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

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

For continued prevention of recurrent VTE

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 […]

Farxiga is the first sodium glucose co-transporter 2 inhibitor cleared by the FDA to treat heart failure with reduced ejection fraction

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 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 […]

Alexion Pharmaceuticals has agreed to buy Portola Pharmaceuticals in a $1.4 billion deal that brings it a first-in-class therapy for treating life-threatening bleeding. According to financial terms announced Tuesday, Boston-based Alexion (NASDAQ: ALXN) will pay $18 for each outstanding share of Portola (NASDAQ: PTLA). That price is a a nearly 132 percent premium to Monday’s […]

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 […]

Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: ALXN) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s […]

Xconomy is excited to announce we’ve had an overwhelming amount of interest in the inaugural National Xconomy Awards. The hundreds of outstanding nominations highlight the groundbreaking, inspiring companies and individuals we look to honor. Stay tuned for when we reveal the finalists on Monday, June 22. Due to COVID-19 we have postponed the planned June […]

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

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.

read more

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

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.

read more

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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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.

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AI drug discovery firm Exscientia has announced the appointment of Dr David Hallett as its Chief Operating Officer and Head of Drug Discovery.

Bringing 20 years of experience to the role, Dr Hallett’s primary remit will see him take responsibility for the company’s entire drug discovery portfolio, as well as managing pharma collaborations, joint ventures and pipeline projects. He will report to Exscientia Founder and CEO Professor Andrew Hopkins.

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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.

read more

In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.

“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.”

Two different groups of researchers have shown that electrical stimulation of the spinal cord, combined with months of intense training, can allow some people who have been paralyzed to regain some walking ability.

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 »

First, let me say thank you to all of the healthcare workers who are putting themselves at risk during this crisis.

As I noted last week, many of the crucial issues for our healthcare system will remain after we all get through this challenging period. In that regard, here’s a look at some noteworthy news from the past month:

• Sanofi discloses new data about insulin prices

• Excellent new academic research on list vs. net drug prices

• Three notable researchers overturn their earlier research on drug costs

• Amazon switches PBM vendors for some of its employees

Plus, we unveil the teaser trailer for Drug Channels Video!

P.S. Join the more than 9,000 followers of my daily links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted such topics as:

• How GoodRx shares patients’ prescription data
• 2019 drug trend at Prime Therapeutics
• Controversy about the independent pharmacy market
• A new $5 generic mail order program, Medicare Part D reform
• Retail pharmacy’s future
• Job openings at Amazon 
• Frozen cookie dough
• And much more!

I have also been tweeting many under-the-radar stories about how the coronavirus affects drug channels.
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 »

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.
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.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.

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For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
Read more »

That emotion is natural in a situation like this, but there are ways to mitigate it

-- Read more on ScientificAmerican.com

The agency fell well short of its goal of evaluating local flood control efforts every five years

-- Read more on ScientificAmerican.com

The pandemic is amplifying nearly every disadvantage that women in STEM already face. But institutions and the scientific community can help

-- Read more on ScientificAmerican.com

Safeguarding public health requires rethinking our relationship to the environment and the inequities that drive its destruction

-- Read more on ScientificAmerican.com

The 100th anniversary of astronomy’s “Great Debate” prompts thoughts on the hunt for life in the universe

-- Read more on ScientificAmerican.com

WASHINGTON – November 14, 2017 – As the Senate begins debate on a tax reform bill, the clinical research industry hopes that...

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,...

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...

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

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

The Association of Clinical Research Organizations (ACRO) is pleased to announce the expansion of its membership to include ERT, Oracle and Veeva. These new ACRO member companies, with their focus on digital technologies that enable global clinical trials, characterize the ongoing innovation and evolution of contemporary clinical research. ACRO now has 12 member companies.

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

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Drugmaker will manufacture and distribute vaccine if human trials are successful

• Coronavirus – latest updates
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AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

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