// Biotech and Pharma Therapeutics
Biogen’s Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises
September 1, 2021 / Alzheimer’s / Drug Access / Aduhelm / Biogen
While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when it comes to the treatment’s safety.
Cytocom to Become Statera BioPharma
July 21, 2021 / Cytocom / Statera BioPharma
Cytocom, Inc., a biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, plans to change its name to Statera BioPharma, Inc. effective September 1, 2021. As part of the name change, Statera BioPharma plans to release a new company logo and launch a new company website at www.staterabiopharma.com.
A drug costing less than €2 a day helps in the treatment of severely ill COVID-19 patients
August 30, 2021 / Covid-19 / Drug Pricing / Metoprolol
The most severe form of COVID-19 is severe respiratory failure, which requires intubation and is associated with a high mortality rate. Pulmonary infection with the SARS-CoV2 virus can progress to acute respiratory distress syndrome (ARDS), in which inflammation and neutrophil hyperactivation play a central role. There is currently a lack of therapies for ARDS associated with COVID-19.
Three JAK Inhibitors Get Boxed Warnings, Modified Indications
September 1, 2021 / JAK Inhibitors / Drug Manufacturing / FDA
Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks.
How long does it take for CBD to work?
November 24, 2021 / CBD / Cannabis
With very few side effects and a whole host of therapeutic health benefits, it’s the perfect option for those who are looking to treat their health conditions naturally.
// 4th Industrial Revolution
The do’s and don’ts of digital transformation for healthcare CIOs
September 1, 2021 / Digital Health / Healthcare / Digital Transformation
Done right, digital transformation in healthcare drives productivity, satisfaction, quality of care, and reimbursement—but it can be easy to get wrong.
Augmented Reality: How It’s Becoming the Future of Medicine
September 10, 2021 / Augmented Reality / AI / New Tech
AR is one of the latest technological trends at present, and it’s likely to be more prevalent in the future. It’s expected that the market will grow to reach around $340 billion by 2028. Companies and individuals are adopting AR-supported online platforms for various purposes, such as e-commerce, education and social media.
Even innocuous-seeming data can reproduce bias in AI
September 1, 2021 / AI / SymphonyRM / Healthcare
Artificial intelligence tools in healthcare, as with any other software, are not immune to bias – especially if they have been trained on data sets that do not accurately reflect the population they ostensibly serve.
Diabetes Patients to Benefit from New Collaboration: Lifescan and Fitbit
August 25, 2021 / Diabetes / Lifescan / Fitbit
LifeScan’s cloud-based digital platform offers data, insights, and connectivity with clinicians to people managing diabetes via the OneTouch Reveal app. The new collaboration will provide a Fitbit Inspire 2 tracker and access to the Fitbit Premium service to LifeScan users at no extra charge.
CRISPR: New Techniques and Complex Models
September 1, 2021 / New Techniques / CRISPR
Possibilities include CRISPR interference (CRISPRi) and CRISPR activation (CRISPRa) systems, which bind to specific DNA sequences and thereby modulate the expression of targeted genes. They use a dCas fused with a transcriptional repressor (in the case of CRISPRi) or a transcriptional effector (in the case of CRISPRa).
// Business & Markets
Alma gets $50M to boost therapists’ practices
September 1, 2021 / Alma / Mental Health / Teletherapy
Finding an in-network therapist has long been a challenge, and with more people experiencing anxiety and depression during the Covid-19 pandemic, it hasn’t gotten any easier. A number of startups are tackling the problem — either by offering teletherapy or self-guided exercises.
Catalent lays out $1B to buy gummy manufacturer Bettera, getting 4 factories and 500 new employees in the process
September 30, 2021 / Consumer Health / Catalent
Catalent has kept busy during the pandemic by helping vaccine heavyweights scale up their supply chains. In an expansion bid beyond its ongoing pandemic work, the company is buying a leading producer of gummies in the nutritional supplements field.
SPAC backs Revelation to tackle respiratory viral infections
September 30, 2021 / Influenza / Mergers and Acquisitions / Nasal Spray / Respiratory Syncytial Virus / San Diego Biotech
San Diego-based Revelation will pocket $73 million through the merger. Revelation will use the money to advance REVTx-99, a nasal drop formulation designed to stimulate the innate immune system via TLR4-TRIF pathway agonism. By driving the production of interferons and other cytokines in the nose, REVTx-99 could tackle viruses as soon as they enter the body.
Money on the Move: August 25 – 31
September 1, 2021 / Biotech / Life Science
The hot days of summer are nearing a close, but these life sciences companies aren’t cooling off their fundraising efforts. Here’s a brief overview of who’s heating up their coffers this week.
// Legal & Regulatory
Abbott takes on competition with FDA approval of device to prevent afib-related strokes
August 16, 2021 / Abbott / FDA / Medical Devices
Abbott Laboratories will go toe-to-toe with competitor Boston Scientific after getting approval from the Food and Drug Administration for a device intended to prevent strokes in people with atrial fibrillation.
CBO: Impact of price control legislation on new drug development
August 29, 2021 / Innovation / Pharmaceuticals / Public Policy / Industrial Oranization
The reason for the slow impact is that it takes many years for a drug to come to market. Thus, drug price reductions in have a modest impact on short-run innovation, but a major impact on long-run innovation. In part, CBO believes that the policies will have the largest impact on Phase 1 and Phase 2 investments, but less so on Phase 3. The figure below show this impact graphically, accounting for uncertainty in some of the underlying parameters.
Europe’s health agency says no urgent need to roll out COVID-19 booster shots to fully vaccinated
September 1, 2021 / Covid-19 / Health Agency / Vaccine / Europe
The global debate over COVID-19 vaccine boosters is continuing, with Europe’s health agency now saying there is no need to rush another round of shots even as multiple countries are doling out additional doses.
// Research & Development
Arthritis Drug “Will Save Thousands” of Covid-19 Patients After Excellent Trail Results
September 1, 2021 / Clinical Trial / Foundation Medicine / Science 37 / Cancer
The drug saved 5% of hospitalized patients that would have otherwise died, according to a new study.
MIT, Novo Nordisk advance oral biologics delivery project
August 31, 2021 / Oral Drug Delivery / Oral Insulin / Humira
The search for a way to orally administer biologics has led Novo Nordisk to the leopard tortoise. By mimicking the shape of the tortoise’s shell, researchers at MIT and Novo have come up with an oral capsule capable of injecting biologics including Humira into the lining of the stomach.
Increasingly savvy patients call for shift in trial approach: Illingworth
September 7, 2021 / Patient Centricity / Patient Recruitment / Patient Engagement / Decentralized Trials
A leader from the home trial services provider say s patients’ increasing awareness of clinical research has how trial teams should consider their approach.
Fractyl activates 10th clinical site in diabetes reversal tech trial
September 1, 2021 / Fractyl / Diabetes / Tech Trial
Lexington, Mass.-based Fractyl’s trial is enrolling patients with type 2 diabetes who are currently on insulin therapy at sites in New Jersey, Louisiana, Texas, Massachusetts and New York to add to the initial U.S. site at Indiana University Health. Additionally, enrollment is ongoing in Belgium, Italy and the Netherlands.
Parallel Bio is putting the immune system in a dish to improve drug discovery
August 30, 2021 / Drug Discovery / Immunology / Organoid / Startups
Imperfect disease modeling in animals can lead to drugs that work fine in animals but don’t work in people and fail in the clinic. Worse, it could result in drugs that are harmful to people. Think thalidomide, a drug shown to be safe in animals and then marketed as a sedative and a treatment for morning sickness in the 1950s and 1960s before it was linked to severe birth defects.
// Politics
Congress relying on flawed model to set drug pricing policy
August 27, 2021 / Drug Pricing / Congress / CBO / Drug Development
The Congressional Budget Office’s model for analyzing how legislative proposals may affect new drug development disregards impacts on early-stage biotech companies, and as result dramatically underestimates the effects of price controls on the development of new medicines, an economist who advises the CBO, a life sciences venture capitalist, and an executive at BIO told BioCentury.
In reopening Tennessee penicillin plant, Jackson Healthcare relieves the US’ dependence on China-made antibiotics
August 30, 2021 / Manufacturing / Amoxicillin / Augmentin / Dr. Reddy’s
Supply chain disruptions during the coronavirus pandemic highlighted a key vulnerability for countries like the United States, which have come to rely on overseas sources for certain medicines and the raw materials to produce them.
HHS will prod hospitals to cut carbon emissions
August 30, 2021 / HHS / Carbon Emissions / Biden
HHS Secretary Xavier Becerra said the new Office of Climate Change and Health Equity will also work with localities to mitigate harmful effects of climate change, such as seniors succumbing to excessive summer heat because their apartments lack air conditioning. Minority communities that often bear a disproportionate impact from environmental problems will get special attention.