science and technology How labelling could help with HAIs during the pandemic By www.medicalplasticsnews.com Published On :: Tue, 05 May 2020 11:51:26 -0000 Polyfuze Graphics, a global manufacturer of polymer fusion technology products for safety labelling and graphics, has introduced an antimicrobial safety product to help with Healthcare Associated Infections (HAIs) during the Covid-19 pandemic. Full Article
science and technology Manufacturer forms alliance to cope with the demand for PPE By www.medicalplasticsnews.com Published On :: Tue, 05 May 2020 15:48:04 -0000 Manufacturer and designer, Placon, has introduced the Face Shield Alliance to provide healthcare workers and first responders with adequate Personal Protective Equipment (PPE) during the Covid-19 pandemic. Full Article
science and technology Med-Tech Innovation Expo rescheduled for June 2021 By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 09:55:25 -0000 Rapid News Group has announced the decision to postpone Med-Tech Innovation Expo, the UK’s flagship event for the medical device industry to 2021. Full Article
science and technology Why 3D printing has proven to be the ‘true hero’ during this pandemic By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 10:59:41 -0000 John Dogru, CEO of 3DPrinterOS, spoke to MPN’s editor Laura Hughes about the pivotal role of 3D printing during the Covid-19 pandemic. Full Article
science and technology AdvaMed launches platform to help scale the production and distribution of ventilators By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 13:08:16 -0000 AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic. Full Article
science and technology Manufacturer vows to work ‘round-the-clock' to provide healthcare workers with PPE By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 13:54:58 -0000 To help with the increased demand for Personal Protective Equipment (PPE), Suffolk based manufacturer Broadwater Mouldings have turned over its 3D printer to produce protective shield frames for healthcare workers. Full Article
science and technology Winner announced for Red Dot Design Award By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 14:12:23 -0000 LoFric Elle – an intermittent catheter with an L-shaped handle – has won the 2020 Red Dot Design Award. Full Article
science and technology Turkish manufacturer creates face shield using expanded polypropylene particle foam By www.medicalplasticsnews.com Published On :: Wed, 06 May 2020 15:28:21 -0000 Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro. Full Article
science and technology This week's top 5: Editor's pick By www.medicalplasticsnews.com Published On :: Thu, 07 May 2020 09:00:00 -0000 Our editor Laura Hughes highlights her five must-read articles for this week. Full Article
science and technology Huffington Post: Data Exclusivity: Getting the Balance Right By patentlybiotech.wordpress.com Published On :: Tue, 24 May 2011 19:12:55 +0000 Huffington Post: Data Exclusivity: Getting the Balance Right A great article on the downsides of cutting or removing data exclusivity provisions for biologics. The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars. However, the author argues that the period must be […] Full Article Uncategorized 12 years exclusivity Biologics data exclusivity huffington post incentivizing drug development
science and technology BIO’s “What Every State Should Know About Bayh-Dole” Webinar By patentlybiotech.wordpress.com Published On :: Tue, 31 May 2011 17:04:27 +0000 BIO’s “What Every State Should Know About Bayh-Dole” Webinar The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.” The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands […] Full Article technology transfer Uncategorized Ashley J. Stevens Bayh-Dole BIO Joe Allen Lila Feisee university start ups webinar
science and technology USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting By patentlybiotech.wordpress.com Published On :: Wed, 01 Jun 2011 18:34:14 +0000 Biotechnology/Chemical/Pharmaceutical Customer Partnership Wednesday, June 8, 2011 Meeting Madison Auditorium Starting Time of 10:00 AM United States Patent and Trademark Office Alexandria, Virginia 600 Dulany Street, Alexandria, VA, Accessing the event: Double click on the link below (or copy it into your internet browser) https://uspto.connectsolutions.com/r80345544/ Click here for detailed login instructions in MS Word. […] Full Article Uncategorized BCP biotechnology Biotechnology Chemical Pharmaceutical Customer Partnership Meeting Clearing the Oldest Patent Applications (COPA) Expedited Examinations Green Tech Microsoft v. i4i Ltd. Patent Prosecution Highway Plant Utility Patents Track 1 USPTO
science and technology Debunking the Myth: Your Genes are Patented By patentlybiotech.wordpress.com Published On :: Fri, 03 Jun 2011 14:50:25 +0000 MYTH: YOUR GENES ARE PATENTED. FACTS: IT IS NOT POSSIBLE TO PATENT YOUR GENES The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and […] Full Article Gene Patents ACLU AMP v. Myriad Genetics AMP v. USPTO DNA patent requirements DNA patents gene patents gene patents pros and cons isolated DNA patents Myriad patenting life patenting people
science and technology Joint Statement of BIO, AAU, ACE, APLU, AUTM and COGR By patentlybiotech.wordpress.com Published On :: Tue, 07 Jun 2011 13:16:23 +0000 Earlier today, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and […] Full Article Supreme Court technology transfer AAU ACE APLU AUTM Bayh-Dole Act BIO biotechnology COGR collaborations licensing public-private partnerships Roche Stanford Stanford v. Roche U.S. Supreme Court
science and technology Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation. By patentlybiotech.wordpress.com Published On :: Thu, 09 Jun 2011 14:30:39 +0000 Myth: ‘Gene Patents’ are not necessary for health care innovation. Facts: Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built. These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear […] Full Article Gene Patents DNA patents gene patents gene patents and innovation gene patents and research gene patents are not necessary gene patents are unnecessary gene patents unnecessary healtcare innovation unnecessary gene patents valley of death
science and technology Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent By patentlybiotech.wordpress.com Published On :: Sat, 11 Jun 2011 12:52:27 +0000 Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent. Microsoft argued for a lower “preponderance […] Full Article patents AUTM BIO clear and convincing evidence CropLife International i4i Microsoft Microsoft v. i4i prior art Stephanie Fischer
science and technology BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act By patentlybiotech.wordpress.com Published On :: Wed, 15 Jun 2011 17:29:46 +0000 by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act. The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […] Full Article Patent Reform Uncategorized America Invents Act BIO fee diversion HR 1249 Managers' Amendment
science and technology University-Industry Partnering at BIO Convention Webinar by AUTM June 16, 3-4PM By patentlybiotech.wordpress.com Published On :: Wed, 15 Jun 2011 21:47:40 +0000 Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30. Full Article Uncategorized AUTM BIO partnering
science and technology Translational Research Forum at BIO International Convention By patentlybiotech.wordpress.com Published On :: Thu, 16 Jun 2011 19:09:54 +0000 BIO is hosting a Translation Research Forum at the BIO International Convention. NIH Director Collins keynotes an event that will explore how private, public and academic sectors can leverage meaningful partnerships, highlight emerging best practices, explore risk-sharing at the clinical research stage, and explore ways to bridge the gap in funding and know-how necessary to take […] Full Article Uncategorized BIO BIO International Convention Francis Collins NIH public pri technology transfer translational research
science and technology E&C Members Hold Bipartisan Teleconference Forum with CDC on Racial Disparities in COVID-19 Health Outcomes By energycommerce.house.gov Published On :: Fri, 01 May 2020 00:00:00 -0400 Members of the Energy and Commerce Committee’s Health and Oversight and Investigations subcommittees today held a bipartisan teleconference forum with Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat, M.D., to discuss racial disparities in health outcomes for COVID-19 patients. Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released a joint statement following the call: “Today, bipartisan members of our two subcommittees discussed the deeply troubling racial disparities in health outcomes for COVID-19 patients with CDC’s Principal Deputy Director Schuchat. During the call, members received an update on CDC’s COVID-19 response, current data collection efforts, and reiterated the need for more accurate and timely demographic data. “Congress stands ready to work with the CDC to secure comprehensive demographic data to help us direct resources and support to close this gap in these health outcomes.” ### Full Article
science and technology House Health Leaders Oppose Rule to Roll Back ACA Nondiscrimination Protections By energycommerce.house.gov Published On :: Fri, 01 May 2020 00:00:00 -0400 Today, Chairs of the House Committees that oversee the Department of Health and Human Services (HHS) voiced their strong opposition to a harmful Trump Administration rule that would roll back Affordable Care Act (ACA) nondiscrimination protections. In a letter, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chairman Richard E. Neal (D-MA), House Education and Labor Committee Chairman Bobby Scott (D-VA), and House Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) urged HHS Secretary Alex Azar not to finalize this troubling rule and to instead focus on responding to the COVID-19 pandemic. The rule would overturn core protections for marginalized communities including LGBTQ+ people, women, individuals with limited English proficiency, and individuals with disabilities, and eliminate many health care programs and activities from coverage of the Affordable Care Act’s nondiscrimination requirements. “At a time when the United States is grappling with the 2019 coronavirus (COVID-19) pandemic and access to health care services is so critical, we are disappointed that this Administration is once again taking steps to limit access to health care and embolden discrimination against some of the most vulnerable among us,” the Chairs wrote. “If finalized, this dangerous rule would open the door to discrimination against patients in express contradiction to the plain language and intent of the law, and would therefore be illegal. Undermining protections for marginalized individuals at any time is unacceptable, but it is particularly egregious to do so during the worst global pandemic in over a century.” Read the full letter to Secretary Azar HERE. ### Full Article
science and technology E&C Committee Members Hold Teleconference Forum with Admiral Giroir on COVID-19 Testing By energycommerce.house.gov Published On :: Mon, 04 May 2020 00:00:00 -0400 Energy and Commerce Committee members held a bipartisan teleconference forum with Admiral Brett P. Giroir, M.D., Assistant Secretary of Health at the Department of Health and Human Services, on the Administration’s COVID-19 testing efforts. Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) released a joint statement following the call: “The Committee continued its discussions with federal health leaders today on the Administration’s ongoing response to the coronavirus pandemic. During the call, members received an update on federal efforts to increase COVID-19 testing and encouraged the Administration to continue working to get more testing supplies to communities in need. “The members asked for more specifics on the testing needs that states have identified, how the federal government is going to increase capacity and what level of testing is necessary to reopen the economy. “Testing is an essential tool in reducing the spread of this horrible virus, and we thank Admiral Giroir for providing the Committee an update today.” ### Full Article
science and technology Pallone, Wyden Slam Trump Admin for Excluding Medicaid Providers from COVID-19 Relief Fund By energycommerce.house.gov Published On :: Wed, 06 May 2020 00:00:00 -0400 House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called on the Trump administration to address the lack of financial relief for Medicaid providers fighting the COVID-19 pandemic. The two Committee leaders voiced concerns that, to date, roughly $70 billion has been distributed to health care providers under the CARES Act in a way that discriminates against Medicaid-dependent health care providers. “HHS’s continued neglect for the needs of Medicaid-dependent providers struggling to deal with the COVID-19 crisis is unacceptable,” the members wrote. “The country is in the middle of a pandemic. The Medicaid program is a first responder, and the providers it relies on must be treated with equity. At a bare minimum that should include expeditious access to the [provider fund] as intended by Congress.” The Provider Relief Fund that Congress created as a part of the CARES Act, within the Public Health and Social Services Emergency Fund (PHSSEF), was intended to support health care providers including those who participate in Medicare and Medicaid. However, to date only Medicare-enrolled providers have been able to access funds, and these funds are being allocated according to a methodology that rewards providers with high levels of privately-insured individuals while providers supporting the safety net are left waiting. This imbalance discriminates against critical health care providers that primarily service the Medicaid population, such as frontline hospitals, nursing homes and home-based providers, behavioral health providers, maternal health care providers and pediatricians. In the letter, sent to Health and Human Services (HHS) Secretary Alex Azar, Pallone and Wyden called on the Trump administration to describe how much funding will go to Medicaid-dependent providers and the steps it has taken to understand the needs of these providers during the pandemic. The full letter is available here. ### Full Article
science and technology E&C Announces Hearing on Protecting Scientific Integrity in COVID-19 Response By energycommerce.house.gov Published On :: Thu, 07 May 2020 00:00:00 -0400 The Energy and Commerce Committee today announced a Health Subcommittee Hearing for Thursday, May 14, entitled “Protecting Scientific Integrity in the COVID-19 Response.” The hearing notice follows this note to the media. NOTE TO THE MEDIA: Due to COVID-19, the Committee will make every effort to adhere to the safety recommendations from the Centers for Disease Control and Prevention (CDC) and the Attending Physician. Therefore, media access will be limited. Please contact your respective gallery for details. As always, congressional press credentials will be required. May 7, 2020 HEARING NOTICE TO: Members of the Subcommittee on Health FROM: Anna G. Eshoo, Chairwoman SUBJECT: Subcommittee Hearing on “Protecting Scientific Integrity in the COVID-19 Response” The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.” Witnesses will be by invitation only. Among the witnesses invited to testify is Dr. Rick A. Bright, former Director of the Biomedical Advanced Research and Development Authority. The logistics of this hearing will be different due to the current circumstances of conducting a public hearing during the COVID-19 pandemic. Members will be advised regarding specifics on hearing procedures and briefings as soon as they become finalized. If you have any questions, please contact Meghan Mullon with the Committee staff at (202) 225-2927. The U.S. House of Representatives Office Buildings and the U.S. Capitol Complex are currently closed to the public. Official meetings of the Committee and its subcommittees are broadcast and available on the Committee’s website: www.energycommerce.house.gov. ### Full Article
science and technology E&C Leaders Announce Committee Teleconference Forum on COVID-19 Testing, Contact Tracing and Surveillance on May 8 By energycommerce.house.gov Published On :: Thu, 07 May 2020 00:00:00 -0400 Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) today announced that the Full Committee will hold a teleconference forum on Friday, May 8, at 12 pm (EDT) on COVID-19 testing, contact tracing and surveillance. “Our nation cannot effectively combat this terrible pandemic in the weeks and months ahead without significant testing, contact tracing and surveillance,” Pallone and Walden said. “We look forward to hearing from health experts about what actions they believe are necessary to ensure our communities have the resources they need to fight this pandemic and to confidently reopen their local economies.” During the forum, the Committee will hear from three health experts: Andy Slavitt, former Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) from 2015-2017. Mark McClellan, M.D., Ph.D., former Administrator of CMS from 2004-2006 and former Commissioner of the Food and Drug Administration (FDA) from 2002-2004. Avik Roy,Co-founder and President of the Foundation for Research on Equal Opportunity. This forum is open to the press. Credentialed reporters interested in listening to the forum live should RSVP to cj.young@mail.house.gov by 4 pm today, Thursday, May 7. ### Full Article
science and technology Consumer Protection and Commerce Subcommittee Announces Teleconference Forum with FTC Chairman Simons on May 11 By energycommerce.house.gov Published On :: Thu, 07 May 2020 16:35:29 -0400 Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) and Ranking Member Cathy McMorris Rodgers (R-WA) today announced that the Subcommittee will hold a teleconference forum on Monday, May 11, at 12 p.m. (EDT) with Federal Trade Commission (FTC) Chairman Joseph J. Simons to discuss critical consumer protection issues related to the COVID-19 pandemic. “The COVID-19 pandemic has brought about significant consumer protection concerns that fall under the purview of the FTC, including COVID-19 related scams, price gouging, privacy and data security issues, and more,” Schakowsky and McMorris Rodgers said. “We look forward to hearing from Chairman Simons about the steps FTC is taking to ensure consumers are protected during this pandemic.” This forum is open to the press. Credentialed reporters interested in listening to the forum live should RSVP to Evan.Gilbert@mail.house.gov by 5 pm on Friday, May 8. ### Full Article
science and technology Pallone and Neal Demand Transparency into Methodology and Distribution of COVID-19 Health Care Provider Relief Funds By energycommerce.house.gov Published On :: Thu, 07 May 2020 17:28:14 -0400 Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent. “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote. “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made. We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.” The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs. In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program. Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available. Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation. We look forward to receiving this information so that we can conduct the business the American people expect of us. We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ### Full Article
science and technology House Chairs Press Trump Administration to Rescind Policies that Delay Release of Migrant Children By energycommerce.house.gov Published On :: Fri, 08 May 2020 12:18:57 -0400 May 8, 2020 (WASHINGTON) – Today, several House committee and subcommittee chairs sent a letter to the Departments of Homeland Security (DHS) and Health & Human Services (HHS) regarding recent news reports alleging that the Trump Administration is considering implementing policies that could unnecessarily delay migrant children in HHS care from being reunified with their sponsors. The chairs again urge the Administration to rescind a Memorandum of Agreement requiring information about sponsors for migrant children be shared by HHS with DHS. A group of House chairs previously wrote the Administration on this issue last July. Despite current law, Congressional directives, and the current COVID-19 epidemic, the Administration continues policies that will lengthen the time migrant children spend in HHS care, thus keeping these children in congregate settings and therefore at heightened risk for exposure to COVID-19. There have been 68 confirmed cases of COVID-19 among children in HHS care. The letter, led by Rep. Bennie G. Thompson (D-MS), Chairman of the Homeland Security Committee, has also been signed by: Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Committee; Rep. Jerrold Nadler (D-NY), Chairman of the Judiciary Committee; Rep. Nita Lowey (D-NY), Chairwoman of the Appropriations Committee; Rep. Lucille Roybal-Allard (D-CA), Chairwoman of the Homeland Security Appropriations Subcommittee; Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee; Rep. Kathleen Rice (D-NY), Chairwoman of the Homeland Security Committee Border Security, Facilitation, and Operations Subcommittee; Rep. Zoe Lofgren (D-CA), Chair of the Judiciary Committee Immigration and Citizenship Subcommittee; and Rep. Diana DeGette (D-CO), Chair of the Energy and Commerce Committee Oversight and Investigations Subcommittee. Link to letter Letter text: We write with deep concern over recent reporting alleging that Administration officials are considering implementing policies that could unnecessarily delay the reunification of unaccompanied minors in the care of the Department of Health and Human Services (HHS) with their sponsors. These concerns are heightened by the current COVID-19 epidemic, which poses significant risks for all individuals held in congregate settings. We are particularly wary of expanded information sharing under the Memorandum of Agreement (MOA) between your Departments. As we wrote last summer, we continue to have strong concerns that the MOA, which has been used in the past to deport a child’s family and loved ones, will have a chilling effect on reunifications by forcing migrant families to choose between sponsoring children and risking arrest. The effect of that policy undermines the best interests of children in HHS care. This is particularly dangerous given the ongoing coronavirus pandemic, which has already resulted in 68 confirmed cases of COVID-19 among children in ORR care, including 38 children within just one facility in Illinois. HHS previously fingerprinted all adults in a sponsor’s household for a period of about six months in 2018. However, according to HHS Administration for Children and Families (ACF) Assistant Secretary Lynn Johnson, HHS found that the extra screening did not add to the protection or safety of the children. In addition, the HHS Office of the Inspector General (OIG) found that the MOA resulted in children spending a significantly increased length of time in HHS care, reaching an average length of stay of 93 days in November 2018. The OIG found that the length of stay declined as HHS reduced fingerprinting requirements. The Administration must not revisit a policy that has been found to be detrimental to the interests of the children in its care. We find it extremely troubling that both the Department of Homeland Security (DHS) and HHS are reportedly considering ignoring Congressional directives and reimplementing policies that are expected to delay the placement of children in HHS care with sponsors. The law has been clear – the Administration is not to deter potential sponsors from coming forward by using information shared under the MOA for deportation purposes, except in very limited, specified circumstances. Yet DHS’ Immigration and Customs Enforcement (ICE) violated the law and utilized the information collected from adults deemed ineligible for sponsorship for deportation purposes. ICE’s continued use of data collected by HHS for the placement of children in safe homes also represents a violation of the law. In addition, Congress directed HHS in the Fiscal Year 2020 Further Consolidated Appropriations Act not to reverse operational directives from 2018 and 2019 that reduced the length of time children spent in HHS care. Congress also directed HHS to “continue to work on efforts to reduce time in care and to consider additional policy changes that can be made to release children to suitable sponsors as safely and expeditiously as possible.” We urge you to prioritize the safety and wellbeing of children in your care and rescind the MOA. In the midst of the COVID-19 epidemic, this should also include taking all reasonable measures to release children in your care to sponsors as quickly as possible. Thank you in advance for your consideration of these requests. # # # Full Article
science and technology Hearing on Protecting Scientific Integrity in the COVID-19 Response By energycommerce.house.gov Published On :: Thu, 14 May 2020 10:00:00 -0400 The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.” Full Article
science and technology Bio Roundup: Remdesivir Data, Erasca’s $200M, a New FDA Nod & More By xconomy.com Published On :: Fri, 01 May 2020 12:55:07 +0000 Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main National top stories New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories ADC Therapeutics Adicet Bio Affinia Therapeutics Akili Interactive Alphabet Alzheimer's disease AMAG Anthony Fauci Aurinia Avadel Pharmaceuticals Avalyn Pharma Axsome Therapeutics BioNtech Biotech cancer clinical trials coronavirus COVID-19 Dascena David Cook Depression Digital Health Drug Development Erasca FDA Financing Forma Gene Therapy Genespire Gilead Sciences google Idiopathic Pulmonary Fibrosis Imvax IPO Joe Miller Kelly Martin Life Sciences Lymphoma Lyra Therapeutics Machine Learning Mark Exley Martin Huber Mirum ModeRNA National Institute of Allergy and Infectious Diseases Neurocrine Biosciences neurodegeneration Parkinson's Disease Pear Therapeutics Pfizer Radius Regeneron Pharmaceuticals remdesivir resTORbio Roche Rome Therapeutics San Raffaele-Telethon Institute for Gene Therapy Sanofi Scott Myers SuperNus Pharmaceuticals US WorldMeds Vaccine Valneva Venture Capital Vertex Pharmaceuticals Xilio
science and technology Lyra Therapeutics IPO Raises $56M for Tests of Tech for Runny Noses By xconomy.com Published On :: Fri, 01 May 2020 16:31:22 +0000 Lyra Therapeutics, a biotech company developing a new way to treat your persistently runny nose, has raised $56 million in its public markets debut. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Those shares are expected to begin trading […] Full Article Boston Boston blog main Boston top stories National blog main 480 Biomedical Arsenal Medical Biotech Bob Langer chronic rhinosinusitis clinical trials COVID-19 deals Drug Delivery FDA Genzyme George Whitesides Inflammation investing IPO Keros Therapeutics Life Sciences Lyra Therapeutics Medical Device MIT mometasone furorate North Bridge Venture Partners ORIC Pharmaceuticals Perceptive Advisors Polaris Venture Partners Renaissance Capital startups Zentalis Pharmaceuticals
science and technology FDA Authorizes “Emergency” Use of Gilead’s Remdesivir for Severe COVID-19 By xconomy.com Published On :: Fri, 01 May 2020 21:14:35 +0000 Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was […] Full Article National National blog main National top stories Biotech clinical trials FDA Gilead Sciences Life Sciences remdesivir
science and technology Pfizer Pays Valneva $130M for a Bite at a Lyme Disease Vaccine By xconomy.com Published On :: Fri, 01 May 2020 22:44:06 +0000 If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant […] Full Article Europe National blog main New York blog main New York top stories Biotech Centers for Disease Control and Prevention Cholera clinical trials deals Encephalitis FDA GlaxoSmithKline Japanese encephalitis Life Sciences Lyme disease LYMErix Pfizer pneumococcal disease Prevnar SmithKline Beecham Thomas Lingelbach Valneva
science and technology Backed by $100M, Praxis Aims to Turn Epilepsy Research Into New Neuro Drugs By xconomy.com Published On :: Mon, 04 May 2020 20:44:46 +0000 The genetic mutations that cause epilepsy don’t stop there. Praxis Precision Medicines CEO Marcio Souza says research also links these genes to other neurological conditions. The biotech startup is turning that research into new neuro drugs and it’s coming out of stealth to share details about its science and its pipeline, which already has two […] Full Article Boston Boston blog main Boston top stories National blog main National top stories New York blog main New York top stories antisense oligonucleotide benzodiazepines Biogen Biotech Blackstone Group Blackstone Life Sciences clinical trials Columbia University David Goldstein Depression Epi4K epilepsy Essential Tremor investing Kiran Reddy Life Sciences Major Depressive Disorder Marcio Souza perimenopausal depression Praxis Precision Medicines PTC Therapeutics startups Steven Petrou Third Rock Ventures University of Melbourne Venture Capital
science and technology Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M By xconomy.com Published On :: Mon, 04 May 2020 20:45:58 +0000 Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group. Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) […] Full Article Europe blog main National blog main New York New York blog main New York top stories Acquisition Biotech blastic plasmacytoid dendritic cell neoplasm Blood Cancer BPDCN clinical trials Deal Elcin Barker Ergun Ivan Bergstein Life Sciences M&A Menarini Merger Oncology Precision Medicine Stemline Therapeutics transaction
science and technology COVID-19 and Fungal Superinfections: The Deadly, Perfect Storm By xconomy.com Published On :: Tue, 05 May 2020 10:00:45 +0000 Virtually unknown just a few months ago, the COVID-19 pandemic has already resulted in over 239,000 deaths worldwide—including over 67,000 in the United States alone. Now, emerging reports suggest that as many as one third of patients with severe COVID-19 infection requiring intensive care may also be battling another life-threatening infection: invasive aspergillosis, a deadly […] Full Article National blog main San Diego San Diego Xcon Biotech COVID-19 Life Sciences
science and technology Alexion Pharma Boosts Blood Drug Lineup With $1.4B Deal for Portola By xconomy.com Published On :: Tue, 05 May 2020 18:18:24 +0000 Alexion Pharmaceuticals has agreed to buy Portola Pharmaceuticals in a $1.4 billion deal that brings it a first-in-class therapy for treating life-threatening bleeding. According to financial terms announced Tuesday, Boston-based Alexion (NASDAQ: ALXN) will pay $18 for each outstanding share of Portola (NASDAQ: PTLA). That price is a a nearly 132 percent premium to Monday’s […] Full Article Boston Boston top stories Europe blog main National blog main National top stories San Francisco blog main San Francisco top stories Alexion Pharmaceuticals andexanet alfa Ardhana Sarin Betrixaban Biotech Bristol-myers Squibb clinical trials deals eculizumab FDA Geoffrey Porges Life Sciences Ludwig Hantson paroxysmal nocturnal hemoglobinuria Pfizer Portola Pharmaceuticals Ravulizumab SVB Leerink
science and technology Kura Narrows Pipeline After Strategic Review Prompted by COVID-19 By xconomy.com Published On :: Wed, 06 May 2020 03:55:26 +0000 Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: KURA) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug […] Full Article National blog main San Diego San Diego blog main San Diego top stories Biotech cancer COVID-19 Drug Development Kura Oncology Life Sciences Syndax Pharmaceuticals Troy Wilson
science and technology Encouraging Signals for New Cancer Cell Therapy Strategies By xconomy.com Published On :: Wed, 06 May 2020 12:14:46 +0000 Chimeric antigen receptor T-cell therapies have shown remarkable efficacy in leukemia and lymphoma patients who relapsed or were refractory to several prior treatments, but many challenges remain in the cancer cell therapy field. Strategies that may improve upon first-generation therapies were presented during the American Association for Cancer Research virtual meeting with encouraging early activity, […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories Acute Lymphoblastic Leukemia American Association for Cancer Research Biotech cancer Cancer Drugs CAR-T immunotherapy clinical trials FDA Gilead Sciences Gracell Biotechnologies Immunotherapy Iovance Biotherapeutics Kite Pharma Leukemia Life Sciences Melanoma National Cancer Institute Non-Small Cell Lung Cancer Roche University of California at Los Angeles Xinin Wang Yvonne Chen
science and technology Ventus Launches With $60M to Shine Light on Innate Immune System Drugs By xconomy.com Published On :: Wed, 06 May 2020 17:07:49 +0000 The innate immune system has become a hot area for drug development, and for good reason. As the body’s first line of defense, its function (or dysfunction) plays a role in many diseases. The problem, says Ventus Therapeutics CEO Marcelo Bigal, is that drug developers have been working in the dark. Scientists don’t know the […] Full Article Boston Boston blog main Boston top stories National blog main San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Alphabet Biotech cancer cardiometabolic disorders deals Douglas Green Feng Shao gasdermin Genentech google GV Hao Wu Harvard Medical School IFM Therapeutics Immunology Inflammasome Inflammation Innate Immune System investing Jecure Therapeutics Judy Lieberman Labrys Biologics Life Sciences Marcelo Bigal National Institute of Biological Sciences nonalcoholic steatohepatitis Novartis Osteoarthritis Quench Bio Richard Flavell Roche Russell Vance St. Jude Children's Research Hospital startups Teva Pharmaceutical University of California at Berkeley Venture Capital Ventus Therapeutics Versant Ventures Yale University
science and technology AstraZeneca Diabetes Drug Gets FDA OK for Reducing Heart Health Risks By xconomy.com Published On :: Thu, 07 May 2020 00:24:10 +0000 An AstraZeneca diabetes drug that brought in more than $1.5 billion in sales last year has won an FDA nod expanding its use to adults with systolic heart failure, a condition in which the heart struggles to pump with enough force to push enough blood into circulation. The drug, the once-daily pill dapagliflozin (Farxiga), was […] Full Article Europe blog main National National blog main AstraZeneca Biotech Boehringer Ingelheim diabetes Eli Lilly Heart Failure Life Sciences
science and technology Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation By xconomy.com Published On :: Thu, 07 May 2020 01:46:05 +0000 As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. The […] Full Article National National blog main American Cancer Society Biotech cancer Cancer Drugs clinical trials companion diagnostic FDA Foundation Medicine Incyte kinase inhibitor Life Sciences myelofibrosis Novartis ruxolitinib
science and technology PTC Therapeutics to Acquire Censa Pharma for Mid-Stage Rare Disease Drug By xconomy.com Published On :: Thu, 07 May 2020 07:09:51 +0000 PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: PTCT) another compound for its pipeline of rare disease drugs. Wellesley, MA-based […] Full Article Boston blog main Boston top stories National blog main New York New York blog main New York top stories Arkin Bio Ventures BioMarin Pharmaceutical Biotech Censa Therapeutics clinical trials Drug Development FDA Life Sciences PTC Therapeutics rare disease
science and technology Join Us Online May 13 for Xcelerating Life Sciences: Biopharma’s Future in Digital Health By xconomy.com Published On :: Thu, 07 May 2020 13:15:48 +0000 Learn how digital tech is accelerating medical breakthroughs by registering your team to attend Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health. While some content focuses on the Boston ecosystem, we’re confident the forum – and virtual networking – will be valuable to a national audience. The May 13, 2020 event will explore the […] Full Article Boston Boston blog main Boston top stories National National blog main National top stories Biotech event Life Science Life Sciences
science and technology Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO By xconomy.com Published On :: Fri, 08 May 2020 03:46:00 +0000 Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […] Full Article National blog main San Diego San Diego blog main San Diego top stories Biotech cancer Cardiff Oncology clinical trials combination therapy Drug Development genetic mutations Life Sciences Mark Erlander Precision Medicine Thomas Adams TrovaGene
science and technology Ayala’s IPO Raises $55M to Test Two Former Bristol Myers Cancer Drugs By xconomy.com Published On :: Fri, 08 May 2020 13:05:23 +0000 Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 […] Full Article National National blog main New York blog main New York top stories Acute Lymphoblastic Leukemia Adenoid Cystic Carcinoma Ayala Pharmaceuticals B-cell maturation antigen Biotech Bristol-myers Squibb clinical trials deals Desmoid tumors FDA investing IPO Israel Biotech Fund Life Sciences Novartis Pfizer SpringWorks Therapeutics triple-negative breast cancer
science and technology Bio Roundup: Acquisitive Alexion, CRISPR on COVID, C. diff Success & More By xconomy.com Published On :: Fri, 08 May 2020 14:33:23 +0000 Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: ALXN) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main National top stories New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories AbbVie Achillion Pharmaceuticals Akcea Therapeutics Alexion Pharmaceuticals Alnylam Pharmaceuticals andexanet alfa Antibe Therapeutics Apotex Arrowhead Pharmaceuticals AstraZeneca Avrobio Axcella Health. Newron Pharmaceuticals basal cell carcinoma BioMarin Pharmaceutical BioNtech Biotech blastic plasmacytoid dendritic cell neoplasm Bristol-myers Squibb Bruce Given cancer Cardiff Oncology Carla Poulson Celgene Cell Therapy cemiplimab Censa Pharmaceuticals Chemotherapy chlorambucil Chronic Lymphocytic Leukemia Clarametyx Biosciences Clostridium difficile COVID-19 CRISPR dapagliflozin Diagnostics DiNAQOR dry eye disease epilepsy Federal Trade Commission Ferring Pharmaceuticals FogPharma Fragile X Syndrome Gemini Therapeutics Gene Therapy Gilead Sciences Grail Incyte Innate Immune System investing Joseph Stauffer Kala Pharmaceuticals Kezar Life Sciences Kura Oncology Life Sciences lisocaptagene maraleucel Ludwig Hantson Magenta Therapeutics Marc Uknis Mark Erlander Menarini Group Microbiome microbiome drugs Myonexus Therapeutics Neurological Diseases Noreen Roth Henig Novartis Obinutuzumab Ovid Therapeutics Pfizer Portola Pharmaceuticals pravastatin Praxis Precision Medicines PTC Therapeutics rare disease drugs rebiotix Regeneron Pharmaceuticals remdesirvir Rett syndrome Sanofi Sarepta Therapeutics sarizotan Sherlock Biosciences startups Stemline Therapeutics systolic heart failure TG Therapeutics Tony Gibney TrovaGene U.S. Department of Justice ublituximab umbralisib Ventus Therapeutics Vir Biotechnology
science and technology 2020 National Xconomy Awards Finalists Will Be Announced on June 22 By xconomy.com Published On :: Fri, 08 May 2020 16:57:32 +0000 Xconomy is excited to announce we’ve had an overwhelming amount of interest in the inaugural National Xconomy Awards. The hundreds of outstanding nominations highlight the groundbreaking, inspiring companies and individuals we look to honor. Stay tuned for when we reveal the finalists on Monday, June 22. Due to COVID-19 we have postponed the planned June […] Full Article National National blog main National top stories exome Life Science Life Sciences xconawards
science and technology Eli Lilly Gets Edge in the “RET” Race With FDA Nod for Cancer Drug By xconomy.com Published On :: Sat, 09 May 2020 02:33:40 +0000 Eil Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces a protein involved in cell signaling. […] Full Article Boston blog main Boston top stories Indiana Indiana blog main Indiana top stories National blog main National top stories New York blog main New York top stories Biotech Blueprint Medicines cancer Cancer Drugs clinical trials Eli Lilly FDA Life Sciences medullary thyroid cancer Non-Small Cell Lung Cancer Novartis pralsetinib selpercatinib Thyroid Cancer
science and technology Early Detection: A New Front in the War on Cancer By blogs.scientificamerican.com Published On :: Wed, 06 May 2020 11:00:00 GMT Blood tests that find malignancies before they spread could transform our approach to treatment -- Read more on ScientificAmerican.com Full Article Health Medicine