FDA newsletter web sites | DNDNQ Message Board Posts (2023)


Sign up to receive the fda newsletters. The latest one has genasense and gvax info. all spun to make it look like they are on top of things. Building a bridge you know.

This is the latest pipeline issue:

Phase III Trials

Merck: Use of Obesity Drug Contributes to Weight Loss
Data from a Phase III study of Merck’s taranabant shows obese patients experienced statistically significant weight loss when they took the drug in combination with diet and exercise, the company says.

The two-year, multinational, double-blind, randomized, placebo-controlled study evaluated the long-term efficacy and safety of 2, 4 or 6 mg of taranabant once daily for up to 104 weeks compared with placebo.

Patients taking the 2-mg dose demonstrated a mean weight loss reduction from baseline of 14.5 pounds compared with 5.7 pounds for placebo, according to Merck.

During the study, patients in the 6-mg taranabant group had to be re-randomized to the placebo or 2-mg taranabant groups after a trend toward a higher side effect profile was observed. Side effects included anxiety, depression and irritability.

Merck anticipates filing an NDA for taranabant this year.

Lilly to Begin Study of Alzheimer’s Candidate
Eli Lilly has started patient enrollment in a Phase III trial of LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer’s disease.

Investigators will test whether LY450139 can inhibit an enzyme that can create a sticky protein called amyloid beta, which scientists hypothesize could form plaques that eventually kill brain cells.

The randomized, multinational, 21-month, double-blind, placebo-controlled IDENTITY trial will enroll 1,500 patients for 21 months. Patients have the option of entering an open-label extension study upon completing the trial, Lilly said.

Acadia Begins Pimavanserin Study
Acadia Pharmaceuticals has started its second Phase III trial to evaluate the safety and efficacy of pimavanserin as a treatment for Parkinson’s disease psychosis.

The multicenter, double-blind, placebo-controlled study will enroll approximately 240 patients who will receive one of two doses of pimavanserin or placebo. The primary endpoint is antipsychotic efficacy as measured by the Scale for the Assessment of Positive Symptoms, the company said.

Acadia also is conducting an open-label safety extension study that will enroll patients who have completed either of the Phase III trials and may benefit from continued treatment.

(Video) Characterizing FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle

Safety Board Gives Thumbs Up for Genasense Trial
A Phase III trial of Genta’s Genasense in melanoma patients will continue as planned after a data safety monitoring board reviewed blinded safety data from the trial.

The randomized, multinational, double-blind, placebo-controlled AGENDA trial will confirm safety and efficacy results from a previous trial of Genasense (oblimersen sodium) plus dacarbazine in patients who have not received chemotherapy. The primary endpoints of the trial are progression-free and overall survival.

The company anticipates meeting its target enrollment of 300 patients by the fourth quarter of the year.

The board’s recommendation comes roughly two weeks after the Center for Drug Evaluation and Research decided available data were not adequate to support approval of Genasense for patients with relapsed or refractory chronic lymphocytic leukemia.

The agency recommended the company either conduct an additional trial or collect more information regarding the clinical course and progression of disease in patients from a previous trial. Genta said it plans to pursue both options.

Degarelix Demonstrates Positive Results in Trial
Data from a Phase III study demonstrated that Ferring’s investigational gonadotrophin-releasing hormone blocker degarelix produced a significant reduction of testosterone levels within three days in prostate cancer patients, the company says.

The 12-month, randomized, open-label, parallel-group study compared monthly degarelix with leuprorelin 7.5 mg. Degarelix quickly suppressed and sustained low levels of serum testosterone and prostate specific antigen when compared with leuprorelin. By day three of the study, testosterone levels were suppressed to less than or equal to 0.5 nanograms per milliliter in the degarelix arm compared with 0 percent of patients in the leuprorelin arm.

Degarelix has been studied in more than 20 studies, all of which have found the drug to be safe, well tolerated and with no evidence of systemic allergic reactions, according to Ferring.

An RxTrials Institute Audioconference Double Feature
Thursday, April 10, 2008
Branding Matters: Turn Up the Heat to Optimize Your Site's Potential
11:00 a.m. – 12:30 p.m. EDT
Getting the Most Out of Your Recruitment & Retention Provider:
All R&R Providers Are Not Created Equal
1:30 p.m. – 3:00 p.m. EDT
Sign up now for this audioconference double feature from RxTrials Institute, and tune in to this one-day-only "live bootcamp" on the basic training skills that are essential to every site's success. You'll tap the minds of two top research site strategists — Margo Whitley of Anderson Whitley and Melynda Geurts of D.L. Anderson International, Inc. — for a total of three full hours devoted to making your site the best it can be ... right from the comfort of your own office!
Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Adverse Event Compliance in Drug and Biologic Clinical Trials, this management report from FDAnews gives dependable guidance on adverse event reporting specifically for drug and biologic companies. Make sense of the key rules and requirements of the FDA and the OHRP and find out what the FDA considers a reportable effect.
To order, go to http://www.fdanews.com/rxti/store/product/detail?productId=24183.

Strategic Money Management for Sites:
Examining Budgets, Contracts and Cash Flow
Presented by RxTrials Institute
April 8–9, 2008 • Orlando, FL
June 19–20, 2008 • Baltimore, MD
Sept. 17–18, 2008 • Chicago, IL
Dec. 9–10, 2008 • Baltimore, MD
You're invited to register your research site team for a hands-on, two-day intensive workshop that reveals how you can control hidden costs at your site (once and for all) through strategic money management. Discover techniques that can transform you into a skilled and successful negotiator ... review actual study budgets ... watch as the "real costs" of running your next clinical trial are exposed and so much more.
Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Phase II Trials

Infectious Diseases
Rabies Cocktail Enters Phase II Trial
Dutch biotechnology firm Crucell has achieved its first milestone with the start of a Phase II trial testing the company’s rabies monoclonal antibodies in combination with a sanofi pasteur rabies vaccine for post-exposure prophylaxis.

The randomized, single-blind, controlled study in 140 healthy volunteers will compare the combination with placebo or the currently marketed human rabies immune globulin plus the vaccine.

Under a December 2007 agreement between the companies, Crucell is responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations.

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According to Crucell, sales for the rabies antibody cocktail could exceed $300 million.

Avant Vaccine Meets Endpoints in Trial
Avant Immunotherapeutics’ Phase II trial of its typhoid fever vaccine Ty800 has met all primary endpoints.

The double-blind, placebo-controlled, multicenter study was an outpatient, dose-ranging trial in 183 healthy volunteers that evaluated two dose levels of the vaccine and followed each subject for six months post-vaccination. The endpoints of the study were to determine the optimal dose of Ty800 for further development.

Data from the trial showed that the vaccine was well tolerated and the desired immune response was achieved, Avant said. Incidence of reactogenicity symptoms and adverse events post-vaccination were similar to placebo, and positive immune response rates were observed in 65.5 percent and 80 percent of patients in the low and high dose groups, respectively.

Avant said it is advancing its pipeline toward creating a “super combination traveler’s vaccine” to protect against multiple bacterial diseases, including cholera, typhoid, enterotoxigenic E. coli and paratyphoid.

Behavioral/Mental Health
Synosia to Evaluate Anxiety Treatment
Swiss drugmaker Synosia Therapeutics has started a Phase II trial to evaluate the efficacy of SYN-111 (rufinamide), a sodium channel blocker, as a potential treatment for general anxiety disorder.

The eight-week, double-blind, placebo-controlled study will assess the efficacy and tolerability of the drug in up to 230 patients. Patients taking rufinamide will receive a 250-mg dose twice daily for one week followed by a 500-mg dose twice daily for seven weeks, Synosia said.

The company obtained SYN-111 development and commercialization rights from Novartis last year. Rufinamide is marketed by Eisai in Europe as Inovelon as a treatment for a form of epilepsy.

MediciNova to Study Asthma Candidate
MediciNova has started a Phase II trial to determine the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma.

The randomized, single-blind, placebo-controlled, dose-escalation trial will involve approximately 36 patients in the U.S. and Puerto Rico. Each patient will receive MN-221 or placebo administered through a continuous infusion in addition to the standardized care and be assessed for treatment response.

The initial dose group will receive MN-221 16 micrograms/minute for 15 minutes or placebo. Subsequent dose groups may receive 30 micrograms for 15 minutes or placebo and 16 micrograms/minute for 15 minutes followed by 8 micrograms for 105 minutes or placebo, the company said.

MediciNova licensed MN-221 from Kissei Pharmaceutical for global markets excluding Japan. The company also is testing the drug as a treatment for preterm labor.

NeoPharm Enrolls Patients in Breast Cancer Study
NeoPharm has begun a Phase II trial with liposomal paclitaxel in patients with metastatic breast cancer.

The company has developed the liposomal formulation to improve the safety profile of paclitaxel formulations by eliminating the need for such toxic excipients as Cremophor and ethanol, which must be co-administered to help decrease unwanted side effects.

The open-label, multicenter outpatient study is designed to evaluate the antitumor effect, safety and tolerability of liposomal paclitaxel in approximately 35 patients with histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.

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The primary objective of the trial will be to assess the overall response rate after treatment with a dose of 275 mg/m2 administered over 90 minutes. Other objectives include progression-free survival and the safety, NeoPharm said.

Clinical Trial Site Selection: Strategies to Gain a Competitive Advantage makes sure the research sites you select will meet your needs. You'll discover proactive pointers to help you find out — fast — if a research site can recruit the subjects you need, think outside the "draft protocol" box, and make sure that your sites share risk with you.
To order, go to http://www.fdanews.com/rxti/store/product/detail?productId=23729.

Achieve Operational Efficiency for Your Site:
How to Start or Improve Your Clinical Research Practice
Presented by RxTrials Institute
June 17–18, 2008 • Dec. 11–12, 2008
Baltimore, MD
You're invited to register your research site team for Achieve Operational Efficiency for Your Site, the hands-on, two-day event that delivers new tips, tools and how-to techniques to boost your research site's performance and profitability. Discover solid strategies to help you command "preferred site status," see where your site stands now with up-to-date performance benchmarks, take home site readiness checklists, compliance blueprints and so much more.
Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Clinical Trials Online Library
With regulatory requirements rapidly changing, you'll need to give your trial staff fast, on-site access to the answers they need ... if you want to guarantee a safe and effective clinical trial. The answers you need are as close as your nearest trial-site computer — when you order the Clinical Trials Online Library, your staff saves time with searchable access to these FDAnews books and management reports, plus key regulatory documents.
To order, go to http://www.fdanews.com/rxti/store/product/detail?productId=23131.

Phase I Trials

Seattle Genetics Expands SGN-35 Program
Seattle Genetics has started a second Phase I trial of SGN-35 in patients with Hodgkin lymphoma and other CD30-positive hematologic malignancies.

The study will evaluate escalating single-agent doses of SGN-35 administered weekly to patients with relapsed or refractory CD30-positive hematologic malignancies. Following the monotherapy portion of the study, the trial will continue with an investigation of SGN-35 in combination with Gemzar (gemcitabine).

The trial is expected to enroll up to 40 patients at multiple centers in the U.S., Seattle Genetics said.

First Patient Dosed in Trubion’s CLL Trial
Trubion Pharmaceuticals has begun a Phase I/II trial with TRU-016 in treatment-experienced chronic lymphocytic leukemia (CLL) patients.

The open-label trial will include a Phase I dose-escalation study to evaluate TRU-016’s safety, tolerability and pharmacokinetics and a Phase II expansion cohort to estimate the drug’s clinical activity.

Peter Thompson, Trubion’s president, CEO and chairman, said the drug has demonstrated potent antitumor activity in preclinical studies and may help patients when used alone or in conjunction with chemotherapy or CD20-targeted immunopharmaceuticals.

Cardiovascular Health
Takeda Discontinues Development of Cholesterol Drug
Japanese drugmaker Takeda Pharmaceutical will stop the development of TAK-475, an investigational compound studied for the treatment of hypercholesterolemia.

The decision comes after the FDA requested last October that the company submit additional clinical trial data for TAK-475 (lapaquistat acetate) and suspend studies with higher doses of the drug.

Takeda said it has decided that the profile of the compound is not superior to existing marketed drugs from efficacy and safety viewpoints following a review of clinical data.

AstraZeneca Halts Crestor Trial After Early Success
AstraZeneca is stopping a trial of its cardiovascular drug Crestor based on evidence of a reduction in cardiovascular morbidity and mortality among patients who took the drug compared with placebo.

(Video) CDER BIMO GCP Compliance and Enforcement

The JUPITER study’s independent data monitoring board and steering committee recommended the clinical trial be stopped early due to Crestor’s (rosuvastatin calcium) success. The trial was designed to determine if patients with no evidence of pre-existing cardiovascular disease, low-to-normal LDL cholesterol and elevated C-reactive protein who took 20 mg of Crestor once daily would suffer fewer major cardiovascular events.

The multinational study is part of a global research initiative, the GALAXY program, which has enrolled more than 64,000 to investigate the impact of Crestor on cardiovascular risk reduction and patient outcomes, AstraZeneca said.

Cell Genesys, Takeda to Collaborate on Prostate Cancer Therapy
San Francisco-based Cell Genesys has signed an agreement with Japanese firm Takeda Pharmaceutical to cooperate on the development and commercialization of GVAX immunotherapy for prostate cancer, its lead product candidate in Phase III development.

In exchange for exclusive worldwide commercial rights to the GVAX immunotherapy, Takeda will pay Cell Genesys $50 million upfront and up to $270 million based on the approval and commercialization of the product in the U.S., the European Union and Japan.

Takeda will pay for all external development costs associated with the ongoing Phase III development of GVAX. Cell Genesys will maintain responsibility for the worldwide manufacture and supply of the product and will retain rights to co-promote the drug in the U.S.

Third Annual Site Solutions Summit
Presented by RxTrials Institute
Oct. 17–19, 2008 • The Sandpearl Resort • Clearwater Beach, FL
It's the only summit of its kind to deliver hands-on solutions to the specific challenges that your clinical research site faces today. And, this year, we will be holding multiple, 40-minute roundtable sessions where you can share what's working for you and hear what's working for your peers in the industry. You'll have the opportunity to attend three roundtables and choose from over a dozen different topics.
Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Lower Your Site Risk Potential (SRP) Score
Lower Your Site Risk Potential (SRP) Score zeroes in on what this risk-ranking model is and how FDA is using it to classify manufacturing plants and prioritize enforcement. This new management report also goes a vital extra step, showing you how to implement practical strategies that can reduce your score, limit inspections and unlock a host of valuable new business benefits.
To order, go to http://www.fdanews.com/rxti/store/product/detail?productId=23141.

Negotiating a Clinical Trial Budget helps you find out how to strengthen the critical — and frequently overlooked — connection between your trial site's cash flow and contract terms, as you use a step-by-step approach to structure your trial site's payment schedule, determine the true cost of running your clinical trial with these cash flow analysis techniques, and quickly see how clinical trial site payment terms — current and future — ultimately predict your site's success.
To order, go to http://www.fdanews.com/rxti/store/product/detail?productId=23727.

A Federally Funded Institute to Compare Drugs? (Pharmalot)
In his blog, Ed Silverman writes about a Reuters report on a proposal by Sens. Max Baucus (D-Mont.) and Kent Conrad (D-N.D.) to establish an independent institute to compare the effectiveness of drugs and devices.

A study by the Lewin Group for the Commonwealth Fund found that such comparative research, when used appropriately, could cut national health spending by $370 billion over 10 years, economist Stuart Guterman, who is with the fund, told Reuters.

“The bill is expected to propose funding of $200 million annually within five years. The institute would be governed by a board with officials from government, nonprofit groups, doctors, patients and industry. ‘Ultimately it’s better to target our healthcare dollars using comparative effectiveness rather than just cutting back because it’s so expensive,’ Steve Wojcik, policy advisor for the National Business Group on Health, tells Reuters,” Silverman writes.


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RxTrials Institute Drug Pipeline Alert (ISSN 1551-8795) is published weekly.
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