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.” ###

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. ###

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 […]

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 […]

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 […]

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 […]

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.

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Gilead has said that Dr John McHutchison is stepping down after nine years at the firm.

Gilead’s Chief Scientific Officer and Head of Research and Development has decided to leave the company next month, Gilead said.

Under McHutchinson, Gilead developed five new hepatitis drugs, which have been used by as many as 3.2 million people around the world.

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Massachusetts-based biotech Disarm Therapeutics has hired Dr Alvin Shih as their new President and CEO.

The Cambridge, Mass.-based firm has set itself the task of creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central drive of neurological disease.

Dr Shih brings to the role a range of experiences. Having graduated with a biology degree from Vanderbilt University in 1996, Shih joined management consultancy McKinsey where he worked as a business analyst for two years.

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Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year.

His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015.

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Cerevel Therapeutics, a pharmaceutical company dedicated to treating neurological diseases, has appointed renowned biotechnology leader Tony Coles as Chief Executive Officer (CEO).

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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.

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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.

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Sir Mark Walport, Chief Executive of UK Research and Innovation (UKRI), the national funding agency responsible for science and research investment in the UK, has announced he is to retire for the role next year.

The decision to leave the organisation in 2020 will mark the end of a three-year tenure at its helm, beginning in 2017 when Walport was appointed to “create a single, ambitious organisation and provide the UK with a world class funding system to keep it at the forefront of global research and innovation”.

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Pfizer’s executive chairman Ian Read, is to be succeeded by CEO Albert Bourla with a date to start the post being January 1st 2020.

Mr Bourla, who joined Pfizer’s animal health division in 1993, succeeded Mr. Read from Chief Operating Officer as Chief Executive earlier this year in January, and will now go on to serve as Executive Chairman.

Mr Read has spent nine years in the role and has been at the company for a total of 41 years, first arriving in 1978 and becoming CEO in 2010, joining the board the following year.

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The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Saniona has announced that Rami Levin will take over as the Chief Executive Officer of the company as it seeks to transition into a fully-fledge biopharmaceuticals company, with a focus on rare diseases.

Levin was appointed by the Board of Directors and the company’s founders. His appointment takes immediate effect.

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Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.

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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.”

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BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

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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.”

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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.”

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 Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.

The pharmaceutical analysis firm is continuing its contract analytical laboratory services running, with changes designed to keep people and products safe.

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.

Led by Medable, the multi-company effort is geared toward ramping up development of treatments, diagnostics and other solutions for the pandemic-causing virus.

ICYMI, the boffins at the Centers for Medicare & Medicaid Services (CMS) recently released their new projections for U.S. National Health Expenditures (NHE). Unfortunately, the coronavirus almost immediately made these predictions obsolete.

It’s still useful to analyze these forecasts for a pre-pandemic examination of U.S. healthcare spending. A few highlights of the 2024 outlook:

• Total U.S. spending on healthcare was projected to grow, from $3.6 trillion in 2018 to $5.0 trillion in 2024.

• Spending on hospitals and professional services was expected to grow by a combined $800 billion—more than 60% of CMS’s projected $1.4 trillion increase in U.S. healthcare spending. That’s consistent with historical trends.

• Net spending on outpatient prescription drugs in 2024 was projected to shrink to less than 9% of total U.S. spending. That would be its lowest level since 2000.

As usual, the actual facts run counter to the popular narrative that drug spending is skyrocketing relative to any other aspect of U.S. healthcare. Of course, the coronavirus will alter these projections. Below, I speculate how COVID-19 and its aftermath will affect healthcare and prescription drug spending.

Prediction is very difficult, especially if it's about the future. Feel free to add your own outlook in the comment section below.
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Rumor has it that Spring has finally reached our worldwide headquarters here in beautiful downtown Philadelphia. (See photo at right.) While we wait to go outside, please enjoy this month’s selection of noteworthy news:

• The outlook for drug prices

• A outstanding (and free!) resource for tracking COVID-19 daily data

• What’s up with community oncology practices?

Plus, I share my favorite chart of 2020 (so far).

P.S. Join the more than 9,200 followers of my curated links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted: Prime Therapeutics new gene therapy offering, AmerisourceBergen’s laudable deal with the Justice Department, the Costco/Instacart deal, Rite Aid’s new CEO, clinical trial trends, vaccine pricing, and much more! I have also been tweeting under-the-radar stories about how the coronavirus is affecting drug channels.

Tomorrow (May 1), Drug Channels Institute will host the first of two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies. We'll host the second video webinar—Industry Update and COVID-19 Impact: PBMs & Payers—on May 8. CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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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.

I suspect this deal will remain profitable for the participating companies even as COVID-19 alters the US. prescription payer mix. Click here to see the original post and comments from January 2020. National market shares for the largest PBMs in 2019 appears as Exhibit 88 of our 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

P.S. Sorry that today's meme is one day too late for Star Wars day.

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Just before the holidays, Cigna’s Express Scripts business announced a market-changing deal with Prime Therapeutics. Click here to read the press release.

There's been very little written about this transaction, though it has potentially major implications. Below, I share my thoughts on the following topics arising from the deal:

• Implications for manufacturers and pharmacies

• The role of the secretive Ascent Health Services

• What this all means for Walgreens

• Why the Federal Trade Commission won’t challenge the deal

A few weeks ago, I explained why integrated insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels. The Express Scripts / Prime deal signals that the channel will continue its amazing pace of reinvention.

The scale, scope, and interconnectedness of today’s market participants make the system increasingly resistant to massive disruption from either external players like Amazon or a government takeover. Like it or not, the channel will continue to gain power and extract profit. Read on and see if you agree.
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I’m an astrophysicist, but that doesn’t mean I have a motivation to debunk them

-- 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

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,...

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,...

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

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

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Pharmaceutical giants will bury treatments in a thicket of patents, making them unaffordable to the world’s poorest

• Coronavirus – latest updates
• See all our coronavirus coverage

How will the Covid-19 pandemic end? According to conventional wisdom, the crisis may ease in a few months, when some of the antiviral medicines on trial succeed. In a few years’ time, when a vaccine becomes available, we may eradicate the virus altogether.

Yet it’s unlikely that this is how the pandemic will actually play out. Although there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents – and pharmaceutical companies will ultimately make the decisions about who lives and who dies.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

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Pharmaceutical company says it can produce tests in the high tens of millions by June

• Coronavirus – latest updates
• See all our coronavirus coverage

The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

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Government bodies, industry and charities to collaborate in research efforts

• Coronavirus – latest updates
• See all our coronavirus coverage
• Coronavirus vaccine – when will we have one?

The government has announced a new vaccines taskforce to help the development of a vaccine for Covid-19 and ensure its rapid production and rollout if one arrives.

The business secretary, Alok Sharma, also gave details of cash grants for work into both vaccines and potential treatments. Among the projects receiving cash is one led by Public Health England (PHE), which hopes to develop an antibody drug, something that has the potential to work as both a prophylactic and a treatment for those infected.

Related: The hunt for a coronavirus vaccine

Hydroxychloroquine, also known by its brand name, Plaquenil, is a drug used to treat malaria. It is a less toxic version of chloroquine, another malaria drug, which itself is related to quinine, an ingredient in tonic water.

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Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

• Coronavirus – latest updates
• See all our coronavirus coverage

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

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Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

• Coronavirus latest updates

• See all our coronavirus coverage

Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

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The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks

• Coronavirus latest updates
• See all our coronavirus coverage

There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

The NHS has set out plans to step up its non-COVID-19 services over the next six weeks.