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Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

Allergan plc. today announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis. [More]
FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Allergan plc today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). [More]
Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today it has completed enrollment of the additional subjects, as directed by the Data Review Committee (DRC) earlier this year, into the company's Phase 2 study for SGX942. [More]
HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

HedgePath Pharmaceuticals, Inc., a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today enrollment has commenced in its Phase II(b) SCORING (SUBA-Cap Objective Response in Gorlin's) clinical trial. [More]
Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant Pharmaceuticals International, Inc. and Sprout Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a wholly-owned subsidiary of Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones. [More]
AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

United Therapeutics Corporation announced today that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc. [More]
TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

TapImmune, Inc., a clinical stage immunotherapy company, specializing in the development of innovative technologies for the treatment of metastatic cancer, announced today the successful conveyance of the Mayo Clinic IND (Investigational New Drug Application) to TapImmune as part of the recently completed licensing agreement. [More]
Mylan sued in connection with ANDA filing for generic version of Zytiga

Mylan sued in connection with ANDA filing for generic version of Zytiga

Mylan N.V. today confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Abiraterone Acetate Tablets, 250 mg. [More]
New OTEMTO phase three results show potential improvement to quality of life for COPD patients

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD [More]
Omeros plans to file patent infringement lawsuit against Par

Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%. [More]
FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Chiasma, Inc., a U.S. late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application (NDA) for the marketing and sale of octreotide capsules, an oral drug proposed for the maintenance therapy of adult patients with acromegaly. [More]
Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

Neurocrine Biosciences, Inc. announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients. [More]
ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

ImmunoCellular Therapeutics, Ltd. announced today that it has reached agreement with the US Food and Drug Administration on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma. [More]
BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. [More]
Sinovac Biotech releases results of 2015 Annual General Meeting of Shareholders held in Beijing, PRC

Sinovac Biotech releases results of 2015 Annual General Meeting of Shareholders held in Beijing, PRC

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced the results of the Company's 2015 Annual General Meeting of Shareholders held on Tuesday, August 11, 2015 in Beijing, PRC. [More]
FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. [More]
Mylan announces launch of Lidocaine Patch 5% in the U.S.

Mylan announces launch of Lidocaine Patch 5% in the U.S.

Mylan N.V. today announced the U.S. launch of its Lidocaine Patch 5%, which is the generic version of Endo Pharmaceutical's Lidoderm. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for relief of pain associated with post-herpetic neuralgia. [More]
GenVec reports net loss of $1.9 million for second quarter 2015

GenVec reports net loss of $1.9 million for second quarter 2015

GenVec, Inc. today reported financial results for the second quarter ended June 30, 2015. For the three months ended June 30, 2015, GenVec reported a net loss of $1.9 million, or $0.11 per share, on revenues of $0.1 million, compared with a net loss of $1.7 million, or $0.10 per share, on revenues of $0.1 million, for the same period in the prior year. [More]
Lexicon Pharmaceuticals' revenues decrease to $0.4 million in second quarter 2015

Lexicon Pharmaceuticals' revenues decrease to $0.4 million in second quarter 2015

Lexicon Pharmaceuticals, Inc., today reported financial results for the second quarter ended June 30, 2015 and provided an overview of key milestones for the company's lead drug candidates. [More]

Mylan announces launch of Esomeprazole Magnesium Delayed-release Capsules USP in U.S.

Mylan N.V. today announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg, which is the generic version of AstraZeneca's Nexium. [More]
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