Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.

Maurits Lugard, a partner, Josefine Sommer, a senior associate, and Anouchka Hoffman, an associate, at Sidley Austin, examines the consequences that come with the delay of the application of EU Medical Devices Regulation by one year.

Small to medium-sized (SME) manufacturers are calling for greater and faster financial support from the government as they confront plummeting sales, production volumes, and the prospect of job cuts amid the ongoing Covid-19 pandemic.

The European Medical Device Regulation (EU MDR) will come into effect on 26th May 2021, a year later than originally planned.

Munich-based software start-up Climedo Health has published a whitepaper assessing the "Impact of Covid-19 on the medtech industry".

HealthBeacon, a medication adherence technology company, has launched a new Covid-19 support offering for patients on injectable therapies.

Adhesives specialist Intertronics has launched a new campaign to highlight the ways that assembly companies can simplify processes, improve output and reduce waste.

Chemicals company Lubrizol is helping with the pandemic by making materials used in Personal Protection Equipment (PPE) as well as hand sanitiser and products to help treat patients who are fighting the virus.

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.

John Dogru, CEO of 3DPrinterOS, spoke to MPN’s editor Laura Hughes about the pivotal role of 3D printing during the Covid-19 pandemic.

Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro.

Experts react to role of distributors, legislation in opioid crisis

Magellan Diagnostics cited for failing to inform agency of changes

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Experts discuss recent cancellation of first-in-class drug

Also, CMS chief vows to lessen docs' record-keeping burden

For continued prevention of recurrent VTE

Says the evidence is equivocal

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 […]

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 […]

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.   […]

  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 […]

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 […]

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.

The charity's Centre for Drug Development will sponsor and fund a future Phase I clinical trial for CB213

BCC marks the second non-melanoma skin cancer for which Libtayo has demonstrated first-in-class data, the firms note

The experimental 5-HT1A receptor agonist and D2 receptor antagonist was not effective on primary or secondary endpoints

The move will establish Menarini's presence in the US biopharma market

The guideline is designed to help healthcare professionals who are not kidney specialists to prevent, detect and manage AKI in hospitalised patients with suspected or confirmed COVID-19

The approval gives NSCLC patients whose tumours carry the MET exon 14 skipping mutation a new treatment option

RBX2660 may bring an innovative therapeutic option to patients suffering from C. diff

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. ###

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. ###

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. ###

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.   ###

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. ###

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. #  #  #

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.”  

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 […]

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 […]

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 […]

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 […]

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) […]

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 […]

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 […]

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, […]

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 […]

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 […]