New Drug Application News and Research

RSS

Pfizer, Mylan enter settlement agreement to resolve generic Detrol LA litigation

Mylan Inc. today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Pfizer Inc., Pharmacia & Upjohn Company LLC and Pfizer Health AB that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Tolterodine Tartrate ER capsules, 2 mg and 4 mg, which is the generic version of Pfizer's Detrol LA, indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

7 Sep 2012

Omeros files OMS824 IND with FDA to initiate clinical trials for cognitive disorders

Omeros Corporation today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to initiate clinical trials evaluating OMS824, the Company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.

6 Sep 2012

FDA continues review of Salix’s Crofelemer new drug application

Napo Pharmaceuticals, Inc. was informed today that the Food and Drug Administration is continuing its review of the new drug application seeking approval of crofelemer for the treatment of chronic diarrhea in people living with HIV/AIDS on anti-retroviral therapy.

6 Sep 2012

Janssen receives FDA Priority Review for bedaquiline NDA to treat MDR-TB

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

6 Sep 2012

EC grants European market authorization for Revestive to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the European Commission has granted European market authorization for the medicinal product teduglutide (trade name in Europe: Revestive) as a once-daily treatment for adult patients with short bowel syndrome.

5 Sep 2012

Janssen submits bedaquiline MAA with EMA for treatment of multi-drug resistant tuberculosis

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.

31 Aug 2012

Bayer submits regorafenib NDA with FDA for treatment of metastatic and/or unresectable GIST

Bayer HealthCare and Onyx Pharmaceuticals today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

31 Aug 2012

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for ZYTIGA (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

30 Aug 2012

Israel's Ministry of Health approves Medgenics’ INFRADURE Phase I/II clinical trials for hepatitis C

Medgenics, Inc., the developer of Biopump, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that Israel's Ministry of Health (MOH) has approved two Phase I/II clinical trials to assess the safety and efficacy of INFRADURE in patients with hepatitis C.

30 Aug 2012

Noven submits LDMP NDA with FDA to treat menopausal vasomotor symptoms

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has submitted to the U.S. Food & Drug Administration a New Drug Application (NDA) seeking approval to market low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms associated with menopause.

30 Aug 2012

Novelos expects to submit CLR1502 IND with FDA for non-invasive tumor imaging

Novelos Therapeutics, Inc., a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging.

29 Aug 2012

Gilead Sciences receives FDA approval for Stribild to treat HIV-1 infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

28 Aug 2012

Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet strength of EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

AcelRx commences third ARX-01 Phase 3 study in post-operative pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced dosing of the first patient in the third of three planned Phase 3 studies for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia (PCA) system.

24 Aug 2012

FDA approves Watson’s ANDA for lidocaine topical patch 5%

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm.

24 Aug 2012

New results describe development of DC cancer vaccine with enhanced immunogenic potential

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, and collaborators at Radboud University Nijmegen Medical Centre in the Netherlands announced today that they have published new pre-clinical results in the journal Cancer Immunology Immunotherapy describing the development of a dendritic cell (DC) cancer vaccine with enhanced immunogenic potential.

23 Aug 2012

FDA extends action date for Pfizer’s tofacitinib NDA review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis (RA).

22 Aug 2012

FDA committee to review NPS’ Gattex NDA in October

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012.

22 Aug 2012

Healthcare announces important changes to the U.S. product label for Optison

GE Healthcare today announced important changes to the U.S. product label for Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to diagnose certain heart diseases such as hypertrophic cardiomyopathy.

22 Aug 2012

New Drug Application News and Research

Pfizer, Mylan enter settlement agreement to resolve generic Detrol LA litigation

Omeros files OMS824 IND with FDA to initiate clinical trials for cognitive disorders

FDA continues review of Salix’s Crofelemer new drug application

Janssen receives FDA Priority Review for bedaquiline NDA to treat MDR-TB

EC grants European market authorization for Revestive to treat short bowel syndrome

Janssen submits bedaquiline MAA with EMA for treatment of multi-drug resistant tuberculosis

Bayer submits regorafenib NDA with FDA for treatment of metastatic and/or unresectable GIST

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Israel's Ministry of Health approves Medgenics’ INFRADURE Phase I/II clinical trials for hepatitis C

Noven submits LDMP NDA with FDA to treat menopausal vasomotor symptoms

Novelos expects to submit CLR1502 IND with FDA for non-invasive tumor imaging

Gilead Sciences receives FDA approval for Stribild to treat HIV-1 infection

Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

AcelRx commences third ARX-01 Phase 3 study in post-operative pain

FDA approves Watson’s ANDA for lidocaine topical patch 5%

New results describe development of DC cancer vaccine with enhanced immunogenic potential

FDA extends action date for Pfizer’s tofacitinib NDA review

FDA committee to review NPS’ Gattex NDA in October

Healthcare announces important changes to the U.S. product label for Optison

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