Kaléo Inc. said yesterday that its Auvi-Q epinephrine auto-injector will be available by prescription in the U.S. beginning Feb. 14th. The Richmond, Virginia-based company’s emergency allergy treatment was pulled from the market in 2015 due to manufacturing issues. The Epipen competitor device will be sold at a list price of $4,500, but Kaléo said that as a […]
Pharmaceuticals
Study finds financial ties between researchers, industry associated with positive trial results
A study conducted by a team of U.S. researchers found that financial ties between researchers and the companies that make the drugs they are studying are independently associated with positive trial results. The team’s work was published in The BMJ this week. The study was observational, so the results can’t be used to draw concrete conclusions. But the […]
Grifols pays $51m for minority stake in Access Biologicals
Grifols (NSDQ:GRFS) said today that it paid $51 million for a 49% stake in Access Biologicals, in a deal that includes an option to acquire the rest of the business. That option, for the remaining 51% share in Vista, Calif.-based Access, goes live in 2022, Grifols said. The agreement also includes a provision to supply Access with non-human-use […]
FDA warns on MRI risks with infusion pumps
The FDA issued a warning today that the strong magnetic fields used in an MRI exam can affect implantable infusion pumps. The federal watchdog has received reports of serious adverse events, including patient death, associated with using an infusion pump in an MR environment. The reports claim that some patients have experienced inaccurate medication dosing […]
J&J to publish list of average drug price increases
Johnson & Johnson (NYSE:JNJ) is reportedly issuing a report next month that will detail how much it has raised the list prices for its prescription drugs. The report will describe average increases in list prices and the average prices after discounts. The move comes after some pharmaceutical companies, including Allergan (NYSE:AGN) and Novo Nordisk (NYSE:NVO), have pledged […]
scPharmaceuticals closes $46m Series B round
scPharmaceuticals said today that it closed a $45.6 million Series B round, co-led by OrbiMed and a subsidiary of Sun Pharmaceutical Industries. Other investors included 5AM Ventures and Lundbeckfond Ventures. The investment will be used to support the development of the operational and commercial infrastructure needed to bring Furoscix and the sc2Wear Infusor to market […]
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit […]
Braeburn Pharmaceuticals files plans for $150m IPO
Braeburn Pharmaceuticals filed plans for a $150 million initial public offering last week with the Securities & Exchange Commission, leaving out any specific pricing details. The Princeton, N.J.-based company plans to list its shares on the Nasdaq market under the symbol “BBRX”. JPMorgan, Merrill Lynch and Deustche Bank are underwriters for the offering and Apple […]
IntelGenx, Endo Ventures ink development and commercialization deal
IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new product using IntelGenx’s VersaFilm drug delivery technology to bring to the market in the U.S. Endo will have certain exclusive rights to market and sell the product in the […]
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba. CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on […]
