Regulatory Affairs
As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission.
Posted: December 13, 2019, 9:28 pm
The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21st Century Cures Act.
Posted: December 13, 2019, 9:17 pm
The medical device association in Switzerland and two attorneys at Sidley Austin are raising questions about the mutual recognition agreement (MRA) between the EU and Switzerland and its impact on the trade of medical devices.
Posted: December 13, 2019, 8:26 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: December 13, 2019, 5:57 pm
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Posted: December 13, 2019, 2:20 pm
Biotechnology
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body's immune system in the fight against cancer, today announced an update regarding the chimeric antigen receptor T-cell (CAR-T) technology it is developing with its partner, Moffitt Cancer Center.
Posted: December 13, 2019, 12:00 am
Pharma and biotech companies strengthen their leadership teams and boards with this week's hires.
Posted: December 13, 2019, 12:00 am
BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce the presentation results of clinical studies with its lead product candidate, Bria-IMT™, summarized in two poster sessions during the 2019 San Antonio Breast Cancer Symposium® (SABCS).
Posted: December 13, 2019, 12:00 am
Genentech, a member of the Roche Group, announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival.
Posted: December 13, 2019, 12:00 am
Exelixis, Inc. announced positive results from IMspire150, the phase 3 trial of atezolizumab, cobimetinib and vemurafenib in people with previously untreated BRAF V600 mutation-positive advanced melanoma.
Posted: December 13, 2019, 12:00 am
Pharmaceuticals
The FDA approval reverses decades of mixed results for fish-oil-based drugs and could result in Vascepa being prescribed to millions of patients.
Posted: December 13, 2019, 10:47 pm
What to do about the Health Insurance Tax isn't a fight over party politics: 80% of Democrats and 84% of Republicans don't want the tax to go into effect. It's…
Posted: December 13, 2019, 7:12 pm
In a surprise showing, the sale of medically important antibiotics given to food-producing livestock rose last year, reversing a trend amid concerns such usage can cause antibiotic resistance in humans.
Posted: December 13, 2019, 5:55 pm
From new hires to departures, promotions and tranfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: December 13, 2019, 3:09 pm
House Democrats passed sweeping legislation to lower prescription drug prices, marking the latest volley in a health care debate that has animated all sides all year.
Posted: December 13, 2019, 2:26 pm
Human Resources
NLRB approved a settlement that absolved the corporation from joint responsibility for certain alleged franchisee labor violations.
Posted: December 13, 2019, 7:38 pm
The airline allegedly forced all pregnant pilots onto unpaid leave at 32 weeks of pregnancy and refused to accommodate on-duty breastfeeding.
Posted: December 13, 2019, 7:18 pm
An employer can be liable when workers engage in unlawful harassment, unless it can show it took immediate, appropriate corrective action.
Posted: December 13, 2019, 6:35 pm
Experts say large companies are leading the way, adding vaping to workplace tobacco policies.
Posted: December 13, 2019, 5:09 pm
The move speaks to why more employers are paying close attention to word choice.
Posted: December 13, 2019, 4:25 pm