New Drug Application News and Research

RSS

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010

Caraco Pharmaceutical Laboratories begins marketing bupropion hydrochloride extended release tablets

Caraco Pharmaceutical Laboratories, Ltd. has started shipping bupropion hydrochloride extended release tablets. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA). These bupropion hydrochloride extended release tablets, 100 mg, 150 mg, and 200 mg, are therapeutically equivalent to GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

22 Jul 2010

Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules receives FDA approval

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.'s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg.

21 Jul 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind's resubmission of its New Drug Application for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act action date of December 29, 2010.

21 Jul 2010

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

A Phase 3 open-label study, recently published online by Pain Practice, has compared tapentadol extended release tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release tablets.

20 Jul 2010

FDA approves Mylan's ANDA for generic Catapres-TTS

Mylan Inc. today announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS®, a treatment for hypertension.

19 Jul 2010

Apicore announces successful conclusion of Somerset API manufacturing plant's FDA inspection

Apicore LLC announced today that the U.S. Food and Drug Administration (FDA) completed an inspection of its API manufacturing plant in Somerset, New Jersey on July 13, 2010.

17 Jul 2010

NEOP receives stockholder approval to increase company shares to 205 milliion

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced at its 2010 Annual Meeting of Stockholders that it received the approval of its stockholders to increase the number of authorized shares of the Company from 155 million to 205 million. In addition, stockholders re-elected Neoprobe President and CEO David C. Bupp, and elected for the first time, Brendan A. Ford and Eric K. Rowinsky, M.D. as Directors of the Company for terms ending at the 2013 Annual Meeting. Stockholders also approved the appointment of BDO Seidman, LLP to act as the Company's independent registered public accounting firm for 2010.

17 Jul 2010

Biomet acquires all assets of Cytosol Laboratories

Biomet, Inc., a global leader in the manufacture of musculoskeletal medical products, announced today its acquisition of substantially all of the assets of Cytosol Laboratories, Inc., located in Braintree, Massachusetts, a market leader in production of small volume anticoagulants.

17 Jul 2010

USFDA approves Sun Pharma's generic Flomax ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for its Abbreviated New Drug Application to market a generic version of Flomax ®, tamsulosin capsules.

16 Jul 2010

JDD publishes long-term efficacy and tolerability study of PyratineXR Moisturizing Lotion

The June 2010 issue of Journal of Drugs in Dermatology (JDD), a full-color, peer-reviewed publication serving the dermatology community, features a study on the long-term efficacy and tolerability of the active ingredient in PyratineXR™.

16 Jul 2010

Sepracor to change name to Sunovion Pharmaceuticals

Sepracor Inc. and Dainippon Sumitomo Pharma Co., Ltd., an Osaka, Japan-based pharmaceutical company, announced today the intent to change the Sepracor name to Sunovion Pharmaceuticals Inc. in the United States. DSP acquired Sepracor in October 2009 and the name change is planned to occur in anticipation of the one-year anniversary of the acquisition. Sepracor intends to begin officially operating as Sunovion Pharmaceuticals Inc. before the end of 2010.

15 Jul 2010

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the first Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

15 Jul 2010

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg.

15 Jul 2010

Gilead sues Lupin over Ranexa patent infringement

Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New Jersey against Lupin Limited for infringement against Gilead's patents for Ranexa® (ranolazine extended-release tablets). The lawsuit is based on an Abbreviated New Drug Application filed by Lupin, which seeks approval to manufacture and market a generic version of Ranexa before the expiration of Gilead's Ranexa patents.

15 Jul 2010

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

15 Jul 2010

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Cell Therapeutics today announced that it has signed a manufacturing agreement with NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l. for CTI's drug candidate pixantrone.

14 Jul 2010

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

14 Jul 2010

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

Protalix BioTherapeutics, Inc. announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists.

13 Jul 2010

New Drug Application News and Research

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Caraco Pharmaceutical Laboratories begins marketing bupropion hydrochloride extended release tablets

Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules receives FDA approval

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

FDA approves Mylan's ANDA for generic Catapres-TTS

Apicore announces successful conclusion of Somerset API manufacturing plant's FDA inspection

NEOP receives stockholder approval to increase company shares to 205 milliion

Biomet acquires all assets of Cytosol Laboratories

USFDA approves Sun Pharma's generic Flomax ANDA

JDD publishes long-term efficacy and tolerability study of PyratineXR Moisturizing Lotion

Sepracor to change name to Sunovion Pharmaceuticals

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

Gilead sues Lupin over Ranexa patent infringement

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

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