io NutraCast Podcast: Michelle Ricker on biohacking By www.nutraingredients-usa.com Published On :: Fri, 08 May 2020 17:08:00 +0100 Youâve likely heard of life hacks, which are tricks or shortcuts that help you be more efficient in life. You may or may not have heard of biohacks. But chances are, youâve already tried some without even knowing it. You might even be biohacking right nowâ Full Article People
io Bifido probiotic may enhance effects of exercise and boost training results: Study By www.nutraingredients-usa.com Published On :: Fri, 08 May 2020 16:14:00 +0100 Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study. Full Article Research
io 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
io What is the optimal biotech burn rate? By thenextelement.wordpress.com Published On :: Mon, 02 Feb 2015 04:02:29 +0000 Ethan Perlstein, founder of Perlstein Lab, asked a question on Twitter and got some great answers from David Grainger, partner at Index Ventures and Katrine Bosley, CEO of Editas Medicine. (You can read the whole thread by clicking through.) @LifeSciVC @sciencescanner @ksbosley @scientre what's the burn rate distribution of biotech NewCos in for the first year ofRead More Full Article Uncategorized biotech biotechnology burn rate drug development venture capital
io Precision in Oncology: Using the Macro and Micro By thenextelement.wordpress.com Published On :: Tue, 03 Mar 2015 15:35:08 +0000 Last week, the New York Times had a nice piece “A Faster Way to Try Many Drugs on Many Cancers” on basket clinical trials, which matches patients to a therapy based on the genetics of their tumor as opposed to the site of their primary tumor. This type of trial feeds into the current excitement about precisionRead More Full Article Uncategorized
io 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
io What Happened Today: Health Care System Crumbles, Testing Questions By www.npr.org Published On :: Fri, 08 May 2020 20:12:00 -0400 Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing. Full Article
io 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
io 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
io Digital transformation in pharma By worldofdtcmarketing.com Published On :: Fri, 24 Apr 2020 13:32:20 +0000 Full Article Book Review DTC Spending in the news
io 10 Predictions for healthcare By worldofdtcmarketing.com Published On :: Thu, 30 Apr 2020 18:26:56 +0000 Full Article in the news
io The MDCG MDR joint implementation plan By medicaldeviceslegal.com Published On :: Fri, 13 Mar 2020 21:10:01 +0000 The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […] Full Article IVDR MDR Recast Brexit Implementation plan MDCG Swixit Turkxit
io 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
io Commission working on proposal to postpone MDR date of application for one year By medicaldeviceslegal.com Published On :: Wed, 25 Mar 2020 20:18:45 +0000 After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […] Full Article Recast Brexit Date of Application IVDR MDR Postponement Swixit Turkxit
io 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
io 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
io 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
io 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
io 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
io 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
io Souplantation's buffet-style restaurants closing for good because of the coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 20:49:58 -0400 Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19 Full Article
io Unemployment hits 14.7% in April. How long before 20.5 million lost jobs come back? By www.latimes.com Published On :: Fri, 8 May 2020 06:00:01 -0400 Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly. Full Article
io Op-Ed: We were left to sicken and die from the coronavirus in immigration detention. Here's how I got out By www.latimes.com Published On :: Fri, 8 May 2020 06:00:41 -0400 It was impossible to maintain any kind of social distance and there was no way to protect oneself from COVID-19. Full Article
io Letters to the Editor: Mr. President, protect us with testing. Then we'll be your coronavirus 'warriors' By www.latimes.com Published On :: Fri, 8 May 2020 06:00:59 -0400 Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing. Full Article
io Op-Ed: I see face masks as a socially acceptable fashion opportunity. So should you By www.latimes.com Published On :: Fri, 8 May 2020 06:05:21 -0400 Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus. Full Article
io At protests, mostly white crowds show how pandemic has widened racial and political divisions By www.latimes.com Published On :: Fri, 8 May 2020 08:00:57 -0400 Coronavirus pandemic widens racial and political divisions Full Article
io Opinion: Remdesivir helps beat COVID-19. But the search for a better drug goes on By www.latimes.com Published On :: Fri, 8 May 2020 09:08:24 -0400 The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for. Full Article
io Opinion: The unemployment rate may be even worse than it looks By www.latimes.com Published On :: Fri, 8 May 2020 10:49:48 -0400 If you factor in a potential undercount of furloughed workers, nearly 1 in 5 working Americans may be in line for unemployment benefits. Full Article
io Coronavirus is making expectant parents anxious. This doula wants to help By www.latimes.com Published On :: Fri, 8 May 2020 13:00:19 -0400 Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age. Full Article
io Hold the Champagne: Pandemic, recession fears hammer traditional European products By www.latimes.com Published On :: Fri, 8 May 2020 14:49:10 -0400 A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods. Full Article
io 'You talkin' to me?' Watch Andrew Cuomo's spot-on Robert De Niro impression By www.latimes.com Published On :: Fri, 8 May 2020 15:39:09 -0400 Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves. Full Article
io 3 more inmates die at Chino prison as coronavirus infections continue to spread By www.latimes.com Published On :: Fri, 8 May 2020 16:38:04 -0400 Three more inmates died of coronavirus and the number who are infected has more than doubled at the California state prison in Chino, officials said. Full Article
io NHL postpones international games planned for 2020-21 season By www.latimes.com Published On :: Fri, 8 May 2020 16:47:31 -0400 The NHL announces it is postponing the Global Series games that were scheduled to be held in the Czech Republic and Finland in the 2020-21 season. Full Article
io Merchants rejoice as they finally swing open doors and greet customers — with restrictions, of course By www.latimes.com Published On :: Fri, 8 May 2020 17:04:05 -0400 Merchants rejoice they finally reopen businesses and greet customers, with social distancing Full Article
io News Analysis: Is the coronavirus crisis reason to worry about how other nations view U.S. leadership? By www.latimes.com Published On :: Fri, 8 May 2020 20:08:41 -0400 U.S. leadership, or the lack thereof, in the time of coronavirus Full Article
io Commissioner Adam Silver tells NBA players that resuming the season remains fluid By www.latimes.com Published On :: Fri, 8 May 2020 20:50:33 -0400 Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans. Full Article
io Roy Horn, dark-haired half of flamboyant illusionists Siegfried & Roy, dies of coronavirus-related complications By www.latimes.com Published On :: Fri, 8 May 2020 22:22:18 -0400 Roy Horn, the dark-haired half of Siegfried & Roy, raised the white tigers and other animals in the duo's extravagant shows that were one of the biggest draws on the Las Vegas Strip. Full Article
io Senior care homes source of nearly half of all California coronavirus deaths, data show By www.latimes.com Published On :: Fri, 8 May 2020 22:36:46 -0400 New data analyzed by the Los Angeles Times show that nearly half of all COVID-19 deaths in the state are associated with elder care facilities. Full Article
io Op-Ed: With our ski resort closed, we're working at a food bank and feeling all the emotions By www.latimes.com Published On :: Sat, 9 May 2020 06:05:22 -0400 The coronavirus-idled events team from a ski resort runs a food bank in Basalt, Colo., pivoting from delivering entertainment to helping the hungry. Full Article
io A politically connected firm gets an $800-million mask contract with California. Then it falls apart By www.latimes.com Published On :: Sat, 9 May 2020 08:00:08 -0400 California's deal with Bear Mountain Development Co. for coronavirus equipment was one of the state's largest. Full Article
io Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some Limitations By feedproxy.google.com Published On :: Wed, 22 Apr 2020 01:35:08 +0000 By Karla L. Palmer — Full Article COVID19 Prescription Drugs and Biologics
io FDA’s Final Device Establishment Inspections Guidance Misses the Mark By feedproxy.google.com Published On :: Thu, 23 Apr 2020 09:19:49 +0000 By Rachael E. Hunt — Full Article cGMP Compliance Medical Devices
io Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled Substances By feedproxy.google.com Published On :: Fri, 24 Apr 2020 09:04:06 +0000 By Karla L. Palmer — Full Article Controlled Substances Drug Enforcement Administration
io Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack Thereof By feedproxy.google.com Published On :: Tue, 28 Apr 2020 02:14:24 +0000 By Sara W. Koblitz — Full Article Biosimilars Prescription Drugs and Biologics
io First child death from mysterious COVID-19-related illness is reported in the U.S By www.nbcnews.com Published On :: Fri, 08 May 2020 20:20:43 GMT Nearly 100 children in the U.S. have been diagnosed with the newly identified syndrome associated with COVID-19. Full Article
io Birx to help lead remdesivir distribution effort as hospitals struggle to access drug By www.nbcnews.com Published On :: Fri, 08 May 2020 20:37:00 GMT Since the drug was granted emergency use authorization, doctors have been left with no clear path to get it. Full Article
io Supply chain headache? Hundreds of millions of syringes will be needed to vaccinate U.S. By www.nbcnews.com Published On :: Sat, 09 May 2020 01:51:00 GMT The world's largest manufacturer says there's not enough capacity to quickly ramp up production to those levels. Full Article
io Meet the Ohio health expert who has a fan club — and Republicans trying to stop her By www.nbcnews.com Published On :: Sat, 09 May 2020 09:04:00 GMT Some Buckeyes are not comfortable being told by a "woman in power" to quarantine, one expert said. Full Article
io The pandemic shows WHO lacks authority to force governments to divulge information, experts say By www.nbcnews.com Published On :: Sat, 09 May 2020 10:05:00 GMT The WHO has come under criticism for its deferential tone toward China, but the organization denies it withheld information about COVID-19. Full Article
io New Zealand's winning virus tactics spell election risks for Ardern By asia.nikkei.com Published On :: Full Article