Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
Pharmaceuticals
Flamel Technologies dose first patient in Phase III narcolepsy trial
Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.The Lyon, France-based company developed the controlled-release oral formulation of sodium oxybate using its Micropump technology. The randomized, double-blind trial has enrolled […]
Mylan launches first generic EpiPen as state AGs sue generics makers for price collusion
Mylan (NSDQ:MYL) launched its 1st generic EpiPen emergency allergy treatment 1 day after attorney generals from 20 states filed a civil complaint against Mylan, Teva Pharmaceuticals (NYSE:TEVA), and 4 other generic drug makers. The complaint alleges that the companies co-conspired in informal gatherings, calls and text messages to fix the price for glyburide, a diabetes drug, and doxycycline […]
Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous and intravenous bolus injections expands Fresenius Kabi’s available Heparin formulations. The Lake Zurich-Ill. company’s Simplist syringes have a 2-year shelf life and do not require any assembly or point-of […]
Lilly, Boehringer’s Basaglar long-acting insulin now available in the U.S.
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals said today that its insulin glargine injection, Basaglar, is available by prescription in the U.S. Basaglar is a long-acting insulin with the same amino acid sequence as Sanofi‘s (NYSE:SNY) Lantus. The companies also offer resources for patients beginning insulin treatment, including an app for smartphones and tablets which provides […]
Ex pharma execs first to be charged in generic drug pricing case
Former Heritage Pharmaceuticals CEO Jeffrey Glazer and ex-president Jason Malek were hit yesterday with the 1st criminal charges from a 2-year federal investigation in an ongoing generic drug pricing case. The 2 former executives were charged by federal authorities with price collusion for doxycycline hyclate, a widely used antibiotic, and a diabetes therapy called glyburide […]
Baxter to put up $625m for Claris Injectables generics biz
Baxter (NYSE:BAX) said today that acquired Claris Lifesciences (BOM:533288) subsidiary Claris Injectables for $625 million. The deal is expected to close in the 2nd half of next year. Deerfield, Ill.-based Baxter said it plans to pay for the acquisition with cash on hand, debt or a combination. Baxter anticipates launching 7 to 9 new products […]
BD launches high volume syringe for biologics
Becton Dickinson (NYSE:BDX) said today that it launched its BD Neopak 2.25 milliliter prefillable glass syringe designed for high-volume injection of biologics. The Franklin Lakes, N.J.-based company said that its prefillable glass syringe was developed to reduce drug degradation and aggregation between the container and therapeutic. The high volume syringe is commercially available in the […]
TiGenix IPO raises $36m
TiGenix (EBR:TIG) said today that it raised $36 million in an initial public offering from the sale of 2.3 million American depository shares, representing 46 million ordinary shares, at $15.50 apiece. The biopharmaceutical company plans to list on the NASDAQ exchange under the “TIG” symbol by Dec. 15. It is listed on the Euronext Brussels under the same symbol. […]
BioDelivery names Ginsberg as biz dev veep | Personnel Moves, Dec. 14, 2016
BioDelivery Sciences International (NSDQ:BDSI) said today that it named Peter Ginsberg as its VP of business development. Prior to joining the Raleigh, N.C.-based company, Ginsberg led business development at United Therapeutics and directed a $350 million sale of the company’s priority review voucher. He has also served as VP of business & technology development for […]