Investors clearly had hoped that the agency would sign off on that plan, clearing a path for a new drug application (NDA) for migalastat monotherapy this year based on those data
By Jennifer Boggs | BioWorld Today | Tuesday, June 18, 2013
Prior to the submission of an investigational new drug application, Genmab may elect to retain equal ownership of the product...in filing a patent infringement lawsuit against Mylan Pharmaceuticals Inc., of Pittsburgh, which filed an abbreviated new drug application (ANDA) seeking to market a generic version of Azasite (azithromycin 1 percent ophthalmic solution
Assuming positive data, Cempra will be able to file a new drug application for solithromycin based on data from one oral study and one I.V.-to-oral study
By Jennifer Boggs | BioWorld Today | Monday, June 17, 2013
The new cash is expected to let San Diego-based Mast reach top-line data, said Brandi Roberts, chief financial officer, although it "probably won't get us through filing the new drug application and getting ready for commercialization
By Randy Osborne | BioWorld Today | Monday, June 17, 2013
Perosphere Inc., of Mount Kisco, N.Y., recently received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse anticoagulant activity of unfractionated heparin low-molecular-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors
By Catherine Shaffer | BioWorld Today | Monday, June 17, 2013
Cornerstone Therapeutics Inc., of Cary, N.C., said it received on June 11 a Paragraph IV notice letter from Exela Pharma Sciences LLC, of Lenoir, N.C., advising the firm of Exela's filing of a supplemental new drug application for use of an injectable form of nicardipine hydrochloride in 9 percent sodium chloride, a generic version of Cornerstone's Cardene I.V
Trius will incorporate the results into its new drug application for tedizolid for the treatment of acute bacterial skin and skin structure infections, which it plans to submit to the FDA in the second half of 2013
The company expects to use the remainder of the funding for filing its new drug application (NDA) for tavaborole, a candidate for onychomycosis, and conducting additional clinical studies
By Dave Silver | BioWorld Today | Thursday, June 13, 2013
In May, the company completed Phase III trials in Taiwan and China under TFDA and CFDA authority and said a new drug application (NDA) had been filed in both countries
By Dave Silver | BioWorld International | Wednesday, June 12, 2013
Biotie may exercise the option right up until the start of the pivotal pharmacokinetic studies that will form the basis of a 505(b)(2) new drug application, but no later than Dec. 3, 2014
Salix Pharmaceuticals Ltd., of Raleigh, N.C., and Progenics Pharmaceuticals Inc., of Tarrytown, N.C., said the FDA will hold an advisory committee meeting to review Salix's supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) subcutaneous injection in opioid-induced constipation (OIC) for patients with chronic pain
Sanbio Inc., of Mountain View, Calif., said the FDA has approved its investigational new drug application for the use of SB623, an allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries
Edge Therapeutics Inc., of New Providence, N.J., said the FDA accepted its investigational new drug application for EG-1962, a bio-absorbable nimodipine microparticle formulation...The agency completed its review of the new drug application as amended in December 2012, and the product is tentatively approved for use as recommended in the submitted and agreed-upon labeling
said Monday it received a complete response letter (CRL) from the agency informing the biotech it will not approve in its present form the new drug application (NDA) for the product
By Peter Winter | BioWorld Today | Tuesday, June 11, 2013
Regen BioPharma, of San Diego, a wholly owned subsidiary of Bio-Matrix Scientific Group Inc., submitted responses to the FDA's comments regarding its investigational new drug application for HemaXellerate, for immune suppressant-resistant aplastic anemia
Biodel Inc., of Danbury, Conn., disclosed plans to submit a new drug application (NDA) to the FDA in 2015 for a glucagon rescue device to treat severe hypoglycemia...The submission of an investigational new drug application to the FDA is expected during the next 12 months
Actavis Inc., of Parsippany, N.J., said it filed an abbreviated new drug application to market drospirenone/ethinyl estradiol/lovomefolate calcium tablets and levomefolate calcium tablets, a generic version of Safyral from Bayer AG, of Leverkusen, Germany
In May, the company completed Phase III trials in Taiwan and China under TFDA and CFDA authority and said a new drug application (NDA) had been filed in both countries
By Dave Silver | BioWorld Today | Thursday, June 6, 2013
Investors clearly had hoped that the agency would sign off on that plan, clearing a path for a new drug application (NDA) for migalastat monotherapy this year based on those data