// Biotech and Pharma Therapeutics
The heart failure market gets a little more crowded, as Eli Lilly and Boehringer Ingelheim score a win for Jardiance
August 19, 2021 / Eli Lilly / Boehringer Ingelheim / Jardiance / Heart Failure
On Wednesday, Eli Lilly and Boehringer Ingelheim secured a win for Jardiance in HFrEF, a condition where the muscle of the left ventricle doesn’t pump normally. The indication accounts for more than half of heart failure patients, and the risk of death increases with each hospitalization, according to the partners.
Florida, Texas Turn to Antibody Treatments as Covid-19 Surges
August 18, 2021 / Florida / Texas / Covid-19 / Eli Lilly / Regeneron
Doctors are increasingly turning to antibody drugs in a bid to keep hospitals from being overwhelmed by a surge of Covid-19 cases, a turnabout after months in which the treatments went mostly unused.
Aspirin trialled as potential treatment for aggressive form of breast cancer
August 18, 2021 / Breast Cancer / Aspirin
A team at the Christie NHS Foundation Trust in Manchester, funded by the Breast Cancer Now Catalyst Programme, will launch a clinical trial to investigate aspirin, hoping it can make tumours more sensitive to immunotherapy in patients with triple negative breast cancer.
With Alzheimer’s market opening up, Lilly forms neuroscience unit
August 17, 2021 / Eli Lilly / Biogen / Eisai / Alzheimer’s
Eli Lilly is one of the front runners in the bid to follow Biogen and Eisai onto the market with an anti-amyloid drug for Alzheimer’s disease, and its preparing the ground with a restructuring of its business units.
// 4th Industrial Revolution
Machine learning boosts spirulina bioproduction by up to 100 percent
August 17, 2021 / Machine Learning / Bioproduction / Google / Lumen Bioscience
Under a research collaboration funded in part by the Bill & Melinda Gates Foundation, Lumen Bioscience worked with Google Accelerated Science to apply ML to increase the productivity of Arthrospira platensis (spirulina) using Bayesian black-box optimisation. The results of the collaboration, which are pending peer-review, have been published in pre-print on the bioRxiv server.
Blockchain use is about more than NFTs and dogecoin. It’s about you
August 16, 2021 / NFT / Blockchain
Blockchain use can save lives, build smart cities and boost data privacy. But before it can do any of that, it has to step out the shadow of dodgy cryptocurrencies and multi-million digital art deals.
A unicorn in women’s health & machine learning skepticism
August 17, 2021 / Women’s Health / Machine Learning
The women’s and family health provider Maven Clinic nailed down a $110 million Series D round led by Dragoneer Group and Lux Capital. Normally we wouldn’t spend more than a sentence on such news at a time when nine-figure fundraising rounds are so common. But the deals puts Maven’s valuation over $1 billion in a category of business that until recently has been given short shrift.
Rendever Awarded $2M NIH Grant to Research Impact of Virtual Reality on Aging Population
August 18, 2021 / NIH Grant / Virtual Reality
The Phase II Grant builds on Rendever’s previously awarded Small Business Technology Transfer (STTR) Phase I Grant to measure the impact of Rendever’s engagement platform. The initial pilot data confirmed the positive impact that virtual family engagement has on both residents and their family members living at a distance.
Developing Precision Medicine for Chronic Kidney Disease
August 18, 2021 / Kidney Disease / Genome
Chronic kidney disease impacted an estimated 850 million people and is responsible for 1 in 60 deaths worldwide. Currently, there are few treatments for chronic kidney disease. However, understanding the genetic variations linked to the disease is critical in developing new precision medicine treatments.
// Business & Markets
Lilly bio-medicines splitting into two business units
August 17, 2021 / Eli Lilly / Bio-Medicines
Eli Lilly is undertaking a strategic transformation that will result in the formation of new business units. The Indianapolis company’s Bio-Medicines unit will split into two separate businesses, with one focusing on neuroscience and one aiming at immunology.
Beckley Psytech raises $80m for psychedelic meds development
August 16, 2021 / Beckley Psytech / Psychedelic
Beckley Psytech said the first use of the proceeds will be to complete an ongoing phase 1b trial low-dose psilocybin – the active ingredient in magic mushrooms – in patients suffering from short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare form of headache thought to affect around 45,000 people in the US and Europe.
AI firm XtalPi swells its coffers with another $400m financing
August 16, 2021 / AI / XtalPi / MIT
Artificial intelligence (AI) specialist XtalPi has chalked up a second big financing in the space of a year, raising $400 million and taking its valuation to around $2 billion.
The Money Keeps On Flowing In
August 12, 2021 / Biopharma / Pipeline
In any market’s upswing, there are always going to be people who make the case that “it’s different this time”, and historically, most of the time that argument doesn’t hold up. But things do change, and right now I also have to add that for several years I’ve also been saying that in my career (post 1989) I have never seen so many interesting and novel therapeutic opportunities as there are right now.
// Legal & Regulatory
What antitrust challenge? Illumina completes $8B Grail buyout while FTC, EU probes remain ongoing
August 19, 2021 / Illumina / FTC
In defiance of FTC and EU scrutiny, Illumina said Wednesday it has completed its multibillion dollar acquisition of Grail, setting off what’s likely to be a contentious brawl ahead of the US regulator’s trial expected to begin next week.
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
August, 2021 / Kidney Disease / FDA / FibroGen
FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).
U.S. courts reviews nearly 6,000 lawsuits over 3M surgical warming device
August 16, 2021 / U.S. court / Lawsuit / 3M
The plaintiffs claimed that the device was defective because it transferred antibiotic-resistant bacteria into open surgical wounds, either by disrupting airflow in the operating room or through contamination of the device itself.
// Research & Development
Pirfenidone could offer ‘viable’ heart failure treatment
August 17, 2021 / Heart Failure / Pirfenidone
While the results are promising for patients with heart failure, larger scale trials will be needed to confirm the findings for pirfenidone before it could be licensed for use on the NHS.
Small protein protects pancreatic cells in model of type 1 diabetes
August 16, 2021 / Diabetes / Pancreatic Cells
The small protein that first made headlines as an “exercise mimetic” increasingly appears to also have a big role in regulating the immune system, said Assistant Professor of Gerontology Changhan David Lee, co-corresponding author of the study.
Clinical Catch-Up: August 9-13
August 16, 2021 / AzurRx BioPharma / Covid-19
AzurRx BioPharma added five new trial sites in Ukraine for its ongoing RESERVOIR Phase II trial of FW-1022 for COVID-19-related gastrointestinal infections. The drug is an oral formulation of micronized niclosamide. The company alsocompleted enrollment of the initial cohort of Part 1 of its ongoing RESERVOIR Phase II trial of FW-1022 for COVID-19-related GI infections.
Researchers Discover On/Off Switch for Inflammatory Pain
August 16, 2021 / Inflammatory Pain / Medical Research
In a preclinical study published in Proceedings of the National Academy of Sciences (PNAS), scientists presented a new approach to treating diseases that involve inflammation and pain, like arthritis.
Researchers develop new way to study neurodegenerative diseases
August 16, 2021 / Develop / Neurodegenerative Diseases
Some proteins in cells can separate into small droplets like oil droplets in water, but faults in this process may underlie neurodegenerative diseases in the brains of older people. Now, researchers have developed a new method to quantify protein droplets involved in these diseases.
// Politics
As Biden signals interest in linking drug prices with R&D costs, new study finds costs per NME are increasing
August 16, 2021 / Biden / R&D costs / NME / Development
Eroom’s law (essentially the opposite of Moore’s law) holds that the development of new drugs has become slower and more expensive over time. And a new analysis, published this month in PharmacoEconomics, confirms not only that costs have gone up over the years but the difficulty in tracking how R&D has shifted.
Global Agencies Seek Clearer Steer On AI In Drug Development & Regulation
August 17, 2021 / AI / Drug Development / Drug Regulation / CNS Drugs
Regulators’ experiences and two hypothetical case studies form the basis of a set of recommendations on the use of artificial intelligence in areas such as safety signal detection and improving decision making, which have just been published by the International Coalition of Medicines Regulatory Authorities.
August 11, 2021 / Healthcare / Bipartisan /
While the debate to address health care affordability intensifies on Capitol Hill, Americans across political parties agree on a path forward: reduce health care costs broadly and help Americans better access and afford their care through commonsense, bipartisan solutions. Here are three findings from recent polling data you should know.