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 […]

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.

Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) and Ranking Member Cathy McMorris Rodgers (R-WA) today announced that the Subcommittee will hold a teleconference forum on Monday, May 11, at 12 p.m. (EDT) with Federal Trade Commission (FTC) Chairman Joseph J. Simons to discuss critical consumer protection issues related to the COVID-19 pandemic. “The COVID-19 pandemic has brought about significant consumer protection concerns that fall under the purview of the FTC, including COVID-19 related scams, price gouging, privacy and data security issues, and more,” Schakowsky and McMorris Rodgers said.  “We look forward to hearing from Chairman Simons about the steps FTC is taking to ensure consumers are protected during this pandemic.”      This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to Evan.Gilbert@mail.house.gov by 5 pm on Friday, May 8.   ###

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 […]

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 […]

Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group. Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) […]

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, […]

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 […]

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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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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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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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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Neuronetics, Inc and Chris Thatcher, the President and CEO, have mutually agreed that he will step down from his positions in the company. He will provide transition services and advice to the company until 1 May 2020.

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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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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.

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

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.

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.
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Will home infusion growth be a long-overdue correction for the buy -and-bill channel or a temporary blip that will soon vanish?

For some time, I have been tracking the evolution of the buy-and-bill system for provider-administered drugs. The data have shown that hospital outpatient departments have been displacing physician offices. Amid this shift, home infusion providers have accounted for a minority of commercial medical benefit spending and a tiny share of Medicare Part B spending.

However, the coronavirus pandemic is triggering new growth in home infusion for buy-and-bill products. Below, I highlight the early signs of a marketplace change. I believe that some of these short-term shifts in the buy-and-bill market will persist even after we have recovered from COVID-19. They may even slow the runaway growth of the 340B Drug Pricing Program.

If not, then I suppose we'll just keep living in a world with limited home infusion over and over.

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. Watch my video invitation below.

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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.

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.
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It’s essential if we’re going to protect our planet

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

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

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.

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...

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

Coronavirus crisis: Employee safety at the top of the agenda / First DAX company to hold virtual stockholders’ meeting / Strategic and operational targets attained in 2019 / Dividend of 2.80 euros per share proposed / Good start to fiscal 2020 / Winkeljohann to succeed Wenning as Supervisory Board Chairman

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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ICI executive who helped turn its bioscience business into the pharmaceuticals giant AstraZeneca

Sir David Barnes, who has died aged 84, was the self-effacing but determined and clear-sighted chief executive who turned the bioscience interests of ICI into one of the world’s major pharmaceutical corporations, AstraZeneca.

Teased at its launch in 1993 that Zeneca sounded like a Czechoslovakian camera, Barnes responded that its performance would define its brand – and was vindicated. The first suggested name had been Zenica, but then Barnes, tracking the Bosnian conflict days before the launch, found to his horror that hostilities were threatening to spread to a previously unremarked town of that name. Alarmed that it “could become as notorious as Guernica”, he changed the spelling and held his breath.

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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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Trial of remdesivir shows fewer deaths and shorter hospital stays

• Coronavirus – latest updates
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The first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.

Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies.

Related: Coronavirus: what do scientists know about Covid-19 so far?

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Drugmaker will manufacture and distribute vaccine if human trials are successful

• Coronavirus – latest updates
• See all our coronavirus coverage

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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Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

• Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?
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The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

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Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

Researchers studying malaria in Kenya have discovered a microbe that blocks transmission of malaria from mosquitoes which could pave the way to eradicating the disease.

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.

AZ has pledged to make the vaccine at cost for the duration of the pandemic

New crop of data suggests drug can speed recovery from COVID-19

Move comes after drug showed preliminary efficacy in clinical trial in late April

Drug could be ready for clinical trials before the end of the year

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