New Drug Application News and Research

RSS

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets. Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

26 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

FDA approves Watson Pharmaceuticals' generic version of VALTREX tablets

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX tablets.

25 May 2010

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid® 8 mg.

25 May 2010

Repligen's RG2833 granted orphan drug designation for treatment of Friedreich's ataxia

Repligen Corporation announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation to RG2833, a selective histone deacetylase 3 inhibitor for the treatment of Friedreich's ataxia. Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia.

24 May 2010

NormOxys raises $17.5M in Series B financing round

NormOxys, Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has raised $17.5 million in a Series B financing round. The financing was led by a new investor, Care Capital, LLC, with participation from existing venture investor Index Ventures.

24 May 2010

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for vilazodone for the treatment of major depressive disorder.

24 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 May 2010

ZIOPHARM Oncology to present phase II data from PICASSO trial for soft tissue sarcoma at ASCO meeting

ZIOPHARM Oncology, Inc. announced today that Dr. Claire Verschraegen of the University of New Mexico, Albuquerque, lead author of the abstract on the palifosfamide study entitled, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)", will present in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 7th at 2:15 pm in the Vista Room (location S 406).

21 May 2010

Onyx Pharmaceuticals announces presentations evaluating carfilzomib for multiple myeloma at 46th ASCO

Onyx Pharmaceuticals, Inc. today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the 46th American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8, 2010 in Chicago, IL.

21 May 2010

Inviragen initiates first clinical trial of DENVax vaccine to protect against dengue fever

Inviragen has announced the initiation of the first clinical trial of its vaccine to protect against dengue fever. The trial, to be conducted at Saint Louis University, is designed to assess the safety of Inviragen's investigational dengue vaccine.

20 May 2010

IMUC, Torrey Pines Institute identify peptides that generate CD-133 specific T-cells

ImmunoCellular Therapeutics, a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that the Company and Torrey Pines Institute for Molecular Studies in San Diego, CA have identified several peptides which can generate CD-133 specific T-cells. CD-133 is found in high abundance on cancer stem cells ("CSCs") which makes it promising for immunological targeting.

18 May 2010

FDA accepts for filing Sigma-Tau Pharmaceuticals' cysteamine hydrochloride ophthalmic solution NDA

Sigma-Tau Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the company's new drug application (NDA) for its cysteamine hydrochloride ophthalmic solution, an investigational therapy for the treatment of corneal cystine crystals in patients with cystinosis. The FDA also granted the NDA Priority Review status, a designation given to drugs that may provide major advances or a treatment where no adequate therapy exists.

18 May 2010

FDA issues complete response letter for roflumilast NDA

Forest Laboratories, Inc. and Nycomed today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

18 May 2010

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

17 May 2010

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

ARCA biopharma, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator.

17 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

New Drug Application News and Research

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

FDA approves Watson Pharmaceuticals' generic version of VALTREX tablets

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

Repligen's RG2833 granted orphan drug designation for treatment of Friedreich's ataxia

NormOxys raises $17.5M in Series B financing round

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

ZIOPHARM Oncology to present phase II data from PICASSO trial for soft tissue sarcoma at ASCO meeting

Onyx Pharmaceuticals announces presentations evaluating carfilzomib for multiple myeloma at 46th ASCO

Inviragen initiates first clinical trial of DENVax vaccine to protect against dengue fever

IMUC, Torrey Pines Institute identify peptides that generate CD-133 specific T-cells

FDA accepts for filing Sigma-Tau Pharmaceuticals' cysteamine hydrochloride ophthalmic solution NDA

FDA issues complete response letter for roflumilast NDA

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

FDA grants tentative approval for Teva's Cinacalcet HCl Tablets ANDA

BioSante Pharmaceuticals first-quarter net loss increases to $10.5 million

Hana Biosciences reports $5.5 million net loss for first-quarter 2010

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News