Baxter (NYSE:BAX) agreed to pay $18 million to settle criminal and civil cases stemming from a North Carolina sterile intravenous solution plant where mold was found in air filters. The agreement includes penalties and forfeitures of some $16 million and another $2.2 million to settle a civil qui tam lawsuit with the U.S. Justice Dept. Whistleblower Christopher Wall, […]
Legal News
Shire to pay feds $350m to settle Dermagraft kickbacks case
The U.S. Justice Dept. said yesterday that Shire (NSDQ:SHPG) and its subsidiaries will cough up $350 million to settle allegations that Shire and the company it acquired in 2011, Advanced BioHealing, gave kickbacks to clinics and physicians in exchange for using its bioengineered human skin substitute, Dermagraft. “This settlement represents the largest False Claims Act recovery by 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 […]
Teva coughs up $519m to settle overseas bribery charges
Teva Pharmaceuticals (NYSE:TEVA) will pay $519 million to settle allegations that the company bribed overseas officials in Mexico, Russia and Ukraine to promote its products, according to the U.S. Justice Dept. The department reported that the millions of dollars in bribes occurred for more than a decade. The pharmaceutical giant agreed to $238 million to […]
Bipartisan report from senators calls for drug pricing reform
The U.S. Senate Special Committee on Aging released a bipartisan report yesterday suggesting ways to respond to spikes in drug pricing. The report comes after a months-long investigation spearheaded by Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Missouri). The senators wrote that massive spikes in drug prices are “gouging” patients and that lawmakers should respond. […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
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 […]
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 […]
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 […]
Federal watchdog to investigate CMS drug rebate program
The Office of the Inspector General of the Health and Human Services Departments said last week that it will begin investigating whether the Centers for Medicare & Medicaid Services properly monitors its Medicaid Drug Rebate Program. The investigation comes after CMS reported that Mylan (NSDQ:MYL) underpaid Medicaid by not paying appropriate rebates. The Canonsburg, Penn.-based company said […]
Mylan, Allergan launch fight over Restasis eye drop patents
Allergan (NYSE:AGN) said this week that it will “vigorously defend” the patents for its Restasis eye drops, after the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board agreed to an inter partes review of 6 patents as requested by generic competitor Mylan (NSDQ:MYL). The patents are valid until August 2024. “Allergan is disappointed in […]