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

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

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

First up: monthly depot formulation from Indivior

Experts discuss recent cancellation of first-in-class drug

Braeburn Pharmaceuticals' CAM2038 gets positive FDA review

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

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 […]

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 […]

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 […]

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 Billion Molecules against Covid19 Grand Challenge aims to screen billions of molecules with blocking interactions on SARS-CoV-2

The Scottish government has given funds £101,903 to support the project

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

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.” ###

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. ###

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.”  

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]

British multinational GlaxoSmithKline have hired computational drug design expert Dr Kim Branson as the company’s new Senior Vice President, Global Head of Artificial Intelligence and Machine Learning.

In his new role, the biotech veteran will oversee projects which use AI to identify novel targets for potential medicines.

Dr Branson brings to the role more than 15 years’ worth of experience in biotech and academia having held positions at a number of Silicon Valley firms including Gliimpse, Lumia and Hessian Informatics.

read more

Troy Robinson has been taken on as the new managing director of Chugai Pharma Europe. Mike Crosher will succeed him in his current role as managing director of Chugai Pharma UK.

Chugai Pharma Europe (CPE) has promoted Troy Robinson and Mike Crosher into the positions of managing director of CPE and managing director of the firm’s UK subsidiary, Chugai Pharma UK (CPU).

read more

London consultant and public health professor, Chris Whitty, has begun his role as England’s Chief Medical Officer, taking over from Dame Sally Davies, who has now stepped down from the position.

Whitty has served as the Department of Health and Social Care’s Chief Scientific Adviser since 2016 and was announced as Dame Sally Davies successor earlier in June this year.

read more

MSD have announced that David Peacock will become Managing Director in the UK and Ireland, succeeding former director Louise Houson, with a start date of October 1st 2019.

Peacock brings with him a broad range of experience and perspectives from senior roles within the company in the United States, Singapore, Vietnam and Japan. Most recently, David was Chief of Staff to Kenneth Frazier, Chairman of the board and Chief Executive Officer of MSD.

read more

The Chief Executive Officer of Immuron, Gary S. Jacob, has resigned as CEO and as a member of the Board due to restructering taking place to prepare the company for a post-coronavirus world.

In a statement, the company said it was the first move to help the “preservation of capital to allow the company to weather the current trading conditions pending strengthening of the travel market. This will involve radical cost-cutting and deferring certain research and development activities.”

read more

Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

read more

Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

read more

In addition to tracing the early history of the Missouri and New York suits, we explain how these lawsuits are being used as conduits for misinformation.

The post Lawsuits as Conduits for Misinformation During COVID-19 appeared first on Bill of Health.

This was the first time in a long time that I’ve renewed my nursing license with the thought that I might need it — that I might be needed.

The post Preparing to Go Back to the Bedside During COVID-19: A Nurse-Turned-Bioethicist Reflects appeared first on Bill of Health.

These policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

The post The Harms of Abortion Restrictions During the COVID-19 Pandemic appeared first on Bill of Health.

A judge ruled recently that a patient, known as MB, who had occupied an NHS bed for over a year, must vacate it and instead receive care in the community.

The post Obtaining a Hospital Bed in the COVID-19 Pandemic: A Legal Perspective appeared first on Bill of Health.

Clinicians and policymakers alike are raising the alarm about potential legal liability for following crisis standards of care during the COVID-19 pandemic.

The post How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic appeared first on Bill of Health.

The question must be: can we accommodate non-emergent/non-urgent care safely or not, and if yes, which care do we address first as we re-open?

The post When and How to Resume Non-Urgent Care During COVID-19 appeared first on Bill of Health.

Mass shooters appear to injure and kill more people when the use semiautomatic rifles instead of handguns, other types of rifles, or shotguns, according to a new analysis in the Journal of The American Medical Association. But the research has significant limitations.

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”

This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.

The companies are committing to find ways to use their businesses to help patients with cancer.

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.

The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.

The research collaboration will seek to identify candidate biomarkers for a group of inflammatory conditions, using AI and other advanced technology.

RESCHEDULED: This event has been rescheduled for November 11-13, 2020. Click here to learn more.

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Informa Connect-CBI’s Patient Support Services Congress
June 16-18, 2020 | The Westin Princeton at Forrestal Village | Princeton, NJ
www.informaconnect.com/patient-support-services-congress

Informa Connect-CBI’s Patient Support Services Congress is a comprehensive meeting for insightful and engaging dialogue around navigating compliance hurdles while strengthening and innovating patient-oriented programs.

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

Download the agenda here and see in-depth coverage on industry trends and next-generation patient services, such as:

• Critical Regulatory Updates and Effective Strategies for Monitoring & Oversight
• Novel Approaches to Services, Program Architecture and Operational Management
• The pros and cons of different support service models
• Measuring the Success of Patient Support Programs
• Innovation, AI, Changing Distribution Models and Market Mergers
• Transparency with Charitable Organizations

Create Your Own Customized Learning Experience for 2020!

Choose from Two In-Depth Tracks

• Legal and Compliance
• Innovation and Operations

Plus! Four Tailored Summits

• Summit A: Patient Adherence – Educate, Engage and Collaborate to Enhance Outcomes
• Summit B: Case Management for Novel and Innovative Therapies
• Summit C: Strategic Planning for Product Launch
• Summit D: Primer Course for Partnering with Patients

Leading Perspectives from Industry Trendsetters:

• Robert Britting, Director, Patient Services and Strategic Solutions, Teva Pharmaceuticals
• Stella Vnook, Chief Executive Officer, Diverse Biotech
• Katherine Chaurette, Vice President healthcare Law and Compliance, Blueprint Medicines
• Kimberly Goldberg, Director, U.S Data Privacy Counsel, Novartis
• Imtiaz Hussain, Senior Director, Patient Services, Bayer
• Cory Potomis, Associate Director, Ethics & Compliance Operations, Novo Nordisk, Inc.
• And so many more!

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

*Offer applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on workshop only or academic/non-profit registrations.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

Today’s guest post comes from Rob Brown, Vice President and General Manager of RxCrossroads by McKesson and Biologics by McKesson.

Rob discusses the importance of access, adherence, and affordability for specialty therapy patients who are uninsured, underinsured, or low-income. He describes three criteria companies should use to evaluate patient assistance program solutions.

Click here to learn more about program pharmacy solutions for biopharma from RxCrossroads by McKesson.

Read on for Rob’s insights.
Read more »

Informa Connect-CBI’s 22nd Annual Medicaid and Government Pricing Congress
May 19-21, 2020 | Orlando, FL
www.cbinet.com/medicaidandgovernment

Exclusive Offer: Register by April 10th and save $500* (mention promo code MDCDC5).

With a volatile healthcare system combined with an election year upon us, the stakes are incredibly high for life sciences manufacturers. Staying on the pulse of industry trends, policies and regulations has never been more critical. The 22nd Annual Medicaid and Government Pricing Congress delivers critical updates and industry best practices to effectively contract, report and comply with state and federal healthcare programs. Gain timely, up-to-the-minute insights on:

• State Invoicing and Disputes
• GTN Models
• Innovative Contracting Strategies
• State Price Transparency and Reporting Requirements
• 340B Oversight and Compliance
• Preparing, Negotiating and Implementing FSS Contracts
• Bona Fide Service Fees and FMV
• And many other critical topics

Download the complete program agenda.

The 2020 agenda features 75+ speakers and 50+ sessions customizable by company type and size, as well as 10 hours of dedicated networking. Bio/pharma, regulatory and government experts representing HHS, Pfizer, Daiichi Sankyo, Sobi, Maryland Department of Health, BMS, Jazz, Novartis, Amneal, J&J, Sunovion, Gilead, VA, Granard, Insmed, UCB, Alnylam, Louisiana Department of Health, AstraZeneca, CMS, CSL Behring, Astellas, Lilly, Oklahoma Healthcare Authority, Theravance, Indivior, Sandoz, Alvogen, Takeda, OIG, AMAG, Aimmune, Exelixis, South Dakota Department of Healthcare Services, Regeneron, Sun Pharma, Teva and many others are set to drive the dynamic dialogue.

Drug Channels readers can register today and use promo code MDCDC5 to save $500.

*Discount offer valid through 4/10/2020; applies to standard rates only and may not be combined with other offers, categories, promotions or applied to an existing registration. Offer not valid on workshop-only or non-profit registrations.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.