Share Name Share Symbol Market Type Share ISIN Share Description
Oxford Biomedica LSE:OXB London Ordinary Share GB0006648157 ORD 1P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  +0.36p +7.64% 5.07p 4.90p 5.24p 5.03p 4.69p 4.80p 7,604,109.00 16:35:13
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 15.9 -17.0 -0.5 - 156.57

Oxford Biomedica Share Discussion Threads

Showing 96401 to 96425 of 96425 messages
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DateSubjectAuthorDiscuss
30/3/2017
00:48
That's all simply great for OXB and seems to vindicate what some of us here have been waiting for for some ie a long time. I expect that we will accordingly have an RNS from OXB in due course or by Monday at the latest. Stupendous.
beanol
29/3/2017
22:22
Some notable examples from hematology/oncology (where the average time from IND to FDA approval has been pegged at 8 years): Novartis' imatinib (Gleevec) for CML -- Phase 1 trials began in June 1998, drug was approved 3 years later in May 2001 (FDA granted fast track and priority review; FDA review was a record 2.5 months) Plexxikon and Genentech's vemurafenib (Zelboraf) for melanoma -- IND in September 2006, drug was approved 5 years later in August 2011 (FDA granted fast track and priority review; FDA review was 3.6 months) Pharmacyclics and J&J's ibrutinib (Imbruvica) for MCL, CLL -- IND in October 2008, drug was approved 5 years later in November 2013 for MCL and February 2014 for CLL (FDA granted breakthrough therapy; FDA review was 4 months) "We're going to streamline the FDA. We have a fantastic person that I think I we'll be naming fairly soon. He's going to streamline the FDA and you're going to get your products either approved or not approved but it's going to be a quick process. It's not going to take 15 years," Trump told the drug company CEOs.
marcusl2
29/3/2017
21:40
Brilliant Northstand. Sign up for the Prosavin alert service please. It`s great for us, OXB but especially the future patients * Says elevates cart therapy ctl019 to group of drugs it expects will be blockbusters, with at least $1 billion in annual sales HTTPS://endpts.com/novartis-gets-a-speedy-review-for-its-car-t-pioneer-as-fda-lines-up-a-marketing-decision/
marcusl2
29/3/2017
21:36
By the skin of their teeth though CP... Still, good to see a target met - I expect they worked very hard to keep that promise.
harry s truman
29/3/2017
21:31
1st qtr 2017. True to plan :-)
cottonpickers
29/3/2017
21:26
Ha! Ha! Marcus,great news isn't it,I only signed up to the email alert service from Novartis a few days ago,1 minute past 9pm tonight and bingo!
northstand
29/3/2017
21:23
Excellent and thanks for the posts chaps. Using that previous example from Marcus (which can only ever be a guide) we can realistically hope for the decision in August and it may be much sooner if they feel that the data / case is compelling.
harry s truman
29/3/2017
21:18
Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review Print March 29, 2017 16:00 ET | Source: Novartis International AG Media release (PDF).pdf Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using their own T cells Novartis made an early commitment to the emerging field of CAR-T investigational therapies through collaboration with the University of Pennsylvania including CTL019 Novartis plans to submit an application for market authorization with the European Medicines Agency (EMA) later this year Basel, March 29, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). This is the first BLA submission by Novartis for a CAR-T. The priority review designation is expected to shorten the anticipated review time by the FDA. CAR-T is different from typical small molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen. "With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "The priority review and file acceptance of CTL019 by the FDA brings us one step closer to delivering this novel treatment option to children and young adults with r/r B-cell ALL in the United States." CTL019 was first developed by the University of Pennsylvania. In 2012, Novartis and the University of Pennsylvania entered into a global collaboration to further research, develop and then commercialize CAR-T cell therapies for the investigational treatment of cancers, including CTL019. Through the collaboration, Novartis holds the worldwide rights to CARs developed through the collaboration with the University of Pennsylvania for all cancer indications. "The past five years have seen tremendous progress in the development and application of cellular engineering in an effort to personalize the treatment of cancer," said the Penn team's leader, Carl June, MD, director of the Center for Cellular Immunotherapies in the Perelman School of Medicine at the University of Pennsylvania. "We now know that it is possible to treat patients in clinical trials across the world using this approach, and the results we have observed mark a potential new paradigm in the treatment of blood cancers that have not responded to standard therapies." The priority review designation and BLA submission for CTL019 is based on the results from the Novartis-sponsored ELIANA study (NCT02435849), the first global CAR-T cell trial with study enrollment having occurred across 25 centers in the US, EU, Canada, Australia and Japan. In the Phase II study, 82% (41 of 50) of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. The data were presented at the American Society of Hematology meeting in December 2016 (Abstract #221)[1]. Forty-eight percent of patients in the ELIANA trial experienced grade 3 or 4 cytokine release syndrome (CRS), a known complication of an investigational therapy that may occur when the engineered cells become activated in the patient's body. CRS was managed per protocol on a global scale using prior site education with implementation of the CRS treatment algorithm. There were no deaths due to CRS. Fifteen percent of patients experienced grade 3 neurological and psychiatric events including confusion, delirium, encephalopathy, agitation and seizure. No cerebral edema was reported and no grade 4 neurological and psychiatric events were observed[1]. The submission is also supported by findings from a US multicenter trial and an earlier single site trial led by the Children's Hospital of Philadelphia (CHOP) examining the safety and efficacy of CTL019 among pediatric and young adult patients with r/r B-cell ALL. Stephan Grupp, MD, PhD, from CHOP was the lead investigator of the trials. "Even if a patient has difficult-to-treat relapsed/refractory leukemia, we have seen treatment with CTL019 in clinical trials put cancer into remission," said Grupp, Director of the Cancer Immunotherapy Frontier Program and Director of Translational Research for the Center for Childhood Cancer Research at CHOP. "This could be a first-of-its-kind treatment with exciting potential to help pediatric and young adult r/r B-cell ALL patients." Acute lymphoblastic leukemia makes up approximately 25% of cancer diagnoses among children under 15 years old and is the most common childhood cancer in the US[2]. Patients with r/r ALL have limited treatment options, and the chance of survival for children with the disease who relapse or fail to attain remission is between 16% to 30%[3]. According to the FDA guidelines, Priority Review status may potentially shorten the window for the agency to take action on an application to within six months of the filing acceptance compared to a standard review. The designation aims to prioritize the evaluation of products that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions when compared to standard applications. CTL019 previously received Breakthrough Therapy designation from the FDA for the treatment of patients with r/r ALL. Novartis plans additional filings for CTL019 in the US and EU markets later this year, including a BLA with the FDA for treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL) and applications for marketing authorization with the European Medicines Agency in r/r B-cell ALL and r/r DLBCL. Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established. Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of the uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world. HTTP://globenewswire.com/news-release/2017/03/29/946535/0/en/Novartis-announces-first-CAR-T-cell-therapy-BLA-for-pediatric-and-young-adult-patients-with-r-r-B-cell-ALL-granted-FDA-Priority-Review.html
status epilepticus
29/3/2017
21:16
I am quite happy to give you a kiss if you`re up for it Northstand? HTTP://finance.yahoo.com/news/novartis-announces-first-car-t-200202645.html According to the FDA guidelines, Priority Review status may potentially shorten the window for the agency to take action on an application to within six months of the filing acceptance compared to a standard review. Novartis plans additional filings for CTL019 in the US and EU markets later this year, including a BLA with the FDA for treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL) and applications for marketing authorization with the European Medicines Agency in r/r B-cell ALL and r/r DLBCL.
marcusl2
29/3/2017
21:14
Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using their own T cells Novartis made an early commitment to the emerging field of CAR-T investigational therapies through collaboration with the University of Pennsylvania including CTL019 Novartis plans to submit an application for market authorization with the European Medicines Agency (EMA) later this year Basel, March 29, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). This is the first BLA submission by Novartis for a CAR-T. The priority review designation is expected to shorten the anticipated review time by the FDA.
northstand
29/3/2017
19:29
Ah, no worries - thought it was a slip. I think that a lot of people are waiting for news now - not just the few of us on these threads.
harry s truman
29/3/2017
19:23
Possibly, its hard to tell if the spread is close but they're listed as sells on the advfn app
sddavies1
29/3/2017
19:16
Steady buying surely SD?
harry s truman
29/3/2017
19:13
Volume looks to be mostly steady selling as well..could something be afoot (at long last!)?
sddavies1
29/3/2017
19:11
Well, I'd honestly imagined this to be on the steady slide until news - which definitely falls into the category of showing just what I know. Good volume for an ordinary day (7m+) up 7% and back in the 5's.
harry s truman
28/3/2017
22:14
Absolutely - and that seems to fit very well with all the predictions for commercial production at the end of the year.
harry s truman
28/3/2017
21:48
CTl019 news soon and a 4.5 month lapse until approval will do nicely.
marcusl2
28/3/2017
21:28
(re your previous post Marcus) True (back then) but of course time has eaten away at that original patent life and unfortunately the outcome hasn't been as hoped (with Pfizer's drug in this case, but there are parallels in our pipeline). There are sometimes ways around this which we have talked about before with patenting slightly different formulations, improvements and such, but I think the trade secret / specialist knowledge gained might end up being our biggest advantage with some of our tech. We're out of my field of expertise here, but I'm sure that a lot of the stuff we do is never going to find its way into off patent mass-production as seen with some of the generics. What we do is expensive and specialised and much more than a few mixing vessels with some active ingredients and a solvent. If it is easily copyable, then it's going to get copied anyway outside of our markets (patent or not), but I think the complexity and cost of the treatment probably self limits the likelihood of that anyway. What we need (and I can see myself getting a sandwich board and a ticket to Basel) is news from Novartis about CTL019. With that we are OK and everything else is rearranging the deckchairs on a ship that hasn't hit an iceberg. So no need to look for the SKOPOS lifeboat.
harry s truman
28/3/2017
21:20
OncLive | Nov 1, 2016 Excerpt: “The FDA granted a priority review to a new drug application (NDA) for ribociclib (LEE011) On 13 March 2017, Novartis has announced that they have received the approval from the FDA for Kisqali (LEE011) 4.5 months for approval
marcusl2
28/3/2017
21:06
Good post Doctor. Paul Blake said that they were confident about their IP. Pfizer must have thought it strong enough to licence 5T4 rights from OXB. HTTP://www.oxfordbiomedica.co.uk/press-releases/oxford-biomedica-announces-us-1-million-milestone-payment-from-pfizer/
marcusl2
28/3/2017
20:08
Thanks for that Doc.
harry s truman
28/3/2017
19:43
OXB will I think have patents for 5T4 in only certain perceived uses. Those uses may be debatable. I don't know enough about the claims vs Trovax vs CAR to have any idea about that. Cellectis has filed IP for a 5T4 CAR (which, note, goes some way to show interest in such a product), however, someone else having IP in an area (pending IP), does not mean the separate, earlier protection to OXB is any less. Impossible to say what OXB has covered or not without a detailed review. The earliest 5T4 patents will be close to expiry, if not already expired. There may not be anything to stop Cellectis/others developing 5T4 CAR and Cellectis seemingly didn't even mention OXB as a reference in that patent. One thing that can be interesting - looking to see which patents are opposed by others in Europe prior to grant. If opposed, then someone else sees it as potentially being in their way.
stocktastic
28/3/2017
19:43
Wasn't it in one of your AGM reports that you first relayed that on Pram? I seem to remember you saying something along the lines of the idea itself (of CAR-T) is actually quite old now but it's one of those things where we've had to wait for technology to catch up with the original good idea. But there have certainly been disputes with Juno and Novartis / Penn State about this therapy that ended up in court (just one example there that we actually know about because it affects us) so I'm sure as you say it's the supporting technology rather than the core idea where the protection will be.
harry s truman
28/3/2017
19:26
I was told that CAR-T patents are probably not enforceable (that may be the wrong terminology) but the process knowledge is valuable and some processes patent-able.
prambigear
28/3/2017
14:44
It is a very complicated area Marcus - almost as much so as the science - and they always seem to settle these things with some kind of horse trade too - like BN and OXB with the TroVax claim and Novartis vs Juno with the CAR-T settlement. I would have thought that being a patent lawyer specialising in biotech I.P. would keep you very gainfully employed with an earnings stream which would pay for some very nice toys. But we aren't, so there you go.
harry s truman
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