Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the […]
Pharmaceuticals
FDA deals setback to Intarcia for diabetes implant
Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes. The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter. Intarcia hinted that the reason behind the […]
FDA approves first glucose sensing tech that doesn’t require routine finger sticks
Abbott (NYSE:ABT) said yesterday that the FDA approved its FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes. The company’s technology doesn’t require finger stick calibration and eliminates the need for users to routinely stick their fingers for samples. The blood glucose monitor replacement indication means that people […]
Baxter launches asset tracking system for infusion pumps
Baxter (NYSE:BAX) today launched the DeviceVue asset tracking solution for hospitals using its Sigma Spectrum infusion system. The product was designed to help clinicians and biomedical engineers quickly find unused pumps by viewing pump location and status data from their computers or phones. The company said it is the first and only smart infusion pump manufacturer to […]
Catalent prices offering to help fund Cook Pharmica acquisition
Catalent today priced an underwritten public offering for 6,395,000 shares of its common stock at $39.10 apiece. The offering will be used to fund, in part, the drug-delivery company’s $950 million purchase of biologics manufacturer, Cook Pharmica. In connection with the offering, Catalent granted underwriters a 30-day option to buy up to an additional 959,250 shares of […]
Press Release: Nemera receives drug manufacturing authorization for its Neuenburg plant in Germany
On 4th September, Nemera received from the German Government Drug Administration (Government Presidium, Tübingen) the pharmaceutical drug manufacturing authorization according to §13 AMG (German Drug &Medicinal Product Law) at its Neuenburg manufacturing facility in Germany. The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for […]
Engage Therapeutics raises $23m Series A for drug-device seizure therapy
Summit, N.J.-based Engage Therapeutics said today that it closed a $23 million Series A round to fund a Phase IIb trial of its lead product, Staccato alprazolam. The round was led by TPG Biotech, Adage Capital Management and Lumira Capital. The drug-device product combines a hand-held inhaler technology, which is FDA-approved, with alprazolam, an FDA-approved […]
Aspire Capital to acquire $20m worth of Valeritas stock
Valeritas (NSDQ:VLRX) said today that it inked a deal with Aspire Capital Fund to buy $20 million of Valeritas’ common stock. According to the deal, Aspire Capital is slated to purchase common stock at Valeritas’ request from time to time during a 30-month period at prices based on the market price at the time of each […]
Catalent floats $250m public offering to fund Cook Pharmica purchase
Catalent said today that it launched an underwritten public offering for $250 million of its common stock to fund, in part, its $950 million purchase of biologics manufacturer Cook Pharmica. In connection with the offering, Catalent is slated to grant underwriters a 3o-day option to buy up to $37.5 million of additional shares of common […]
pSivida partners for sustained-release glaucoma drugs
pSivida (NSDQ:PSDV) said today that it inked a deal with an unnamed global pharmaceutical company to develop two glaucoma drugs with pSivida’s sustained-release technology. The partnership includes $750,000 worth of upfront payments for initial development and the potential for $200,000 in additional payments contingent upon subsequent development activities, according to the Watertown, Mass.-based company. “A key […]