BioSpace.com News

New Johnson & Johnson Anti-Depressant Related to "Special K" Party Drug

Fri, 24 May 2013 12:00:00 AM GMT

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Johnson & Johnson said it plans to seek approvals for 11 new drugs by 2017, including a treatment for patients with depression who have failed to benefit from standard medications. The intranasal drug, called...

Johnson & Johnson Forecasts 10 New Drug Apps by 2017

Thu, 23 May 2013 12:00:00 AM GMT

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Johnson & Johnson, the worlds biggest maker of health-care products, anticipates submitting more than 10 new medicines for approval by regulators worldwide by 2017. There also are plans to improve more than...

FDA Panel Backs Merck & Co., Inc. Insomnia Drug Suvorexant, But at Lower Doses

Thu, 23 May 2013 12:00:00 AM GMT

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The U.S. Food and Drug Administration advisory committee has Wednesday found clear evidence that healthcare giant Merck & Co., Inc.'s (MRK: Quote) blockbuster drug candidate suvorexant is quite effective in...

Celgene International S??rl Announces U.S. FDA Grants Priority Review for ABRAXANE® sNDA in Advanced Pancreatic Cancer

Thu, 23 May 2013 12:00:00 AM GMT

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BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Srl, a subsidiary of Celgene Corporation (Celgene) (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has assigned a...

Biogen Idec, Inc. (Massachusetts) Submits Application to FDA for Approval of PLEGRIDY™ (Peginterferon Beta-1a) in Multiple Sclerosis

Tue, 21 May 2013 12:00:00 AM GMT

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WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY (peginterferon...

TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China

Thu, 16 May 2013 12:00:00 AM GMT

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TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that...

Johnson & Johnson Unit Gets Priority Revenue for Simeprevir NDA

Wed, 15 May 2013 12:00:00 AM GMT

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Johnson & Johnson (JNJ) unit Janssen Research and Development LLC said the U.S. Food and Drug Administration has granted priority review to its new drug application for simeprevir, its investigational treatment...

Seattle Genetics, Inc. Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA

Tue, 14 May 2013 12:00:00 AM GMT

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BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplement to the Biologics License Application...

TWi Pharmaceuticals, Inc. Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets

Tue, 14 May 2013 12:00:00 AM GMT

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TAIPEI, Taiwan, May 14, 2013 /PRNewswire/ -- TWi Pharmaceuticals...

FDA Rejects Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) Petition to Protect Its Painkiller Franchise

Mon, 13 May 2013 12:00:00 AM GMT

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Endo Health Solutions Responds to FDA's Denial of OPANA ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone

MALVERN, Pa.<...

FDA Accepts Biogen Idec, Inc. (Massachusetts)???s Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A

Mon, 13 May 2013 12:00:00 AM GMT

WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for the marketing approval of ELOCTATE (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor...

Janssen Research & Development Release: FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C

Mon, 13 May 2013 12:00:00 AM GMT

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RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today...

Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA

Mon, 13 May 2013 12:00:00 AM GMT

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PARSIPPANY, N.J., May 13, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that the U.S. Food and...

Pfizer Inc. Yet to Decide on Pain Therapeutics Painkiller

Fri, 10 May 2013 12:00:00 AM GMT

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DURECT Announces Update on Remoxy®

CUPERTINO, Calif., May 10, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that Pfizer has...

Merck & Co., Inc. Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet

Wed, 08 May 2013 12:00:00 AM GMT

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WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen...

FDA Committee Turns Down AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.)/Astellas Pharma Inc.'s Cancer Drug

Mon, 06 May 2013 12:00:00 AM GMT

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CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- AVEO Oncology (AVEO) and Astellas Pharma Inc. (TSE:4503) today reported that the U.S. Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee...

Gilead Sciences, Inc. Fails FDA Approval for Two HIV Drugs in 4-in-1 Pill

Mon, 06 May 2013 12:00:00 AM GMT

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FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) today announced that the company has received Complete Response Letters from the U.S. Food and Drug Administration (FDA) for its New...

FDA Delays Approval of Titan Pharmaceuticals's Suboxone Implant

Wed, 01 May 2013 12:00:00 AM GMT

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SOUTH SAN FRANCISCO, CA--(Apr 30, 2013) - Titan Pharmaceuticals, Inc. (OTCBB: TTNP) announced that the U.S. Food and Drug Administration (FDA) has issued this evening a Complete Response Letter (CRL) to...

CureMark Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism

Tue, 23 Apr 2013 12:00:00 AM GMT

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RYE, N.Y., April 23, 2013 /PRNewswire/ -- Curemark LLC announced...

Amarin Corporation PLC Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia

Tue, 23 Apr 2013 12:00:00 AM GMT

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BEDMINSTER, N.J. and DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to...

FDA Panel Backs Approval of GlaxoSmithKline, Theravance, Inc. Lung Drug

Mon, 22 Apr 2013 12:00:00 AM GMT

LONDON and SOUTH SAN FRANCISCO, CA--(Marketwired - April 17, 2013) - GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide...

FDA Rejects Allergan Inc. Migraine Drug on Manufacturing Issues

Mon, 22 Apr 2013 12:00:00 AM GMT

IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults.

Allergan is pleased that, in addition to the response, the company has already received draft...

Immune Response BioPharma to Seek Emergency Approval of REMUNE in Thailand

Mon, 22 Apr 2013 12:00:00 AM GMT

Apr. 21, 2013 - NEW YORK -- Immune Response BioPharma, Inc. to Seek Emergency Approval of REMUNE in Thailand & Begin Stockpiling HIV/AIDS Vaccine.

Immune Respone BioPharma, Inc. Today Announces it will seek emergency approval of REMUNE in Thailand as well begin stockpiling & manufacturing the HIV/AIDS vaccine once we have an agreement in place with the Thailand officials.

Overseas...

GlaxoSmithKline and Theravance, Inc. Announce Regulatory Submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan

Mon, 22 Apr 2013 12:00:00 AM GMT

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LONDON and SOUTH SAN FRANCISCO, CA--(Marketwired - April 22, 2013) - GlaxoSmithKline plc(GSK) and Theravance, Inc. (NASDAQ:

Amarin Corporation PLC Announces Approval of Supplemental New Drug Application for Chemport as Additional Vascepa® Active Pharmaceutical Ingredient Supplier

Thu, 18 Apr 2013 12:00:00 AM GMT

BEDMINSTER, N.J. and DUBLIN, Ireland, April 18, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the approval of the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to add Chemport, Inc. as an additional...

Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) Drops After FDA Asks for More Info

Wed, 17 Apr 2013 12:00:00 AM GMT

CAMBRIDGE, MA--(Marketwired - April 15, 2013) - Sarepta Therapeutics, Inc. (NASDAQ: SRPT) today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) regarding a potential application for accelerated approval of eteplirsen for the treatment of Duchenne muscular dystrophy...

Santarus Inc. and Pharming Group Announce Submission of RUCONEST Biologics License Application to FDA

Wed, 17 Apr 2013 12:00:00 AM GMT

SAN DIEGO & LEIDEN, Netherlands--(BUSINESS WIRE)-- Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema...

FDA Accepts Otsuka Pharmaceutical Co., Ltd. Tolvaptan NDA for Priority Review

Tue, 16 Apr 2013 12:00:00 AM GMT

The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug candidate tolvaptan, a selective V2 vasopressin receptor antagonist. Otsuka Pharmaceutical president and representative director Dr. Taro Iwamoto said the NDA submission...

DURECT Corporation Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)

Tue, 16 Apr 2013 12:00:00 AM GMT

CUPERTINO, Calif., April 16, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational product POSIDUR (SABER-Bupivacaine). POSIDUR is a post-operative pain relief depot...

Biocryst Pharmaceuticals Completes Peramivir Type C Meeting

Tue, 16 Apr 2013 12:00:00 AM GMT

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has completed its Type C meeting regarding intravenous (i.v.) peramivir with the U.S. Food & Drug Administration (FDA) and has received final meeting minutes. The minutes of the meeting were consistent with the FDAs preliminary comment letter, which was previously referenced in the Company...

Otsuka Pharmaceutical Co., Ltd.'s New Drug Application for Tolvaptan, the Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Accepted for Review by the FDA

Fri, 12 Apr 2013 12:00:00 AM GMT

TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the company's new drug application (NDA) for the potential use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published online...

BTG plc: Varisolve® NDA Accepted for Full Review by FDA

Fri, 12 Apr 2013 12:00:00 AM GMT

London, UK, 12 April 2013: BTG plc (LSE: BTG), the specialist healthcare company, announces that the New Drug Application (NDA) seeking approval of Varisolve (polidocanol endovenous microfoam (PEM)) as a comprehensive treatment for varicose veins, which was submitted to the US Food & Drug Administration (FDA) on 4 February 2013, has been accepted for full review by the FDA.

Based on standard...

FDA Asks ACADIA Pharmaceuticals, Inc. to Skip Late Stage Study and File NDA After Successful Results

Thu, 11 Apr 2013 12:00:00 AM GMT

Acadia Pharmaceuticals Inc. (ACAD), a biotechnology company with $5 million in annual sales, rose 43 percent in early trading after saying it will gain a U.S. regulatory review of its lead drug sooner than anticipated. Acadia increased to $11.37 at 9 a.m. New York time. The shares had risen fivefold in the 12 months through yesterday. The San Diego-based company plans to apply for Food and Drug Administration...

Gilead Sciences, Inc. Pushes for FDA Blockbuster Approval

Thu, 11 Apr 2013 12:00:00 AM GMT

April 09, 2013 -- Gilead Sciences (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy...

Merck & Co., Inc. NDA for NOXAFIL Accepted by FDA

Wed, 10 Apr 2013 12:00:00 AM GMT

WHITEHOUSE STATION N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA).

Merck currently markets NOXAFIL Oral Suspension for prophylaxis...

China's SFDA Ready to Fast-Track Approvals of Peramivir, a Flu Treatment

Tue, 09 Apr 2013 12:00:00 AM GMT

by Richard Daverman, PhD

April 8, 2013 -- In the wake of the growing bird flu outbreak, Chinas SFDA will fast-track approvals of a flu treatment not a vaccine known as peramivir (peramivir sodium chloride injection). The drug is a neuraminidase inhibitor, which works by preventing the virus from moving from an infected cell to infect other cells. Guangzhou Nanxin Pharma has been approved...

Bayer HealthCare AG: NDA for Riociguat Gets Priority Review

Mon, 08 Apr 2013 12:00:00 AM GMT

WAYNE, N.J., April 8, 2013 /PRNewswire/ -- Bayer HealthCare announced today that the New Drug Application (NDA) for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent...

New-Look Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) Eyes Approval for Muscular Dystrophy Drug

Fri, 05 Apr 2013 12:00:00 AM GMT

After three decades without bringing a drug to market, Sarepta Therapeutics Inc stands on the verge of a breakthrough with its treatment for a crippling genetic disorder that affects one in every 3,500 newborn boys. If U.S. regulators fast-track approval of its treatment for Duchenne muscular dystrophy, as some investors are betting, it would complete a remarkable turnaround for the company that began...

Biocryst Pharmaceuticals Receives Preliminary Comment Letter From FDA on Peramivir

Mon, 01 Apr 2013 12:00:00 AM GMT

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- BioCryst Pharmaceuticals, Inc. (BCRX) today announced that it received a preliminary comment letter from the U.S. Food & Drug Administration (FDA) that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of intravenous (i.v.) peramivir. The letter was sent in response to questions BioCryst submitted...

Rockwell Medical Technologies Submits Calcitriol Manufacturing Data to FDA for Approval

Mon, 01 Apr 2013 12:00:00 AM GMT

WIXOM, MI--(Marketwire - April 01, 2013) - Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism...

pSivida Corp Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema

Mon, 01 Apr 2013 12:00:00 AM GMT

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN...

Janssen Research & Development Submits New Drug Application for Simeprevir

Fri, 29 Mar 2013 12:00:00 AM GMT

RARITAN, N.J., March 28, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and...

FDA Accepts Merck & Co., Inc.'s BLA for Investigational Allergy Immunotherapy Tablet

Fri, 29 Mar 2013 12:00:00 AM GMT

The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the investigational sublingual dissolvable tablet from Phase III trials including a long-term, multi-season trial. Merck Research Laboratories senior vice president, global scientific...

FDA Rejects A.P. Pharma, Inc.'s Cancer Drug

Thu, 28 Mar 2013 12:00:00 AM GMT

REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The CRL describes the...

pSivida Corp Takes Another Stab at FDA Approval for Iluvien

Wed, 27 Mar 2013 12:00:00 AM GMT

As pSivida gears up to begin distribution of its Illuvien eye treatment in Europe, it plans to re-submit its new drug application to the FDA for the drug/device combination. It's been a rocky road for pSivida's (NSDQ:PSDV) Illuvien, a drug/device combination for macular degeneration, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.

Merck & Co., Inc. Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet

Wed, 27 Mar 2013 12:00:00 AM GMT

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA...

IntelGenx Corp. Submits New Drug Application for Anti-Migraine VersaFilm™

Wed, 27 Mar 2013 12:00:00 AM GMT

SAINT LAURENT, Quebec, March 27, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx" or the "Company"), a Canadian drug delivery company focusing on oral drug delivery, today announced that, together with its co-development partner RedHill Biopharma ("RedHill"), it has submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for...

RedHill Biopharma Ltd. Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film

Wed, 27 Mar 2013 12:00:00 AM GMT

TEL-AVIV, Israel, March 27, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, today announced that the Company and its co-development partner, IntelGenx...

United Therapeutics Corporation Falls After Hypertension Pill Rejected

Tue, 26 Mar 2013 12:00:00 AM GMT

SILVER SPRING, Md., March 25, 2013 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a second complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diolamine extended...

Novartis AG Breast Cancer Drug Rejected Despite Being Hailed as a "Breakthrough"

Mon, 25 Mar 2013 12:00:00 AM GMT

Novartis drug Afinitor, expected to be a big seller for the Swiss group, has been rejected by Britain's health cost agency NICE due to uncertainty over its survival benefits in breast cancer. Novartis said it was "extremely disappointed" by Thursday's draft decision from the National Institute for Health and Clinical Excellence. Afinitor, or everolimus, is the first in a class known as mTOR inhibitors...

Vanda Pharmaceuticals, Inc. Reports Successful Completion of Pre-NDA Meeting With FDA on Tasimelteon for the Treatment of Non-24-Hour Disorder in the Totally Blind

Mon, 25 Mar 2013 12:00:00 AM GMT

WASHINGTON, March 25, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the company held a pre-NDA meeting with the Division of Neurology Products of the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon...

Boehringer Ingelheim Corporation and Eli Lilly and Company Submit New Drug Application to FDA for Empagliflozin, an Investigational Type 2 Diabetes Treatment

Mon, 25 Mar 2013 12:00:00 AM GMT

RIDGEFIELD, Conn. and INDIANAPOLIS, March 25, 2013 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin* was recently...

Titan Pharmaceuticals Announces FDA Advisory Committee Recommends Approval of Probuphine for the Treatment of Adult Patients With Opioid Dependence

Fri, 22 Mar 2013 12:00:00 AM GMT

SOUTH SAN FRANCISCO, CA--(Marketwire - March 21, 2013) -

Highlighted Links

Titan Pharmaceuticals, Inc.

pSivida Corp Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

Fri, 22 Mar 2013 12:00:00 AM GMT

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported a number of updates with respect to ILUVIEN for chronic diabetic macular edema (DME). Alimera announced that it intends to resubmit its New Drug...

FDA Rejects Pharmaxis Ltd Drug Push Bid

Tue, 19 Mar 2013 12:00:00 AM GMT

19 March 2013 -- Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had received a complete response letter from the Food and Drug Administration (FDA) confirming Bronchitol cannot yet be approved for marketing for the treatment of cystic fibrosis in the United States.

The FDA has concluded its review of the Bronchitol New Drug Application (NDA) and recommended Pharmaxis conduct...

Stellar Biotechnologies, Inc. Submits Biological Master File to FDA for Subunit KLH

Tue, 19 Mar 2013 12:00:00 AM GMT

PORT HUENEME, CA--(Marketwire - March 19, 2013) -

Highlighted Links

Stellar Corporate Profile

Seattle Genetics, Inc. Submits Supplemental BLA to FDA for Retreatment and Extended Duration of Therapy With ADCETRIS® (Brentuximab Vedotin) in Relapsed Hodgkin Lymphoma and Systemic ALCL

Mon, 18 Mar 2013 12:00:00 AM GMT

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma...

Biogen Idec, Inc. (Massachusetts) Submits Application to FDA for First Long-Lasting Factor VIII Therapy for Hemophilia A

Tue, 12 Mar 2013 12:00:00 AM GMT

WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. Recombinant FVIIIFc is the first hemophilia A product candidate in a new class of long-lasting...

GlaxoSmithKline Files for European Approval of Diabetes Drug Albiglutide

Fri, 08 Mar 2013 12:00:00 AM GMT

March 08, 2013 -- GlaxoSmithKline plc (GSK) today announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN, to the European Medicines Agency (EMA). Albiglutide is an investigational once-weekly treatment for adult patients with type 2 diabetes which is not yet approved anywhere in the world. On 14th January 2013, GSK announced the submission...

FDA Rejects Johnson & Johnson's Xarelto Again for ACS

Thu, 07 Mar 2013 12:00:00 AM GMT

RARITAN, N.J., March 4, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute...

AMAG Pharmaceuticals, Inc. Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron Deficiency Anemia Patients Who Cannot Take Oral Iron

Wed, 06 Mar 2013 12:00:00 AM GMT

LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the United States Food and Drug Administration (FDA) has accepted for review the companys supplemental new drug application (sNDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for...

FDA Panel Rejects Depomed, Inc. Menopause Treatment

Tue, 05 Mar 2013 12:00:00 AM GMT

NEWARK, Calif., March 4, 2013 /PRNewswire/ -- Depomed, Inc.(Nasdaq: DEPO), a specialty pharmaceutical company, announced today that the Reproductive Health Drugs Advisory Committee (RHDAC) of theU.S. Food and Drug Administration (FDA) voted 2-12 against approval for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to...

Nuvo Research Inc. Announces FDA Response to PENNSAID® 2% NDA

Tue, 05 Mar 2013 12:00:00 AM GMT

MISSISSAUGA, ON, March 5, 2013 /PRNewswire/ - Nuvo Research Inc. (Nuvo) (TSX:NRI) announced today that its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien (NYSE:COV), has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration...

FDA Panel Votes Against Approval of Noven Pharmaceuticals Inc.'s Menopause Drug

Tue, 05 Mar 2013 12:00:00 AM GMT

MIAMI, FL and NEW YORK, NY, March 4, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support...

FDA Accepts Biogen Idec, Inc. (Massachusetts)'s Biologics License Application for First Long-Lasting Factor IX Therapy for Hemophilia B

Mon, 04 Mar 2013 12:00:00 AM GMT

WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFc is the first product candidate...

Iroko Pharmaceuticals Announces Acceptance for NDA Filing of Lower Dose Submicron Diclofenac for the Treatment of Mild to Moderate Acute Pain in Adults

Mon, 04 Mar 2013 12:00:00 AM GMT

PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals, LLC, a Philadelphia-based pharmaceutical company focused on the development and commercialization of innovative therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed...

Pharma Tech Industries Selected to Manufacture Innovative Nasal Delivery System for NDA Submission

Mon, 04 Mar 2013 12:00:00 AM GMT

ROYSTON, Ga.--(BUSINESS WIRE)--Pharma Tech Industries (PTI), the largest pharmaceutical contract manufacturer and packager of powder products in the world, has been selected to handle filling, assembly and packaging services for a migraine relief medication administered through an innovative new method: a breath-powered nasal delivery system. The drug itself is powder-based, and PTI was chosen for...

Menopause Drugs From Depomed, Inc., Hisamitsu Pharmaceutical Offer Benefits

Fri, 01 Mar 2013 12:00:00 AM GMT

Drugs being developed by Depomed Inc. (DEPO) and Hisamitsu Pharmaceutical Co. (4530) to ease menopausal hot flashes yielded inconsistent results in trials that call into question how meaningful the benefits would be, regulators said. Depomeds gabapentin and Hisamitsus paroxetine mesylate were shown to help women avoid sudden feverish feelings linked to menopause, staff at the Food and Drug Administration...

FDA Delays Approval of Zogenix, Inc. Painkiller

Thu, 28 Feb 2013 12:00:00 AM GMT

SAN DIEGO, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone...

QRxPharma Pty Ltd. Resubmits MOXDUO® New Drug Application to the FDA

Thu, 28 Feb 2013 12:00:00 AM GMT

SYDNEY and BEDMINSTER, N.J., Feb. 28, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the Company resubmitted its MOXDUONew Drug Application (NDA). As disclosed on 16 January 2013, at its last meeting...

AstraZeneca PLC Ready to File Constipation Drug Naloxegol

Wed, 27 Feb 2013 12:00:00 AM GMT

SAN FRANCISCO, Feb. 26, 2013 /PRNewswire/ -- AstraZeneca today announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC). UC was defined as the investigator's choice of an existing laxative treatment regimen...

Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine® for the Treatment of Opioid Dependence

Wed, 27 Feb 2013 12:00:00 AM GMT

SOUTH SAN FRANCISCO, CA--(Marketwire - February 27, 2013) -

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Titan Pharmaceuticals, Inc.

Sunovion Pharmaceuticals Inc. Announces FDA Acceptance for Review of New Drug Application Resubmission for STEDESA® (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults With Epilepsy

Wed, 27 Feb 2013 12:00:00 AM GMT

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Companys New Drug Application (NDA) resubmission for STEDESA (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. STEDESA...

Amarin Corporation PLC Announces Submission of Supplemental New Drug Application (sNDA) for Vascepa® for the Treatment of Patients With High Triglycerides With Mixed Dyslipidemia

Tue, 26 Feb 2013 12:00:00 AM GMT

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing...

FDA: Dynavax Technologies Corporation Hep B Vaccine Needs More Evaluation

Mon, 25 Feb 2013 12:00:00 AM GMT

BERKELEY, CA--(Marketwire - February 25, 2013) - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult...

VIVUS, Inc. Diet Pill Rejected Again by EU Regulators

Fri, 22 Feb 2013 12:00:00 AM GMT

European health regulators for a second time rejected a diet pill developed by Vivus Inc and said the obesity treatment would not be approved there unless the company conducts a large lengthy trial to prove its heart safety, Vivus said on Thursday. The drug, sold in the United States as Qsymia, was approved by U.S. regulators last year. The U.S. Food and Drug Administration also approved another diet...

Chelsea Therapeutics, Inc. Expects to Resubmit Northera for FDA Approval in 2nd Quarter

Thu, 21 Feb 2013 12:00:00 AM GMT

Chelsea Therapeutics International Ltd plans to repitch its once-rejected hypotension drug Northera in the second quarter after a review by U.S. health regulators determined that the company could use its original data for the resubmission. Shares of Chelsea were up 93 percent at $1.48 in heavy volume trading on Wednesday on the Nasdaq. The stock traded around the $4 levels before the FDA rejection...

U.S. Rejection of Novo Nordisk A/S Drug Seen Temporary But Costly

Thu, 21 Feb 2013 12:00:00 AM GMT

U.S. regulators are likely to approve Novo Nordisk's long-acting insulin drug in three years after a surprise rejection earlier this month, analysts forecast in a poll. The delay, however, is expected to be costly, with analysts trimming their earnings forecasts for 2017 by over six percent. The U.S. Food and Drug Administration requested more tests on potential heart risks from Novo Nordisk's Tresiba...

Depomed, Inc.'s Drug Serada Ready for FDA Approval

Thu, 21 Feb 2013 12:00:00 AM GMT

On March 4, 2013, the FDA will hold an advisory committee meeting for Depomed's (DEPO) drug Serada. The committee will evaluate whether Serada is a safe and efficacious treatment for menopausal hot flashes. In this article we review scientific and clinical aspects of Serada and conclude it is likely to receive a favorable vote during its upcoming advisory committee meeting. Depomed is a specialty pharmaceutical...

GlaxoSmithKline and Theravance, Inc. Announce FDA Acceptance of New Drug Application (NDA) Submission in the U.S. for ANORO ELLIPTA™ for COPD

Tue, 19 Feb 2013 12:00:00 AM GMT

LONDON and SOUTH SAN FRANCISCO, CA--(Marketwire - February 19, 2013) - GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary...