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 […]
Auto-injectors
EpiPen manufacturer is hit with FDA warning letter
Mylan (NSDQ:MYL) today made public a warning letter that the FDA sent to EpiPen manufacturer, Meridian Medical Technologies. In the letter, the regulatory agency summarizes “significant violations of current good manufacturing practice requirements for combination products”, including issues relating to quality control procedures, product complaint resolution and design verification. Among other products, Meridian manufactures Mylan’s EpiPen […]
Express Scripts, other PBMs named in lawsuit over pricey EpiPens
Express Scripts (NSDQ:ESRX) and other pharmacy benefit managers have been accused of giving Mylan‘s (NSDQ:MYL) EpiPens favorable placement on drug formularies in exchange for kickbacks, according to a proposed class action filed in Kansas federal court this week. The suit was brought by people covered under Employee Retirement Income Security Act benefit plans. These consumers claim […]
Mylan inks $465m settlement with DOJ over EpiPen Medicaid classification
Mylan (NSDQ:MYL) said today that it inked a $465 million deal with U.S. Dept. of Justice to settle claims that it misclassified its EpiPen allergy auto-injector device with the Medicaid Drug Rebate Program. In October last year, The Centers for Medicare & Medicaid Services said that Mylan had been overcharging Medicaid for its EpiPen device for years, […]
Kaleo launches program to give Auvi-Q allergy devices to schools
Kaleo said today that it launched a new program to offer its epinephrine auto-injector, Auvi-Q, free-of-charge to all public elementary schools in the U.S. The program is slated to give up to four Auvi-Q cartons per school each academic year. Each carton has two auto-injectors and a training device. Kaleo’s emergency allergy auto-injector features voice […]
Express Scripts covers Mylan’s EpiPen on 2018 formulary, excluding rivals
Express Scripts (NSDQ:ESRX) said yesterday that it would include Mylan‘s (NSDQ:MYL) EpiPen emergency allergy device on its 2018 formulary, favoring the drugmaker’s product over auto-injectors from competitors like Impax Laboratories (NSDQ:IPXL) and Kaleo. The largest pharmacy benefit manager in the U.S. has practiced excluding certain medicines from its list of covered drugs since 2014, pointing towards […]
FDA grants priority review to Kaleo’s auto-injector for infants, kids
Kaleo said today that the FDA granted priority review to a supplemental new drug application for Kaleo’s Auvi-Q 0.1 milligram epinephrine auto-injector. The privately-held pharmaceutical company touted this version of its device as the first specifically designed for the treatment of life-threatening allergic reactions in infants and small kids. The 0.1 mg auto-injector sports a […]
Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders […]
Enable Injections launches multi-vial/syringe biologics delivery system
Enable Injections Inc. launched a new single, partial or multi-vial/syringe transfer system used to fill its large volume wearable injectors. The system enables patients to either use multiple vials or syringes to deliver biologics and high volume drugs subcutaneously. The hand-held transfer system can work with any pharmaceutical primary container closure, Enable Injections said, and […]
Adamis up, Mylan down on generic EpiPen approval
Shares in Adamis Pharmaceuticals (NSDQ:ADMP) soared more than 50% yesterday after it won FDA approval for its generic EpiPen emergency allergy pre-filled syringe, sending shares in competitor Mylan (NSDQ:MYL) down -3%. For years, Mylan has commanded more than 90% of the market for emergency epinephrine injectors. Adamis’ device, called Symjepi, is intended to be a cheaper […]