// Biotech and Pharma Therapeutics
UKRI awards three projects £25m for vaccine development
October 13, 2023 / UKRI / Vaccine Development
The projects aim to build understanding of viruses and how the immune system reacts to different challenges, as well as inform the development of new, broader and longer-lasting vaccines. The funding for the projects is part of one of five of the UKRI’s strategic themes, as part of its £185m-funded five-year strategy, ‘Transforming tomorrow together 2022 to 2027’.
The Ozempic Effect Is Coming for Everything From Kidney to Heart Disease Treatments
October 18, 2023 / Ozempic / GLP-1 Receptors
Recent studies have started to illuminate the far-reaching benefits of Ozempic and other medicines in the same class, known as GLP-1 receptor agonists. The drugs appear to have a protective effect on the heart, liver and kidneys in addition to helping people lose weight, which in itself reduces the risk of many ailments. There’s also reason to believe GLP-1s could help combat substance abuse or even Alzheimer’s disease.
GE HealthCare gets $44M to create AI for mass casualty event preparedness
October 16, 2023 / GE HealthCare / AI / MedTech
GE HealthCare announced it signed a $44 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop AI-enabled point-of-care ultrasound technology to help clinicians diagnose and treat lung pathologies and traumatic injuries to the head, chest and abdomen.
Can Psychedelic-Assisted Therapy Be Used for Prevention?
October 17, 2023 / Mental Health / Psychedelic-assisted therapy
Psychedelic-assisted therapy has been cited as a breakthrough in the mental health space, mainly for severe conditions when all other options haven’t been successful. But can it be used to prevent these severe conditions from happening? There’s potential, but more research needs to be done, one expert said.
Lilly links up European ADC network, snagging Elahere rival in latest biotech buy
October 19, 2023 / Elli Lilly / Antibody-drug Conjugates / Mergers and Acquisitions / Solid Tumor
Eli Lilly is hoovering up European antibody-drug conjugate (ADC) startups. Months after making a move for Emergence Therapeutics, Lilly has struck a deal to buy one of its partners, Mablink Bioscience, to add more ADC technology and drug candidates to its portfolio.
// 4th Industrial Revolution
Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients
October 16, 2023 / Microsoft / Healthcare / AI / Patients
Microsoft rolled out several AI tools at the HLTH conference last week to enable providers to harness the power of data to be more efficient in their care delivery efforts. The overarching goal is to reduce costs, burnout and improve outcomes. Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly, to patients.
Microsoft adds Cloud for Healthcare data and AI enhancements
October 13, 2023 / Microsoft / Healthcare / Azure / AI
New tools announced this week enable Microsoft Cloud for Healthcare users to access, analyze and visualize data-driven insights across their organization through Fabric architecture, find multilingual support for text analytics, and leverage three new artificial intelligence models in Azure.
4 ways to usher in ‘smooth scaling’ of generative AI
October 19, 2023 / AI / Healthcare / MIT
When it comes to embracing generative AI, healthcare is something of a straggler. Some 89% of organizations in pharma/healthcare have neither deployed nor experimented with the technology.
AI Pain Recognition Tool Detects Pain Before, During and After Surgery
October 18, 2023 / AI / Pain Recognition / Healthcare / Automation
Researchers presenting at the ANESTHESIOLOGY 2023 annual meeting demonstrated that an automated pain recognition system leveraging artificial intelligence (AI) may be capable of detecting pain in patients before, during, and after surgery.
Brainomix, Nanoflex Robotics partner to create AI robotics platform for stroke
October 13, 2023 / Brainomix / Nanoflex / AI / Stroke / Patient Care / MedTech
British medtech company Brainomix and Switzerland-based remote robotic surgical company Nanoflex Robotics announced the receipt of £400,000 ($420,418) and CHF 400,000 ($443,700), respectively, to codevelop an AI-assisted magnetic navigation system for stroke-related robotic surgical tools.
// Business & Markets
Pfizer to cut costs, lay off staff on waning demand for COVID products
October 13, 2023 / Pfizer / Covid / Lay-offs / Paxlovid
The bulk of that adjustment is due to the return by the U.S. government of nearly 8 million treatment courses of Paxlovid labeled under the drug’s emergency clearance. Distribution of that product will be stopped in November as Pfizer shifts to selling Paxlovid commercially, which it now expects to begin on a wide scale in January. The antiviral treatment won full U.S. approval in May.
Midi Health partners with health system for women’s midlife care
October 18, 2023 / Midi Health / Health Systems / Women’s Health
California-based Midi Health, a virtual care clinic for women 40 years and above, has partnered with Houston-based Memorial Hermann Health System to expand access to care for perimenopausal and menopausal women.
How to Pay for Million-Dollar Cures
October 15, 2023 / Gene Therapies / Sickle Cell / Healthcare / Genetic Disorders
LaShaundra Carter spent the first three decades of her life defying the odds. When she was 5, a doctor delivered the news that she might not make it to 12. When she turned 12, her family was told that 16 might be out of reach. Then it was 21. Then it was that she shouldn’t have children.
Nkarta stock soars 112% after FDA clears cell therapy to go beyond cancer into lupus
October 18, 2023 / Nkarta / Cell & Gene Therapy / Lupus / Autoimmune Disease
Nkarta wants cell therapy to go beyond cancer and has been given the FDA green light to move forward with a CAR NK candidate in human trials for lupus—news that sent the company’s stock soaring 112%.
Abbott says market overestimating sales hit from new diabetes drugs
October 18, 2023 / Abbott / Diabetes / New Drug
Abbott Laboratories (ABT.N) said the market was overestimating the hit to sales of its glucose monitoring products from growing popularity of new diabetes drugs, adding the treatments could end up boosting sales of the medical device maker.
// Legal & Regulatory
Intellia gets FDA OK to begin first phase 3 trial of an in vivo CRISPR-based therapy in the US
October 18, 2023 / Intellia Therapeutics / Regeneron Pharmaceuticals / CRISPR / CRISPR-Cas9
Intellia Therapeutics has received the green light to study its in vivo CRISPR-based gene editing therapy in the U.S., positioning it to start a phase 3 trial of the Regeneron-partnered candidate by the end of the year.
FDA Approves UCB’s Complement Inhibitor for Generalized Myasthenia Gravis
October 18, 2023 / FDA / Zilbrysq / Healthcare
The FDA on Tuesday approved UCB’s zilucoplan, now to be marketed under the brand name Zilbrysq, for the treatment of generalized myasthenia gravis in patients who are positive for antibodies against the acetylcholine receptor.
BrainStorm eyes FDA meeting to find path for rejected ALS drug after withdrawing application
October 18, 2023 / BrainStorm Cell Therapeutics / Amyotrophic Lateral Sclerosis / FDA / Fierce Biotech
Almost a month after FDA advisers delivered a near-unanimous rejection of BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis (ALS) drug, the biotech is looking to sit down with the regulator to map out next steps.
After long journey, Ardelyx gets FDA OK for kidney disease drug
October 18, 2023 / FDA / Kidney Disease Drug / Xphozah
Typically, an FDA rejection is the end of the regulatory road for an experimental drug. With Tuesday’s approval of Xphozah, Ardelyx is the rare company to overcome such a hurdle, some two years after it received a complete response letter from the agency in July 2021.
WHO releases key regulatory considerations on AI for health
October 19, 2023 / WHO / AI / Regulations
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the safety and effectiveness of AI systems.
// Research & Development
UCL study suggests changes to improve MRI scans for prostate cancer
October 16, 2023 / UCL / Prostate Cancer / MRI Scans
Researchers from University College London (UCL) and UCL Hospitals NHS Foundation Trust (UCLH) have identified simple ways to improve the quality of magnetic resonance imaging (MRI) scans for prostate cancer screening.
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma
October 18, 2023 / Ultimovacs / Cancer Vaccine
Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. The addition of the vaccine added no toxicities to patients. The trial included 118 patients randomized 1:1 into the two treatment arms.
Thousands of programmable DNA-cutters found in algae, snails, and other organisms
October 13, 2023 / RNA / Enzymes / Fanzors / Eukaryotic Organisms
A diverse set of species, from snails to algae to amoebas, make programmable DNA-cutting enzymes called Fanzors — and a new study from scientists at MIT’s McGovern Institute for Brain Research has identified thousands of them. Fanzors are RNA-guided enzymes that can be programmed to cut DNA at specific sites, much like the bacterial enzymes that power the widely used gene-editing system known as CRISPR.
Roche Claims ‘Unprecedented’ Phase III NSCLC Victory for Oral TKI Alecensa
October 19, 2023 / Roche / TKI Inhibitory / Cancer
Roche‘s Genentech on Wednesday revealed results from the Phase III ALINA study, showing that its oral TKI inhibitor Alecensa (alectinib) met the study’s primary endpoint of disease-free survival in patients with a specific type of non-small cell lung cancer.
Roche drops oral eye disease drug after completing phase 2, pulls back from solid tumor bispecific
October 19, 2023 / Roche / Eye Disease / Diabetic Retinopathy / Bispecific Antibodies
Roche’s vision of developing an oral diabetic retinopathy treatment has taken a hit, with the drugmaker stopping development of vicasinabin after completing phase 2. The CB2 agonist was discarded (PDF) as part of a cull that also saw Roche pull back from its CEAxCD3 bispecific candidate cibisatamab.
// Politics
Insurers bash Biden’s mental health parity proposal
October 18, 2023 / Insurers / Biden / Mental Health
Insurers and some employers contend the Biden administration’s recent proposal to bolster coverage of mental and behavioral care could actually backfire and make it more difficult for patients to access quality care.
As Adderall shortage enters 2nd year, lawmakers press FDA and DEA for update
October 13, 2023 / Adderall / Congress / Drug Shortage / FDA
As the nationwide shortage of Adderall and other meds for attention-deficit/hyperactivity disorder (ADHD) drags on, several members of Congress are pushing for more transparency and urgency from regulators on their mitigation efforts.
CMS wants Part D plans to be on their best behavior
October 13, 2023 / CMS / Medicare
How to rebuild trust in science: NIH director nominee fields questions
October 19, 2023 / NIH / US Senators / Biden
Monica Bertagnolli, US President Joe Biden’s pick to lead the National Institutes of Health (NIH), hinted today during a long-awaited Senate committee hearing at what her priorities will be for the biomedical agency if she is confirmed. At the top of the list is improving the diversity of clinical-trial participants, enhancing collaboration among the NIH’s 27 institutes and centres and restoring public trust in scientists and the agency.
This Healthcare Reform Could Finally Bring Democrats And Republicans Together
October 16, 2023 / Healthcare / Bipartisan
So what about a healthcare policy that would encourage individuals to shop around for coverage that meets their needs but would also enroll more people in Obamacare’s exchanges? Perhaps that would attract support from Republicans and Democrats alike?