// Biotech and Pharma Therapeutics
UnitedHealth CSO says no nopay for insulin, other critical drugs from 2023
July 15, 2022 / Insulin / New Drugs / Drug Pricing
The news comes amid heightened public scrutiny over soaring prices of the life-saving drug, with the U.S. House of Representatives in March passing a bill that caps monthly out-of-pocket insulin costs at $35 for those with health insurance.
Gilmore O’Neill picked a bad time to become a biotech CEO. He’s Confident Editas has the goods
July, 2022 / Gilmore O’Neill / Biotech / Business
Gilmore O’Neill probably couldn’t have picked a worse time | Editas’ new CEO Gilmore O’Niell has already checked off a few items on his to do list in his first six weeks, including hiring a chief medical officer. Fierce Biotech caught up with him and his new CMO to find out what’s next.
Marinus parts with priority review voucher, selling skip-the-line pass to Novo Nordisk for $110M
July, 2022 / Marinus / Novo Nordisk / Pharma
Marinus Pharmaceuticals is using a priority review voucher granted four months ago as a financial life preserver, selling the accelerated review pass designated for rare pediatric diseases to Novo.
Novartis looking for new homes for midphase asthma, eye disease and NASH assets after pipline review
July, 2022 / Novartis / NASH / Asthma / Pipeline
Novartis has put a trio of midphase drugs up for partnering. Novartis has put a trio of midphase drugs up for partnering. After performing its annual portfolio review, the Swiss Big Pharma decided to bring in outside support to drive development of treatments for retinitis pigmentosa, asthma…
Personalized cancer therapy iotech PACT Pharma lets go of nearly 100 staffers
July, 2022 / Cancer / Biotech / PACT
PACT Pharma has let go of 94 employees, leaving remaining staff to work on two clinical stage assets in immuno-oncology, according to a state workforce report in…
// 4th Industrial Revolution
Lack of payment pathway clarity hinders digital therapeutics, analysts say
July, 2022 / Digital Therapeutics / New Tech
The report warns of a sector beset by payment issues, “snake oil” and “middling adoption”.
What the POTS shutdown will mean for faxing in the healthcare industry
July, 2022 / POTS / Healthcare Industry / FCC
The FCC is officially closing the door on analog/copper POTS lines. Read what this means for the healthcare industry.
How California is building the nation’s largest healthcare data exchange
July 15, 2022 / California / Healthcare
The state of California recently embarked on an ambitious endeavor. Using hundreds of millions of dollars in public funding, the nation’s largest state plans to connect its hospitals and healthcare providers through a statewide health information exchange.
How 4 health systems are using AI, data analytics and machine learning
July 15th, 2022 / Health Systems / AI / Data Analytics / New Tech
Hospitals are using AI, data analytics and machine learning to improve health outcomes, produce predictive clinical insights and improve patient care. Here are four artificial intelligence projects health systems have recently created and deployed as reported by Becker’s Hospital Review:
Artificial Intelligence-related deals significantly decreased in the pharmaceutical industry in H1 2022
July 19, 2022 / AI / H1 2022 / GlobalData
Deals relating to AI in the pharmaceutical sector have seen a decrease of 47.8% from H1 2021 to H1 2022 an analysis of GlobalData’s deals database reveals.
// Business & Markets
Vertex signs agreement to acquire ViaCyte for $320m
July 12, 2022 / Vertex / ViaCyte / Acquisition
Vertex Pharmaceuticals has signed a definitive agreement for the acquisition of ViaCyte in a deal totaling $320m in cash.
Biotech earnings arrive after dreadful 6 months, but upcoming readouts offer hope to analysts
July, 2022 / Biotech
With signs that biotech’s nosedive may be starting to level off, will the sector’s big players use their second-quarter earning results to point to green shoots? With signs that biotech’s nosedive may be starting to level off, will the sector’s big players use their second-quarter earnings result…
Morgan Health makes $30M investment in Centivo
July, 2022 / J.P. Morgan / Healthcare / Centivo
Morgan Health, the healthcare arm of JPMorgan Chase, will invest $30 million in Centivo, a health plan for self-funded employers. Morgan Health, the healthcare arm of JPMorgan Chase, will invest $30 million in Centivo, a health plan for self-funded employers
Nestle wagers $41M on Enterome’s preclinical food allergy and IBD prospect
July, 2022 / Nestle / Food Allergy / IBD
Nestle Health Science has returned to the deal table once again,
Zymeworks plots corporate move from Canada to tax-friendly Delaware
July, 2022 / Zymeworks / Canada / Delaware
After launching in Vancouver nearly 20 years ago, Zymeworks is looking to shave a few dollars off its tax bill, announcing plans to become a Delaware corporation. Zymeworks is shifting its corporate home base from Canada to tex-friendly Delaware in a bid to reduce costs.
// Legal & Regulatory
Biogen gains prominent ally in bid for Supreme Court to review Tecfidera patent case
July, 2022 / Biogen / Supreme Court / Patent
After the U.S. Court of Appeals for the Federal Circuit scuttled Biogen’s bid for a rehearing on its Techfidera patent case in March, the big biotech was left with few options but to appeal to the Supreme Court. Now, as the high court considers whether to take up the case.
FDA Regulatory News and Trends
July 15, 2022 / FDA / Regulatory
Welcome to the latest issue of FDA Regulatory News and Trends, designed to help you identify significant legal developments and naviate the evolving…
Parents become drug developers to save their children’s lives
July 21, 2022 / Parents / Drug Developers
Maggie Carmichael wasn’t developing like other kids. As a toddler, she wasn’t walking and had a limited vocabulary for her age.
Novo Strikes $110M deal for regulatory fast pass
July 15, 2022 / Novo Nordisk / FDA
Danish drugmaker Novo Nordisk has agreed to pay $110 million to acquire a voucher that speeds up Food and Drug Administration reviews, reaching a deal with Pennsylvania-based Marinus Pharmaceuticals that was disclosed Thursday.
FDA to Review food program structure for potential overhaul
July 27, 2022 Drug Pricing / Senate / Pharma Industry
While the incident that triggered this investigation has little to do with general CPG food and beverage, it could bring in wide-reaching recommendations that could inspire real change at the agency. Those who regularly deal with the FDA have experienced the structural challenges of the agency firsthand, but to others, it may outwardly seem like it has been doing its job.
// Research & Development
NYU surgeons successfully implant two pig hearts into brain-dead patients
July 13, 2022 / NYU / Organ Shortages
It’s the latest in a series of experimental attempts to find out if pig heart transplantation into human bodies is possible, without harming the patient’s quality of life. NYU doctors conducted the procedures on on June 16th and July 6th.
New gene identified that contributes to progression to type 1 diabetes
July, 2022 / New Gene / California / Diabetes
Michael Holahan, Augusta University Scientists report that the combination of an pro-inflammatory pair of receptors called CCR2 and its ligand, CCL-2 increases the risk of developing type 1 diabetes.
Why brain stimulation should not be overlooked as an antidepressant treatment for older adults
July, 2022 / Brain Stimulation / Mental Health
In the US, rTMS was cleared by the food and drug Administration in 2008 to treat patients suffering from treatment resistant depression, or in other words, patients who do no respond to standard antidepressants. It has since been approved or recommended in several other countries.
Drug Recommendation System for Diabetes using a Collaborative Filtering and Clustering Approach: Development and Performance Evaluation
July 15, 2022 / Diabetes / AI / Machine Learning
Principal component analysis to reduce the dimensionality of the data showed that eight components best explained the variability of the data. We identified six groups of patients using the clustering algorithm, which were evenly distributed. These groups were identified based on the available information of patients with diabetes, and then the variation between groups was examined to predict a suitable medication for a target patient.
Sesen slams brakes on phase 3 bladder cancer program to save cash as it looks for off-ramp
July, 2022 / Sesen / Cancer
Sesen Bio is pumping the brakes on its phase 3 bladder cancer program. After weighing up what it will take to get Vicineum to market, the biotech has paused clinical development in the US to preserve the cash that could be….
// Politics
The Drug Pricing ‘Slippery Slope’
July 27, 2022 Senate / Drug Pricing
Progressives are disappointed with the tentative drug-pricing deal that Senate Majority Leader Chuck Schumer appears to have struck with West Virginia’s Joe Manchin. But no worries, says Vermont Rep. Peter Welch, the price controls are merely the start of what will be a long raid on drug makers to fund Democratic spending ambitions.
Lowering Insulin prices isn’t the (only) answer to helping patients with diabetes
July 18, 2022 / Drug Prices / Insulin / Diabetes
It is time to shift the converstation, incentives, and polity solutions to help people improve their health and get off of medication – not just make them cheaper.
Fauci to retire by the end of biden’s term
July, 2022 / Fauci / Biden
Dr. Anthony Fauci, who has helped shepherd Americans through the pandemic amid heavy fire from critics, plans to retire as the director of the National Institute of Allergy and Infectious Diseases by the end of President Joe Biden’s term.
Health Care Renovation
July, 2022 / Healthcare / Medicare
The changes arn’t major reconsideration of the health care system in the U.S. as Medicare for all would be. Instead, Democrats in Congress have crafted smaller solutions to gaps in the current sustem.
Australia Subsidizes Glucose Monitoring Devices
July 13, 2022 / Australia / Glucose / New Tech
The Australian government is turning to a digital solution to address a prevalent health issue: Type 1 diabetes. The plan, under the helm of the National Diabetes Services Scheme (NDSS), is to give…