// Biotech and Pharma Therapeutics
Tome Biosciences debuts with $213M and a new way to edit the genome
December 12, 2023 / Tome Biosciences / Gene Editing / DNA / Startup
Biotechnology startup Tome Biosciences emerged from stealth on Tuesday with $213 million in venture funding to develop a new gene editing technology it believes can overcome some of the limitations of existing methods.
Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients
December 19, 2023 / Gene Therapy / Cystic Fibrosis / Gene Therapy
Thanks to simultaneous achievements in gene therapy and medicine delivery platforms, new solutions to intractable problems are bringing us to a real watershed moment in the treatment of respiratory disease. This synchronicity of science and tech advancements is no accident; along with colleagues in my own and other organizations, I have been working for the past several years on the medical and technological leaps that together signal hope for respiratory-disease patients with unmet need.
Barinthus’ new mission gets $35M booster from CEPI funding to develop MERS shot
December 21, 2023 / Barinthus Biotherapeutics / Middle East Respiratory Syndrome / Coronaviruses / CEPI
Barinthus Biotherapeutics, formerly known as Vaccitech, is getting a shot in the arm thanks to $34.8 million in funding to develop a Middle East respiratory syndrome (MERS) vaccine.
GSK Inks Potential $1.7B ADC Deal with China’s Hansoh Pharma
December 20, 2023 / GSK / Hansoh Pharma / Anti-body Drug
Aclaris lays off 46% of staff, resurrects zunsemetinib as potential cancer treatment
December 20, 2023 / Aclaris Therapeutics / Layoffs / JAK Inhibitors / Ulcerative Colitis
The Pennsylvania-based company is reducing its headcount by around 46%, with the changes to begin “immediately” and likely to be completed by the end of June next year. The company entered 2023 with 100 full-time employees, all of whom were based in the U.S.
// 4th Industrial Revolution
Wearable technology to be offered to thousands with type 1 diabetes in UK
December 21, 2023 / Diabetes / UK / Wearable Tech
The National Institute for Health and Care Excellence (NICE) has published final guidance announcing a five-year roll-out of a wearable technology for patients living with type 1 diabetes.
AI scaling and sustainability – tips for success from providers, payers and vendors
December 18, 2023 / AI / Healthcare / Digital Health / Clinical Trials
A common theme at the HIMSS AI in Healthcare Forum this past week was that artificial intelligence represents a new paradigm shift for how care is delivered (and paid for) and that with such a fast-emerging technology, we’re all figuring it out together.
Japanese demand for digital hospital tech starting to pick up
December 18, 2023 / Telehealth / New Tech / Japan / Digital Health
Until 2022, Japanese hospitals had been slow to adopt digital health solutions, such as EMR, likely due to high costs and low digital literacy among older doctors. In the coming years, they are expected to take up more technologies with available budget to cover demand among staff.
The AI Tool that Matters Most for Clinical Care Isn’t ChatGPT
December 21, 2023 / AI / Digital Health / Healthcare
The excitement for artificial intelligence (AI) use cases in healthcare—especially those involving generative AI and ChatGPT—is palpable, with experts predicting generative AI could help unlock $1 trillion in healthcare savings. However the AI solution that holds the strongest potential to strengthen care outcomes and health equity isn’t the one healthcare leaders think of first.
Patients Crave Conversational Texting, Frustrated by Simplistic Healthcare Communication
December 13, 2023 / NIST / AI / Privacy
A new survey by Artera, a leader in patient communication technology, reveals a stark disconnect between how healthcare providers communicate and what patients actually want.
// Business & Markets
3 Ways To Cut Employer Costs in Auto Immune Diseases And Promote Long-Term Employee Health
December 20, 2023 / Auto Immune Disease / Employees
The recent explosion of buzzy (and expensive) weight-loss drugs like Ozempic has many employers worried about the potential price tags associated with covering the costs. As they should be: employer health care spend is currently rising at the steepest rate seen in years.
Lilly tames Fauna to go on the prowl for obesity targets in $494M deal
December 21, 2023 / Eli Lilly / Obesity / Deals
Biogen holds onto Tecfidera market in Europe for a little longer
December 19, 2023 / Biogen / Europe / Tecfidera / Drug Approvals
The European Commission has revoked the approvals for five generic versions of Biogen’s multiple sclerosis medicine Tecfidera, ensuring the once top-selling drug’s market position there is maintained through early 2025.
Patients Regain Weight After They Quit Using Ozempic Rival Zepbound. Here’s Why That Makes Eli Lilly Stock an Even Better Buy.
December 16, 2023 / Ozempic / Eli Lilly / Weight Loss
AI-Enabled Prescription Digital Therapeutics Should Be An Investment Priority
December 17, 2023 / AI / Investment / Medical Devices
// Legal & Regulatory
Merck gets FDA decision date for new pneumococcal vaccine
December 19, 2023 / Merck / FDA / Vaccine
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent
December 19, 2023 / CureVac / BioNTech / Comirnaty
The German Federal Patent Court ruled that one of eight CureVac patents involved in the litigation is invalid, the company said in a Tuesday release. The patent in question covers a process that improves the expression of mRNA in cells, Juve Patent reports.
HIPAA Enforcement is Changing. Providers Must Too.
December 20, 2023 / HIPAA / Healthcare
Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time
December 21, 2023 / Merck / FDA Approval / Chronic Cough
In a Complete Response Letter issued Wednesday, the FDA said that Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness” for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The regulator did not point to safety issues related to the drug candidate.
Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo
December 20, 2023 / FDA / Calliditas / Immunoglobulin / Kidney Disease / Tarpeyo
Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has scored a full FDA endorsement for the oral, delayed-release drug.
// Research & Development
Sanofi’s oncology strategy suffers another blow as ADC scrapped over phase 3 lung cancer fail
December 21, 2023 / Sanofi / Oncology / Antibody Drug Conjugates / Failed Trials / Clinical Data
Sanofi’s cancer strategy has suffered a major blow as the French Big Pharma jettisoned its only clinical-stage antibody-drug conjugate (ADC) after it failed to beat chemotherapy in a phase 3 trial of lung cancer patients.
Roche, Novartis move Xolair closer to FDA finish line for food allergies
December 19, 2023 / Roche / Peanut Allergy / Xolair / Genentech
On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes.
Argenx autoimmune drug study fails in blow to expansion hopes
December 20, 2023 / Argenx / Auto Immune / Failed Trials
The latest study, called Address, showed no significant benefit for Argenx’s Vyvgart Hytrulo in people with two forms of an autoimmune skin disease called pemphigus. The condition causes painful blisters that can break open and leave patients at risk of infection.
‘Explainable’ AI discovers new class of antibiotics that stop MRSA in mice
December 20, 2023 / Antibiotics / AI / Drug Discovery / MIT
Carina Biotech Doses First Patient in Phase 1/2a Clinical Trial of LGR5-Targeted CAR-T Cell Therapy
December 18, 2023 / Carina / Clinical Trial / Cell Therapy
Carina Biotech Limited (Carina), a cell therapy immuno-oncology company, today announced the dosing of the first patient in a Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 for the treatment of adult patients with metastatic colorectal cancer (mCRC). Enrolment in the Phase 1 segment commenced in Australia with three sites currently activated.
// Politics
White House gets pledges from big healthcare players on AI safety and ethics
December 14, 2023 / White House / AI / Healthcare
Tennessee company in battle with European regulators over weight-loss drug
December 18, 2023 / Weight-Loss / Currax
Currax’s drug is marketed as Contrave in the U.S. and Mysimba in Europe, receiving FDA and European Medicines Agency approvals in 2014. The U.S. is a much larger market for Currax than is Europe, although the company still claims more than 400,000 Mysimba prescriptions were written last year. The company argues that its orally-administered drug is focused on helping “emotional eaters,” whereas GLP-1 medicines like Ozempic and Wegovy are about satiating “hungry gut.”
In 2023, opioid settlement funds flowed to states. Here’s how it’s going
December 21, 2023 / Supreme Court / OxyContin / Opioid / Settlement
In 2023, state and local government received about $1.5 billion in settlement funds from more than a dozen companies that manufactured, sold, or distributed prescription painkillers and were sued for their role in fueling the opioid crisis.
Democrats haunted by past support for signature Biden law as seniors face ‘dramatic rise’ in Medicare costs
December 19, 2023 / Biden / Medicare
A number of Democrats facing tough reelection fights next year are being haunted by their past support for one of President Biden’s signature pieces of legislation that experts say is causing a “dramatic rise” in Medicare costs for seniors.
OxyContin, murder when you’re not at the scene, and stigmatize hard drugs | Readings
December 18, 2023 / OxyContin / Opioids
We live in a partisan age, and our news habits can reinforce our own perspectives. Consider this an effort to broaden our collective outlook with essays beyond the range of our typical selections.