|POZEN Receives CRL From FDA; Actavis Suing FDA Related to Delay of Generic Celebrex Approval|
|By Staff and Wire Reports|
|Monday, 28 April 2014 20:36|
POZEN Inc. (NASDAQ: POZN) announced that its drug candidates received a complete response letter (CRL) form the United States food and drug administration.
A complete response letter is a document issued by the FDA when the drug is completed for review but questions still remain related to the approval of the new drug in its current form.
Within this document, the FDA listed that they had inspected the manufacturing facility of an active ingredient supplier and they also recorded that inspection deficiencies were found.
“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA. The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised,” said John R. Plachetka, Chairman, President and Chief Executive Officer.
“We don't want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8th.”
There also were not any deficiencies or insecurities related to either of its drugs.
Shares of the company are down 10.41 percent or $0.95 per share to $8.18, shares were originally down as low as $6.02 per share.
Actavis plc (NYSE: ACT) announced its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.
Actavis maintains that the FDA improperly awarded sole exclusivity on generic Celebrex® to Teva Pharmaceutical Industries Ltd., despite an earlier ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva's sole exclusivity on the product.
Actavis is seeking a judgment from the U.S. District Court for the District of Columbia declaring that the FDA decision is arbitrary, capricious and contrary to law, as well as the entry of an injunction directing FDA to approve its ANDA for generic Celebrex® no later than the same date that the first ANDA for a generic version of Celebrex® is approved. Actavis is also asking the Court to issue an injunction granting a 180-day exclusivity period for generic Celebrex® to Actavis as a first filer of a substantially complete ANDA containing a Paragraph IV certification to U.S. Patent No. RE44,048.
For the 12 months ending December 31, 2013, Celebrex® had total U.S. sales of approximately $2.2 billion, according to IMS Health data.
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that the publication of data from a multi-institutional trial of MuGard has been featured in the print edition of the journal Cancer, available today.
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Athersys, Inc. (Nasdaq:ATHX) today announced interim results from the Phase 2 clinical study of the administration of Athersys' MultiStem® cell therapy to treatment refractory ulcerative colitis (UC) patients being conducted by Pfizer, Inc.
Biocept, Inc. (Nasdaq:BIOC), a molecular diagnostics company specializing in oncology biomarker detection and monitoring through circulating tumor cells (CTCs) and cell-free circulating tumor DNA, today announced the launch of its clinical research services offering.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the European Commission has granted marketing authorization for VIMIZIM® (elosulfase alfa), the first specific treatment approved in the European Union for Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) in patients of all ages.
Cellular Dynamics International, Inc. (Nasdaq:ICEL) today announced that the company will host a webcast and conference call to discuss its financial results for the first quarter ended March 31, 2014.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, will announce results for the first quarter ended March 31, 2014 on Thursday, May 8, 2014, after market close.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced that it is scheduled to report financial results for its first quarter ended March 31, 2014, on Thursday, May 8, 2014, after the market closes.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that it signed a final settlement and license agreement with Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) and Acasti Pharma Inc.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that it will release financial results for the first quarter ended March 31, 2014 on Wednesday, May 14, 2014, before the market opens.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the Department of Defense (DoD) will provide funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high-risk HER2 3+ patients.
ICU Medical, Inc., (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its first quarter 2014 earnings release conference call.
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT), a Canadian drug delivery company focused on oral drug delivery, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, today announced the commencement of a comparative bioavailability clinical study comparing their anti-migraine VersaFilm™ Product to the European reference drug.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, today invites shareholders, and other followers of the Company's developments, to visit the new Kraig investor relations website at www.kblbinvestors.com.
LipoScience, Inc. (Nasdaq:LPDX) today announced that it will release its first quarter 2014 financial results after the market close on Monday, May 12, 2014.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that it will present pre-clinical data on its novel DART® candidate for the treatment of autoimmune disorders, MGD010, at IMMUNOLOGY 2014, the American Association of Immunologists Annual Meeting, in Pittsburgh, PA.
Medical Marijuana Sciences, Inc. (MMS), a subsidiary of Nuvilex, Inc. (OTCQB:NVLX), a clinical stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Mark L. Rabe, MD, ABIHM, the Scientific Advisory Board Chairman of MMS, addressed conservators, guardians and trustees at the Professional Fiduciary Association of California (PFAC) Educational Conference in San Diego as part of the Medical Marijuana Education Session that occurred at the PFAC Educational Conference on April 25, 2014, where he discussed the medical benefits of the components of Cannabis (Marijuana).
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced first quarter momentum for iConnect® Network with 19 new contract wins.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO) and NeuroBioPharm Inc. today jointly announce the resignation of Henri Harland as President and Chief Executive Officer of Neptune, Acasti and NeuroBio with immediate effect. Mr. Harland remains a Director of Neptune, Acasti and NeuroBio.
Novavax, Inc. (Nasdaq:NVAX) today announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in women of childbearing age.
PetMed Express, Inc. (Nasdaq:PETS) will announce its financial results for the year ended March 31, 2014 on Monday, May 5, 2014 at 8:00 A.M. Eastern Time, then at 8:30 A.M. Eastern Time, Menderes Akdag, the Company's Chief Executive Officer and President, will host a conference call to review the financial results.
Premier, Inc. (Nasdaq:PINC) today announced that it plans to report fiscal 2014 third-quarter results after the market closes on Monday, May 12, 2014, followed by a conference call at 5:00 p.m. ET to discuss the results.
Prosensa Holding N.V. (NASDAQ: RNA) the Dutch biopharmaceutical company focusing on rare diseases with a high unmet medical need, today announced that it will present at the following US conferences: 66th American Academy of Neurology (AAN) Annual Meeting, Philadelphia, PA.
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Surgical Care Affiliates, Inc. (Nasdaq:SCAI) today announced that it will release its first quarter 2014 financial results on Monday, May 12, 2014, after the market closes.
Tandem Diabetes Care®, Inc. (Nasdaq:TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that Kim Blickenstaff, president and CEO, will present a company update at the following upcoming investor conferences: Deutsche Bank 39th Annual Health Care Conference, which will be held at the InterContinental Boston Hotel in Boston, Massachusetts on Thursday, May 8, 2014 at 3:30pm Eastern Time (12:30pm Pacific Time). Bank of America Merrill Lynch 2014 Health Care Conference, which will be held at the Encore at the Wynn Hotel in Las Vegas, Nevada on Wednesday, May 14, 2014 at 7:20pm Eastern Time (4:20pm Pacific Time).
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified life sciences company with a pending acquisition in the cannabis space, is pleased to announce that Lawrence A. May, M.D., F.A.C.P., ("Dr. May") has accepted the position of Chief Medical Officer ("CMO").
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the upcoming presentation of data from a Phase 2 clinical study of sialic acid extended-release (SA-ER, UX001) tablets in hereditary inclusion body myopathy (HIBM; also known by its new name as GNE myopathy).
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced financial results for the fourth quarter and full year fiscal 2014, ended March 31, 2014.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that based on its meeting with the U.S Food and Drug Administration (FDA), the Company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers.