// Biotech and Pharma Therapeutics
Biogen’s Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises
There’s “room for surprises” when it comes to the safety of Biogen’s Aduhelm because of the company’s tightly controlled clinical trials, which recruited a narrower group of Alzheimer’s patients compared to the treatment’s FDA label, RBC Capital Markets wrote on Wednesday, citing a recent study.
www.fiercepharma.com
Cytocom To Become Statera BioPharma
New name reflects strategic focus on addressing autoimmune and inflammatory diseases, blood disorders, infectious disease and cancer.
www.contractpharma.com
A drug costing less than €2 a day helps in the treatment of severely ill COVID-19 patients
Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial
www.worldpharmanews.com
// 4th Industrial Revolution
The do’s and don’ts of digital transformation for healthcare CIOs - MedCity News
Done right, digital transformation in healthcare drives productivity, satisfaction, quality of care, and reimbursement—but it can be easy to get wrong.
medcitynews.com
Augmented Reality: How It’s Becoming the Future of Medicine - Healthcare Weekly
It’s no surprise that more applications for technological advancements emerge in various fields. In health care and medicine, new technologies can be leveraged to improve patient care, enhance operational efficiency, and assist doctors, surgeons and nurses with their daily tasks. For example, artificial intelligence (AI) and machine learning (ML) are growing in popularity and applications. Virtual reality (VR) is being used in physical therapy, and the Medical Internet of Things (MIoT) is expanding. The one technology missing? Augmented reality (AR).
healthcareweekly.com
Even innocuous-seeming data can reproduce bias in AI
Chris Hemphill, VP of applied AI and growth at SymphonyRM, says a good model performance may mask bias under the surface.
www.healthcareitnews.com
Diabetes Patients to Benefit from New Collaboration: Lifescan and Fitbit
The original, clip-on Fitbit tracker, released in 2009, brought the idea of consumer wearables that track personal wellness to the mass market. Fitbit cemented its status as a visionary leader in this new industry when the company introduced an integrated user website and mobile app in 2014. The Fitbit platform gave the average consumer a revolutionary way to track personal health data and easy access to meaningful insights regarding their own wellness and exercise performance.
healthtechinsider.com
// Business & Markets
Alma gets $50M to boost therapists’ practices - MedCity News
Alma, a startup building tools to help therapists grow their practices and take insurance, raised $50 million in funding. It’s drummed up more than 2,000 therapists on its membership-based platform.
medcitynews.com
Catalent lays out $1B to buy gummy manufacturer Bettera, getting 4 factories and 500 new employees in the process
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.
www.fiercepharma.com
SPAC backs Revelation to tackle respiratory viral infections
The spectrum of SPAC mergers encompasses all deal sizes. While multibillion-dollar mergers have defined the space in 2021, Revelation Biosciences is joining with Petra Acquisition to create a Nasdaq-listed company with the relatively Lilliputian enterprise value of $128 million.
www.fiercebiotech.com
// Legal & Regulatory
Abbott takes on competition with FDA approval of device to prevent afib-related strokes - MedCity News
Abbott Laboratories received FDA approval for its Amulet device to treat people with atrial fibrillation who are at risk of ischemic stroke. The device would go head-to-head with one developed by Boston Scientific that was approved in 2015.
medcitynews.com
CBO: Impact of price control legislation on new drug development – Healthcare Economist
It stands to reason that policies that aim to reduce drug prices or squeeze life science companies profits are likely to decrease incentives to finance the research and development needed to bring a drug to market. Previous estimates claim that bringing a new drug to market may cost over $2 billion, and life science companies will need to cover these cost.
www.healthcare-economist.com
Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera
Johnson & Johnson’s Janssen scored an FDA nod on Wednesday for a 6-month formulation of its schizophrenia treatment paliperidone palmitate, making it the first and only twice-yearly injectable for the condition.
www.fiercepharma.com
Europe’s health agency says no urgent need to roll out COVID-19 booster shots to fully vaccinated | CBC News
The European Centre for Disease Prevention and Control says that, based on available data on vaccine effectiveness, there was no urgent need for the administration of booster doses of COVID-19 vaccines to fully vaccinated individuals.
www.cbc.ca
CBO Says Medicare Drug Negotiations Bill Could Result in 60 Fewer New Drugs Over Three Decades
The number of new drugs expected to come into the marketplace will drop by 60 over the next 30 years due to effects of the Medicare drug price negotiations bill H.R. 3, the Congressional Budget Office (CBO) said in a new report.
www.fdanews.com
// Research & Development
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Arthritis Drug “Will Save Thousands” Of Covid-19 Patients After Excellent Trial Results
The drug saved 5% of hospitalized patients that would have otherwise died, according to a new study.
www.forbes.com
MIT, Novo Nordisk advance oral biologics delivery project
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.
www.fiercepharma.com
Fractyl activates 10th clinical site in diabetes reversal tech trial | Drug Delivery Business
Fractyl Health announced today that it activated the 10th clinical site in its pivotal REVITA-T2Di trial in the U.S. and Europe.
www.drugdeliverybusiness.com
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Parallel Bio is putting the immune system in a dish to improve drug discovery
It’s no secret that drug development is a tough business, with the majority of efforts never reaching approval. Parallel Bio aims to help with organoids: 3D mini-organs that look and work just like the organs found in people. It’s starting out by modeling the human immune system in a dish.
www.fiercebiotech.com
Amneal touts results from Phase III trial in Parkinson’s; NovaRock partners on cancer drug
Amneal Pharmaceuticals announced positive results yesterday from a pivotal Phase III clinical trial that evaluated IPX-203 in patients with Parkinson’s disease who have motor fluctuations.
endpts.com
// Politics
Congress relying on flawed model to set drug pricing policy
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
www.biocentury.com
In reopening Tennessee penicillin plant, Jackson Healthcare relieves the US’ dependence on China-made antibiotics
Last year, when Neopharma closed a penicillin plant in Bristol, Tennessee, the U.S. suddenly became dependent on China for antibiotic drug such as Amoxil and Augmentin. But Jackson Healthcare has reopened the plant under the name USAntibiotics.
www.fiercepharma.com
