI-NETs."
http://bit.ly/1ssE4bW
$OREX PDUFA not AdCom.
I believe so.
$KERX approved.
NEW YORK, Sept. 5, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (KERX) (the "Company") today announced that the U.S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
$NKTR is having a PDUFA on 9/16
$GILD.....I also found this but its an October PDUFA.
elvitegravir PDUFA
Start: 10/04/2014 - 00:00
.
Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA
-- Final FDA Decisions Anticipated by October 3 and 4, 2014 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 21, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. The FDA has set target review dates under the Prescription Drug User Fee Act (PDUFA) of October 3, 2014 for cobicistat and October 4, 2014 for elvitegravir.
Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In April 2013, the company received Complete Response Letters from the FDA. In its communications, the agency stated that it could not approve the cobicistat and elvitegravir applications in their current forms, citing deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during inspections. Gilead has worked with the FDA to address the questions raised in the Complete Response Letters.
Cobicistat and elvitegravir are components of Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a once-daily single tablet regimen for the treatment of HIV-1 infection. Stribild was approved in the United States in August 2012.
Cobicistat is approved under the tradename Tybost® and elvitegravir is approved under the tradename Vitekta® in Europe, Canada and Australia.
bit.ly/1lsfDyl
Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.
http://bit.ly/1t6QImg
It was. Check this link. bit.ly/1ph1hRm
$PGNX nice move today.
$HALO.....no specific PDUFA date yet isn't helping the sp.
bit.ly/1ph1hRm
$CNAT I'm long and strong.
Everybody has their own agenda. Some bash, some pump and others know what they own. ;~)