New Drug Application News and Research

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Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Teva Pharmaceutical Industries Ltd. today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237).

30 Apr 2014

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Purdue Pharma L.P. announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet (HYD).

30 Apr 2014

Highland subsidiary begins enrolment in Phase III study of HLD-200 in pediatric ADHD patients

Highland Therapeutics Inc., an emerging pharmaceutical company, today announced that its wholly owned subsidiary has begun enrolment in a Phase III study of HLD-200, the Company's novel formulation of methylphenidate, in pediatric patients with Attention-Deficit Hyperactivity Disorder ("ADHD").

28 Apr 2014

Forest Laboratories enters into definitive agreement to acquire Furiex

Forest Laboratories, Inc. nd Furiex Pharmaceuticals, Inc. today announced that Forest has entered into a definitive agreement to acquire Furiex, a drug development collaboration company, for $95 per share, or approximately $1.1 billion in cash, and up to $30 per share (approximately $360 million in aggregate) in a Contingent Value Right (CVR) that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval.

28 Apr 2014

Sinovac Biotech commits to commercialize Sabin Inactivated Polio Vaccine in China

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China that focuses on the research, development, manufacturing and commercialization of vaccines, announced today that it has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for distribution to China and other countries.

28 Apr 2014

TWi and Endo Pharmaceuticals settle patent litigation over Lidoderm product

TWi Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. to settle all outstanding patent litigation related to TWi's lidocaine topical patch 5% product.

23 Apr 2014

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer Inc. announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.

23 Apr 2014

Cubist submits ceftolozane/tazobactam NDA for treatment of cUTI and cIAI

Cubist Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).

21 Apr 2014

Sarepta Therapeutics plans to submit eteplirsen NDA for treatment of Duchenne muscular dystrophy

Sarepta Therapeutics, Inc., a developer of innovative RNA-based therapeutics, today announced it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

21 Apr 2014

Actavis to purchase four currently marketed products from Akorn

Actavis plc, a leading global specialty pharmaceutical company, today announced that it has entered into agreements with Akorn, Inc. and Hi-Tech Pharmacal Co. Inc. to purchase four currently marketed products and one product under development

18 Apr 2014

FDA approves Lannett's ANDA for Diazepam Oral Solution

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution (Concentrate), 5 mg/mL, a Schedule C-IV controlled drug.

15 Apr 2014

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson today announced sales of $18.1 billion for the first quarter of 2014, an increase of 3.5% as compared to the first quarter of 2013. Operational results increased 5.3% and the negative impact of currency was 1.8%. Domestic sales increased 2.2%. International sales increased 4.5%, reflecting operational growth of 7.9% and a negative currency impact of 3.4%.

15 Apr 2014

Federal district court enforces settlement between Mylan and Endo Pharmaceuticals on generic FROVA

Mylan Inc. today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Frovatriptan Succinate Tablets, 2.5 mg.

11 Apr 2014

Impax resubmits NDA for RYTARY providing updated safety and stability information

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA).

11 Apr 2014

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection.

10 Apr 2014

Spero Therapeutics enters into antibiotics partnership with Roche

Spero Therapeutics, LLC, a biopharmaceutical company founded to develop novel therapies for treatment of bacterial infections, has entered into an antibiotics partnership with Roche.

9 Apr 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes plc today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441 mg, p<0.001 aripiprazole lauroxil 882 mg), which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014.

8 Apr 2014

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical Inc., a company developing its ImmunoPulse DNA-based immunotherapy to treat solid tumors, will re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment.

7 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

New Drug Application News and Research

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Highland subsidiary begins enrolment in Phase III study of HLD-200 in pediatric ADHD patients

Forest Laboratories enters into definitive agreement to acquire Furiex

Sinovac Biotech commits to commercialize Sabin Inactivated Polio Vaccine in China

TWi and Endo Pharmaceuticals settle patent litigation over Lidoderm product

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Cubist submits ceftolozane/tazobactam NDA for treatment of cUTI and cIAI

Sarepta Therapeutics plans to submit eteplirsen NDA for treatment of Duchenne muscular dystrophy

Actavis to purchase four currently marketed products from Akorn

FDA approves Lannett's ANDA for Diazepam Oral Solution

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Federal district court enforces settlement between Mylan and Endo Pharmaceuticals on generic FROVA

Impax resubmits NDA for RYTARY providing updated safety and stability information

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Spero Therapeutics enters into antibiotics partnership with Roche

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

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