Regulatory Affairs
A quick look at biopharma’s top-selling drugs (including forecast sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion.
Posted: August 16, 2019, 8:05 pm
The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year.
Posted: August 16, 2019, 7:59 pm
Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA).
Posted: August 16, 2019, 6:33 pm
Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: August 16, 2019, 6:06 pm
The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.
Posted: August 16, 2019, 3:58 pm
Biotechnology
Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration reevaluates its policies regarding opioid pain medications. Here’s a look.
Posted: August 19, 2019, 12:00 am
The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.
Posted: August 16, 2019, 12:00 am
Nordic Nanovector ASA announces that it will report its results for the second quarter and first half 2019 on Thursday, 22 August 2019.
Posted: August 16, 2019, 12:00 am
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Posted: August 16, 2019, 12:00 am
The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance...
Posted: August 16, 2019, 12:00 am
Pharmaceuticals
Medicare and its beneficiaries could have saved an estimated $17.7 billion earlier this decade on generic versions of older medicines instead of paying for brand-name drugs, a study found.
Posted: August 16, 2019, 7:50 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: August 16, 2019, 2:40 pm
Congo's yearlong Ebola outbreak has spread to a third province, with two cases, including one death, confirmed in South Kivu, according to the government health ministry.
Posted: August 16, 2019, 2:25 pm
The Trump administration is pushing forward with a controversial proposal to lower drug prices, despite opposition from some fellow Republicans.
Posted: August 16, 2019, 1:27 pm
A top analyst sent a note to clients asking whether Roche is starting a “pricing war in cancer.” The answer may be more complicated.
Posted: August 16, 2019, 12:40 pm
Human Resources
The company was quick to respond to accusations on social media with statements asserting it takes the claims seriously.
Posted: August 16, 2019, 3:51 pm
FlexJobs' annual survey reflected many of its past insights about workers' desires for flexibility — including their preference for 100%-remote work.
Posted: August 16, 2019, 3:33 pm
Employee health management IT products can allow employers to more easily tailor health benefits to individual employees, Frost & Sullivan said in its report.
Posted: August 16, 2019, 3:22 pm
Turnover impacts performance profoundly in the telecom, pharmaceutical and business services sectors, among others, ENGAGE Talent found.
Posted: August 16, 2019, 3:13 pm
Bosses and colleagues were the most-cited cause of workers' tears in a Monster survey.
Posted: August 16, 2019, 2:56 pm