it Pfizer, BioNTech dose first U.S. subject with COVID-19 vaccine By www.fiercebiotech.com Published On :: Tue, 05 May 2020 12:10:42 +0000 Pfizer and BioNTech have begun dosing participants in a U.S. clinical trial of their COVID-19 vaccine candidates. The dose-escalation stage of the trial will enroll up to 360 subjects, initially out of sites in New York and Maryland. Full Article
it CSL Behring joins pandemic R&D fight with antibody work By www.fiercebiotech.com Published On :: Wed, 06 May 2020 09:38:11 +0000 Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19. Full Article
it COVID-19: Lilly ramps up to beat the virus with neutralizing antibodies as scientists raise worries By www.fiercebiotech.com Published On :: Wed, 06 May 2020 11:34:39 +0000 Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple. Full Article
it 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
it 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
it 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
it Orchard Therapeutics cuts 25% of staffers, rethinks pipeline, closes California site By www.fiercebiotech.com Published On :: Fri, 08 May 2020 13:21:08 +0000 Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others. Full Article
it 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
it Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says By www.nutraingredients-usa.com Published On :: Tue, 05 May 2020 13:22:00 +0100 The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future. Full Article Markets
it ‘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
it Report: “Calm” resonates with consumers By www.nutraingredients-usa.com Published On :: Wed, 06 May 2020 17:05:00 +0100 Recent research suggests that some brands may want to calm down their messaging. Full Article Markets
it Persona CEO Jason Brown on state of personalized nutrition By www.nutraingredients-usa.com Published On :: Wed, 06 May 2020 17:09:00 +0100 Consumers arenât just looking for custom-made approaches any more, theyâre expecting it. As technology advances, more companies are offering custom nutritional solutions. Full Article Personalized Nutrition
it 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
it Herbal ingredient supplier benefits from incontinence product supply problems By www.nutraingredients-usa.com Published On :: Thu, 07 May 2020 15:30:00 +0100 The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues. Full Article Suppliers
it 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
it Google Says Most Of Its Employees Will Likely Work Remotely Through End of Year By www.npr.org Published On :: Fri, 08 May 2020 16:22:07 -0400 The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer. Full Article
it 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
it Haitian Doctor Says This Is The Worst Epidemic He's Faced By www.npr.org Published On :: Fri, 08 May 2020 17:56:35 -0400 A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable. Full Article
it COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home By www.npr.org Published On :: Sat, 09 May 2020 07:00:27 -0400 Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains. Full Article
it 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
it 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
it 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
it Can pharma become a digital industry? By worldofdtcmarketing.com Published On :: Wed, 29 Apr 2020 11:11:33 +0000 Full Article in the news Working in the industry Pharma Digital Transformations
it Brexit is a fact – now deal with it By medicaldeviceslegal.com Published On :: Thu, 30 Jan 2020 16:36:58 +0000 Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […] Full Article Brexit IVDR MDR
it The MDCG cybersecurity guidance – a helpful rush job By medicaldeviceslegal.com Published On :: Mon, 16 Mar 2020 09:00:42 +0000 It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […] Full Article Cybersecurity Data Protection Software Telemedicine IVDR MDCG MDR risk management software
it 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
it 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
it I'm gaining weight in quarantine and I couldn't be more thrilled about it By www.latimes.com Published On :: Thu, 7 May 2020 13:39:03 -0400 If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude. Full Article
it 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
it 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
it 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
it 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
it 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
it Editorial: L.A.'s trails and parks are reopening. C'mon, people, don't screw it up this time By www.latimes.com Published On :: Thu, 7 May 2020 17:15:23 -0400 For goodness sake, if you're going to hike, wear a mask. Full Article
it 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
it 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
it '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
it 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
it Protesters stage illegal rally at California Capitol to support law enforcement By www.latimes.com Published On :: Thu, 7 May 2020 20:05:42 -0400 Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week. Full Article
it First Californian to get coronavirus in community spread was infected at a nail salon, Newsom says By www.latimes.com Published On :: Thu, 7 May 2020 20:12:17 -0400 Newsom cited the case when asked why personal services, such as nail salons, must remain closed. Full Article
it Coronavirus unemployment: WME cuts 20% of its workforce By www.latimes.com Published On :: Thu, 7 May 2020 20:19:58 -0400 Beverly Hills-based William Morris Endeavor said it is reducing its workforce by 20% through furloughs, layoffs and moving people to part-time employees. Full Article
it 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
it Letters to the Editor: Old Americans shouldn't have to prove their value to combat ageism By www.latimes.com Published On :: Fri, 8 May 2020 06:00:18 -0400 The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope. Full Article
it Column: No, wearing a mask isn't for libs. It's for people who don't want to die By www.latimes.com Published On :: Fri, 8 May 2020 06:00:39 -0400 The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America. Full Article
it 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
it 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
it Fears of a second coronavirus surge haunt California as it begins slow-speed reopening of economy By www.latimes.com Published On :: Fri, 8 May 2020 08:00:20 -0400 Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave. Full Article
it An Orange County cafe opened in defiance of Newsom. Now it's the center of stay-at-home resistance By www.latimes.com Published On :: Fri, 8 May 2020 08:00:26 -0400 When it opened last week for the first time since mid-March, Nomads Canteen in San Clemente quickly filled with customers eager to get out of the house and return to some sense of normalcy amid the COVID-19 pandemic. Full Article
it Someday we'll return to the office. It'll be nothing like we've seen before By www.latimes.com Published On :: Fri, 8 May 2020 08:00:35 -0400 With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy. Full Article
it Column: The cruise ship industry is sinking. I'm OK with that By www.latimes.com Published On :: Fri, 8 May 2020 08:00:54 -0400 Norwegian Cruise Line says it's in danger of going out of business. Maybe that's not the worst thing for an industry of floating petri dishes. Full Article