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GSK/THRX next-generation combination respiratory therapy programs moving on:
http://www.gsk.com/media/pressreleases/2011/2011_pressrelease_10022.htm
Same here.
That explains why APP Pharma and not some other comp. Could have been a nice quiz :)
Apropos to cGMP issues, Teva received an FDA warning letter regarding its manufacturing practices at its Jerusalem manufacturing facility, which was inspected in September.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000620442&fid=1725
Teva/APP generic Gemzar question update
Found out why Teva couldn't manufacture on their own - a cGMP issue with its Irvine, CA facility. They had to partner so they can at least enjoy some of the exclusivity period.
This would still result in wastage of 45-IU (your former "25% of the purchased drug being wasted" quiz), which I assume is difficult to avoid as it isn't likely that docs can schedule patients in a row very often. I suppose AGN was hoping that docs would use two 100-IU vials per patient, but in order to encourage them, I guess the new 200-IU vial should cost less than twice the 100-IU vial.
AGN’s 4Q10 Latisse sales were only $17M, -20% quarter-over-quarter and -33% year-over-year.
SNY’s lixisenatide achieved its primary endpoint of noninferiority to exenatide in Phase-3 trial:
http://www.prnewswire.com/news-releases/positive-top-line-phase-iii-data-in-type-2-diabetes-achieved-for-lixisenatide-once-daily-vs-exenatide-twice-daily-115083734.html
Since Nov 2010, he was selling PLX shares like there's no [PDUFA date] tomorrow. He still has 3.8% in the company.
From Biogen's CC:
Think you posted the wrong link.
Made me remember the "we are smaller that's why we try harder" slogan
I think OREX needs to pay all and their cash isn't enough.
Actually, Prolor is located in the Weizmann Science Park, outside of Nes-Ziona. As for your anti Israeli remark, this is just like saying that almost every poster called 'BioTechHedge' is dense.
4Q10 Tysabri end user sales - $333M, of which $162 million were in the U.S. and $171 million were in rest of world.
http://finance.yahoo.com/news/CORRECTING-andREPLACING-bw-3184710322.html?x=0&.v=2
Another case where the FDA overruled its advisory panel, which voted that a CV trial can be done post rather than pre-approval.
You're right, Bentley was the company which licensed Testim to Auxilium so the split was not with the drug developer but with the licensee.
AUXL had a co-promote arrangement with Oscient in which Oscient marketed Testim to primary care physicians, while AUXL to specialists.
Allergan Inc (AGN.N) bought co-promotion rights on Map Pharmaceuticals Inc's (MAPP.O) experimental treatment for acute migraine for $60 million in upfront payment, in a move to expand its migraine franchise.
The two companies will co-promote the drug, Levadex, to neurologists and pain specialists in the United States, pending regulatory approval.
http://www.reuters.com/article/2011/01/31/allergan-idUSSGE70U0CE20110131?feedType=RSS&feedName=rbssHealthcareNews&rpc=43
None of those cases are similar to the Momenta vs. Teva case and I certainly don't think that Momenta's IP is worthless, rather I wanted to show how the courts increasingly have expanded the scope of the safe harbor provision. Patented research tools may well fall outside the safe harbor exemption.
It's true that BRCA mutations represent a very small subset (and very resistant btw) of patients with breast cancer but various other cancers are linked to these mutation.
BSI-201 (iniparib) phase III in mTNBC
I would also note that patients enrolled in the trial were sicker than those in phase II and that the trial had a cross-over design.
I thought the PARP inhibitors class was the most promising new anti cancer therapy and that they could at least allow to reduce the doses of some chemotherapy agents in treating tumors with homologous recombination deficiency, such as BRCA1/2. There’s still hope that the the concept is correct in specific cancer mutated population.
Bolar exception
A partial list of acts in which this has been extended to:
Manufacturing a device or drug; selling to institutions/hospitals to obtain PMA; testing or selling the device to international distributors for clinical trials; demonstrating the device at a trade show. (in Intermedics). Exporting the reference standards for commercial development overseas; conducting purity and safety testing; producing scaled up amounts of the drug in the U.S.; characterizing the drug (in Amgen). Using a patented process; submitting data for foreign regulatory approval after it was first submitted to the FDA (in NeoRx). Conducting product research & development activity “upstream” in product development (in Bristol-Myers Squibb).
GSK/Actelion almorexant in insomnia discontinued
http://www.bloomberg.com/news/2011-01-28/actelion-glaxo-stop-development-of-insomnia-medicine-on-safety-concern.html
After SNY's PARP inhibitor failure, I see that AZN's compound Olaparib/AZD2281 (developed by KuDOS), is now in the Discontinued Projects section in gBRCA breast:
http://info.astrazenecaevents.com/content/other/AZN-Q4-2010-Pipeline-table.pdf
Teva/APP generic Gemzar
Obviously they couldn't manufacture on their own but didn't say why.
Unfortunately, The Supreme Court expressly declined to decide whether the exemption is available for use of patented research tools so this is yet to be dealt with in future cases. Enjoyed addressing the issue with you guys from the legal department
Dunno about anything new with the patent. Perhaps the agreement with APP Pharmaceuticals took time.
Teva and APP announced today the commercial launch of Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials, the generic version of Gemzar.
http://www.tevapharm.com/pr/2011/pr_989.asp
Is the lower rate of sexual dysfunction even in Vilazodone's label?
Bolar Exception
I believe there are broader interpretations to the Bolar exception.
So what is your understanding of chapter C in #msg-59147723?
I believe "minor" vs "major" means the questions asked by the FDA are more easy ones to address plus time for the FDA response is shorter.
I don't really have a better insight as Teva didn't give the list of questions. My hunch is that Peter, Roy, and Jim will have dinner in a fancy restaurant sooner than I though.
It was just surprising to me these patents were mentioned because I read here that Teva's request to amend its complaint to include these patents was denied by the Court. I would be even more surprised if they have been discussed to support or refute an indefiniteness argument in an earlier patent because they are only related to the characterization of Copaxone by patented markers. Surely Momenta could use other markers or methods.