Clinical Intelligence

The CenterWatch Monthly, July 2015

Wednesday, July 1, 2015 08:00 AM

Integrated research partnerships build momentum

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PharmaEngine receives FDA Priority Review, EMA MMA acceptance for MM-398

Monday, June 29, 2015 10:16 AM

PharmaEngine has announced that its license partner, Merrimack Pharmaceuticals, has received FDA acceptance and Priority Review designation for their NDA and its sublicense partner, Baxalta, a wholly owned subsidiary of Baxter International, has received Market Authorization Application (MAA) from the EMA, of MM-398 (irinotecan liposome injection, also known as nal-IRI) in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

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FORUM Pharmaceuticals receives FDA Fast Track for schizophrenia

Thursday, June 25, 2015 12:12 PM

The FDA has granted Fast Track designation to encenicline, FORUM Pharmaceuticals’ lead compound in development to treat cognitive impairment in schizophrenia. Encenicline is a novel alpha 7 agonist in phase III development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer's disease. The company recently completed patient enrollment in its pivotal phase III COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics.

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DBV Technologies planning Viaskin Peanut global phase III trial in children

Thursday, June 25, 2015 11:11 AM

DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Pediatric Committee of the EMA on Viaskin Peanut’s Pediatric Investigation Plan (PIP).

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AveXis gains EMA Orphan designation from for spinal muscular atrophy treatment

Thursday, June 25, 2015 11:02 AM

The EMA has granted Orphan Drug designation to a gene transfer therapeutic currently in clinical development in the U.S. for the treatment of type 1 spinal muscular atrophy (SMA). AveXis, a gene therapy company developing treatments for rare and life-threatening genetic diseases, received Orphan Drug designation for SMA in the U.S. in Oct. 2014.

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Pfizer enrolls first patient in phase III sickle cell disease trial

Thursday, June 25, 2015 10:54 AM

Pfizer has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study—a phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older.

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Heron Therapeutics initiates phase II trial of HTX-011 for post-operative pain

Wednesday, June 17, 2015 10:53 AM

Heron Therapeutics has initiated a phase II clinical trial of HTX-011, the company’s lead product candidate for the prevention of post-operative pain, following clearance from the FDA of its IND application for HTX-011. HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.

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Protalex receives FDA Orphan designation for PRTX-100 to treat immune thrombocytopenia

Wednesday, June 17, 2015 10:46 AM

The FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug designation to Protalex’s PRTX-100 for the treatment of immune thrombocytopenia (ITP). PRTX-100, Protalex’s lead product, is a highly purified form of Staphylococcal Protein A. The FDA previously accepted the company’s IND application for a phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Protalex expects to enroll its first patient in an ITP study in the third quarter of 2015.

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Ocular Therapeutix begins enrollment in phase III trial for allergic conjunctivitis

Wednesday, June 17, 2015 10:41 AM

Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has enrolled its first patients in a phase III clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone, 0.4mg) for the treatment of allergic conjunctivitis. Dextenza is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.

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Akaal Pharma to initiate phase II trial for the topical treatment of psoriasis

Wednesday, June 17, 2015 07:50 AM

Akaal Pharma, a clinical-stage biopharmaceutical company, has received approval to initiate a randomized, double-blind, placebo-controlled phase-II clinical trial of its topical drug candidate AKP-11. AKP-11 is a novel First-in-Class topical Sphingosine 1-Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque psoriasis in patients. Patients will be treated daily for six weeks with the topical drug AKP-11.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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