"Phosphate binders appear to be more top-of-mind for nephrologists given the FDA approval of Velphoro (Vifor Fresenius Medical Care Renal Pharma) in November 2013 and the very recent approval of ferric citrate, formerly known as Zerenex," comment from Decision Resources Group Business Insights Analyst Jihan Khan, Ph.D
The webinar in this series is: ASH/FDA Update on: Belinostat for Treatment of Peripheral T-cell Lymphoma (PTCL). Recordings of ASH webinars are available on ASH On Demand.
Today at 4 pm EST, the American Society of Hematology presents a one hour webinar:
Wyndham Wilson, MD, PhD (Moderator) , Robert Kane, MD, Steven M. Horwitz, MD
In collaboration with the Food and Drug Administration (FDA), ASH is now offering webinars that feature an unbiased discussion of newly-approved hematology therapies. These webinars feature presentations by an FDA representative and a key clinical physician involved in the drug’s development, and are moderated by a physician with experience serving on the oncologic drugs advisory committee (ODAC) of the FDA. Discussion of the newly-approved therapy will be followed by a Q&A session led by the moderator, with questions from the audience submitted via chat.
To my knowledge, no Captisol-enabled med has failed to meet its clinical goal and all the applications in the US and the EU have been approved. As close to a sure thing as I've seen.
Today, Merck ( known as MSD outside the United States and Canada } said it had received approval for Captisol-enabled NOXAFIL® (posaconazole) 300 mg Concentrate for Infusion from the European Medicines Agency (EMA) which represents 28 nations. Ligand earns a $550,000 milestone payment as a result of the approval. Ligand will sell Captisol to Merck for the product marketed in Europe under an existing commercial supply agreement. CE-Melphalan will also obtain this approval, imho.
Except for surprise announcements like the China deal, the next scheduled event will be the Q3 report. Last year this occurred on Nov 12th and was followed the next day by the Credit Suisse Annual Healthcare Conference. This years Conference will be Nov 10th through the 13th (Mon to Th) so that week should be interesting.
Agreed! The selection of Spectrums two most underperforming drugs for the China expansion will test both CASI and the drugs true value with no real loss to SPPI. Melphalan will be a winner worldwide and was added to the deal to sweeten it, imho.
Raj may be highlighting Renazorb due to the lack-luster results reported by KERX for their product. That leaves Renazorb as the competitor to be developed.
The KERX binder "Zerenex" has been panned by Adam Feuerstein today which certainly should add interest in Spectrum's Renazorb (SPI-014) which is being offered for sale by the company. It's an oral tablet which has shown good results in a P2 study - an another undervalued gem in the company pipeline.
Nothing remarkable about the report. Earnings near nil as expected and clinical trial results not expected until late in the year. Company has enough funds to carry them till 2016.
Found report that PRX-105 passed the P1 trial and a Nov 2011 release on possible role of AChE-R in the brain's protective mechanisms. The research highlights that a splice shift, either inherited or induced by environmental factors (e.g. neurotoxins), from the more common 'synaptic form' of acetylcholinesterase (AChE-S) to the monomeric 'read-through' variant of AChE (AChE-R), is important in conferring protection against Parkinson-like symptoms. Furthermore, intravenous injection with PRX-105 induced a protective gene expression profile in the striatum of the brain. "Adaptive alternative splicing correlates with less environmental risk of Parkinsonism," has been published online in the Journal of Neurodegenerative Diseases, reported scientists from the Hebrew University of Jerusalem, Israel and Protalix BioTherapeutics. Company continued listing 105 until a year ago.
Given the war with Hamas and chemical weapons use in Syria, the absence of any acetylcholinesterase for Biodefense (PRX-105) news seems odd, and it is no longer listed among products in development. The last news was the announcement of a P1 trial on May 17, 2010. Anyone know what happened to it?
PLX has no reason for seeking redemption as their plan is not flawed. Results coming in the next five months will invigorate share price, imho. As for Ebola antibodies, the PLX system could be applied given the right genetic additions, but others are already their so your suggestion is a lame distraction, shortie.