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Finding and analyzing content can be challenging. Many teams start with searching Google, Twitter, LinkedIn, and other digital sources. Having more sophisticated methods for gathering and analyzing digital insights is important. There are three keys to effective KOL digital listening: 1: Look Beyond Social Media There are millions of digital sources world-wide. Social media is …

KOL Digital Listening – 3 Things you need to understand today Read More »

BY JESSICA DaMASSA, WTF HEALTH HUGE news on the “food-as-medicine” front for Medicaid/Medicare Advantage beneficiaries! Now, they can get fresh fruits and veggies delivered directly to their doorsteps and they can pay for them using their SNAP/EBT benefits. FarmboxRx is behind this first-of-its-kind partnership with the U.S. Department of Agriculture, and here to talk through …

WTF Health: Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight” Read More »

By JESSICA DaMASSA, WTF HEALTH HUGE news on the “food-as-medicine” front for Medicaid/Medicare Advantage beneficiaries! Now, they can get fresh fruits and veggies delivered directly to their doorsteps and they can pay for them using their SNAP/EBT benefits. FarmboxRx is behind this first-of-its-kind partnership with the U.S. Department of Agriculture, and here to talk through …

Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight” Read More »

Conduent recently participated at CBI PAP (Patient Assistance & Access Programs) Conference – a virtual event where pharma stakeholders collaborate on programs and policies for better patient outcomes. While there, I had the opportunity to discuss some of the ways pharma can make patient engagement easier in an increasingly digital world. Creating a better experience …

Digital Engagement in Pharma: Staying Ahead of Patient Needs to Shape Better Outcomes Read More »

Joining Matthew Holt (@boltyboy) on THCBGang Thursday are fierce patient activist Casey Quinlan (@MightyCasey); cardiologist & provocateur Anish Koka (@anish_koka); patient activist, author & entrepreneur Robin Farmanfarmaian (@Robinff3); and THCB regular writer Kim Bellard (@kimbbellard). You can see the video below but if you’d rather listen to the episode, the audio is preserved as a weekly …

THCB Gang Episode 71, Nov 4 1pm PT – 4pm ET Read More »

By JESSICA DaMASSA, WTF Health A sign of effective ‘merging-and-acquiring’ among innovative healthcare companies? How about a new brand-name? The company known as “Grand Rounds Health and Doctor on Demand,” which merged in March 2021 and quickly acquired LGBTQ+ virtual care company, Included Health, announced that the company would be moving forward as Included Health …

WTF Health: Included Health’s CEO Owen Tripp on Grand Rounds, Doctor-on-Demand Merger & New Name Read More »

By JESSICA DaMASSA, WTF HEALTH Healthcare startups serving the Medicaid population are FINALLY catching the attention of investors and, this time, it’s for improving access to mental health services. Brave Health’s CEO Anna Lindow and I catch up in person at HLTH 2021 – under a super-secret embargo – to talk about Brave’s $10M Series …

Inside Scoop: Medicaid Mental Health Startup Brave Health Lands $10M Read More »

A white paper from Cannon and Pohida (2021) calls for applying “public option principles” to Medicare. Who would have thought that the Cato Institute would call for a public option? Well in fact, the do not really call for a public option. The proposal should be called introducing a voucher system into Medicare. Under the …

Cato supports public option? Read More »

Piramal Pharma Solutions-Walk-In Interviews for R&D On 23rd October 2021 Job Description Company Profile:  Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Pharma Ltd., with operations across North America, Europe and Asia. We are a global leader in integrated solutions and offer a unique platform of services across the drug lifecycle …

Piramal Pharma Solutions-Walk-In Interviews for R&D On 23rd October 2021 Read More »

AbbVie’s Rinvoq (upadacitinib) Receives the Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, Health Canada, Approval, Atopic Dermatitis Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients Published: Oct 8, 2021 | Tags: …

PharmaShots Weekly Snapshots (October 04 – 08, 2021) Read More »

Pharma continues to evolve in the way Medical Affairs engages with Healthcare Professionals (HCPs) and Key Opinion Leaders (KOLs). From a Medical Affairs perspective, the global upheaval of 2020-21 highlighted the importance of targeting the best stakeholders, knowing exactly how team members are engaging with those stakeholders, and maximizing the effectiveness of field-based medical teams. …

Reworking the Recipe: Expanding Customer-Facing Medical Teams Beyond Medical Science Liaisons Read More »

This is what a study by Whaley et al. (2021) aims to find out. Many employers have introduced rewards programs as a new benefit design in which employees are paid $25–$500 if they receive care from lower-priced providers. Our goal was to assess the impact of the rewards program on procedure prices and choice of …

Are patients able to shop for lower priced providers? Read More »

Traditional cost-effectiveness measures measures treatment value based on how it affects your health. Health is often decomposed into longevity (i.e., survival) and quality of life while alive. However, Nobel laureate Amartya Sen argued that improvements in one’s life should be based on capabilities (a.k.a. opportunities, freedoms, advantages) to perform desired tasks rather than more abstract …

Capability measures to value health interventions for kids Read More »

Shots: Dyadic to receive $10M up front in cash & stock and ~$4M in reimbursements for pre/ clinical development costs for DYAI-100 vaccine & ~ $33M in milestone along with royalties following commercialization Sorrento acquire exclusive rights to use Dyadic’s C1 technology to develop and commercialize vaccines, Abs, protein therapeutics, and diagnostics for COVID-19, including …

Sorrento to License Dyadic’s DYAI-100 and C1 Technology for Protein-Based Coronavirus Vaccines and Therapeutics Read More »

Mankind Pharma Limited- Walk-In Drive for QC/  Microbiology / Quality Assurance On 14th & 15th August 2021 Job Description We are looking for young and dynamic personnel from Pharma background with proven track records, who have exposure to advance market operations (USFDA, TGA, EDQM, MHRA, etc) for Tablets, Capsules, Sterile Injectable USFDA Approved Formulation Unit …

Mankind Pharma Limited- Walk-In Drive for QC/  Microbiology / Quality Assurance On 14th & 15th August 2021 Read More »

Many of us who are patients have the unpleasant experience of navigating the complex world of drug utilization management. This includes determining what formulary tier a drug will be on, if there are any prior authorization requirements and what our copay will be. The burden also falls on physicians in that they need to justify …

Cost of drug utilization management is over $90 billion per year Read More »

Shots: The P-III NORSE TWO trial evaluates the safety & efficacy of ONS-5010 / Lytenava vs ranibizumab in 228 patients with wet AMD across 39 clinical trial sites in the US for 12mos. The trial met 1EP & 2EPs i.e proportion of patients who gain at least 15 letters in the BCVA & mean change …

Outlook Reports Results of ONS-5010 / Lytenava (bevacizumab-vikg) in P-III NORSE TWO Trial for the Treatment of Wet AMD Read More »

Quironsalud Madrid University Hospital Madrid,Spain Quironsalud Madrid University Hospital is considered to be a benchmark for other private hospitals in the Madrid region. Top-level professionals, cutting edge technology and personalized attention and the three pillars that comprise the hospital’s healthcare philosophy. The hospital complex is spread across a vast area of 54,000 square meters. The …

test Read More »

Here’s a new paper with a surprise: a small molecule that appears to be very effective against malaria, with what may be a high barrier to developing resistance (C&E News coverage here). It’s from a large multicenter (multicontinent) team, and the chemical matter has its origins at Sanofi. The idea was to search for human …

A New Small Molecule Candidate for Malaria Read More »

Health Biotech Ltd-Walk-In Interviews for QA/ QC On 19th to 23rd July 2021 Job Description Company Profile:  Health Biotech Ltd, We are reputed WHO, GMP, ISO 9001:2008 pharma company, having global presence, manufacturing of injectables, liquid syrups, dry syrups, eye / ear / nasal drops, pre-filled syringes and non sterile / sterile ointments, tables, Capsules. …

Health Biotech Ltd-Walk-In Interviews for QA/ QC On 19th to 23rd July 2021 Read More »

I wanted to do a follow-up to this post, about a reaction that removes nitrogen atoms from heterocyclic rings. Some readers took issue with the paper in the comments, pointing out that a mechanistically similar transformation had been published in 2017. The group that did the earlier work has a new paper on the subject out …

Carving Out Nitrogens: Pick Your Conditions Read More »

This paper (open access) is not going to be to everyone’s taste, but the people who are working in its area – and there’s an ever-increasing number of them – will want to read it closely. It’s a close look at the red-hot fields of targeted protein degradation and “molecular glues”, and for those who aren’t …

Hard Thinking About Protein Degradation and Bifunctional Molecules Read More »

Macleods Pharma- Requirement for Production/ Quality Control Dept. -Apply Now Job Description Openings for Production We are looking for experienced professionals in Production (API) Department for our API Plant, Sarigam (Vapi), Gujarat Location. Department: Production (API) Department Experience: 03-8 years Educational Qualification: BE/B.Tech.(Chemical)/ B.Sc./ M.Sc. Location: Vapi Skill Set: Relevant experience in API/ Intermediate Manufacturing industry. Interested Candidates May send …

Macleods Pharma- Requirement for Production/ Quality Control Dept. -Apply Now Read More »

Episode 56 of “The THCB Gang” will be Thursday, June 3. Matthew Holt (@boltyboy) will be joined by regulars: medical historian Mike Magee (@drmikemagee), THCB regular writer Kim Bellard (@kimbbellard) and health futurist Jeff Goldsmith; We are hoping that WTF Health host & Health IT girl Jessica DaMassa (@jessdamassa) will sneak in later after she’s finished …

THCB Gang Episode 56 – Thurs June 3, 1pm PT-4pm ET Read More »

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet!–Matthew Holt In this week’s health care tidbits, we’re discussing hedge …

Matthew’s health care tidbits Read More »

Rise in mental health tele-visits. Inequality, conspicuous consumption and health expenditures. Treating serious illness at home. Why do scientists lie? BMI and income.

Episode 55 of “The THCB Gang” will be live-streamed on Thursday, May 20 at 1pm PT — 4PM ET. Matthew Holt (@boltyboy) will be joined by regulars: futurists Ian Morrison (@seccurve) & Jeff Goldsmith; patient safety expert and all around wit Michael Millenson (@MLMillenson); and policy & tech expert Vince Kuraitis (@VinceKuraitis)

This is a simple post This is post body content. This is post body content.This […] The Doctor Weighs In

A positive participant experience underpins the success of any clinical trial. Leverage three strategies to help establish trust between participants and study staff. Read the blog by @advarra. https://www.pharmavoice.com/blog/engage-participants-trial/ The post Establishing trust in clinical trials appeared first on PharmaVOICE.

The UK’s Drug Safety Research Unit (DSRU) has launched a Global Pharmacovigilance Observatory to help the pharma industry understand why international regions reach different decisions on the use of medicines. The observatory will review and collate pharmacovigilance and drug safety data, analyses, evaluations and decisions made in different countries or regions to help regulators and …

Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions Read More »

The Pistoia Alliance, a global, not-for-profit alliance advocating for greater collaboration in life sciences R&D, has launched its Data Governance Community of Interest (CoI). The CoI was set up after a roundtable discussion assessing industry priorities, attended by professionals from pharma companies such as AbbVie, Bayer, Bristol Myers Squibb, Novo Nordisk, Pfizer, Roche and Sanofi, …

New group to tackle data governance and guide digital transformation in pharma Read More »

GlaxoSmithKline Consumer Healthcare (GSKCH) has joined the Pulpex paper bottle partner consortium and will explore incorporating recyclable paper bottles into its packaging. The partnership is part of GSKCH’s commitment for all consumer product packaging to be recyclable or reusable, including eliminating all problematic and unnecessary plastics, where quality and safety permits, by 2025. Pulpex Limited …

GSK Consumer Healthcare to incorporate paper bottles into its packaging Read More »

Dependency vs. Addiction: How to Know If You’ve Crossed the Line With so much attention focused on the opioid addiction crisis, many doctors are reluctant to prescribe prescription pain medications and many people are reluctant to take them. The fear of becoming addicted is often perpetuated by widespread media coverage of how “addictive” medications like …

Dependency vs. Addiction: How to Know If You’ve Crossed the Line Read More »

There’s a report of an interesting small-molecule drug effort against the coronavirus that seems to have produced rather significant results. The idea goes back to effects that were noticed last year – for example, in this population-based study from Italy. It’s been known since the early days of the pandemic that males were overall more …

Androgen Receptors for COVID-19 Read More »

IQVIA has a new LinkedIn page, and they want you to be part of the conversation about moving health care forward. It promises to be an outstanding source for the latest news, insights, and updates. Be part of this dedicated community. http://bit.ly/IQVIA-LI The post Get the latest news and views for how to drive healthcare …

Get the latest news and views for how to drive healthcare forward Read More »

A lot of people have been wondering about what’s up with a small-molecular antiviral compound that’s been in the news on and off during the pandemic. That’s molnupiravir, below, also known as EIDD-2801 and MK-4482. It has all those numbers because it has some history behind it. The compound was discovered at Emory in the …

Molnupiravir: Last of the Small-Molecule Coronavirus Hopes? Read More »

As the world knows, the mRNA vaccines for the coronavirus are proving to be very effective. That’s welcome news for the obvious pandemic reasons, but it’s also welcome validation for a technique that’s been in the works for many years now. I’ll take a moment to re-emphasize how fortunate we are that so much of …

How to Administer RNA – And How to Do It Again Read More »

Some thoughts about the current vaccine trials and data, some of which are probably obvious, but which might be worth bringing together: First, as many have been mentioning, it’s tempting but quite difficult to compare the vaccines (and vaccine candidates) head-to-head by looking at their phase III data. I would only feel safe doing this …

Early March Vaccine Thoughts Read More »

This story has been passed around a lot the last few days, and I’ve had several people ask me what I’ve thought of it. It’s on a really interesting possibility for a malaria vaccine, and part of the narrative hook is that it’s using mRNA technology, which is about as attention-getting a topic these days …

A Malaria Vaccine Candidate Read More »

In my experience, most organic and medicinal chemists are always ready to hear about the latest results in two branches of the science: things that explode and things with weird smells. Maybe we are in our way “singularly in touch with the primitive promptings of humanity”, as Captain Grimes says in Decline and Fall (although …

Vetiver Read More »

The briefing documents are out at the FDA site for tomorrow’s hearing on the J&J vaccine. Here’s a summary at STAT from Matthew Herper and Helen Branswell, and I agree with their take: overall, the numbers look good. Update: here’s a good Twitter thread from Hilda Bastian, and here’s one from Eric Topol. Like every …

The J&J Vaccine at the FDA Read More »

Here’s a good article from the Washington Post that updates some details that I talked about in this post on the lipids used in the mRNA vaccines and in this one about their overall manufacturing process. It focuses on Acuitas, who make the two proprietary lipids that are used in the Pfizer/BioNTech vaccine. Actually, if …

More on mRNA Vaccine Manufacturing Read More »

Travel is fatal to prejudice, bigotry, and narrow-mindedness. Mark Twain

Over the years I’ve very much enjoyed being startled by the scientific literature, and there haven’t been many times when I’ve been more surprised than I was this morning. I’ve been making references on this blog for years about how we don’t even know how antidepressants work, but if this new paper is correct, then …

How Antidepressants Work, At Last? Read More »

It’s my impression that the pace of headlines and tweets, etc. about the many COVID-19 variants has increased recently (and it wasn’t exactly an unexplored topic before). Some of the coverage is just horse-race stuff (here comes this one, around the curve comes that one), but some of it is downright alarmist. And while I’m …

Coronavirus Variants: Down to the Details Read More »

Cipla Limited-Walk-In Interviews for Multiple Departments On 21st Feb ‘ 2021 Walk-In Interviews for Multiple Departments-Production/ Engineering/ Quality Control/ Quality Assurance/  Store Departments @ Cipla Limited Cipla Limited-Walk-In Interviews for Multiple Departments On 21st Feb ‘ 2021

How did COVID-19 affect mortality rates and how did that vary by racial and ethnic groups? Using January 2011 – April 2020 data from the Census Bureau’s version of the Social Security Administration’s Numerical Identification (Numident) database, a paper by Polyakova et al. (2021) find significantly higher all-cause excess mortality rates for minority groups, particularly …

COVID-19 excess mortality by race Read More »

There’s news today that Bluebird has suspended its gene therapy work on sickle cell disease because of two cases of cancer in its treatment population. Another had been reported in 2018, so that takes us to two cases of myelodysplastic syndrome and one case of myeloid leukemia (which can be a sequel of MDS in …

Cancer and Gene Therapy Read More »

Let’s have a look at a paper that came out recently in the New England Journal of Medicine. It shows strong results in a therapeutic area that a lot of people have spent a lot of effort on: obesity. I’ve been kicking around the idea of reviewing the history of anti-obesity drug discovery, but it’s …

GLP-1 and Obesity Read More »

In preclinical studies, injection of a novel ionic liquid formulation (“locally active agent for tumour treatment and eradication” or LATTE) allowed uniform delivery of a chemotherapy drug in solid tumours. According to the study’s senior author, Dr Rahmi Oklu, a vascular and interventional radiologist at Mayo Clinic and director of Mayo Clinic’s Minimally Invasive Therapeutics …

Novel ionic liquid enables uniform chemotherapy delivery in solid tumours Read More »

I’m getting a lot of queries about antibody-dependent enhancement these days, and I can only assume that’s because there’s a lot of talk about this making the rounds of various social media platforms. Many of the people who are contacting me sound a lot more worried than I would have thought, so that prompts me …

Antibody-Dependent Enhancement and the Coronavirus Vaccines Read More »

A NBER working paper by Chandra et al. (2021) finds that even small levels of cost sharing have a major impact on pharmaceutical use and mortality. …we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in coinsurance, or $10.40 per drug) causes a 22.6% drop in total drug …

Impact of pharmaceutical cost-sharing on health Read More »

The US Food and Drug Administration (FDA) has approved the first immunotherapy for patients with advanced basal cell carcinoma (BCC). Libtayo® (cemiplimab-rwlc), a PD-1 inhibitor, was also granted accelerated approval in metastatic BCC. “Today’s FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma,” remarked Dr Karl Lewis, Professor …

First immunotherapy for advanced basal cell carcinoma approved in US Read More »

A third (35 percent) of obese patients treated with semaglutide in a large-scale international trial lost at least a fifth of their total bodyweight within 68-week. According to the researchers, the results are a gamechanger for improving the health of people with obesity and could play a major part in helping reduce the impact of …

Semaglutide: “a significant advance in the treatment of obesity,” say scientists Read More »

There’s a new paper out that clears up some of our thinking about the current pandemic and what protection people might have had before the latest coronavirus showed up. As so many people know by now, there are a lot of coronaviruses running around out there, and they are responsible for a small-but-real fraction of …

Does Prior Exposure to Coronaviruses Protect You? Read More »

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older weighing at least 40) who are at high risk for progressing to severe COVID-19. The indication …

FDA approves emergency use of Lilly’s COVID-19 antibody combination Read More »

The other day I had a look at the process used to make the mRNA vaccines, so I thought it would be a good idea to do the same for the adenovirus vector ones, such as J&J, Oxford/AstraZeneca, CanSino, Gamaleya et al. It’s a different system, with its own advantages and disadvantages, and that’s the …

How You Make an Adenovirus Vaccine Read More »

In a recent interview with PharmaShots, Duncan Short, Ph.D., Director of Global Implementation Science at ViiV Healthcare shared his views on the findings of a new study demonstrating how the inclusion of a brief survey focused on patient-reported outcomes (PROs) during doctor’s appointments can improve HIV care. Shots: In the study, people living with HIV were …

ViewPoints Interview: ViiV Healthcare’s Duncan Short Shares Insight on PROgress Study Demonstrating that Pre-Visit Survey Can Improve HIV Care Read More »

A new trial suggests a single injection of an experimental antiviral drug, peginterferon-lambda, can significantly sped up the recovery of non-hospitalised patients with COVID-19. In the trial, participants who received peginterferon-lambda were four times more likely to clear the infection within seven days than those on placebo. “People who were treated cleared the virus quickly, …

Peginterferon-lambda accelerates COVID-19 recovery, finds trial Read More »

Breyanzi (lisocabtagene maraleucel), a chimeric antigen receptor (CAR) T cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or relapsed, after at least two other types of systemic treatment has been approved by the US Food and Drug Administration (FDA). According to the agency, Breyanzi …

FDA approves third gene therapy for large B-cell lymphoma Read More »

We’ve had yet more news in this area in the ten days or so since my last vaccine news roundup post, so here’s a look at the current situation. Most all the news has been in the viral vector area, so I’ll stick to that this time around. The big news here is the publication …

Adenovirus-Vector Vaccine Roundup, Feb 5: Sputnik and More Read More »

The UK National Institute of Health and are excellence (NICE) has published draft guidance approving Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy, to treat patients with non-squamous, non-small cell lung cancer (NSCLC). The treatment will now be available for patients on the UK National Health Service (NHS).  The draft guidance means pembrolizumab with pemetrexed and …

NICE recommends treatment for non-squamous, non-small cell lung cancer Read More »

Johnson & Johnson (J&J) has announced that Janssen has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The company’s EUA submission is based on topline efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the …

J&J submits COVID-19 vaccine data to FDA for emergency authorisation Read More »

Let’s take a one-day break from the coronavirus, but fear not, I will not be forsaking immunology. We’ll take a look at an interesting therapeutic idea involving T-cells and how it’s going. For some years now, Amgen has been working on a technology called “BiTE“, which stands for “bispecific T-cell engager“. It fits into the …

T Cells (and Bifunctionals) For Everything Read More »

An experimental single-dose, intranasal influenza vaccine was safe and produced a durable immune response, a Phase I study has shown.  The investigational vaccine, called Ad4-H5-VTN, is a recombinant, replicating adenovirus vaccine designed to spur antibodies to haemagglutinin, a protein found on the surface of influenza viruses that attaches to human cells. The investigational vaccine was …

Intranasal influenza vaccine produces strong immune response, Phase I study shows Read More »

We have some more data to mull over with the Oxford/AstraZeneca vaccine. The situation so far has been pretty confused, with various efficacy numbers appearing from different people in different venues. It’s fair to say that the rollout of the clinical data has not gone smoothly, and that it’s done the effort no favors. As …

Oxford AstraZeneca Data, Again Read More »

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve… The post The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA appeared first on DrugPatentWatch – Make Better Decisions.

The UK National Institute for Health and Care Excellence (NICE) has issued final guidance, also known as Technology Appraisal Guidance (TAG), recommending Beovu® (brolucizumab) as an option in the National Health Service (NHS) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.  According to Novartis, which produces the drug,  the guidance was based on findings from the Phase III HAWK and …

NICE recommends Beovu (brolucizumab) for treatment of wet AMD Read More »

An interim analysis of data from the Phase III trial of the Sputnik V COVID-19 vaccine from Russia (Gam-COVID-Vac) suggests that a two-dose regimen of the adenovirus-based vaccine offers 91.6 percent efficacy against symptomatic COVID-19. The preliminary findings are based on analysis of data from nearly 20,000 participants, three-quarters of whom received the vaccine and one …

Phase III trial shows Sputnik V COVID-19 vaccine is 91.6 percent effective Read More »

In the last few days, the question of why more drug companies haven’t been enlisted for vaccine production has come up. It’s mostly due to this tweet: The problem is, as far as I can see, this is simply wrong. There are not “dozens of other pharma companies” who “stand ready” to produce these mRNA …

Myths of Vaccine Manufacturing Read More »

According to a new report, there has been a 639 percent increase in the number of COVID-19 clinical trials worldwide, from 549 COVID-19 clinical trials in early April 2020 to over 4,000 in January 2021. Of this figure, 762 trials are taking place in the US – a figure greatly outnumbering activity in other countries, …

COVID-19 clinical trials have risen by 639 percent, says report Read More »

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a ‘rolling review’ of data on REGN-COV2 antibody combination (casirivimab/imdevimab) for the treatment and prevention of COVID-19. The treatment is being co-developed by Regeneron Pharmaceuticals and Roche. The CHMP’s decision to start the rolling review is based on preliminary results from a study that indicate …

EMA initiates rolling review of Regeneron’s COVID-19 mAb Read More »

So I’m a small-molecule drug discovery person at heart, since I started out as a synthetic organic chemist. Talking about vaccines and antibodies nonstop is a bit of a strain, then, because immunology is full of stuff that’s rather far removed from good ol’ small-molecule ligands. Actually immunology eventually wears out everyone. Even immunologists. It …

Screening, Within and Without Read More »

An interim analysis of Phase III clinical trial data has shown that the investigational COVID-19 vaccine developed by Janssen Pharmaceuticals, a division of Johnson & Johnson (J&J), appears to be safe and effective at preventing moderate and severe COVID-19 in adults. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be …

J&J COVID-19 vaccine shows success in interim analysis of Phase III trial Read More »

According to new reports, AstraZeneca will deliver nine million more doses of its COVID-19 vaccine to the EU in the first quarter of this year, bringing the company’s commitment to the bloc to total of 40 million for the period. As reported in Reuters, AstraZeneca will also start deliveries one week earlier than expected, the President …

AstraZeneca to provide EU with extra nine million doses of COVID-19 vaccine following dispute Read More »

The UK Government has signed a deal ordering a further 40 million doses of Valneva’s promising COVID-19 vaccine candidate, after an initial order of 60 million doses. The UK Government also retains the option to order over a further 90 million doses between 2023 and 2025.  According to the government, the latest deal will bolster …

UK Government orders 100 million doses of Valneva COVID-19 vaccine Read More »

Suddenly we have a lot more vaccine efficacy data to discuss! Yesterday came an announcement from Novavax about trials they’ve been conducting in the UK and in South Africa with their recombinant protein vaccine, and today comes equally anticipated data from J&J (Janssen) on their adenovirus vector candidate. We’ll have a look at the numbers …

J&J and Novavax Data Read More »

The Coalition for Epidemic Preparedness Innovations (CEPI) has opened a new funding opportunity, providing up to $140 million, contingent upon the availability of funds, to support the rapid generation of additional clinical research on COVID-19 vaccines. This includes COVID-19 vaccine developers, as well as public health organisations, academic institutions and others who may not be …

CEPI offers $140 million to support research on COVID-19 vaccines Read More »

In a Phase II trial, sotorasib was shown to provide durable clinical benefit with a favourable safety profile in patients with pre-treated non-small cell lung cancer (NSCLC) who harbour KRAS p.G12C mutations. The CodeBreak 100 trial results validate the CodeBreak 100 Phase I results. Sotorasib is a first-in-class small molecule that specifically and irreversibly inhibits …

Sotorasib shows success against non-small cell lung cancer in Phase II trial Read More »

Until very recently, smallpox vaccines were delivered using a technique known as skin scarification, in which the skin is repeatedly scratched with a needle before a solution of the vaccine is applied. Almost all other vaccines today are delivered via intramuscular injection, with a needle going directly into the muscle, or through subcutaneous injection to …

Vaccine delivered via skin scarification could help fight respiratory diseases Read More »

The European Medicines Agency (EMA) has accepted Global Blood Therapeutics (GBT) marketing authorisation application for Oxbryta® (voxelotor) for the treatment of haemolytic anaemia in sickle cell disease (SCD). According to the company, the EMA has now started its standard review process.  A first-in-class oral, once-daily therapy, Oxbryta directly inhibits haemoglobin polymerisation, the root cause of the …

EMA accepts MAA for Oxbryta to treat haemolytic anaemia in sickle cell disease Read More »

We’re definitely not out of the pandemic woods yet, and neither is this blog – so let’s talk some more about antibodies today, in the hopes that we’re getting closer to the time when I (and all of us) can ignore immunology for a while. But we’re not ignoring it today! There’s a lot of …

Vaccination Against the New Variants: Real-World Data Read More »

Moderna has announced results from in vitro neutralisation studies of sera from individuals vaccinated with the company’s COVID-19 vaccine showing activity against emerging strains of SARS-CoV-2. According to the company, vaccination with the Moderna COVID-19 vaccine (mRNA-1273) produced neutralising titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and …

Moderna COVID-19 vaccine successful against emerging variants, study shows Read More »

The clinical trial results from a Phase Ib study of IGV-001 for patients with newly diagnosed glioblastoma have been published by Imvax.  IGV-001 is a first-in-class personalised immunotherapy that uses the patient’s own tumour cells combined with an antisense molecule to induce a potent immune response. The treatment comprises irradiated autologous glioma cells with an antisense …

IGV-001 demonstrates success against glioblastoma in Phase Ib trial Read More »

What You Should Know: – AstraZeneca and Care Access Research are teaming up to provide decentralized, mobile research site operations for AstraZeneca’s AZD7442 phase III clinical trial in the US. – The Phase III clinical trial called STORM CHASER will assess the safety and efficacy of AZD7442 for post-exposure prophylaxis and pre-emptive treatment in approximately …

AstraZeneca and Care Access Research Collaborate on Decentralized COVID-19 Clinical Trial Read More »

AbbVie has announced that the European Commission (EC) has approved RINVOQ (upadacitinib, 15mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA). The treatment will be used in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). …

EC approves RINVOQ (upadacitinib) to treat active psoriatic arthritis Read More »

Merck has announced that the company is discontinuing development of its COVID-19 vaccine candidates, V590 and V591. The company now plans to focus its COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 (molnupiravir) and MK-7110. This decision follows Merck’s review of findings from Phase I clinical studies for the vaccines. In …

Merck to discontinue development of COVID-19 vaccine candidates Read More »

We have a good amount of news in the coronavirus vaccine world, so it’s time for another look over the field. My most recent overview post is here, from late December, with this one from mid-December, and about ten days ago I looked at news from J&J and SinoVac (also summarized below). I’m going to …

Vaccine Roundup: Merck Wipes Out (and More) Read More »

The UK National Institute for Health and Care Excellence (NICE) has recommended a new CAR T-cell therapy to be available to National Health Service (NHS) patients via the Cancer Drugs Fund.  The personalised treatment, called Tecartus or autologous anti-CD19-transduced CD3+, is produced by Kite. NHS clinicians in England will be able to consider the treatment for …

NICE recommends new CAR T-cell therapy to treat mantle cell lymphoma Read More »

The Lupus Research Alliance (LRA) has responded to the US Food and Drug Administration’s (FDA) approval of the use of Lupkynis (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis in combination with standard-of-care. Voclosporin has been approved in combination with a background immunosuppressive therapy regimen.  Developed by Aurinia Pharmaceuticals‘, the …

Voclosporin approved by FDA to treat lupus nephritis Read More »

Last week, my Healthcare Economist blog celebrated its 15th year of existence. I started this blog in graduate school at UC-San Diego in January of 2016 with the very original inaugural post titled “Welcome!“. Since then, I’ve written more than 4,600 posts on various topics of in health and economics. Some of the most popular …

Healthcare Economist blog celebrates 15 years Read More »

Writing the other day about the lipid formulations used in the current mRNA vaccines makes me want to highlight something else that I hit on from time to time around here. When you learn in school about the major classes of biomolecules, you hear about proteins, lipids, carbohydrates, and nucleic acids. That’s a reasonable classification, …

The Other Guys Read More »

According to reports, a fire at the Serum Institute of India (SII) has killed five people. However, government officials have said that this would not affect production of the Oxford-AstraZeneca COVID-19 vaccine that is being made at the facility.  As reported by Reuters, black smoke could be seen coming out of the multi-storey building in …

Fire at Serum Institute of India, production site of COVID-19 vaccine Read More »

The US has stated that it will remain a member of the World Heath Organization (WHO). US President Joe Biden wrote to António Guterres, Secretary-General of the United Nations (UN), to announce this intention in a letter.  On 6 July 2020, the US notified the UN that it intended to leave the WHO, however the …

President Biden announces intention for US to remain member of WHO Read More »

What insurance is better: private commercial health insurance or public health insurance? This is a more difficult question than it seems since individuals with commercial vs. public health insurance differ over a number of dimensions which affect health care spending, quality and outcomes. To try and get at this question, a paper by Allen et …

Health Insurance Battle Royal: Commercial vs. Medicaid Read More »

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19 Premature birth is also known as preterm birth. It is defined as a baby born alive before reaching the gestational age (term to describe the length of pregnancy) of 37 weeks. The typical gestational period is usually 40 weeks which is considered a full-term pregnancy. Premature …

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19 Read More »

A question that comes up a lot about mRNA vaccines is what happens at the cellular level after you’re injected with one. The mechanism of any such vaccine is to cause cells to produce a viral protein antigen, but which cells actually do this? It’s also understood that mRNA vaccines tend to act as their …

mRNA Vaccines: What Happens Read More »

Micky Tripathi, ONC National Coordinator for Health IT – The ONC has named Micky Tripathi as the new National Coordinator for Health IT under President Joe Biden’s administration, succeeding Don Rucker, M.D. who held the post since April 2017. – The Office of the National Coordinator for Health Information Technology is the principal entity charged …

ONC Names Micky Tripathi New National Coordinator for Health IT Read More »

Pfizer and BioNTech have announced results from an in vitro study that provides additional data on the capability of sera from individuals immunised with the Pfizer-BioNTech COVID-19 vaccine to neutralise a SARS-CoV-2 UK strain. Also known as B.1.1.7 lineage or VOC 202012/01, the strain is a rapidly spreading variant of SARS-CoV-2 initially detected in the UK …

Pfizer COVID-19 vaccine effective against B.1.1.7 variant from UK Read More »

A new report has said that clinical microbiology will play a key role in understanding SARS-CoV-2 pathogenesis. According to ResearchAndMarkets, as COVID-19 antiviral drugs and vaccine development intensifies, billions of dollars are being invested in over 100 vaccine candidates forcing labs to work at full and extended capacity. The report also says that the global …

Clinical microbiology to play key role in COVID-19 response, report says Read More »

Up to 2,000 people working in roles crucial to the continuity of the COVID-19 vaccine supply chain will be offered inoculations against the coronavirus to help ensure the UK gets the doses it needs to protect the most vulnerable, the government has announced. Highly trained workers who have been identified by the government as crucial …

UK vaccine supply chain workers to be offered COVID-19 jabs Read More »

According to a new report, Israel is currently on track to be the first country in the world to vaccinate its entire population against COVID-19. The authors of the report say that this inoculation progress could provide a gold standard for other countries if Israel begins to see no new resurgence in COVID-19 cases in …

Israel set to be first country to vaccinate entire population against COVID-19 Read More »

This new article, I have to say, is rather reassuring about the human immune response to the coronavirus. It’s from a large team centered at Rockefeller University in New York, and it examines 87 people who have previously been infected. We’ve seen many studies of antibody titers and the like over time, but this is …

Memory B Cells, Infection, and Vaccination Read More »

A team of neuroscientists and engineers has created a nasal spray to deliver schizophrenia medication directly to the brain instead of having it pass through the body. The study was conducted at McMaster University, Canada.  According to the researchers, the leap in efficiency means patients with schizophrenia, bipolar disorder and other conditions could see their …

New system could deliver schizophrenia medicine directly to brain Read More »

A new report has revealed the strength of Scotland’s pharmaceutical industry and its value to the economy and communities across the country. Conducted by the University of Strathclyde’s Fraser of Allander Institute, Scotland, the report charts the success of the sector, which has seen an increase in employment, exports and research investment since the last major …

Pharma industry employs 5,600 people in Scotland, report says Read More »

A clinical trial involving hospitalised COVID-19 patients has found that a combination of the drugs baricitinib and remdesivir reduce time to recovery. The study was co-ordinated at the University of Texas Health San Antonio and University Health, US, and was conducted at roughly 100 sites globally. The Adaptive COVID-19 Treatment Trial 2 (ACTT-2), which compared …

Baricitinib and remdesivir reduce time to recovery in COVID-19 patients Read More »

Over its first 50 years in existence, how did the EHR lose its way? Given that EHR adoption doubled between 2007 and 2012 and EHR expenditures in the United States grew an annual average of 5.4% from 2015 to 2019, totaling $14.5 billion in 2019, this may sound like a strange question to ask. But …

Solving the 50-Year-Old EHR’s Midlife Crisis: How Platform EHRs are Finally Delivering Clinical Intelligence Read More »

We have some more data on the vaccine front that’s worth looking at. J&J has published a bit more on their trials of their adenovirus-vector candidate, with data on the immunogenicity of the vaccine in patients. They have several cohorts evaluated: a single shot of low dose, single shot of high dose, two shots of …

Johnson and Johnson, SinoVac and More Read More »

A joint statement from a range of biopharmaceutical industry groups has said they recognise that with the first COVID-19 vaccines authorised by regulatory authorities and administered to the public, a critical new phase of the pandemic has begun. The statement was released by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufacturers …

Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines Read More »

According to a new report, the global antibiotics market is estimated to generate a revenue of $58,798.1 million at a compound annual growth rate (CAGR) of four percent during the forecast period 2020-2027. The researchers say that the market will increase from its worth in 2019, at $43,298.5 million. The report was compiled by Research Dive. …

Antibiotics market set to generate revenue of $58,800 million by 2027 Read More »

According to new reports, the COVID-19 vaccine produced by Pfizer and BioNTech, BNT-162b2, is currently projected to generate at least $30 billion in sales from 2020 to 2026. GlobalData, which released the research, said that the vaccine would peak with sales in 2021 worth $13.9 billion.  The report highlights that the Pfizer-BioNTech vaccine, a two-shot …

Pfizer COVID-19 vaccine set to generate sales of $30 billion Read More »

The European Commission (EC) has granted marketing authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients. ViiV Healthcare, which produces the tablets, said that the therapy is now approved for treatment-naïve or treatment-experienced but …

European Commission approves dispersible tablets to treat paediatric HIV Read More »

Synairgen has announced that the first patient has been dosed in the UK a part of a global Phase III trial evaluating the inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients.  According to the company, several UK sites have now been initiated, with further sites in the US and EU …

Phase III trial to study interferon beta therapy in COVID-19 patients initiated Read More »

We know that COVID-19 has increased both mortality and morbidity around the world. But is there a systematic way of estimating the impact of COVID-19 on both mortality and morbidity. A paper by Briggs et al. (2021) proposes one simple solution. They start by creating standard life tables. Life tables are created by estimating the …

Impact of COVID-19 on quality‐adjusted life‐year lost Read More »

After yesterday’s post on mRNA vaccines and RNA mechanisms, I wanted to highlight a completely non-coronavirus application that has recently appeared in the literature. It’s from BioNTech, the German company who’s been working with Pfizer on one of the two mRNA coronavirus vaccines, of course, but they have other therapeutic interests as well. This latest …

More Things to Do With mRNA Read More »

The first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19. The randomised, double-blinded, placebo-controlled dose-escalation study will evaluate the safety and tolerability COVI-VAC at multiple dose levels in a total of 48 volunteers. In addition, the study will …

First patient dosed with COVI-VAC, an intranasal COVID-19 vaccine candidate Read More »

The European Medicines Agency (EMA) has announced that it has received an application for conditional marketing authorisation (CMA) for the COVID-19 vaccine developed by AstraZeneca and Oxford University. According to the EMA, the assessment of the vaccine will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January …

EMA receives authorisation application for AstraZeneca COVID-19 vaccine Read More »

Amgen has announced the launch of a new seven-year environmental sustainability plan, which includes a commitment to achieve carbon neutrality, while also reducing water use by 40 percent and waste disposed by 75 percent. “As a science-based company with a mission to serve patients, we understand the profound impact that climate change is having on …

Amgen sets target of achieving carbon neutrality by 2027 Read More »

So now that people (not enough of them!) are getting vaccinated in the US with the Pfizer/BioNTech and Moderna mRNA vaccines, let’s talk about some more details of what are in those injections and what happens once the shot is given. The workings of an mRNA vaccine touch on a lot of different cellular processes …

RNA Vaccines And Their Lipids Read More »

The US Food and Drug Administration (FDA) has announced that it is monitoring the potential impact of SARS-CoV-2 viral mutations, including a variant from the UK known as the B.1.1.7 variant. The FDA has alerted clinical laboratory staff and healthcare providers that the agency is using authorised SARS-CoV-2 molecular tests and that false negative results can …

FDA monitoring impact of SARS-CoV-2 mutations Read More »

New research has predicted that the global rapid microbiology testing market will increase to be worth $6.48 billion in 2026, up from $3.45 billion in 2018. According to the report, the market will register a compound annual growth rate (CAGR) of 8.2 percent in the forecast period 2019-2026.  The researchers, from Data Bridge Market Research, …

Rapid microbiology testing market set to be worth over $6 billion in 2026 Read More »

A new collaboration has been established to enhance the nasal drug delivery of Parkinson’s therapies using nanoparticle technology.  Nanoform Finland and Herantis Pharma announced that they have signed a letter of intent to work together on the latter’s CDNF and xCDNF therapies.  The planned and non-exclusive collaboration is intended to assess the utility of Nanoform’s …

Collaboration to investigate nasal drug delivery using nanoparticle technology Read More »

Episode 37 of “The THCB Gang” will be live-streamed here 1pm PT / 4pm ET on Thursday, Jan 7. You can see it below! Matthew Holt (@boltyboy) will be joined by regulars: data & privacy expert Deven McGraw, (@Healthprivacy), Patient entrepreneur extraordinaire Robin Farmanfarmaian (@RobinFF3) & consultant/author Rosemarie Day (@Rosemarie_Day1). Balancing them out will be the …

THCB Gang, Episode 37, Jan 7 – LIVE 1pm PT- 4pm ET Read More »

Researchers have grown small crystals from nanoscale encapsulated droplets. According to the scientists, their innovative method, involving the use of inert oils to control evaporative solvent loss, has the potential to enhance the drug development pipeline. The study was conducted at the University of Newcastle and University of Durham, both UK, in collaboration with SPT …

New technique to grow crystals from nanoscale droplets developed Read More »

The European Commission (EC) has approved PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy, making it the first treatment for the condition. Produced by Aimmune Therapeutics, a Nestlé Health Science Company, PALFORZIA is indicated in patients aged four to 17 years with a confirmed diagnosis of peanut allergy in conjunction with …

European Commission approves first treatment for peanut allergy Read More »

A new study has shown that microbial surface recovery was superior for vinyl when compared with stainless steel, two surfaces common to pharmaceutical facilities.  According to Tim Sandle, the author of the paper, viable environmental monitoring methods in healthcare and pharmaceutical settings remain primarily culture based, with one example being the contact plate. However, although …

Microbial surface recovery superior for vinyl than stainless steel Read More »

Well, here I am with the first “In the Pipeline” post of 2021, and damn itall, I’m right back to the stuff I was writing about last time. I still expect this year to be the time when we beat back the coronavirus pandemic, and (as a minor side effect for me) to be the …

Variants and Vaccines Read More »

Following India’s approval of the internally developed Covaxin COVID-19 vaccine, experts have raised concerns over whether the jab should have been authorised without sufficient publication of its safety and efficacy data. The vaccine has been given permission to be used “in clinical trial mode… specifically in the context of infection by mutant strains.”  According to …

Concerns raised over India’s approval of COVID-19 vaccine with incomplete data Read More »

There’s been a lot of news, so it’s time to survey the vaccine landscape. For this post, I’m only going to cover the big players that are either deep into human trials or have actually been rolling out vaccines to the general population – another post to come will go further down the list. But …

Vaccine Roundup, Late December Read More »

Here’s another one that we make every so often around stately Lowe Manor. When we had it last week, I just had to roast it in the oven – normally I’d put it on the rotisserie on the grill outside, but weather conditions did not allow it. Like many such recipes, this one is all …

Recipe: Peruvian Roast Chicken Read More »

Dan Lyon, Sr. Principal Security Consultant at Synopsys Over the last several years of my career, I’ve had the opportunity to work with a variety of global medical device manufacturers.  Recently, I have also started working with some new organizations that are not yet global in scale.  A theme that I have discovered is that …

3 Common Missteps for Manufacturers to Avoid When Securing Medical Devices Read More »

A novel method of purifying gentamicin, a widely used antibiotic, reduces the risk that it will cause deafness, according to new study. The new formulation to prevent hearing loss was developed at Stanford Medicine, US.  Gentamicin is used in US hospitals to treat a variety of bacterial infections. It is a popular drug in developing …

Optimised formulation of gentamicin could reduce hearing loss Read More »

Optrix Laboratories Pvt. Ltd-Walk-In Interviews for Production/ QC On 30th Dec’ 2020 & 2nd Jan’ 2021 Optrix Laboratories Pvt. Ltd-Walk-In Interviews for Production/ QC On 30th Dec’ 2020 & 2nd Jan’ 2021

In short, because we had built years and years of previous science, particularly work related to another corona virus, the Middle East Respiratory Syndrome (MERS) virus. As This American Life reports on the speed of vaccine development: That’s because the spike on this coronavirus that would cause the pandemic, it was very, very similar to …

How did we get the COVID-19 vaccine so fast? Read More »

I’ll be taking a holiday break, with intermittent blogging. I hope to put in a recipe or two (as often happens around here this time of year), and I’ll certainly pop up if we have some big news. Otherwise, from now until January 2nd I’ll be on my end-of-the-year schedule. 2020 has been. . .well, …

Holiday Break Read More »

OK, time to write about the topic that’s been the talk of the coronavirus world the last day or two: the new strain that has been detected in the UK. I’ll go ahead and put the bottom line right here, and then go into the details: I’m not sounding any alarm bells, but this does …

The New Mutations Read More »

Moderna has announced that the European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, the company’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses. The first deliveries of mRNA-1273 to European countries from Modena’s dedicated European supply chain are expected to commence early in …

EC orders additional 80 million doses of Moderna’s COVID-19 vaccine Read More »

I’ve had several questions about antibody-dependent enhancement, which has always been a worry as the coronavirus vaccines have been developed. I figured it might be worth a look at just what we know about it, why one might be worried, and why (on the other hand) one might be hopeful. The simple definition of ADE …

Antibody-Dependent Enhancement Read More »

Here’s a preprint from a large team at Yale with a close look at a less-studied aspect of coronavirus infection. It’s been well established by now that a feature of severe cases is a misfiring immune response (the “cytokine storm”, etc.), and one reason that fatality rates have been going down for hospitalized cases is …

Autoantibody Problems Read More »

I wanted to follow up on something that came up much earlier in the coronavirus pandemic. Back in February, a group at BenevolentAI proposed the kinase inhibitor baricitinib as a possible therapeutic for the coronavirus. They identified this through their company’s machine-learning approach to the medical literature and disease mechanisms, and identified the compound due …

Baricitinib Follow-Up: An AI Prediction for Coronavirus Therapy Read More »

Well, it’s definitely been a Vaccine Week around here, but it’s understandable. And we’ll finish off the week with a look at some types that we haven’t seen report yet. The news is. . .mixed. First off is a preliminary report on the inactivated virus vaccine from Sinopharm – more specifically, their China National Biotec …

A Wider Variety of Vaccine Platforms Report Read More »

For people looking for an accessible writeup on the coronavirus mutational landscape, I can recommend this Reuters article that came out today. It has a lot of good information in it, and a lot of very well-made graphics to show what’s going on. Past blog posts on this subject are here, here, here, here, and …

The Latest on Coronavirus Mutations Read More »

Pfizer and BioNTech have a date on Thursday in front of an FDA advisory committee to review their vaccine data, and the briefing document is available for all to read (here’s the FDA’s own document as well). It’s very interesting stuff, and far more information than we’ve had so far. First off, safety. There continue …

The FDA Weighs Its First Coronavirus Vaccine Read More »

This weekend brought some really significant news in the long-running effort to use gene editing to treat human disease. As most readers will have heard, Bluebird and a Vertex/CRISPR effort both published papers in the NEJM addressing sickle-cell anemia and beta-thalassemia. These diseases have long been linked when it comes to gene therapy ideas, because …

Gene Therapy, Absolutely and For Real Read More »

We’re in the beginning of the vaccine endgame now: regulatory approval and actual distribution/rollout into the population. The data for the Pfizer/BioNTech and Moderna vaccines continue to look good (here’s a new report on the longevity of immune response after the Moderna one), with the J&J and Novavax efforts still to report. The AZ/Oxford candidate …

Get Ready for False Side Effects Read More »

We seem to be heading for a world with multiple coronavirus vaccines in it, and right off, I have to say that that this is a very good situation. But it has its complications, and one that I know many people have been wondering about is, what if you get two different ones? That could …

Taking Two Different Vaccines? Read More »

Every two years there’s a big challenge competition in predicting protein folding. That is. . .well, a hard problem. Protein chains have (in theory) an incomprehensibly large number of possible folded states, but many actual proteins just manage to arrange themselves properly either alone or with a few judicious bumps from chaperones. It’s been clear …

Protein Folding, 2020 Read More »

What You Should Know: – Philips unveils a new multimodality virtual imaging command center that enables real-time, remote collaboration to broaden expertise between technologists, radiologists, and imaging operations teams across multiple sites via private, secure telepresence capabilities. – In addition, Philips debuts AI-enabled, automated Radiology Workflow Suite at RSNA 2020 to advance precision diagnosis into clear …

Philips Unveils Vendor-Neutral Radiology Operations Command Center, Automated Radiology Workflow Suite Read More »

As of this morning, we have a first look at the Oxford/AstraZeneca vaccine’s efficacy in clinical trials via press releases from both organizations. The number in the headlines says about 70% efficacy, but there’s more to the story. Here’s the landscape so far: we have results from Pfizer and from Moderna, both of them developing …

Oxford/AZ Vaccine Efficacy Data Read More »

That is the basic question that Reed et al. (2020) attempt to answer in their recent paper. The approach they use is as follows: We designed a discrete-choice experiment to administer 10 choice questions to each respondent representing experimentally controlled pairs of scenarios defined by when nonessential businesses could reopen (May, July, or October 2020), …

How much extra COVID-19 risk would you be willing to accept to open the economy? Read More »

I know that it’s been a run of vaccine posts around here, but the numbers just keep on coming. Today we have two more papers to look at, both published in The Lancet. – The first is from the SinoVac inactivated virus effort (the CoronaVac vaccine). In this one, the virus is grown in Vero …

More Vaccine Data, in Advance of More Efficacy Read More »

Now that we’re seeing that coronavirus vaccines are indeed possible (and are on their way), let’s talk about the remaining unanswered questions and the things that we will be getting more data on. Here are some of the big issues – it’ll be good to see this stuff coming into focus. I’ll put these into …

Vaccine Possibilities Read More »

What You Should Know: Today AliveCor, the leader in AI-based, personal ECG devices and cardiology platforms, announced they closed $65 million in Series E funding to accelerate its growth. To date, AliveCor’s FDA-cleared Kardia devices have recorded more than 85 million ECGs. Since the pandemic began, nearly 15 million ECGs were taken which is an …

AliveCor Lands $65M to Advance Remote Cardiology Platform Worldwide Read More »

As expected, we have more vaccine news this morning. And the news is good. Moderna reports that their own mRNA candidate is >94% effective (point estimate), with 95 total cases in the trial to date, split 90/5 between the control group and the vaccinated group. 11 of those were severe infections: all 11 in the …

Moderna’s Vaccine Efficacy Readout Read More »

Earlier this morning, Pfizer and BioNTech announced the first controlled efficacy data for a coronavirus vaccine. And the news is good. You may recall that these vaccine trials are set up to get to a defined number of coronavirus cases overall, at which time the various monitoring committees lock the door and unblind the data …

Vaccine Efficacy Data! Read More »

So it’s finally time for Biogen to sit down with an FDA advisory committee to look at their proposed Alzheimer’s therapy, the anti-amyloid antibody aducanumab. I last wrote about it here, back in December, and you know what? I haven’t changed my mind a bit, because (1) no new data have emerged (none were expected) …

Aducanumab at the FDA Read More »

One side effect of the coronavirus has been an explosion of lower-quality publications in the scientific literature. This has come in several forms, some more excusable than others. In the former category are the papers that were rushed out earlier this year, observational studies that sometimes investigated possible therapies as well. These were often done …

The Scientific Literature’s Own Pandemic Read More »

Wouldn’t be great if we could find a treatment to improve longevity? Not just a treatment for a specific disease but one that could dramatically improve longevity for a large percentage of human kind. While there is a lot of longevity research going on and much progress has been made. There are some challenges. Milan …

Longevity Read More »

I wanted to mention something that was reported a week or so ago, and may sound a bit exotic or obscure, if you’re not a structural biologist. But it’s yet another sign of a revolution in our ability to get structures of biomolecules (and others) that we never would have before, and the effects over …

Down to the Atoms Read More »

We have a new paper in the NEJM from the Eli Lilly effort on monoclonal antibodies against the coronavirus. And there’s no reason not to be up front about it: it’s disappointing. This is the BLAZE-1 trial (mentioned in this recent post), which is studying non-hospitalized patients. It was another trial (ACTIV-3) where this antibody …

The Latest Antibody Data From Lilly and From Regeneron Read More »

So here’s an ambitious idea that’s about to get a hearing in human clinical trials. A startup called Shasqi is using click chemistry as a drug delivery method, and they have a new manuscript on the idea here at ChemRxiv. The idea is this: you produce a modified version of a hyaluronate biopolymer, decorated with …

Click Chemotherapy Read More »

As AJMC reports, Governor Gavin Newsom signed into law legislation that will allow California to produce and distribute its own line of biosimilars, biosimilar insulins, and generic drugs. My thoughts on SB-852 are covered in an interview in Radar on Specialty Pharmacy. Shafrin tells AIS Health that there are two key reasons for manufacturers to …

Will California Produce and Distribute Biosimilars and Generics Drugs? Read More »

Unfortunately, we’re getting a dose these days of “That’s why you run clinical trials”. Word came Monday evening (Peter Loftus in the WSJ, and a Lilly statement) that the ACTIV-3 trial being run by the NIH has shown lack of efficacy for the combination of the Eli Lilly/AbCellera anti-coronavirus antibody (bamlanivimab, LY-CoV555) when combined with …

More Antibody Data Read More »

I was speaking to a university audience the other day (over Zoom, of course) and as I often do I mentioned the studies that have looked at what kinds of reactions medicinal chemists actually use. The cliché is that we spend most of our time doing things like metal-catalyzed couplings and amide formation, and well, …

Are Medicinal Chemists Taking It Too Easy? Read More »

This is one of the main topics explored by the interesting book Remedy and Reaction by Paul Starr. The U.S. has gotten close to national health insurance programs a number of times. One of the first times was in New York after World War I. The one state where compulsory health insurance came close to …

Why doesn’t the US have nationalized health care? Read More »

We’re getting closer to having to deal with a number of tricky issues around the first Emergency Use Authorizations (EUAs) for coronavirus vaccines. These have never quite come up in this way before, because (for one thing) EUAs for vaccines are relatively rare events, and (for another) we’ve never had so many simultaneous vaccine trials …

The Vaccine Tightrope Read More »

Here’s a new paper in Nature on computer-generated synthesis of natural products. More formally, you’d call it retrosynthesis, since the htought process in organic chemistry tends to work backwards when you have a particular target that you’re trying to make: “OK, this part could could be made from something like this. . .and that, you …

The Machines Rise a Bit More Read More »

OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of it’s a real surprise. One drug reported on is hydroxychloroquine. This showed no …

The SOLIDARITY Data Read More »