a 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
a 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
a Rising Leaders Conference Set for Nov. 18-19: Reserve Your Place Today! By cohealthcom.org Published On :: Thu, 12 Mar 2020 16:23:00 +0000 March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […] Full Article CHC News
a FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment By cohealthcom.org Published On :: Mon, 16 Mar 2020 19:02:11 +0000 March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […] Full Article Regulatory/FDA Coronavirus COVID-19 FDA FDA commissioners FDA enforcement FTC Jon Bigelow PURELL unapproved drug Warning Letter
a Amid COVID-19 Outbreak, Protecting 2020 Election Should Start Now By cohealthcom.org Published On :: Mon, 23 Mar 2020 18:06:21 +0000 March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […] Full Article General 2020 election Amy Klobuchar Coronavirus COVID-19 early voting election day Jon Bigelow mail-in voting Ron Wyden voting
a Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
a 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
a FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims By cohealthcom.org Published On :: Mon, 13 Apr 2020 19:38:22 +0000 April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […] Full Article Regulatory/FDA clinical trials COVID-19 FDA FDA approval process FDA enforcement FTC Jon Bigelow promoting unapproved drug unapproved drug Warning Letter
a Despite Late Changes and COVID-19, CCPA Enforcement Date Remains July 1 By cohealthcom.org Published On :: Mon, 20 Apr 2020 21:01:00 +0000 April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […] Full Article Data Privacy 4A's Alison Pepper ANA California Consumer Protection Act CCPA Dan Jaffe data privacy data privacy legislation Gavin Newsom Jon Bigelow online data privacy Xavier Becerra
a COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines By cohealthcom.org Published On :: Mon, 27 Apr 2020 17:50:36 +0000 April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […] Full Article Regulatory/FDA Biohaven Bristol-Myers Squibb clinical trials COVID-19 drug approvals FDA approval process FDA Approvals
a 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
a 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
a COVID-19 the focus, but Pfizer isn't ignoring other vaccine R&D as its pens new deal By www.fiercebiotech.com Published On :: Fri, 01 May 2020 08:47:53 +0000 Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere. Full Article
a 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
a Inovio's COVID-19 vaccine claims echo Theranos, says short attack By www.fiercebiotech.com Published On :: Fri, 01 May 2020 12:32:30 +0000 Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine. Full Article
a Newron ditches sarizotan program after pivotal trial flop, sees shares crater By www.fiercebiotech.com Published On :: Mon, 04 May 2020 07:54:54 +0000 Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial. Full Article
a Lilly-partnered AbCellera gets COVID-19 boost from Canadian government By www.fiercebiotech.com Published On :: Mon, 04 May 2020 09:43:23 +0000 After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government. Full Article
a 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
a Repairing spinal cord injuries with a protein that regulates axon regeneration By www.fiercebiotech.com Published On :: Mon, 04 May 2020 13:03:05 +0000 Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries. Full Article
a BioMarin pens gene therapy pact with little-known Swiss biotech By www.fiercebiotech.com Published On :: Tue, 05 May 2020 10:12:40 +0000 BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor. Full Article
a Oberland Capital nabs $1.05B raise for late-stage plays, handing out cash for royalties By www.fiercebiotech.com Published On :: Tue, 05 May 2020 10:29:40 +0000 Come on in, the water’s warm. After billions already raised by VC firms since the advent of the pandemic for life science companies, Oberland Capital has tossed more than $1 billion into the pot. Full Article
a 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
a Months after closing $617M life sciences fund, Frazier Healthcare nabs biopharma vets By www.fiercebiotech.com Published On :: Tue, 05 May 2020 14:26:49 +0000 Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants. Full Article
a 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
a 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
a 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
a Janssen promotes R&D exec into newfound data science role By www.fiercebiotech.com Published On :: Wed, 06 May 2020 13:30:55 +0000 Following in the footsteps of an increasing number of biopharmas that want to use data to get more bang for their buck in R&D, J&J has promoted Najat Khan, Ph.D., to the role of chief data science officer. Full Article
a 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
a PTC Therapeutics nabs 'phase 3 ready' biotech Censa for just $10M upfront plus stock By www.fiercebiotech.com Published On :: Thu, 07 May 2020 11:05:29 +0000 PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks. Full Article
a Moderna eyes 'early summer' start for phase 3 COVID-19 vaccine trial By www.fiercebiotech.com Published On :: Thu, 07 May 2020 12:10:49 +0000 Moderna is finalizing the protocol for a phase 3 trial of its COVID-19 vaccine with a view to starting the study early in the summer. The establishment of the timeline, which follows FDA clearance to run a phase 2 trial, puts Moderna on track to win approval for its mRNA vaccine mRNA-1273 next year. Full Article
a 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
a 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
a After Alexion buyout, ex-Achillion nephrology lead jumps ship to Gemini Therapeutics By www.fiercebiotech.com Published On :: Fri, 08 May 2020 11:03:12 +0000 Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer. Full Article
a 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
a 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
a 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
a 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
a 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
a No difference found in caffeine's effects on exercise power among 'fast' or 'slow' metabolizers By www.nutraingredients-usa.com Published On :: Mon, 04 May 2020 17:09:00 +0100 A recent study looking at the effects of caffeine on brief, high intensity exercise found the substance improved performance, regardless of genetic variations in how subjects metabolized caffeine. Full Article Research
a 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
a 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
a 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
a ‘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
a Surge in screen time has led to jump in sales, says eye supplement president By www.nutraingredients-usa.com Published On :: Tue, 05 May 2020 16:41:00 +0100 With social distancing in full effect, families have not only found themselves with a lot more time together, but a lot more time in front of their screens. Full Article Markets
a Study: Potato protein a winner for women By www.nutraingredients.com Published On :: Fri, 08 May 2020 08:13:00 +0100 The recommended daily allowance of protein may be inadequate to support maintenance of muscle in young women and eating protein from the humble potato can help to maintain muscle, according to research from McMaster University funded by the Alliance for Potato Research & Education. Full Article Research
a Probiotic combination boosts amino acid absorption from plant protein: RCT By www.nutraingredients-usa.com Published On :: Wed, 06 May 2020 15:38:00 +0100 A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study. Full Article Research
a Casein-encapsulated calcium eases GI concerns, study finds By www.nutraingredients-latam.com Published On :: Wed, 06 May 2020 15:31:00 +0100 Researchers working with a group of postmenopausal women found that a technology using casein to encapsulate calcium nanoparticles reduced GI issues compared with more conventional calcium carbonate or calcium citrate supplements. Full Article Research
a 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
a 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
a 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