Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus. The Canonsburg, Penn.-based company said it is “in the process of reviewing this response and will provide an update on its application as soon as practicable once it has […]
Regulatory/Compliance
Trump FDA pick to recuse himself from agency decisions involving 20 companies
Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than 20 companies, including GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Gottlieb has received millions of dollars for his roles as advisor, paid speaker […]
New clinical guidelines for medical devices from Australian TGA
By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
New medical device rules change India’s Authorized Agent role
By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
EU regulators: We should suspend drugs at suspect Indian facility
This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. European officials have reportedly […]
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
European advisory committee backs label update for Nordisk’s Tresiba
Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection. The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected […]
Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7 billion. In 2014, Mylan bought Abbott’s generics business outside the U.S. in a deal that rang in at nearly $5.3 billion. The deal allowed Canonsburg, Penn.-based Mylan […]
Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the […]
Mylan recalls 81,000 EpiPens over reports of device failure
Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it […]
