v GSK taps experimental arthritis antibody to calm the cytokine storm hitting COVID-19 patients By www.fiercebiotech.com Published On :: Thu, 07 May 2020 12:11:25 +0000 GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease. Full Article
v Chutes & Ladders—Johnson & Johnson elevates Khan to data science officer role By www.fiercebiotech.com Published On :: Thu, 07 May 2020 18:15:30 +0000 Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO. Full Article
v Sorrento ventures into COVID-19 with Mount Sinai antibody pact By www.fiercebiotech.com Published On :: Fri, 08 May 2020 12:14:09 +0000 Sorrento Therapeutics is jumping into the race to develop therapies against COVID-19, teaming up with Mount Sinai to develop a cocktail of antibodies from the blood of 15,000 recovered patients. The company's scientists believe their multipronged therapy will sidestep risks such as treatment resistance. Full Article
v Fortress joins KRAS race through Columbia University deal By www.fiercebiotech.com Published On :: Fri, 08 May 2020 12:35:03 +0000 Fortress Biotech has licensed a treatment for KRAS-driven cancers from Columbia University. Sticking to its blueprint, Fortress has set up a new biotech, Oncogenuity, to advance the preclinical asset and work to generate more oligonucleotides from the underlying platform. Full Article
v What’s driving sports nutrition segmentation? By www.nutraingredients-usa.com Published On :: Mon, 04 May 2020 17:26:00 +0100 A new report out by Innova Market Insights has identified several new trends that are driving sports nutrition. Full Article Markets
v Essential oils marketers added to list of coronavirus claims offenders By www.nutraingredients-usa.com Published On :: Mon, 04 May 2020 16:56:00 +0100 Some producers of essential oils have thrown their hats into the coronavirus claims ring, according to recent warning letters from the US Food and Drug Administration and the Federal Trade Commission. Full Article Regulation
v UNPA’s Israelsen: ‘We’ve had a good six weeks, but consumers have used some of their last spending power to buy supplements’ By www.nutraingredients-usa.com Published On :: Mon, 04 May 2020 17:35:00 +0100 While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money. Full Article People
v BENEO president: ‘We have seen higher and more volatile demand during the pandemic’ By www.foodnavigator-usa.com Published On :: Tue, 05 May 2020 02:05:00 +0100 From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more. Full Article Suppliers
v ‘Overwhelming evidence’ supports Vitamin D’s immune function benefits By www.nutraingredients-usa.com Published On :: Tue, 05 May 2020 14:55:00 +0100 There is an âindisputable relation between vitamin D and the immune systemâ, says a new review that shows that avoiding vitamin D deficiency has clear benefits for immune health. Full Article Research
v Personalized Nutrition: New research highlights value society places on genetic testing By www.nutraingredients-usa.com Published On :: Thu, 07 May 2020 15:58:00 +0100 The results provide priceless information on ancestry and predispositions to various illnesses. Full Article Research
v Lief Labs launches GMP starter kit initiative By www.nutraingredients-usa.com Published On :: Thu, 07 May 2020 16:40:00 +0100 The GMP Starter Kit aims to help guide brands through current Good Manufacturing Practices (cGMP) regulations and FDA compliance for nutritional and dietary supplement brands. Full Article Regulation
v Supporting Biotech Development in Madison By thenextelement.wordpress.com Published On :: Tue, 02 Dec 2014 23:08:38 +0000 As part of our follow up to our recent Biotech in Wisconsin Meetup about professional development skills, we are asking folks to fill out this poll. Full Article Uncategorized
v Case Study: When does “technology” turn into medical device By thenextelement.wordpress.com Published On :: Sun, 08 Feb 2015 18:59:48 +0000 This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “healthRead More Full Article Uncategorized biotech biotechnology cancer drug drug development health IT health tech mobile health Wisconsin
v #MHVF Approaches to Drug Development By thenextelement.wordpress.com Published On :: Tue, 10 Mar 2015 22:18:30 +0000 Today I had the chance for a panel conversation with Geeta Vemuri from Baxter Ventures and Ed Silverman from Pharmalot blog (Wall Street Journal) at the Midwest Healthcare Venture Forum. Our general topic was how we (an entrepreneur and a corporate venture capitalist) look at bringing drugs/devices to market. Here are a couple of takeaways from ourRead More Full Article Uncategorized
v None Better than One? (A Brief Note on VC in Smaller Hubs) By thenextelement.wordpress.com Published On :: Wed, 20 May 2015 00:58:24 +0000 Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well. – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if youRead More Full Article Uncategorized angel investors biotech biotechnology VC venture capital Wisconsin
v The Terrible, Horrible, No Good, Very Bad Pharma Day* By thenextelement.wordpress.com Published On :: Tue, 29 Sep 2015 12:34:47 +0000 A challenge You are passionate about providing an intervention (drug or device) to a group of patients who can’t access the current options due to availability or pricing. You could could go the philanthropic route to pay for the interventions. You could work towards regulation to apply downward pressure on pricing. No matter what, you have toRead More Full Article Uncategorized biotech biotechnology drug development drug pricing drug shortage patient advocacy pharma pharmaceutical
v Some Questions On The Future Of The Coronavirus Vaccine, Answered By www.npr.org Published On :: Fri, 08 May 2020 16:01:00 -0400 Scientists work tirelessly to find a coronavirus vaccine. But there are some questions to answer: How soon a viable vaccine would be developed? Would billions of people worldwide be able to to get it? Full Article
v V-E Day: Europe Celebrates A Subdued 75th Anniversary During COVID-19 Pandemic By www.npr.org Published On :: Fri, 08 May 2020 16:05:46 -0400 "Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era. Full Article
v Seen 'Plandemic'? We Take A Close Look At The Viral Conspiracy Video's Claims By www.npr.org Published On :: Fri, 08 May 2020 16:52:19 -0400 The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation." Full Article
v More Census Workers To Return To Rural Areas In 9 States To Leave Forms By www.npr.org Published On :: Fri, 08 May 2020 17:46:45 -0400 The Census Bureau says it plans to continue its relaunch of limited 2020 census operations on May 13, when the next round of workers is set to resume hand-delivering paper forms in rural communities. Full Article
v Coronavirus FAQs: Do Temperature Screenings Help? Can Mosquitoes Spread It? By www.npr.org Published On :: Fri, 08 May 2020 17:53:41 -0400 And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool? Full Article
v Reopening After COVID: The 3 Phases Recommended By The White House By www.npr.org Published On :: Sat, 09 May 2020 07:00:57 -0400 President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states. Full Article
v Anti-Vaccination Activists Join Stay-At-Home Order Protesters By www.npr.org Published On :: Sat, 09 May 2020 07:00:57 -0400 Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement. Full Article
v So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy By www.npr.org Published On :: Sat, 09 May 2020 07:59:00 -0400 With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should. Full Article
v Tracking The Pandemic: How Quickly Is The Coronavirus Spreading State By State? By www.npr.org Published On :: Sat, 09 May 2020 08:15:27 -0400 View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off. Full Article
v Coronavirus World Map: Tracking The Spread Of The Outbreak By www.npr.org Published On :: Sat, 09 May 2020 08:22:13 -0400 A map of confirmed COVID-19 cases and deaths around the world. The respiratory disease has spread rapidly across six continents and has killed thousands of people. Full Article
v New EU Rules for Medical Devices By feedproxy.google.com Published On :: Tue, 12 Jul 2016 20:50:14 +0000 After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading Full Article Life Sciences Practice MDR SRN UDI
v En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers By feedproxy.google.com Published On :: Fri, 15 Jul 2016 16:04:54 +0000 Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1] The en banc opinion...… Continue Reading Full Article Intellectual Property Ben Venue Laboratories CMO MedCo On-Sale Bar
v A vaccine probably won’t arrive any time soon. By worldofdtcmarketing.com Published On :: Fri, 01 May 2020 12:10:27 +0000 Full Article As I See It Vaccines
v Do HCP’s want to hear from pharma during COVID-19? By worldofdtcmarketing.com Published On :: Tue, 05 May 2020 13:07:02 +0000 Full Article in the news Marketing to health care professionals Bad Research
v The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck By medicaldeviceslegal.com Published On :: Fri, 20 Mar 2020 08:50:26 +0000 What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […] Full Article Notified Body bottleneck Commission recommendation IVDR MDR notified bodies
v MDR amendment proposal article 120 (3) oversight set to be fixed by Council By medicaldeviceslegal.com Published On :: Wed, 08 Apr 2020 11:31:54 +0000 It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […] Full Article Recast Date of Application MDR Postponement
v New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions By medicaldeviceslegal.com Published On :: Wed, 08 Apr 2020 18:53:57 +0000 When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […] Full Article Notified Body Recast AIMDD audits IVDD IVDR MDD MDR notified bodies Unannounced audits
v MDR date of application move: politically a done deal now By medicaldeviceslegal.com Published On :: Sat, 18 Apr 2020 10:31:43 +0000 With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […] Full Article MDR Recast Date of Application Eudamed
v Face masks will be an even bigger part of L.A. life as reopening begins By www.latimes.com Published On :: Thu, 7 May 2020 13:41:16 -0400 Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements. Full Article
v COVID-19 cases higher among San Diego's Latinos; advocates call for more testing By www.latimes.com Published On :: Thu, 7 May 2020 14:16:36 -0400 In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts. Full Article
v First coronavirus, now 'murder hornets'? 'The Simpsons' predicts the future again By www.latimes.com Published On :: Thu, 7 May 2020 14:18:01 -0400 Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events. Full Article
v California tops 2,500 coronavirus deaths as fears of second wave temper reopening efforts By www.latimes.com Published On :: Thu, 7 May 2020 14:27:21 -0400 Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday. Full Article
v Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities By www.latimes.com Published On :: Thu, 7 May 2020 14:39:50 -0400 Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday. Full Article
v Coronavirus torpedoes 50th L.A. Pride parade; online celebration planned By www.latimes.com Published On :: Thu, 7 May 2020 15:28:50 -0400 The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak. Full Article
v Newsom unveils rules governing how quickly California communities can reopen businesses By www.latimes.com Published On :: Thu, 7 May 2020 16:01:33 -0400 Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions. Full Article
v Drive-through celebrations and car parades nixed in Santa Clara County By www.latimes.com Published On :: Thu, 7 May 2020 16:23:40 -0400 The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now. Full Article
v Even if you want to buy a home, it's harder now to get a loan. Or tap home equity By www.latimes.com Published On :: Thu, 7 May 2020 16:46:58 -0400 As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home. Full Article
v Axl Rose called Steven Mnuchin an expletive on Twitter, sparking 2020's weirdest feud By www.latimes.com Published On :: Thu, 7 May 2020 16:54:07 -0400 Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat. Full Article
v U.N. nearly triples its coronavirus fundraising goal to $6.7 billion By www.latimes.com Published On :: Thu, 7 May 2020 17:01:11 -0400 The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency. Full Article
v California to reopen 25 DMV field offices on Friday after they were shut down amid coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 17:44:05 -0400 California DMV will reopen 25 field offices after shutdown Full Article
v 138 employees at Central California meat plant test positive for coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 17:53:51 -0400 Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases. Full Article
v Here are the Orange County communities with coronavirus cases By www.latimes.com Published On :: Thu, 7 May 2020 18:09:55 -0400 Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66. Full Article
v 'A wild ride': Expanding coronavirus testing takes center stage with reopening By www.latimes.com Published On :: Thu, 7 May 2020 18:23:11 -0400 Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up. Full Article
v Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 18:33:05 -0400 The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it. Full Article