t COVID-19 Outbreak Pausing Live Speaking Engagements By regulatoryrx.blogspot.com Published On :: Fri, 20 Mar 2020 17:26:00 +0000 I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands! Full Article COVID-19 DIA FDAnews RAPS
t Supplies of some COVID-19 medicines to run out within days, government warns By feeds.pjonline.com Published On :: Mon, 20 Apr 2020 14:39 GMT Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned. To read the whole article click on the headline Full Article
t Pharmacies' dispensing increases by up to a third as a result of COVID-19, survey finds By feeds.pjonline.com Published On :: Tue, 21 Apr 2020 15:22 GMT Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association. To read the whole article click on the headline Full Article
t One in three pharmacists unable to access PPE, finds RPS survey By feeds.pjonline.com Published On :: Wed, 22 Apr 2020 14:05 GMT A third of pharmacists cannot obtain continuous supplies of personal protective equipment, according to a survey conducted by the Royal Pharmaceutical Society. To read the whole article click on the headline Full Article
t Myocardial injury associated with increased risk of death from COVID-19, research suggests By feeds.pjonline.com Published On :: Thu, 23 Apr 2020 11:37 GMT The development of myocardial injury in COVID-19 patients is associated with an increased risk of death, researchers have found. To read the whole article click on the headline Full Article
t Neurological symptoms common in COVID-19 patients, researchers say By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:13 GMT Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests. To read the whole article click on the headline Full Article
t Care home pharmacists redeployed, despite COVID-19 palliative care increase By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:22 GMT Exclusive: Pharmacy staff in care homes are being redeployed to cover other roles during the COVID-19 pandemic, even though demands on care homes are increasing rapidly, The Pharmaceutical Journal has learnt. To read the whole article click on the headline Full Article
t 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
t Apixaban may be more effective and safer than rivaroxaban, research suggests By feeds.pjonline.com Published On :: Mon, 27 Apr 2020 13:15 GMT Adults with non-valvular atrial fibrillation prescribed apixaban have a lower rate of ischaemic stroke and systemic blood clots compared with those prescribed rivaroxaban, according to a retrospective cohort study in Annals of Internal Medicine. To read the whole article click on the headline Full Article
t Pharmacy staff who have died during COVID-19 pandemic to be remembered during minute's silence By feeds.pjonline.com Published On :: Tue, 28 Apr 2020 09:49 GMT Pharmacy staff who are thought to have died as a result of the COVID-19 pandemic are to be among the healthcare workers remembered with a minute’s silence on 28 April 2020. To read the whole article click on the headline Full Article
t Pharmacists will not be automatically included in government COVID-19 life assurance scheme By feeds.pjonline.com Published On :: Tue, 28 Apr 2020 16:21 GMT Pharmacists will not be automatically eligible for a new government life assurance scheme for healthcare workers in England who die from COVID-19 during the pandemic. To read the whole article click on the headline Full Article
t Community pharmacies need £200m extra to stay afloat during COVID-19, trade body warns By feeds.pjonline.com Published On :: Wed, 29 Apr 2020 14:21 GMT Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned. To read the whole article click on the headline Full Article
t COVID-19 updates: 5 April 2020 – 30 April 2020 By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 11:43 GMT All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen. To read the whole article click on the headline Full Article
t 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
t Community pharmacists will now be included in COVID-19 death-in-service scheme By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 15:30 GMT Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced. To read the whole article click on the headline Full Article
t 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
t Manufacturer to move hydroxychloroquine production to the UK to avoid shortages By feeds.pjonline.com Published On :: Tue, 5 May 2020 15:41 GMT A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages. To read the whole article click on the headline Full Article
t Everything you should know about the coronavirus outbreak By feeds.pjonline.com Published On :: Wed, 6 May 2020 10:44 GMT The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public. To read the whole article click on the headline Full Article
t NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19 By feeds.pjonline.com Published On :: Wed, 6 May 2020 12:29 GMT NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background. To read the whole article click on the headline Full Article
t COVID-19 LATEST: Valproate reviews must not be delayed, says medicines regulator By feeds.pjonline.com Published On :: Thu, 7 May 2020 00:01 GMT All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen. To read the whole article click on the headline Full Article
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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