// Biotech and Pharma Therapeutics

Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom
March 20, 2023 / Novo Nordisk / Ozempic / Wegovy / Eli Lilly – Novo Nordisk confirmed the restocking in an emailed statement. A company spokesperson credited continued constraints on the higher 2 mg Ozempic dose to “the combination of incredible demand coupled with overall global supply constraints.” Read Full Article on Fierce Pharma >>
Medtronic and NVIDIA announce medical device collaboration
March 22, 2023 / Medtronic / NVIDIA / Medical Devices – Integrating the NVIDIA Clara healthcare platform could allow Medtronic to scale the development of algorithms to enhance real-time procedures and improve patient care. Read Full Article on Healthcare IT News >>
Novartis, Biogen Scrap Gene Regulation Partnerships with Sangamo
March 20, 2023 / Novartis / Biogen / Gene Regulation / Sangamo – Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued their partnerships studying gene regulation therapies in the neurology space. Read Full Article on Biospace >>
Quantum healthcare computing coiled for liftoff on US soil
March 20, 2023 / Quantum Healthcare – Superconductivity is a critical element supporting quantum computing. In IBM’s own lay-friendly words, the latter “harnesses the laws of quantum mechanics to solve problems too complex for classical computers.” Read Full Article on Health Exec >>
Amwell Adds Cardiometabolic Program with DarioHealth Partnership
March 22, 2023 / Amwell / Cardiometabolic / DarioHealth – Amwell, a leader in digital healthcare enablement, today announced the expansion of its digital clinical programs to include a cardiometabolic program, enabling health plans and clinicians to seamlessly connect members living with common chronic diseases, such as diabetes and high blood pressure, to Dario’s highly personalized digital therapeutic solution on the Amwell platform. Read Full Article on HIT Consultant >>

// 4th Industrial Revolution

Dante Genomics launches Avanti Software for a plug-and-play genomic interpretation that takes minutes instead of hours
March 20, 2023 / Dante Genomics / Avanti Software / B2B – Dante Genomics, a global leader in genomics and precision medicine, launched today the beta version of Avanti, the Company’s proprietary B2B software for variant interpretation and report writing at scale. Read Full Article on Biospace >>
Amwell partners with DarioHealth to offer digital cardiometabolic health program
March 22, 2023 / Amwell / DarioHealth / Cardiometabolic – Under the partnership, patients who receive care from clinicians using Amwell’s telehealth platform can be referred to Dario’s program for chronic conditions like diabetes, high blood pressure and weight management. Read Full Article on Mobi Health News >>
How AI can ease the burden of stressed-out teletriage nurses
March 22, 2023 / AI / Teletriage – Teletriage nurses often face intense pressure as they work in fast-paced situations while assessing patients, employing critical thinking and delivering high-quality care. This can lead to staff burnout – contributing to an already existing exodus among healthcare professionals. Read Full Article on Health IT News >>
Enable Biosciences Announces Relaunch of Website for Early Detection of Type 1 Diabetes
March 21, 2023 / Biosciences / Diabetes – Type 1 diabetes is an autoimmune disease affecting over 1.6 million people in the United States. It occurs when the body’s immune system mistakenly destroys insulin-producing cells, causing high blood sugar levels and a range of health complications. Early detection is crucial for managing the disease and reducing its impact. Read Full Article on Biospace >>
Early decisions to de-risk the transition to combination products
March 20, 2023 / Drug Development / FDA / Drug Approval – To address these changes, you could focus solely on drug development and risk unforeseen obstacles by leaving combination product and device considerations to later phases. Alternately, you could go to market with a simple containment system, but it may not meet patient needs. Finally, you could rely on multiple outsourcing partners to develop your combination product, which could complicate planning and lead to costly delays. Read Full Article on Biopharma Dive >>

// Business & Markets

Cognito Therapeutics Raises $73M Series B to Advance Neurotechnology Platform for Alzheimer’s Disease
March 22, 2023 / Cognito Therapeutics / Nerotechnology / Alzheimer’s – Cognito Therapeutics, a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, announced today a $73M Series B financing round led by FoundersX Ventures with participation from all existing investors. New investors Alzheimer’s Drug Discovery Foundation (ADDF), Starbloom Capital, IAG Capital and WS Investment Company (Wilson Sonsini’s venture arm) joined the round. Read Full Article on Biospace >>
Novo Nordisk pens $745M biobucks pact with Dewpoint to tackle insulin resistance, diabetes complications
March 22, 2023 / Dewpoint Therapeutics / Novo Nordisk / Biotech Deals / Diabetes – The partnership aims to identify drug candidates using Dewpoint’s discovery platform and is the first biomolecular condensates research deal to be made in the insulin and diabetes space. Read Full Article on Fierce Biotech >>
Raises for Moderna, Pfizer CEOs Highlight Continuing Trend
March 20, 2023 / Moderna / Pfizer / Spikevax – Moderna is one of those companies. Its sole product, Spikevax, has made billions for the biotech’s leaders. With the entire pharmaceutical sector earning higher mean profit margins compared to other sectors, Moderna and other large companies, such as GSK and AbbVie, are hardly alone. Read Full Article on Biospace >>
Takeda’s $4B drug clears psoriasis in one-third of patients, laying down marker in bid to challenge BMS
March 20, 2023 / Takeda / Bristol Myers Squibb / Sotyktu / Nimbus – Takeda has revealed the data that persuaded it to pay $4 billion for Nimbus Therapeutics’ TYK2 inhibitor. The highest dose completely cleared psoriasis in one-third of patients, adding weight to claims that the candidate is an improvement on Bristol Myers Squibb’s rival drug Sotyktu. Read Full Article on Fierce Biotech >>
As approvals roll in, Takeda details pricing strategy for dengue vaccine launch
March 21, 2023 / Takeda / Qdenga / Dengue Fever – Six months after Takeda’s dengue vaccine Qdenga scored its first approval in Indonesia, another large dengue-affected country has signed off on the shot. And with a Brazilian approval in hand, the company has unveiled its pricing and access approach to the key launch. Read Full Article on Fierce Pharma>>

// Legal & Regulatory

Brainomix Receives FDA Clearance for Its Flagship Stroke AI Imaging Software
March 21, 2023 / Brainomix / FDA / AI- Brainomix, the AI-powered medtech solutions company, today announced that its Brainomix 360 e-ASPECTS tool for stroke has received FDA clearance, enabling the Oxford-based company to deploy its cutting-edge stroke AI imaging platform to US stroke centers. Read Full Article on Biospace >>
Merck, Viatris close in on settlement in long-running Januvia patent case
March 21, 2023 / Januvia / Merck / Viatris / Mylan – In a recent filing with the U.S. District Court for the Northern District of West Virginia, the companies said they have reached a settlement after the court last year ruled in favor of Merck and Viatris’ appeal. They’re asking the court to enter a new judgment that would allow their proposed deal to become a reality. Read Full Article on Fierce Pharma >>
Top FDA official: Agency needs to start using accelerated approval for gene therapies
March 20, 2023 / FDA / Gene Therapies / Drug Approvals – A top Food and Drug Administration official said Monday that the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare disease. Read on STAT News >>
Tenax Announces Issuance of U.S. Patent Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
March 22, 2023 / Tenax / U.S. Patent / Heart Failure – The patent term expires December 2040 and provides the Company substantial added intellectual property (IP) protection for the use of levosimendan. The newly issued patent expands upon the Company’s existing IP for levosimendan, which includes U.S. Patent No. 11,213,524, issued in January 2022, covering all medical uses of the subcutaneous formulation of levosimendan in humans. Read on Biospace >>
AbbVie’s blockbuster-to-be Parkinson’s combo hits a wall as FDA questions delivery pump
March 22, 2023 / AbbVie / U.S. FDA / Parkinson’s Disease / Complete Response Letter – The FDA has rejected AbbVie’s application for ABBV-951 for controlling motor fluctuations in patients with advanced Parkinson’s disease, the company said Wednesday. Read on Fierce Pharma >>

// Research & Development

Karuna’s schizophrenia drug succeeds in a second late-stage trial
March 20, 2023 / Karuna / Schizophrenia Drug / KarXT / Brai Disorder – The trial, which enrolled just over 250 participants, found that after five weeks of treatment, those who were given Karuna’s drug as opposed to a placebo experienced significantly greater reductions on a scoring system used to measure the severity of schizophrenia symptoms. Read Full Article on Biopharma Dive >>
First Patient Dosed in Europe in Clairvoyant’s Phase 2b Clinical Trial Exploring Psilocybin Therapy as a Treatment for Alcohol Use Disorder
March 20, 2023 / Alcoholism / Europe / Clairvoyant Therapeutics – The first CLA-PSY-201 trial site in Finland is overseen by principal investigator, Dr. Hannu Alho. Dr. Alho is a Professor with the Finnish National Institute for Health and Welfare (THL) and Chief Doctor at Addiktum Oy, a Finnish company founded and owned by drug addiction treatment specialists and a research center for the study. Read Full Article on Biospace >>
AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application
March 22, 2023 / AbbVie / ABBV-951 / New Drug Application – In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible. Read Full Article on Biospace >>
Higher cancer rates found in military pilots, ground crews
March 20, 2023 / Military / Cancer – The data had long been sought by retired military aviators who have raised alarms for years about the number of air and ground crew members they knew who had cancer. They were told that earlier military studies had found they were not at greater risk than the general U.S. population. Read Full Article on STAT News >>
AstraZeneca and MSD’s Lynparza gets green light
March 20, 2023 / AstraZeneca / MSD / Drug Approval – AstraZeneca and MSD have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza. The therapy – also known as olaparib – will be for use in the UK with both abiraterone and prednisone or prednisolone. Read Full Article on Pharma Times >>

// Politics

Novo Nordisk remains under UK scrutiny as MHRA conducts its own review in ‘incredibly rare’ case
March 21, 2023 / Novo Nordisk / MHRA / Healthcare – The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Read Full Article on Endpoints News >>
Biden Administration to unveil “bold goals” for biotechnology, biomanufacturing
March 21, 2023 / Biden / Biotechnology / Biomanufacturing – In Washington, the Biden Administration unveiled bold new goals for biotechnology and biomanufacturing, plus a new report — a delegation of 14 high-ranking officials are headed to ABLC 2023 this week in the capital to provide first reactions and briefings to the bioeconomy industry on the new goals and targets of the Administration. Read Full Article on The Digest >>
California Picks Generic Drug Company Civica to Produce Low-Cost Insulin
March 20, 2023 / California / Insulin – Gov. Gavin Newsom on Saturday announced the selection of Utah-based generic drug manufacturer Civica to produce low-cost insulin for California, an unprecedented move that makes good on his promise to put state government in direct competition with the brand-name drug companies that dominate the market. Read Full Article on Physicians Weekly >>
Biden’s victory lap on drug prices is premature
March 18, 2023 / Biden / Drug Prices / Medicare – That’s why Biden and his team have traveled around the country to tout his policy accomplishments, including the drug pricing provisions of the Inflation Reduction Act, which he is seeking to build on with his proposed budget. Read Full Article on Herald Tribune >>
Patient groups balk at former AstraZeneca official negotiating U.K.-India free trade dealMarch 21, 2023 / AstraZeneca / Patient – More than 200 civil society and patient advocacy groups are urging the U.K. government to remove the key negotiator working on a free trade agreement with the Indian government because of his previous ties to a major pharmaceutical company. Read Full Article on STAT News >>