of Manufacturers report 'sporadic' resupply of sertraline following COVID-19 related shortage By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 16:32 GMT Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. To read the whole article click on the headline Full Article
of Transcending boundaries: the role of pharmacists in gender identity services By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 14:42 GMT There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge. To read the whole article click on the headline Full Article
of Wholesalers 'almost completely out' of government-supplied PPE, trade body warns By feeds.pjonline.com Published On :: Fri, 1 May 2020 10:30 GMT Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned. To read the whole article click on the headline Full Article
of Just 550 pharmacy staff referred for COVID-19 testing in first ten days of national scheme By feeds.pjonline.com Published On :: Thu, 7 May 2020 16:26 GMT Just over 550 community pharmacy staff members were referred for COVID-19 tests through a national booking system run by the Care Quality Commission, over ten days in mid-April 2020, the NHS watchdog has told The Pharmaceutical Journal. To read the whole article click on the headline Full Article
of In Surprise Move, SCOTUS to Rule on Constitutionality of ACA Next Term By cohealthcom.org Published On :: Wed, 04 Mar 2020 22:22:16 +0000 March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […] Full Article Courts/First Amendment ACA Affordable Care Act Jon Bigelow sunshine act Supreme Court U.S. Supreme Court
of CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising By cohealthcom.org Published On :: Mon, 06 Apr 2020 19:23:10 +0000 April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […] Full Article Legislative chc coalition for healthcare communication digital advertising Gov. Larry Hogan HB 732 Jon Bigelow Maryland the advertising coalition
of As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds By cohealthcom.org Published On :: Mon, 04 May 2020 20:17:45 +0000 May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […] Full Article Regulatory/FDA COVID-19 FDA FDA enforcement fraud FTC Jon Bigelow promoting unapproved drug scams Warning Letter
of EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral By www.fiercebiotech.com Published On :: Fri, 01 May 2020 08:07:12 +0000 The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients. Full Article
of COVID-19: T cells offer clues to the potential power of Roche's Actemra By www.fiercebiotech.com Published On :: Fri, 01 May 2020 11:56:40 +0000 The successful activation of T cells is critical to the immune system's ability to clear infections. A retrospective study in China found that COVID-19 patients had remarkably low T-cell counts in their blood, while some pro-inflammatory cytokines such as IL-6—which Roche’s Actemra targets—were elevated. Full Article
of Alnylam, Vir plan year-end trial of new RNAi COVID-19 antiviral By www.fiercebiotech.com Published On :: Mon, 04 May 2020 12:34:58 +0000 Alnylam and Vir Biotechnology have identified an anti-SARS-CoV-2 development candidate, putting them on track to start testing the inhaled RNAi treatment for COVID-19 in humans around the end of the year. Full Article
of FDA delays decision on approval of Bristol Myers' CAR-T By www.fiercebiotech.com Published On :: Wed, 06 May 2020 12:02:53 +0000 The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA. Full Article
of Could Sanofi and Regeneron's Dupixent also treat age-related macular degeneration? By www.fiercebiotech.com Published On :: Thu, 07 May 2020 10:57:05 +0000 Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration. Full Article
of 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
of 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
of 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
of 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
of 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
of 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
of 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
of 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
of 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
of Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry By feedproxy.google.com Published On :: Tue, 19 Jan 2016 17:34:48 +0000 Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading Full Article Biotechnology FDA Intellectual Property Legislation
of 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
of Notes on Day 4 of the JPMorgan Healthcare Conference By feedproxy.google.com Published On :: Fri, 13 Jan 2017 19:06:20 +0000 Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading Full Article Medicaid Medicare ASC health plan Medicare Advantage population health management Telehealth
of New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements By medicaldeviceslegal.com Published On :: Wed, 18 Mar 2020 08:28:42 +0000 I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […] Full Article Class I Recast Article 120 Blue Guide MDR
of 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
of 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
of 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
of 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
of The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers By www.latimes.com Published On :: Thu, 7 May 2020 15:01:18 -0400 The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter. Full Article
of 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
of Judge grants request to delay start of prison sentence for former Rep. Duncan Hunter By www.latimes.com Published On :: Thu, 7 May 2020 19:34:43 -0400 A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay. Full Article
of 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
of 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
of As coronavirus reshapes campaigns, Republicans fear loss of Senate control By www.latimes.com Published On :: Fri, 8 May 2020 06:00:38 -0400 Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns. Full Article
of Remembering a past global struggle in the midst of a present one By www.latimes.com Published On :: Fri, 8 May 2020 06:52:36 -0400 As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe. Full Article
of 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
of 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
of 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
of L.A. Phil's 100th birthday bash: Your quarantine must-watch of the day By www.latimes.com Published On :: Fri, 8 May 2020 09:30:59 -0400 It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free. Full Article
of Tens of thousands of California college students to get relief from emergency grants By www.latimes.com Published On :: Fri, 8 May 2020 10:00:34 -0400 California college students will get emergency CARES grants Full Article
of With the prospect of empty stadiums, how will the NFL move forward? By www.latimes.com Published On :: Fri, 8 May 2020 13:11:21 -0400 The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league. Full Article
of Most California counties fall short of reopening criteria as coronavirus cases climb By www.latimes.com Published On :: Fri, 8 May 2020 13:53:41 -0400 The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds. Full Article
of With the prospect of empty stadiums, how will the NFL move forward? By www.sandiegouniontribune.com Published On :: Fri, 8 May 2020 14:20:56 -0400 The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league. Full Article
of 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
of On Venice's hip Abbot Kinney, there are signs of retail life after devastating coronavirus closures By www.latimes.com Published On :: Fri, 8 May 2020 18:08:19 -0400 California reopening: On Abbot Kinney Boulevard in Venice, the normally bustling shopping district that has been largely vacant amid the coronavirus, there were signs of life Friday as some retailers opened for curbside service. Full Article
of 'Chinese virus' and other COVID-19 racism have designers, stylists of Asian heritage pushing back By www.latimes.com Published On :: Fri, 8 May 2020 19:20:44 -0400 Enough is enough, says a growing number of creatives from the fashion industry, including designer Kimora Lee Simmons, stylist Jeanne Yang and designer Prabal Gurung. Full Article
of Facebook and YouTube race to squash viral video full of coronavirus lies By www.latimes.com Published On :: Fri, 8 May 2020 21:26:28 -0400 The "Plandemic" video was the latest breakout hit from the coronavirus conspiracy theory industry. Social media companies are scrambling to ban it from their platforms. Full Article
of 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
of 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