On August 28, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has approved FoundationOneLiquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours (Press release, Hoffmann-La Roche, AUG 28, 2020, View Source [SID1234564135]). FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised treatment plan for each individual patient based on the specific mutations identified.

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As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing.

"Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling," said Levi Garraway, M.D., Ph.D., Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. "The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease."

FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.

"With the acceleration towards precision therapy approaches, it is important that physicians have the highest quality tools that can provide an accurate picture of their patients’ cancers in a timely manner," said Fortunato Ciardiello, M.D., Ph.D, Professor of Medical Oncology, Director of the Division of Medical Oncology at the Università della Campania Luigi Vanvitelli, Italy. "With the approval of FoundationOne Liquid CDx physicians have the choice of two high-quality, FDA-approved comprehensive genomic profiling tests, enabling them to select the most optimal option for their patients."

The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples 1,2.

FoundationOne Liquid CDx is the latest addition to Foundation Medicine’s portfolio of high-quality CGP tests and the second of the company’s CGP tests to receive FDA approval. FoundationOneCDx, Foundation Medicine’s tissue-based genomic test for patients with solid tumours received FDA approval in 2017. Together, these high-quality genomic profiling tests offer physicians important options for detecting specific genomic alterations that help guide efficient, personalised treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time. FoundationOne Liquid CDx can also provide complementary insights to tissue-based testing regarding tumour heterogeneity (the differences between cancer cells), and clonal evolution (how tumours evolve over time).

About FoundationOneLiquid CDx
FoundationOne Liquid CDx is a qualitative next-generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyse 324 genes utilising circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

On August 28, 2020 Triumvira Immunologics Inc. ("Triumvira"), a privately-held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported that successfully completed a USD $55 million Series A financing round (Press release, Triumvira Immunologics, AUG 28, 2020, View Source [SID1234564096]). The financing was co-led by Leaps by Bayer, the impact investment unit of Bayer AG, and Northpond Ventures. Additional investors include Oceanpine Capital and Viva Biotech Holdings, and existing investors include Bloom Burton & Co. and the Centre for Commercialization of Cancer Immunotherapy (C3i).

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T-cells are a type of white blood cell that is critical in ridding the body from abnormal and cancerous cells in healthy individuals. In cancer patients, these T-cells frequently fail to either recognize or effectively engage cancer cells. Novel T-cell therapies have the potential to disrupt cancer care and potentially even provide cures. Triumvira is committed to developing novel T-cell therapies that are safer and more efficacious than current cell therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T-cell receptor (TCR) therapies. This financing will enable Triumvira to advance multiple autologous and allogeneic programs into the clinic for solid tumors and hematologic malignancies.

Curing and preventing cancer is one of the main focus areas of Leaps by Bayer, as this disease still represents one of today’s most pressing health concerns, especially since there are limited curative or preventative therapies available.

"We are very excited about the potential of Triumvira’s platform. It represents a unique opportunity in the development of next-generation cell therapies that promise to address previously incurable cancers," said Juergen Eckhardt, MD, Head of Leaps by Bayer.

"At Northpond we believe that an entirely different construct and mechanism of action is needed for cell therapies to demonstrate activity in difficult-to-treat tumors, particularly solid tumors," said Dr. Michael Rubin, Founder & Chief Executive Officer at Northpond Ventures. "Today’s funding round marks an important milestone in enabling cell therapies to treat a broader array of cancer patients."

"As a co-founder of Triumvira, Bloom Burton is thrilled to see a strong syndicate of investors commit to advancing Triumvira’s novel TAC technology," said Brian Bloom, Chairman & Chief Executive Officer of Bloom Burton & Co. "The execution of Triumvira’s Series A funding further demonstrates Bloom Burton’s unique position to invest in life sciences in Canada and beyond our border."

Triumvira’s foundational technology is the T-cell Antigen Coupler (TAC). TAC is a hybrid molecule comprising multiple protein domains to combine tumor targeting abilities with the T-cell’s own activation machinery, leveraging the potential for the development of superior therapies for a broader range of patients with solid or liquid malignancies. Triumvira’s preclinical data with autologous and allogeneic programs demonstrate unique biological differences between TAC-engineered T-cells and second-generation CAR-T cells, with TAC-T cells showing absence of tonic signaling, strong tumor penetration, and long-term persistence. These functional properties help TAC T-cells produce strong anti-tumor activity and no evidence of toxicity, particularly in models of solid tumors.

"With so many engineered T-cell therapy companies developing new T-cell technologies, it is all about differentiation," said Dr. Paul Lammers, President and CEO of Triumvira. "We are excited to have a strong group of investors join our Series A syndicate, who believe in the promise of our proprietary TAC technology, which incorporates an innovative, well-differentiated, and patented design. As we develop our technology that has the potential to be used in treating both hematological and solid tumors, we hope to show that differentiation in clinical trials soon and provide a significant benefit to cancer patients."

Dr. Juergen Eckhardt and Dr. Jak Knowles will represent Leaps by Bayer by actively participating on Triumvira’s board of directors together with Dr. Shaan Gandhi, Principal at Northpond Ventures. Additionally, Scott Smith, current President at BioAtla and former President and Chief Operating Officer at Celgene, has been named Chairman of the Board. Brian Bloom, Dr. Paul Lammers, Dr. John Holyoake, and independent Director Cynthia Collins, President & CEO at Editas Medicine, will remain on the Triumvira board.

Wedbush PacGrow acted as the exclusive placement agent for the Series A financing. Shanghai Elite Choices LLC served as an advisor to Triumvira.

On August 27, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study evaluating RAS mutation status in circulating tumor DNA (ctDNA) of colorectal cancer (CRC) patients undergoing anti-EGFR antibody therapy (cetuximab or panitumumab) rechallenge using the OncoBEAM RAS CRC test in two different multicenter Japanese retrospective trials, JACCRO CC-08 and JACCRO CC-09 (Press release, Sysmex Inostics, AUG 27, 2020, View Source [SID1234568255]).

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OncoBEAM RAS CRC is a test that uses BEAMing technology, an enhanced digital PCR method optimized for high sensitivity blood-based mutation detection for metastatic colorectal cancer (mCRC) patients. In this study, investigators utilized the highly sensitive nature of OncoBEAM testing to explore the clinical value of monitoring changes in plasma RAS mutations in CRC patients during treatment with anti-EGFR antibody therapy.

Colorectal cancer continues to be one of the leading causes of cancer-related deaths globally. Treatment of mCRC patients with anti-EGFR monoclonal antibodies have demonstrated significant improvements in the survival of patients with wild-type RAS tumors. mCRC patients being considered for anti-EGFR therapy rechallenge could greatly benefit the overall patient survival by undergoing initial plasma testing to establish RAS mutation status at baseline, as well as performing subsequent tests to monitor RAS mutation dynamics during treatment. By receiving regular blood draws throughout the anti-EGFR rechallenge treatment, patients would benefit from periodic OncoBEAM RAS testing, which would in turn deliver valuable insights for clinicians in assessing therapy response.

The study published in JCO Precision Oncology by Sunakawa et al., demonstrated that RAS mutations were found in 38% of CRC patients after receiving the first course of anti-EGFR mAb therapy, but prior to rechallenge treatment. The disease control rate (DCR) was 33% in patients with RAS mutations in ctDNA, whereas it was 80% in patients without RAS mutation detected by OncoBEAM at baseline. The data also showed that patients with RAS mutations detected just before anti- EGFR mAb rechallenge had no survival benefit from rechallenge treatment. Moreover, post-progression survival time after rechallenge was worse in patients with RAS mutations than in patients without mutations at disease progression. The emergence of RAS mutations during rechallenge treatment at disease progression is therefore useful for predicting outcomes of anti- EGFR mAb therapy rechallenge.

"We found that the OncoBEAM RAS CRC assay was not only effective in monitoring the resistance to anti-EGFR therapy, but was also important in helping us determine the efficacy of the rechallenge treatment and therefore predict patients who would have favorable outcomes. Overall, our novel findings support the value of using the ultrasensitive OncoBEAM RAS liquid biopsy test in the clinical management of CRC patients receiving anti-EGFR mAb as rechallenge treatment. " stated Dr. Yu Sunakawa, MD, PhD, Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.

Besides results of this publication, a new prospective observational trial "REMARRY (UMIN000036424)" has been initiated with over 100 patients recruited as of June 2020. This clinical trial, supported by SCRUM-Japan MONSTAR-SCREEN, will expand the evaluation of patient-specific dynamics in ctDNA RAS mutational status as a predictor of anti-EGFR mAb rechallenge efficacy. Overall, the aggregate results from these trials should strongly support the clinical utility of performing longitudinal plasma OncoBEAM RAS testing in monitoring tumor response during anti-EGFR antibody therapy.

The publication, titled "RAS Mutations in Circulating Tumor DNA and Clinical Outcomes of Rechallenge Treatment with Anti-EGFR Antibodies in Patients with Metastatic Colorectal Cancer," was published in JCO Precision Oncology, July 28, 2020, by Yu Sunakawa et al.: View Source

The poster, titled "REMARRY and PURSUIT trials: Liquid biopsy-guided rechallenge of anti-EGFR monoclonal antibody for patients with RAS/BRAF V600E wild-type metastatic colorectal cancer" was presented at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2020 by Hiromi Nakajima et al.: View Source

On August 27, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the pace, risk and cost of oncology drug discovery and development, and identify patients who will benefit from its targeted oncology drug candidates, reported that Panna Sharma, CEO and President, will provide company updates at the following investor events in September (Press release, Lantern Pharma, AUG 27, 2020, View Source [SID1234568094]):

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The LD Micro 500
Date/Time: September 1, 2020 at 2:40 p.m. ET
MedInvest AI, Big Data & Digital Health Conference
Date/Time: September 9, 2020 at 10:40 a.m. ET
Colliers Institutional Investor Conference
Date/Time: September 10, 2020 at 9:00 a.m. ET to 5:00 p.m. ET (1×1 only; no presentation)
H.C. Wainwright 22nd Annual Global Investor Conference
Date/Time: September 15, 2020 at 4:30 p.m. ET
AI 2020, 13th Annual BioPharm America Conference
Fireside Chat: Using AI to Optimize Drug Selection and Development, hosted by Zacks Investment Research John Vandermosten
Date/Time: September 21, 2020 at 11:45 a.m. ET
All meetings and presentations will be held virtually. Investors and media interested in meeting with Panna Sharma should contact Marek Ciszewski, J.D., at: [email protected] or +1.628.777.3167. Registered conference attendees may also request meetings through the respective conference registration system.

On August 27, 2020 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that the Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX (onabotulinumtoxinA) intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of improvement of overactive bladder symptoms, as measured by the reduction in urinary incontinence episodes per day (Press release, UroGen Pharma, AUG 27, 2020, View Source [SID1234564492]). Data suggests that this result may have been due to BOTOX not effectively permeating the urothelium.

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Safety and tolerability were evaluated compared to placebo, as well as the dwell time manifested by hydrogel excretion. The combination was reported to be safe and well tolerated compared to placebo, with extended dwell time for up to 10 hours following initial instillation. Patients also reported satisfaction with the ease of hydrogel administration which is performed through a standard urinary catheter. A full evaluation of the data is underway, and the companies are working collaboratively on next steps in the partnership.

"In our own research experience, we have clearly demonstrated the ability of RTGel to successfully deliver active molecules to the urothelium resulting in a therapeutic effect. While we were disappointed with the results of the APOLLO trial, the data are very informative and provide important learnings for future experiments," said Dr. Mark Schoenberg, Chief Medical Officer at UroGen. "The topline data from this trial reinforces that our RTGel technology could be combined with a substantial library of molecules to deliver therapy where dwell time may improve outcomes and we look forward to our continued collaboration with AbbVie as they develop their portfolio of toxin proteins."

The Phase 2 trial was conducted by AbbVie under the license agreement entered into with UroGen in October 2016. This agreement granted an exclusive worldwide license to Allergan plc, now an AbbVie company, to research, develop, manufacture, and commercialize pharmaceutical products formulated with an RTGel hydrogel formulation and clostridial toxins, including BOTOX. The license agreement allows the companies to continue exploration of the RTGel hydrogel formulation in combination with AbbVie’s portfolio of clostridial toxins in OAB and other patient populations. UroGen is eligible to receive payments from AbbVie related to the achievement of certain development, regulatory, and commercial milestones, in addition to royalties on potential net sales.

"Our RTGel sustained release technology has repeatedly established its unique ability to reach and remain in body cavities that have long presented treatment challenges to the medical community," said Liz Barrett, President and Chief Executive Officer of UroGen. "With one drug on the market and a second soon to enter a pivotal study, we remain confident that our innovative technology is a true advance and are committed more than ever to find ways in which our novel approach could expand therapy options for patients."

BOTOX injection into the bladder is approved as a pharmacologic therapy for the treatment of overactive bladder in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken. UroGen’s innovative, hydrogel-based technology platform is designed to enable longer exposure to active pharmaceutical ingredients. Jelmyto (mitomycin) for pyelocalyceal solution, which utilizes the RTGel technology, was recently approved in the U.S. for the treatment of adults with low-grade upper tract urothelial cancer.

About the Phase 2 APOLLO Trial
The trial is a multi-center, randomized, double-blind, placebo-controlled, single-treatment, two-stage, dose-finding clinical trial on patients with overactive bladder with urgency urinary incontinence who have an inadequate response to or are intolerant to pharmacologic therapy. The first stage of the trial is a placebo-controlled, dose escalation design, followed by the second stage, a randomized, placebo-controlled design. Patients received a single bladder instillation of an RTGel hydrogel formulation in combination with BOTOX. The primary efficacy endpoint is the improvement of overactive bladder symptoms as measured by the reduction in urinary incontinence episodes per day.

BOTOX Indication and Important Safety Information

Indication
BOTOX is a prescription medicine that is injected into the bladder muscle and used to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents, going too often, and the strong, sudden need to go in adults 18 years and older when another type of medication (anticholinergic) does not work well enough or cannot be taken.

IMPORTANT SAFETY INFORMATION
BOTOX may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX:

Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing
BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX if you: are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), or Xeomin (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own (and are not routinely catheterizing). Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate self-catheterization post treatment, if required, should be considered for treatment.
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.

The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, or Xeomin in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In people being treated for urinary incontinence, other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
For more information, refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.