Omeros reported positive results of its phase 2b trial using OMS302

Omeros annonuced that the phase 2b trial using OMS302 to maintain pupil dilation (intra-operative mydriasis), to reduce operative pain and irritation in patients undergoing cataract and other lens replacement surgery met the study's primary endpoint.

The trial conducted in 221 patients showed that OMS302 significantly maintain mydriasis throughout the procedure when it was compared to OMS302-mydriatic agent only and other groups.  In addition, OMS302 also significantly reduce early postoperative pain when compared to OMS302-anti-inflammatory-agent alone and other groups.

The study was a multicenter, randomized, double-blind vehicle

KaloBios initiated the phase I trial using KB004

KaloBios announced that it has initiated the phase 1 clinical trial using KB004 in patients with EphA3-positive hematologic malignancies (chronic myelogenous leukemia, acute meylogenous leukemia, acute lymphocytic leukemia, and myelodysplastic syndromes).

About the trial:

• It's a multi-center, open-label phase 1 trial to evaluate the maximum tolerated dose in patients using KB004
• Enrollment target 39 patients with up to 24 patients will be enrolled in the dose-escalation phase in which patients will receive of the four dose levels once a week for three weeks.  The maximum number

SCT: Qualitest of Endo received FDA approvals for torsemide

Qualitest announces that its generic version of Demadex has been approved by the US FDA. (Note: Endo website has misspelled the drug name: instead of torsemide, it was spelled as toresmide - when I first read it, I thought it was a bit weird because it was pronounced differently as I remember.  In anycase, torsemide is the correct way to spell the medication).

Demadex is the brand name for torsemide which has been approved for the treatment of edema associated with congestive heart failure, renal disease, or liver disease.  The medication is also approved to be used as

Yervoy of Bristol-Myer Squibb has been approved by the FDA

The FDA has approved Yervoy or ipilimumab of Bristol-Myers Squibb for the treatment of late-state or metastatic melanoma.

About ipilimumab: 

• Ipilimumab is a monoclonal antibody that block cytotoxic T-lymphocyte or CTLA-4 which has been associated with its ability to slow down or turn off the immune system and hence could possibly make the body unable to fight off the cancerous cells.  

• Most common side effects that have been reported: fatigue, diarrhea, skin rash, endocrine, certain deficiencies in gland or hormone and inflammation of the intestines

SCT: GSK stops pursuing the development of Avodart for prostate cancer globally

GSK announced that it will not pursue the development of Avodart (dutasteride) as potential agent to reduce risk of prostate cancer globally.

GSK will voluntarily withdraw all regulatory approval applications for the proposed indications.  In addition, GSK will also work with regulatory agencies in countries that have already approved Avodart as agent that can be used to reduce risk of prostate cancer to remove this indication from the package insert. 

The decisions came after the FDA and the Swedish MPA (the reference member state in Europe) said they were unable to approve Avodart for the proposed indications due to lack of clinical evidence and potential risk

PharmaPodia introduces Short Communication Topics

Introducing: Short Communication Topics

Didn't I say this site will always evolve?  At times, it's appropriate to go in details for certain post.  Sometimes, the short news would do the trick.

Here it is: PharmaPodia introduces Short Communication Topics or SCT.

So what is SCT technically?

• SCT is a brief news update that would allow PharmaPodia to update our readers about the constant news releases that have been put out through companies/media.  It's almost like a short communication.  

• The reason we introduces SCT is to provide our readers a short but succinct news update about certain companies/drugs/compounds.  

• We hope this will be useful for readers who would like to know what is going on but don't have time to read though the long/detail posts and the headlines would help to do just that. 

• So are we still writing the long post with detail information?  Of course because this is what PharmaPodia is about.  

With that, PharmaPodia wants to thank you for your supports! 


Best,

PharmaPodia

Targacept releases preliminary results for TC-5619's phase II trial

Targacept reported that the top-line results from its phase II trial using TC-5619 in adult patients diagnosed with ADHD did not meet the study's primary endpoint.    ADHD: Attention Deficit/Hyperactivity Disorder.  The difference or change in Conner's Adult ADHD Rating Scale-Investigator Rated Total ADHD Score Symptoms Score (CAARS-INV) were not significant. 

About the trial:

• It's a double-blind, placebo controlled, forced titration phase II trial that enrolled 135 non-smokers evaluating TC-5619 against placebo in the treatment of ADHD.
• Dosing and Administration:
• TC-5619 were dose at 1 mg daily for the first four weeks, 5 mg daily for the next four weeks and 25 mg daily for the last four weeks.  
• The primary efficacy outcome: change from baseline on CAARS-INV after 4, 8, and 12 weeks of dosing compared to placebo.
• The results showed that the change in CAARS-INV scores at weeks 4,8, and 12 from baseline were not significantly different between the TC-5619 group and placebo group. 
• For its secondary efficacy measures, the study used the p-value of less than 0.1 to detect significant

Nordion Pharmaceuticals initiated the phase III trial of its approved TheraSphere in new patient poulation

Nordion Pharmaceuticals announced that it has initiated the phase III trial using TheraSphere for potential treatment of colorectal cancer patients.

About the trial:

• The trial is a randomized clinical study that plans to enroll up to 350 patients at approximately 30 sites worldwide.  The trial name is EPOCH which will evaluate the safety and effictiveness of TheraSphere in patients with colorectal cancers that have spread to the liver.
• Patients will be randomized into two treatment groups:
• Group A: TheraSphere and second-line chemotherapy
• Group B: chemotherapy only

About TheraSphere:

• TheraSphere is a considered as a medical device and is approved by the FDA under a Humanitarian

Merck has returned all rights for betrixaban to Portola Pharmaceuticals

Portolo Pharmaceuticals announced that Merck has returned all rights for betrixaban to Portola Pharmaceuticals.  Portola Pharmaceuticals intends to continue the development of betrixiban in the future.


About betrixaban:

• Betrixaban is an investigational oral factor Xa inhibitor.  It's being developed for the prevention of stroke in patients who have been diagnosed with atrial fibrillation. It is metabolized minimally through the cytochrome P450 and i

AcelRx released financial earnings

AcelRx Pharmaceuticals announced the results of the fourth quarter and full-year 2010 financial results with a net loss of 14.3M, a 5.8M decrease from the net loss of 20.1M in 2009.

AcelRx also announced that it plans to initiate the phase 3 programs for ARX-01 to be used in acute post-operative pain.  The company plans to initiate the first trial in the second half of 2011 in patient undergoing abdominal surgery.  The second phase 3 trial will compare ARX-01 to intravenous administration of morphine via PCA (which is the current standard of care) in early 2012.  The results are expected in the first half of 2012. 

AcelRx currently has 3 products in development:

• ARX-01: contains the active ingredient sufentanil incorporated into the NanoTab  that will be put into the PCA System.  Delivery method: sublingual.  Phase 3 development is planned. Instead of receiving intravenous morphine, patients will use the novel hand-held PCA system in order to administer the medication to relieve pain.
• ARX-02: contains the active ingredients sufentanil incorporated in the NanoTab that will be used for breakthrough pain.  The Breakthrough pain System will contain 30 single dose applicators.  Each dose will contain 1 tablet of sufentanil Nanotab.
• ARX-03: is the combination of sufentanil and triazolam that have been formulated into NanoTab and can be used sublingually for mild sedation, anxiety reduction and pain relief in patients who are prepared to have pain procedure at the doctor's office.  The combination will be administered by healthcare professional. 
• Both the development of ARX-02 and ARX-03 will be put on hold until additional funding is available.  Both are in phase 2 developments.

	4th quarter 2010	4th quarter 2009	Change
Net income (loss)	(3.5M)	(3.7M)	0.2M
Research and Development	1.88M	2.32M	0.54M
General Administrative expenses	0.96M	1.02M	0.06M

	Full year 2010	Full year 2009	Change
Net income (loss)	(14.3M)	(20.1M)	5.8M
Research and Development	8.19M	15.5M	7.31M
General Administrative expenses	3.99M	3.53M	0.46M
Cash, Cash Equivalents & Short-term investments	3.7M	12.5M	8.8M

Actavis received the FDA approval for valacyclovir

Actavis announced that it has received the US approval for valacyclovir hydrochloride tablets: 500 mg and 1 gram.

Valacyclovir generic has already been available on the market.  Although the market of valacyclovir is diverse,  many other generic markers have already entered the market.  This entry into the billion dollar market (sales of valacyclovir reached 1.5B in the 12 months ending December 31, 2010) will bring some revenues into Actavis however this will also depend on how it will negotiate with other wholesalers.

About valacyclovir:

• Valacyclovir is a generic name for Valtrex which is marketed by GlaxoSmithKline (GSK).
• Valacyclovir is a nucleoside analogue DNA polymerase inhibitor that has been approved to be used as followed:
• In Adults: cold sores, genital herpes, recurrent episodes, suppressive therapy,

Sucampo acquires additional development and commercialization rights of Unoprostone Isopropyl

Sucampo announced that it has acquired additional development and commercialization rights to Unoprostone Isopropyl or Rescula from R-Tech Ueno in European Union and Switzerland.  This means Sucampo will have rights to Rescular in the US, Canada and all countries in Europe as well as other countries in the world except Japan, Korea, Taiwan and the People's Republic of China.  The agreement gives Sucampo rights to develop Rescula for all indications.

Under the agreement, Sucampo will pay RTU a 3M in upfront payment.  RTU will be eligible to receive additional milestone payments as Unoprostone Isopropyl moving through clinical and regulatory developments

InSite Vision released positive results of the phase 1/2 trial using its ISV-303

InSite Vision announced positive results from the phase 1/2 trial using its ISV-303 to reduce pain and inflammation after cataract surgery.

Based on the positive results, InSite Vision plans to meet with the FDA to discuss the possible design for the pivotal phase 3 program for ISV-303 given once a day.

In addition, a phase 2 pharmacokinetic comparing ISV-303 once a day with Bromday is planned.  Bromday of Ista was approved last year and Ista is in the process of replacing all Xibrom products with Bromday after the approval.

About the trial:

• It's a randomized, four-arm trial comparing ISV-303 given once a day or twice a day against Xibrom given twice a day and DuraSite given twice a day in patients undergoing cataract surgery. 
• Total number of patients enrolled in the study: 169 patients.
• The study primary endpoint: absence of cells in the anterior chamber of the eye at day 15 post surgery. 

Vismodegib showed positive results in phase II trial - regulatory submission planned

Curis announced that the phase II pivotal trial using GDC-0449 for the treatment of advanced basal cell carcinoma met the trial's preimary endpoint.  The trial was conducted by Roche and Genentech.

Roche intends to submit the marketing application or new drug application in 2011 for vismodegib.

About the trial:

• It’s an international, single-arm, multi-center, two-cohort, open-label phase II trial (ERIVANCE BCC/SHH4476g) evaluating the efficacy of vismodegib in 104 patients who have been diagnosed with advanced Basal Cell Carcinoma (metastatic or locally) and whom surgeries would lead to severe deforminty.
• Dosing and Administration: 
• 150 mg vismodegib once a day was given to all patients enrolled in the study
• The study primary endpoint: overall response rate (tumor shrinkage) as assessed by independent reviewers
• Secondary endpoints: overall response rate assessed by study investigators, duration

Rexahn enrolls 100 patients in its phase IIb trial

Rexahn announces that it has enrolled 100 patients in the phase IIb trial using Serdaxin for the treatment of major depressive symptoms.  The trial was initiated in Jan 2011 and it planned to enrolled up to 300 patients.

The company expects to complete enrollment of the trial in the first half of 2011 and the preliminary results are expected in late 2011.

About the trial

• The phase IIb trial is a randomized, double blind, placebo-controlled study evaluating

Cumberland completes the launch of Acetadote

Cumberland announces that it has completed the launched of Acetadote or acetylcysteine injection which has been approved to be used in acetaminophen poisoning in the US.

Acetadote is a proprietary formulation that does not contain ethylene diamine tetracetic acid or EDTA or other chelating or stabilization agents.  The product has been stocked at wholesalers what serve hospitals across the country.

Cumberland announces that it is currently working with the USPTO in regard to protect the new formulation of acetylcysteine injection.

Cumberland has also submitted the supplemental NDA of Acetadote for its use in patients with liver

Xoma's Phase IIb trial did not meet primary endpoint

Xoma Ltd announced that its phase IIb trial using XOMA052 in patient with type 2 diabetes did not meet the study primary endpoint.

Xoma recently reported its full-year financial results with net loss of 68.8M at the end of Dec 31, 2010 (which was a significant decrease from a net income of 0.6M at the end of Dec 31, 2009).  The company had total revenues of 33.6M in 2010 which is a 64.8M decrease from 2009.  The company had 37.3M in cash and cash equivalent as of December 31, 2009.

The company plans to initiate the phase 3 trial using XOMA052 in the treatment of Behcet's uveitis in 2011.  Based on the result, it also plans to start the phase 2 trial using XOMA052 as potential treatment for

BioStar Pharmaceuticals sets date to release its financial results

BioStar Pharmaceutical will release its fourth quarter and full year financial results on March 25, 2011.  The company will also hold a conference call at 10:00 am EST on the same date. The company stock is currently traded in the NASDAQ: BSPM.  In the past year, it has risen to as high as 5.51 and has also hit to the bottom of 1.62. 

To access the phone call on Friday, March 25, 2011:

• US residents can call:
• 1-877-941-4775
• International residents can call:
• 1-480-629-9661
• Conference ID: 4427253

A replay will be available until April 1, 2011. To access the playback:

Auxilium entered into a strategic alliance agreement with Asahi Kasei Pharma

Auxilium announced that it has entered into an agreement with Asahi Kasei Pharma to develop, commercialize and supply Xiaflex (R) in Japan.  Based on the terms of the agreement, Asahi Kasei Pharma will have exclusive rights to commercialize Xiaflex for the treatment of Dupuytren's contracture and Peyronie's disease in Japan.  In addition, the company will also be responsible for all clinical and regulatory development and commercialization of Xiaflex in Japan.

Upon singing the agreement, Auxilium receives an upfront payment of $15M.  The company is eligible to receive up to $247M which is composed of $37 milestone payment related to development and regulatory milestones and the other $210M milestone payment related to sales milestones.  The company is also eligible to receive tiered double-digit royalties based on sales of Xiaflex in Japan.  In addition, Xiaflex will be provided to Asahi Kasei Pharma at a predetermined cost.

In 2010, Auxilium initiates the phase III trial using Xiaflex as potential treatment for Peyronie's disease.  The company expects to have top line data in the first half of 2012.  The company will continue to be responsible

The FDA accepts the Supplemental Application for Zevalin of Spectrum Pharmaceuticals

Spectrum Pharmaceuticals announced that the FDA has accepted its Supplemental Application for Zevalin which requests the FDA to remove the Bioscan requirement (which is the Indium-111 Zevalin).

The FDA has announced that the PDUFA date for the application submitted by Spectrum in Jan 20, 2011 is November 20, 2011.

About Zevalin

• Zevalin or ibritumomab tuixetan is an intravenous administration that has been approved to be used in the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieves a partial or complete response to first-line therapy.  Zevalin has also been approved for the treatment in

Cephalon acquires Geminx X

Cephalon signed a definitive agreement with Gemin X to acquire all outstanding capital stock of Gemin X for 225 million in cash on a cash-free, debt-fre basis.

Under the agreement, Gemin X stockholders are eligible to receive up to $300 M in cash payments as Gemin X’s products move through regulatory and achive certain sales milestones.

The companies expect to have the acquisition completed in the second quarter of 2011.

About Gemin X

• Gemin X is a biopharmaceutical company focusing its resources to develop therapy for oncology indication.   The company currently develops obatoclax (GX-15-070) for the treatment of extensive stage

Additional clinical data are needed for Zybrestat of Oxigene

Oxigene announces that during the Type C meeting taken on March 6, 2011, the FDA stated additional clinical data are needed for Zybrestat or fosbretabulin for its use in the treatment of anaplastic thyroid cancer (ATC).

In addition, the company said the Special Protocol Agreement between the FDA and Oxigene is no longer effective. 

Oxigene conducted a study in 84 patients diagnosed with anaplastic thyroid cancer who were treated with Zybrestat.  The result showed that approximately 24% of patients lived one year or longer which was more than historical rates of patients (only less than 10% of patients with anaplastic thyroid cancer survived one

Cell Therapeutics initiates the pivotal trial for pixantrone

Cell Therapeutics announced that it has initiated the pivotal trial using pixantrone for potential treatment with relapsed/refractory Diffuse Large B-cell lymphoma.  The trial is named PIX-R or PIX 306.

The company has submitted its appeal to the FDA in regard to the decision from the FDA on its NDA in December 2010.    Since then the company has met with the FDA in March 2011.  The company stated that the FDA asked for additional analyses from the phase III PIX301 trial  which Cell Therapeutics plan to submit in order to provide the FDA more information to make the decision on its NDA.

The PIX-R or PIX306 trial  can be used either as post-marketing commitment trial or a follow-on pivotal trial

XenoPort discontinued the development of arbaclofen placarbil for the treatment of GERD

XenoPorts reported results from its phase 2b trial using arbaclofen placarbil as an adjunctive treatment for patients who have been diagnosed with GERD but did not have their symptoms resolved after taking Proton Pump Inhibitors.

Based on the result, the company decided to discontinue the development of arbaclofen placarbil for the treatment of GERD.

The company stock drops almost 10% (0.6 cents) after the news release.  XenoPort stocks are traded in the NASDAQ as XNPT

The company hosted a conference called on March 21 at 9:00 AM EST.  The replay can be accessed here

To access the replay by phone:

• Domestic callers: 1-800-642-1687
• International callers: 706-645-9291
• Reference number: 53835577

The replay will be available for approximately one month after its release.


About the trial:

• It's a randomized, double-blind, placebo-controlled trial evaluating the following treatments:

Insmed received FDA clearance of its IND for the Pivotal phase III trial using Arikace

Insmed received FDA clearance of its IND for the Pivotal phase III trial using Arikace in nontuberculous Mycobacteria indication.

The company intends to start the phase III trial in the second half of 2011.



About Arikace:

• Arikace is an inhalation formulation of liposomal amikacin developed by Insmed.  The new formulation allows amikacin to be released in the lung at a longer time and hence minimizing the drug systemic exposure.  
• The investigational formulation is currently being studied with the eFlow Nebulizer system developed by PARI Pharma GmbH.  
• Arikace has been granted the orphan drug status by the US FDA and European Medicines agency for its use in cystic fibrosis patients with Pseudomonas infections. 
• Insmed intends to file for the orphan drug designation in the US and Europe with the FDA and EMA respectively for its use in the treatment of nontuberculous mytobacteria infection at the lung by the end of 2011. 
• Amikacin is currently available as injection solution for the treatment of short-term infection caused by gram-negative bacteria.

Nektar initiates the phase I trial using NKTR-181

Nektar announces that it has initiated the phase I trial using NKTR-181 for the treatment of pain. The company plans to have the trial completed in the second half of 2011.

About the trial:

• It is a single-dose phase I trial studying the pharmacokinetics, pharmacology, safety and efficacy of NKTR-181 in healthy volunteers.  
• The trial plans to enroll up to 75 healthy subjects.
• The trial primary endpoint: pain relief evaluated using standard measurement and CNS effects such as euphoria, respiratory depression and pupillary response.

About NKTR-181

• NKTR-181 is a novel mu-opioid analgesic investigational drug candidate developed by Nektar using its small molecule polymer conjugate technology.  The technology developed by Nektar can also prevent the product from being abused once it reaches the market.  
• It is designed so that it can cross the blood brain barrier at a lower rate than other opioid therapy.  The company stipulates that because of the lower rate of transmission, it might be able to reduce the euphoria effect that have been associated with opioid abuse liability and dependence as well as other CNS side effects such as respiratory depression and sedation.

The FDA advisory committee recommends the approval of Pipeline(TM) embolization device of Covidien

Covidien announced that the FDA advisory committee has voted to recommend the approval of its Pipeline(TM) embolization device.

Pipeline(TM) Embolization Device is develop to divert the blood flow from going to the aneurysm.  The device has been studied in the trial called The Pipeline for Uncoilable or Failed Aneurysms (PUFS) that enrolled 108 patients who had large and giant, wide-neck or fusiform aneurysms typically not coilable.  The study endpoints

Gilenya is now approved in the EU

Novartis announced that it has received European Comission approval to market Gilenya for the treatment of multiple sclerosis in the EU.

Gilenya has just received the Canadian Approval in 2011 and US approval in 2010

The approval came from the results of the trial showing that Gilenya was superior to beta-1 alfa intramuscular injection in reducing relapses at one year.  When compared to placebo, Gilenya has also been shown to significantly reduce the risk of disability progression in a two year study.  It has also been shown to significantly reduce brain lesion activity in other clinical studies.

About Gilenya or fingolimod

• Gilenya or fingolimod is the sphingosine 1-phosphate receptor modulator.  It works to retain certain white blood cells from going to the central nervous system and prevent the attack of these white blood cells at myelin and fatty substances by binding to sphingosine 1-phosphate receptors (1,3,4,5).  As a result, this leads to the reduction in the frequency of multiple sclerosis relapses.  Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation
• Fingolimod is a prodrug and is required to be metabolized by sphingosine kinase before it can become an active ingredient.
• Supplies: 0.5 mg capsules
• Most common adverse reactions (over 10%):  headache, influenza, diarrhea, back pain, liver transaminase elevations and cough
• Full indication:  It is approved to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis.
• Some concerns: Patients might experience a decrease in heart rate as a result for patients who will be started on fingolimod, they will need to be monitored at the doctor office for 6 hours after the first dose.  The decrease in heart rate is transient and it will return to normal within a month.
• Patients taking fingolimod are also at risk of contracting certain infections due to a decrease in lymphocytes (white blood cells) circulating in the blood.  Careful measure needs to be taken in order to prevent infection from hapenning.
• Patients might experience macula edema.  Regulator eye exams are required while patients taking fingolimod.

Zogenix received patent extensions for its Sumavel DosePro

Zogenix announced that its new received patent extension (US patent number 7,776,007) covering Sumavel DosePro (sumatriptan injection) has been recorded into the US FDA Orange Book.  The patent is expected to expire in 2025 (an additional 8 years from the previous listed patents for Sumavel DosePro).

About Sumavel DosePRo

• Sumavel DosePro is a brand of sumatriptan injection that has been approved in the US to be used for the acute treatment of migraine and cluster headache.  The drug was originally approved in Jan 2010.  Zogenix is currently co-marketing it with Astellas Pharma.
• Sumavel Dose Pro is supplied in the needle-free delivery system.  The system will deliver 6 mg of

Biodel announced developments of its new insulin formulations

Biodel announced that it has selected two new formulations of recombinant insulin that it will use to move into clinical development.  The two new formulations are dubbed BIOD-105 and BIOD-107.

Both of them are designed to exert a more rapid insulin response than other marketed meal time insulin analogs. 

The company plans to initiate the phase 1 trial in 18 type 1 diabetes patients using both formulations.  Trial completion is expected to be in the third calendar quarter of 2011.  If the trial shows positive response, Biodel plans to initiate the phase II trial in type 1 diabetes patients in the fourth calendar quarter of 2011.

About the trial:

• It will be a double-blind, three-period cross over trial.  Patients will receive all three regimens (at different time): BIOD-105, BIOD-107 and Humalog.
• The trial aims to evaluate the pharmacokinetic, pharmacodynamic and tolerability profiles of these two new formulations compared to Humalog.If the trial

Jevtana of sanofi-aventis has been approved in the EU

Sanofi-aventis announced that the European Commission has approved Jevtana or cabazitaxel for its use in the treatment of advanced second-line prostate cancer.

The decision came from the result of the phase III TROPIC trial  showing that Jevtana significantly increased overall survival in patients with metastatic hormone-refractory prostate cancer (mHRPC) who have been previously treated with a docetaxel-contaiming regiment.

About the trial

• It's multinational, randomized controlled evaluating the safety and efficacy of cabazitxel in combination with prednisone against the combination of mitoxantrone and prednisone.
• Dosage and administration:  
• cabazitaxel group:
• prednisone 10 mg a day
• cabazitaxel 25 mg/m2 every 3 weeks given intravenously
• mitoxantrone group
• prednisone 10 mg a day
• mitoxantrone 12 mg/m2 every 3 weeks given intravenously
• Primary endpoint: overall survival
• Secondary endpoints: progression-free survival, response rate, pain measures, and safety

Repligen announced positive results of the phase III trial using its RG1068

Are you going into the era of imaging for diagnostics?

Repligen announced positive results for its phase III trial using RG1068 in pancreatic imaging.

Repligen held a conference on the date the news was announced.  To access the replay of the webcast here


About the trial:

• It was a multi-center, baseline controlled, single dose trial enrolled 258 patients at 29 clinical sites in the US and Canada.  Patients in the trial received MRI of patients' pancreases with or without RG1068 and an endoscopy separately as a diagnostic reference.  What this means is: each patient received both

FDA Approval - March

Drug Approval for March has been updated!

March Approval


Enjoy!

Pharmapodia