// 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
Ozempic, which has been in short supply for some six months, is once again available in two common, lower doses, according to the U.S. Food and Drug Administration’s drug shortage database. A third higher dose will maintain limited availability through the end of the month.
Medtronic and NVIDIA announce medical device collaboration
March 22, 2023 / Medtronic / NVIDIA / Medical Devices
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.
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.”
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
Patient groups balk at former AstraZeneca official negotiating U.K.-India free trade deal
March 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.