NHS England has expanded access to targeted hormone therapies for advanced prostate cancer

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. ###

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. ###

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. ###

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 […]

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 […]

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 […]

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 […]

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. […]

Dr Reshma Kewalramani has been made the new Vertex CEO.

Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023.     

Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen.

read more

The Royal College of Physicians (RCP) has appointed Dr Wajid Hussain as its new clinical director for digital health.

Dr Hussain, a cardiologist and cardiac electrophysicist at the Royal Brompton and Harefield NHS Trust, has a demonstrated interest in IT and health.

While he currently represents the views of clinicians on the Trust’s IT committee, Dr Hussain completed a Diploma in Digital Health Leadership at the NHS Digital Academy last year. He is also currently studying for a Master’s in Digital Health leadership at Imperial College London.

read more

The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.

Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.

read more

Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.

Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.

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

Gilead Sciences have announced that Merdad Parsey will join the company as Chief Medical Officer, effective November 1st.

Dr Parsey will be responsible for and oversee the company’s global clinical development and medical affairs organisations – reporting directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.

read more

Ipsen has named Dr Steven Hildemann as its new Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance.

In his new role, which begins on 1 March 2020 and will be based in Paris, he will report directly to Ipsen CEO Aymeric Le Chatelier. His remit will include the provision of medical strategy to the company’s scientific, clinical and business teams, while also working in tandem with its R&D operations to design and direct clinical trials efforts to generation of post-launch data.

read more

Khondrion has revealed that Dr Rob van Maanen has joined the company as its new Chief Medical Officer (CMO).

Dr van Maanen’s career has spanned more than 20 years and seen him take on roles at major industry names such as Roche, Astellas and Eisai. In the role, he will manage the company’s medical operations and clinical strategy.

read more

Galecto has announced Bertil Lindmark as their new Chief Medical Officer. He began his posting on 1 February 2020.

Lindmark joins from the eTheRNA immunotherapies, which is a Belgian mRNA immunotherapy company. He has also had an extensive and successful career in the pharmaceutical industry.

read more

Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.

Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.

He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.

read more

Dr Lisa von Moltke has left Aklermes and has joined Seres Therapeutics as its new Chief Medical Officer.

Chief Executive Officer at Seres, Eric Shaff, said Seres will benefit from von Moltke’s “extensive experience directing successful development programs, leading clinical teams, and interacting with regulatory agencies across multiple areas of medicine.”

read more

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.

If we’re going to have a central database of conflict of interest disclosures in medicine – and there is one, created by law – it’s high time that people start using it.

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

The results, if they hold up, are likely to result in many patients getting the medicine, and could upend decades of orthodoxy among cardiologists.

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

CAS, a division of the American Chemical Society, has released a dataset of chemical compounds with known or potential antiviral capabilities.

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.

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.

---

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 David Holladay, President of CoverMyMeds and Austin Raper, Healthcare Writer at CoverMyMeds.

First, David discusses how CoverMyMeds supports medication access. Then, Austin highlights key findings from CoverMyMeds’ 2020 Medication Access Report. This new report includes industry research, patient interviews, novel survey data, and strategies for boosting patients’ medication access.

Read on for David’s and Austin’s insights.
Read more »

The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

Read more »

Today’s guest post comes from Scott Dulitz, Chief Strategy Officer at TrialCard. Scott discusses how combining payer intelligence with market-leading technology can enhance patient access.

TrialCard recently acquired Policy Reporter, a healthcare software solutions company that provides payer intelligence to the biopharmaceutical, medical device, and diagnostics industries. To learn more, schedule a demo of Policy Reporter or contact Scott (scott.dulitz@trialcard.com).

You can also register for Trialcard’s upcoming webinar: Leveraging Payer Intelligence in Patient Service Programs.

Read on for Scott’s insights.
Read more »

Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
Read more »

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.

---

The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
Read more »

Blood tests that find malignancies before they spread could transform our approach to treatment

-- Read more on ScientificAmerican.com

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com

They don’t stand on one leg around just anybody but often prefer certain members of the flock.

-- Read more on ScientificAmerican.com

Higher temperatures and wetter weather may spur soil microbes to release more carbon into the atmosphere

-- Read more on ScientificAmerican.com

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...

The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,...

The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts...

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...

Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients