general FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS By www.kkblaw.com Published On :: Mon, 30 Mar 2020 13:51:24 +0000 By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1] FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements, The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP. Full Article Insights cigarette advertisements cigarette plan cigarette warning FDA graphic warning health warning tobacco control act
general Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? By www.kkblaw.com Published On :: Tue, 31 Mar 2020 17:25:41 +0000 By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country. In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP. Full Article Insights 3D Printing Additive manufacturing FDA Personal protective equipment PPE
general New Opportunities for OTC Monograph Drugs under the CARES Act By www.kkblaw.com Published On :: Thu, 02 Apr 2020 20:11:58 +0000 By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA). This law The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP. Full Article Insights
general Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act By www.kkblaw.com Published On :: Fri, 03 Apr 2020 21:47:14 +0000 By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA). The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP. Full Article Insights animal drugs CARES Act device shortage drug shortage
general LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19 By www.kkblaw.com Published On :: Mon, 06 Apr 2020 18:46:35 +0000 Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD – FDA Update and the Impact of COVID-19. Since 2015, KKB and VS have worked closely together in advising clients on the ever-evolving legal landscape for hemp-derived products. During this The post LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19 appeared first on Kleinfeld Kaplan & Becker LLP. Full Article News cannabidiol CBD COVID-19 FDA hemp
general TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule By www.kkblaw.com Published On :: Tue, 07 Apr 2020 17:52:47 +0000 #TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected). The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP. Full Article Insights #advertising #alcohol distilled spirits malt beverages Modernization Rule neutral spirits TTB wine
general KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” By www.kkblaw.com Published On :: Thu, 23 Apr 2020 21:54:10 +0000 We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC. They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category. In addition, for the sixth year in a row, KKB The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP. Full Article News FDA attorney Food and Drugs Food and Drugs attorney Super lawyers Washington DC attorney
general Thumbs Up to Latest CAR T-Cell Approval By www.medpagetoday.com Published On :: Thu, 19 Oct 2017 18:00:00 -0400 New era for lymphoma, leukemia, possibly other cancers Full Article
general Device Supplies from Puerto Rico Under Threat (FDA</em>) By www.medpagetoday.com Published On :: Fri, 20 Oct 2017 15:45:00 -0400 FDA working with manufacturers to prevent shortages Full Article
general Friday Feedback: Undercutting the DEA By www.medpagetoday.com Published On :: Fri, 20 Oct 2017 16:30:00 -0400 Experts react to role of distributors, legislation in opioid crisis Full Article
general Morning Break: Is the IRS an Obamacare Savior? No Mugabe at WHO; Price on HIV Quarantine By www.medpagetoday.com Published On :: Mon, 23 Oct 2017 09:15:00 -0400 Health news and commentary from around the Web gathered by the ALLMedPage Today staff Full Article
general FDA Says Maker of Lead Tests Broke the Law By www.medpagetoday.com Published On :: Mon, 23 Oct 2017 16:45:00 -0400 Magellan Diagnostics cited for failing to inform agency of changes Full Article
general Towards Faster Device Approvals (FDA</em>) By www.medpagetoday.com Published On :: Tue, 24 Oct 2017 14:45:00 -0400 Agency moves toward more accelerated reviews Full Article
general Morning Break: Shingrix Gets CDC Blessing; Judge Won't Reinstate ACA Subsidies; Obamacare Fix Score By www.medpagetoday.com Published On :: Thu, 26 Oct 2017 09:15:00 -0400 Health news and commentary from around the Web gathered by the ALLMedPage Today staff Full Article
general Morning Break: Paddock's Brain; Amazon's Pharmacy Push; Marijuana-Sex Connection By www.medpagetoday.com Published On :: Fri, 27 Oct 2017 09:15:00 -0400 Health news and commentary from around the Web gathered by the ALLMedPage Today staff Full Article
general Expert Panel to Review Long-Acting Buprenorphine Injections (FDA</em>) By www.medpagetoday.com Published On :: Fri, 27 Oct 2017 14:15:00 -0400 First up: monthly depot formulation from Indivior Full Article
general Friday Feedback: Research on Lipid-Lowering Therapies 'Alive and Well' By www.medpagetoday.com Published On :: Fri, 27 Oct 2017 15:00:00 -0400 Experts discuss recent cancellation of first-in-class drug Full Article
general D.C. Week: Trump Declares Opioid Abuse a Public Health Emergency By www.medpagetoday.com Published On :: Sat, 28 Oct 2017 12:00:00 -0400 Also, CMS chief vows to lessen docs' record-keeping burden Full Article
general Low-Dose Rivaroxaban Green-Lighted by FDA By www.medpagetoday.com Published On :: Mon, 30 Oct 2017 14:30:00 -0400 For continued prevention of recurrent VTE Full Article
general FDA May Renege on Soy Heart Claim (Reuters</em>) By www.medpagetoday.com Published On :: Mon, 30 Oct 2017 16:16:17 -0400 Says the evidence is equivocal Full Article
general FDA to Review Second Long-Acting Opioid Treatment (FDA</em>) By www.medpagetoday.com Published On :: Mon, 30 Oct 2017 16:45:00 -0400 Braeburn Pharmaceuticals' CAM2038 gets positive FDA review Full Article
general Morning Break: Black Licorice Warning; Obamacare Questions; Haunted Hospitals By www.medpagetoday.com Published On :: Tue, 31 Oct 2017 09:00:00 -0400 Health news and commentary from around the Web gathered by the ALLMedPage Today staff Full Article
general Imperial College London to lead major coronavirus home testing programme By www.pmlive.com Published On :: Fri, 01 May 2020 12:39:45 +0100 Aims to track the progress of the infection across the UK Full Article
general AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine By www.pmlive.com Published On :: Fri, 01 May 2020 12:50:48 +0100 AZ has pledged to make the vaccine at cost for the duration of the pandemic Full Article
general EMA starts rolling review of Gilead’s COVID-19 hope remdesivir By www.pmlive.com Published On :: Fri, 01 May 2020 13:01:24 +0100 New crop of data suggests drug can speed recovery from COVID-19 Full Article
general Amgen adds Otezla to the COVID-19 candidate list By www.pmlive.com Published On :: Mon, 04 May 2020 12:18:21 +0100 Psoriasis therapy may be a potential treatment for COVID-19 Full Article
general Roche’s COVID-19 antibody test approved for emergency use in the US By www.pmlive.com Published On :: Mon, 04 May 2020 12:25:11 +0100 Ramps up capacity for testing across the country Full Article
general US clears emergency use of Gilead’s remdesivir By www.pmlive.com Published On :: Mon, 04 May 2020 12:32:39 +0100 Move comes after drug showed preliminary efficacy in clinical trial in late April Full Article
general Novartis’ asthma triple heads CHMP’s latest meeting By www.pmlive.com Published On :: Tue, 05 May 2020 12:50:48 +0100 Eight new medicines recommended for approval Full Article
general Alnylam and Vir plan gene-silencing attack on COVID-19 virus By www.pmlive.com Published On :: Tue, 05 May 2020 12:59:41 +0100 Drug could be ready for clinical trials before the end of the year Full Article
general World leaders donate to COVID-19 vaccine funding drive By www.pmlive.com Published On :: Tue, 05 May 2020 13:08:40 +0100 Experts says $20bn needed to vaccinate global population Full Article
general Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo By www.pmlive.com Published On :: Wed, 06 May 2020 11:57:45 +0100 Drug has shown “clinically meaningful responses” for basal cell carcinoma Full Article
general Coronavirus contact-tracing app trial to begin on the Isle of Wight By www.pmlive.com Published On :: Wed, 06 May 2020 12:06:00 +0100 Initial roll-out will see key workers utilise the app Full Article
general US trials of Pfizer/BioNTech coronavirus vaccine start By www.pmlive.com Published On :: Wed, 06 May 2020 12:16:48 +0100 It is hoped that the drug may prevent COVID-19 Full Article
general Novo Nordisk trumpets NASH data with semaglutide By www.pmlive.com Published On :: Thu, 07 May 2020 15:39:49 +0100 Results could unlock another big market for the company’s star drug Full Article
general FTC clears AbbVie’s $63bn Allergan takeover By www.pmlive.com Published On :: Thu, 07 May 2020 15:48:00 +0100 US regulator satisfied that antitrust concerns are remediated Full Article
general Regeneron says antibody for COVID-19 could be ready this year By www.pmlive.com Published On :: Thu, 07 May 2020 15:59:05 +0100 Two antibody cocktails for COVID-19 could be available as early as this autumn Full Article
general Oligonucleotide Therapeutics and Delivery Conference 2020 By www.pharmanews.eu Published On :: Wed, 22 Apr 2020 10:00:00 +0200 16 - 17 September 2020, London, UK. Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules. Full Article Featured Events
general Oxford COVID-19 vaccine programme opens for clinical trial recruitment By www.pharmanews.eu Published On :: Thu, 23 Apr 2020 10:00:00 +0200 University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still. Full Article Featured Research Research & Development
general AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients By www.pharmanews.eu Published On :: Fri, 24 Apr 2020 10:00:00 +0200 AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. Full Article Featured AstraZeneca Business
general Key nose cells identified as likely COVID-19 virus entry points By www.pharmanews.eu Published On :: Mon, 27 Apr 2020 10:00:00 +0200 Two specific cell types in the nose have been identified as likely initial infection points for COVID-19 coronavirus. Scientists discovered that goblet and ciliated cells in the nose have high levels of the entry proteins that the COVID-19 virus uses to get into our cells. The identification of these cells by researchers from the Full Article Featured Research Research & Development
general Loss of smell associated with milder clinical course in COVID-19 By www.pharmanews.eu Published On :: Tue, 28 Apr 2020 10:00:00 +0200 Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published findings that olfactory impairment suggests the resulting COVID-19 disease is more likely to be mild to moderate, a potential early indicator that could help health care providers determine which patients may require hospitalization. Full Article Featured Research Research & Development
general Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia By www.pharmanews.eu Published On :: Wed, 29 Apr 2020 10:00:00 +0200 Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. Full Article Featured Novartis Business
general AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine By www.pharmanews.eu Published On :: Thu, 30 Apr 2020 10:00:00 +0200 AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Full Article Featured AstraZeneca Business
general Antibodies from llamas could help in fight against COVID-19 By www.pharmanews.eu Published On :: Fri, 01 May 2020 10:00:00 +0200 The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell. Full Article Featured Research Research & Development
general Researchers identify four possible treatments for COVID-19 By www.pharmanews.eu Published On :: Mon, 04 May 2020 10:00:00 +0200 While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments. Full Article Featured Research Research & Development
general Supercomputer simulations present potential active substances against coronavirus By www.pharmanews.eu Published On :: Tue, 05 May 2020 10:00:00 +0200 Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world, Full Article Featured Research Research & Development
general Pre-filled Syringes San Francisco Conference 2020 By www.pharmanews.eu Published On :: Tue, 05 May 2020 12:00:00 +0200 14 - 15 September 2020, San Francisco, USA. The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry. Full Article Featured Events
general Study reveals most critically ill patients with COVID-19 survive with standard treatment By www.pharmanews.eu Published On :: Wed, 06 May 2020 10:00:00 +0200 Clinicians from two hospitals in Boston report that the majority of even the sickest patients with COVID-19 - those who require ventilators in intensive care units - get better when they receive existing guideline-supported treatment for respiratory failure. The clinicians, who are from Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center, published their findings in the American Journal of Respiratory and Critical Care Medicine. Full Article Featured Research Research & Development
general Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine By www.pharmanews.eu Published On :: Thu, 07 May 2020 10:00:00 +0200 Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today. Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus. Full Article Featured Research Research & Development
