This Week’s Top Headlines
FDA, EU Release New Pharmaceutical Regulation Agreements
Posted 3/08/17
Earlier this month, the US FDA and multiple EU drug inspection agencies released amendments to the Pharmaceutical Annex of the 1998 U.S.-EU Mutual Recognition Agreement. Under the new agreements, regulatory agencies are now able to use information gathered from mutual inspections, streamlining approval processes. Also included in the agreement are standardized approval procedures which eliminate miscommunication between agencies. This cooperation represents three years of collaboration n from both the United States and the European Union. Read the full article here.
GOP Releases Healthcare Bill to Replace Affordable Care Act
Posted 3/08/17
The Trump administration this week revealed its long-awaited healthcare bill. The law, which retains some popular aspects of its predecessor, was introduced to congress on Monday as a means of repealing and replacing the Affordable Care Act. Included in the healthcare bill are provisions for pre-existing conditions, insurance premiums, and Medicaid expansion. The new act is being referred to as the American Health Care Act, or the AHCA. Read the full article here.
Velano Vascular Releases Needle-Free Blood Draw Device
Posted 3/08/17
Velano Vascular has secured funding to begin commercializing its line of needle-free blood drawing device. The company secured FDA funding for the device in February. The device allows for medical professionals to draw blood without using a needle, as needle-induced blood drawing is one of the most common invasive medical procedures. This device will allow patients medical needs to be attended to while also maintaining non-invasive comfort levels. Read the full article here.
Merck & Co. Unveils Amazon Partnership for Diabetes Treatment
Posted 3/08/17
Merck & Co. has announced plans to incorporate technology and patient wellness into a user-friendly interface. Syncing patient information with Amazon’s voice-enabled home system, Alexa, Merck will offer diabetes patients an alternative outlet to track treatment and progress. This proposal comes a home systems rise in popularity and ability. Read the full article here.
OncoCyte Prepares for Liquid Biopsy Tests
Posted 3/08/17
OncoCyte has begun preparations to launch liquid biopsy tests this year. This announcement comes after a 300-person study has confirmed the validity of the liquid biopsy. The biopsy’s correct detection rate for lung cancer was 90% and 62% for benign nodules. The innovative diagnostic will prevent invasive biopsy procedures from being necessary, and will also be the first liquid biopsy for the use of confirming a cancer diagnosis. This was the second study executed to confirm the abilities of the biopsy, as Wistar had previously tested the biopsy. Commercial rights were handed over to OncoCyte from Wistar in January. Read the full article here.