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

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

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

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

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… Read More »Androgen Receptors for COVID-19

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

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

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

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… Read More »Early March Vaccine Thoughts

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… Read More »A Malaria Vaccine Candidate

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… Read More »Vetiver

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… Read More »The J&J Vaccine at the FDA

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… Read More »More on mRNA Vaccine Manufacturing

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… Read More »How Antidepressants Work, At Last?

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),… Read More »Coronavirus Variants: Down to the Details

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… Read More »COVID-19 excess mortality by race

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… Read More »Cancer and Gene Therapy

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… Read More »GLP-1 and Obesity

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

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… Read More »Antibody-Dependent Enhancement and the Coronavirus Vaccines

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… Read More »Impact of pharmaceutical cost-sharing on health

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

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

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… Read More »Does Prior Exposure to Coronaviruses Protect You?

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

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… Read More »How You Make an Adenovirus Vaccine

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

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

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

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… Read More »Adenovirus-Vector Vaccine Roundup, Feb 5: Sputnik and 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… Read More »NICE recommends treatment for non-squamous, non-small cell lung cancer

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

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“,… Read More »T Cells (and Bifunctionals) For Everything

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

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… Read More »Oxford AstraZeneca Data, Again

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… Read More »The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

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

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

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… Read More »Myths of Vaccine Manufacturing

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

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

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… Read More »Screening, Within and Without

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

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

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

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… Read More »J&J and Novavax Data

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

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

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

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

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

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

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

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

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

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

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… Read More »Vaccine Roundup: Merck Wipes Out (and 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… Read More »NICE recommends new CAR T-cell therapy to treat mantle cell lymphoma

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… Read More »Voclosporin approved by FDA to treat lupus nephritis

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… Read More »Healthcare Economist blog celebrates 15 years

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… Read More »The Other Guys

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

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

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

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

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… Read More »mRNA Vaccines: What Happens

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

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

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

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

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

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… Read More »Memory B Cells, Infection, and Vaccination

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

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

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

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

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… Read More »Johnson and Johnson, SinoVac and 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… Read More »Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines

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

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

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

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

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

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,… Read More »More Things to Do With mRNA

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

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

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

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… Read More »RNA Vaccines And Their Lipids

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

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

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

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

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

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… Read More »European Commission approves first treatment for peanut allergy

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

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… Read More »Variants and Vaccines

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

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… Read More »Vaccine Roundup, Late December

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… Read More »Recipe: Peruvian Roast Chicken

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

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… Read More »Optimised formulation of gentamicin could reduce hearing loss

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

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… Read More »Holiday Break

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… Read More »The New Mutations

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

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… Read More »Antibody-Dependent Enhancement

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… Read More »Autoantibody Problems

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

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… Read More »A Wider Variety of Vaccine Platforms Report

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… Read More »The Latest on Coronavirus Mutations

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… Read More »The FDA Weighs Its First Coronavirus Vaccine

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… Read More »Gene Therapy, Absolutely and For Real

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… Read More »Get Ready for False Side Effects

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… Read More »Taking Two Different Vaccines?

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… Read More »Protein Folding, 2020

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

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… Read More »Oxford/AZ Vaccine Efficacy Data

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

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

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… Read More »Vaccine Possibilities

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

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.… Read More »Moderna’s Vaccine Efficacy Readout

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… Read More »Vaccine Efficacy Data!

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,… Read More »Aducanumab at the FDA

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… Read More »The Scientific Literature’s Own Pandemic

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… Read More »Longevity

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)… Read More »Down to the Atoms

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

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… Read More »Click Chemotherapy

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

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… Read More »More Antibody Data

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… Read More »Are Medicinal Chemists Taking It Too Easy?

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

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… Read More »The Vaccine Tightrope

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… Read More »The Machines Rise a Bit 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… Read More »The SOLIDARITY Data