Alkermes (NSDQ:ALKS) shares tumbled this morning after the company revealed that the FDA will not review its application for an investigational depression drug. The U.S. regulatory issued a refusal to file letter to Alkermes, writing that it can’t review the drug’s application based on “insufficient evidence of overall effectiveness for the proposed indication,” and that […]
Myriad’s breast cancer diagnostic wins approval in Japan
Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK). Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck […]
Dexcom CEO on ‘treading new ground’ with G6 glucose monitor
Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes. This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
Foundation Medicine launches genomic profiling test for solid tumors
Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S. The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients. The assay looks for genomic changes in 324 genes that are known to promote cancer […]
FDA committee backs Senseonics’ implantable continuous glucose monitor
An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week. The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective. The company’s […]
Pulmatrix prices $15m underwritten public offering
Pulmatrix (NSDQ:PULM) today priced an underwritten public offering of 23,500,000 units, including one share of common stock, one Series A warrant to buy one share of common stock and one Series B warrant to buy one share of common stock per unit. The Lexington, Mass.-based company also gave underwriters a 30-day option to buy an additional […]
pSivida buys Icon Bioscience and rebrands as EyePoint Pharmaceuticals
With the help of $61 million from EW Healthcare Partners and a third-party investor, pSivida (NSDQ:PSDV) announced today that it acquired Icon Bioscience and its FDA-approved dexamethasone intraocular suspension designed to treat postoperative inflammation. The two companies combined and plan to do business as EyePoint Pharmaceuticals. pSivida also landed a $20 million debt facility from SWK […]
FDA committee backs first non-opioid medicine to treat opioid withdrawal
Specialty pharma company US WorldMeds said today that an FDA committee voted 11-1 to recommend approval for lofexidine, a selective alpha 2-adrenergic receptor agonist designed to mitigate the symptoms of opioid withdrawal. The oral drug, which US WorldMeds intends to market under the name Lucemyra, reduces the release of norepinephrine in a person’s brain and suppresses […]
Bigfoot brings Series B total to $55m with new investment from Abbott
Reeling in an $18 million add-on to the $37 million Series B that it reported last year, Bigfoot Biomedical touted today that it has raised over $90 million in total funding since the Milpitas, Calif.-based company first launched. Investments from Abbott (NYSE:ABT), which has an established partnership with Bigfoot, and other new and existing investors, brought the […]
