// Biotech and Pharma Therapeutics

Moderna reveals Claudin18.2 ambitions via cancer vaccine, solid tumor CAR-T combo plans
August 21, 2023 / Moderna / CARsgen Therapeutics / Cancer Vaccine / mRNA –
That sounds like the plan, according to CARsgen Therapeutics. The Chinese biotech is developing CT041, also known as satricabtagene autoleucel, as a Claudin18.2-focused CAR-T for the potential treatment of gastric, pancreatic and other digestive system cancers. Despite being an autologous—as opposed to an allogeneic or “off-the-shelf” therapy—the Shanghai-based company claims that CT041 is the “most advanced solid tumor CAR-T in development” on account of it having entered a “pivotal” phase 2 trial. Read Full Article on Fierce Biotech >>
Fulcrum’s sickle cell disease program is back in business after FDA lifts 6-month hold
August 22, 2023 / Fulcrum Therapeutics / Sickle Cell Disease / Clinical hold / FDA – The regulator instigated the full clinical hold on the therapy, dubbed FDX-6058, back in February. Details were sparse at the time, with Fulcrum only able to say that the hold was initiated due to previously reported preclinical data. Read Full Article on Fierce Biotech >>
Apellis flags needle problems in hunt for Syfovre side effect source
August 23, 2023 / Apellis Pharmaceuticals / Syfovre / Side Effects / Drug Safety – Apellis has discovered “variations” in the 19-gauge filter needle included in certain Syfovre injection kits. Filter needles are used to withdraw the therapeutic from the vial when preparing for an injection, the company explained in a press release. Apellis stressed that a “causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.” Read Full Article on Fierce Pharma >>
Andreessen Co-Leads $200 Million Investment in Biotech Startup Genesis Therapeutics
August 21, 2023 / Startup / Genesis Therapeutics / Clinical Trials – Venture firm Andreessen Horowitz has co-led a $200 million investment in Genesis Therapeutics, a biotechnology startup that uses artificial intelligence to discover medicines against molecular targets that have thwarted drugmakers. Read Full Article on Wall Street Journal >>
Redwire and Sierra Space partner on commercial space station biotech research platform
August 21, 2023 / Redwire / Sierra Space – The two companies announced Aug. 21 that Redwire will provide a set of equipment that will be installed on a Sierra Space inflatable module known as Large Integrated Flexible Environment (LIFE). That “pathfinder” module will be launched later this decade for commercial pharmaceutical and other biotech research. Read Full Article on Space News >>

// 4th Industrial Revolution

Deep Learning-Based Electrocardiogram Screening Detects Heart Defects
August 22, 2023 / Electrocardiogram / Heart Defects / Deep Learning – Researchers from Brigham and Women’s Hospital and Keio University in Japan have developed a deep learning (DL) model capable of screening electrocardiograms (ECGs) for signs of atrial septal defects (ASD), according to a study published last week in eClinicalMedicine. Read Full Article on Health IT Analytics >>
SpaceX astronauts embark on expedition to research reversing immune system aging
August 23, 2023 / SpaceX / Immune System Aging / ISS National Laboratory – Among the various studies, researchers from the University of California San Francisco will perform tissue chip investigations to better understand the correlation between liver regeneration and immune aging to find new ways of improving the liver healing process. Read Full Article on Mobi Health News >>
Epic, Microsoft, Nuance Expands Partnership to Accelerate Generative AI
August 22, 2023 / Epic / Microsoft / AI / Nuance – Epic and Microsoft’s expanded collaboration will build upon our recently announced integrations, including Azure OpenAI Service into Epic’s EHR to automatically draft message responses, as well as a solution that will bring natural language queries and interactive data analysis to SlicerDicer, Epic’s self-service reporting tool. Microsoft and Nuance also recently collaborated to integrate Nuance® Dragon® Ambient eXperience™ Express (DAX Express™) solution into the Epic platform with a comprehensive approach to incorporating a broader array of AI-powered capabilities for clinical and administrative users. Read Full Article on HIT Consultant >>
AI NLP models extract SDOH data from clinical notes
August 23, 2023 / AI NLP / Clinical Notes / SDOH / Regenstrief Institute / Indiana University – The NLP system developed by the research team can “read” and identify keywords or phrases indicating housing or financial needs (for example, a lack of a permanent address) and deliver highly accurate performance, the institutions reported. Read Full Article on Healthcare IT News >>
AI (Software & Service Providers) in the Global Clinical Trials Market, 2023-2035: Oncological Disorders Likely to Be the Primary Target Therapeutic Area
August 21, 2023 / AI / Clinical Trials / Oncology – The global AI in clinical trials market is projected to grow from $1.4 billion in 2023 at a compounded annual growth rate (CAGR) of 16% during the forecast period (2023-2035). The drug development process is time and cost-intensive, with clinical trials accounting for nearly 50% of the time and capital expenditure. The success rate of drug candidates advancing through clinical trials to marketing approval has remained relatively constant at 10%-20% over the past few decades. To address challenges such as inadequate study design, patient recruitment issues, and high attrition rates, the pharmaceutical industry is exploring innovative solutions, and AI integration in drug development, particularly in clinical trials, is gaining traction. Read Full Article on Business Wire >>

// Business & Markets

J&J-backed startup raises another $150M for brain drug development
August 23, 2023 / Johnson & Johnson / Drug Development / Rapport Therapeutics – Rapport’s work revolves around “RAPs,” or receptor-associated proteins. These proteins, unlike other kinds, are local to specific areas of the brain and central nervous system. By targeting RAPs, Rapport believes it can create precision drugs that are either more effective or safer than other treatment options. Read Full Article on Biopharma Dive >>
Moderna Surges On A Second, Unexpected Shot At The Cancer Vaccine Market
August 21, 2023 / Moderna / Vaccines / Cancer – The move gives Moderna a second stab at cancer vaccines. The company is partnered with Merck (MRK) on a bespoke vaccine for patients who’ve had their melanoma surgically removed. It’s also developing a cancer vaccine “off the shelf,” meaning the drug won’t be tailored to each individual patient. Read Full Article on Investors >>
Teva, Glenmark To Pay $255M, Divest Cholesterol Drug to Settle DOJ Price Fixing Charges
August 22, 2023 / Teva / Cholesterol Drug / DOJ Price / Drugmakers- On Monday, Teva Pharmaceuticals and Glenmark Pharmaceuticals became the sixth and seventh drugmakers to resolve criminal charges as a result of the Department of Justice’s yearslong investigation into generic drug price fixing. The settlement agreement requires both companies to pay hefty fines as well as divest their drug lines for pravastatin, a widely used statin that lowers cholesterol. Read Full Article on Med City News >>
Venture firm Questa Capital scores $397M to invest in health technology
August 24, 2023 / Venture firm / Questa Capital Scores / Health Tech – The firm will use the capital to invest in 10 to 14 early-stage companies in the healthcare services, medical device and technology sectors. It will continue to blend elements of growth equity with venture capital, and said it will fund companies working in many of the same focus areas as its prior investments. Read Full Article on Mobi Health News >>
As the obesity drug market grows, digital health companies juggle patients and payers
August 21, 2023 / Obesity / Digital Health / Payers / Patients – Payers are reeling as they try to figure out how to sustainably cover GLP-1 receptor agonists, a class of remarkably effective but expensive obesity and type 2 diabetes drugs. So in the last six months, digital health companies including Teladoc, Found, Hello Alpha, and Calibrate have advanced enterprise products that pair virtual visits and prescriptions with lifestyle coaching. Their hope is that more and more payers and employers will offer their programs as a way to support lasting weight loss and metabolic health — or even require them if patients want their drugs reimbursed. Read Full Article on STAT News >>

// Legal & Regulatory

FDA greenlights medical device to combat bladder issues
August 22, 2023 / FDA / Medical Device / BlueWind Medical – Overactive bladder can be a debilitating condition — but those affected now have a new treatment option. Last week, the FDA authorized a small ankle implant with an accompanying wearable that provides stimulation, both built by BlueWind Medical. The stimulation, called tibial neuromodulation, blocks abnormal nerve signals around the bladder. Read on STAT News >>
FDA expands use of Neurocrine drug to Huntington’s patients
August 21, 2023 / FDA / Neurocrine Drug / Patients / Teva – Ingrezza should help address an unmet need in the treatment of Huntington’s-associated chorea, according to Charles Duncan, an analyst who covers Neurocrine for the investment firm Cantor Fitzgerald. In a note to clients, Duncan wrote that in the U.S. there are about 30,000 Huntington’s patients, of which roughly 90% experience chorea. And among that group, approximately 70% have moderate-to-severe forms of the disorder. Read Full Article on Biopharma Dive >>
Insurers must cover injectable HIV prevention drug — unless courts void mandate
August 22, 2023 / HIV / Insurers / Lawsuit – A national health task force’s sterling new endorsement of a long-acting injectable medication for use as HIV prevention will require health insurers to begin covering the pricey drug by 2025. Such expanded access to the preventive therapy could lend a much-needed boost to the country’s relatively anemic efforts to thwart the HIV epidemic. Read Full Article on NBC >>
Boehringer Ingelheim Joins Legal Battle Against IRA Drug Pricing Provisions
August 22, 2023 / Boehringer Ingelheim / IRA / Drug Pricing – Boehringer Ingelheim on Friday sued the U.S. government in an attempt to block the Inflation Reduction Act’s drug price negotiation program. The complaint, filed in a Connecticut district court, alleges that the Medicare negotiation program violates the U.S. Constitution’s Fifth Amendment right to due process and just compensation. Boehringer Ingelheim also claims that the program forces pharmaceutical companies to agree that the government’s negotiated prices are fair, thereby breaching the First Amendment. Read on Biospace >>
FDA approves first RSV vaccine given to pregnant mothers to protect babies
August 21, 2023 / FDA / Women’s Health / RSV Vaccine –The Food and Drug Administration on Monday approved a vaccine that is administered to pregnant people to protect their babies from RSV, or respiratory syncytial virus, through their first six months. The single-dose shot, made by Pfizer, spurs the production of protective antibodies that transfer from mother to infant through the placenta. It’s the first vaccine that can protect babies from RSV, which causes a lower respiratory illness that can be severe in infants. Read on NBC News >>

// Research & Development

Novavax’s Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6
August 22, 2023 / Novavax / Covid Vaccine – “Our data have shown that Novavax’s protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6,” said Filip Dubovsky, President of Research and Development, Novavax. “We have a lot of confidence in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall.” Read Full Article on Biospace >>
The first complete sequence of Y chromosome offers chance to solve longstanding genetic mysteries
August 23, 2023 / Genetic Mysteries / Y Chromosome – Two years ago, when an international team of scientists announced it had finally sequenced and assembled the first fully complete human genome, including previously unmappable regions, Melissa Wilson was ecstatic. She reached out to Adam Phillippy, a researcher at the National Institutes of Health and a leader of the Telomere-to-Telomere Consortium to congratulate him on the accomplishment. And to ask the question she was almost too excited to utter: “And the Y?” Read Full Article on STAT News >>
Ultimovacs mulls alternative ways to end phase 2 cancer trial as wait for survival data drags on
August 22, 2023 / Melanoma / Opdivo / Yervoy / Survival Time – The long, ever-extending wait for midphase melanoma data is driving Ultimovacs to weigh its options. After slow disease progression drove another delay, the Norwegian biotech revealed it will explore alternative data readout approaches if the event-driven trial continues to advance sluggishly. Read Full Article on Fierce Biotech >>
Foundery, a new biotech venture firm, sets out to speed early immune drug research
August 22, 2023 / Foundery / Immunology – Foundery bills itself as a “venture studio.” Unlike more traditional venture firms that form and fund biotech companies, its focus is earlier, helping academic researchers overcome the roadblocks they can often face advancing scientific discoveries. This “valley of death,” as it’s called, can stymie the progress of medical research before a drugmaker or venture investor will buy in. Read Full Article on Biopharma Dive >>
Alabama launches new bioscience technician workforce development program
August 22, 2023 / Alabama / Workforce Development – The new workforce development program comes on the heels of Ivey’s calls to shift focus to improve the state’s labor participation rate, which, unlike the unemployment rate which measures the number of unemployed adults seeking work, measures all unemployed adults. While Alabama’s unemployment rate in July was a record-low of 2.1%, the labor participation rate was 57%, among the highest in the country. Read Full Article on Alabama Daily News >>

// Politics

Novo Nordisk boosts lobbying as it seeks Medicare coverage for obesity drugs
August 22, 2023 / Novo Nordisk / Obesity Drugs / Medicare – Novo Nordisk, the maker of the weight loss drug Wegovy and diabetes medication Ozempic, went on a federal lobbying spending spree in the first six months of 2023. The Danish drugmaker is pushing Congress to pass a bill that would nix Medicare restrictions on covering weight management treatments. Novo Nordisk has hired three new lobbying firms over the past three months, all of which disclosed being solely focused on issues related to obesity and Medicare coverage of anti-obesity drugs.Read Full Article on Fox 40 >>
What you should know about the Mexico-US litigation
August 22, 2023 / Mexico / US / Litigation – Faced with this disagreement, the United States wants to take the case to a dispute resolution body, a figure agreed in the renewed TMEC. Mexico produces the vast majority of white corn, but in recent years has intensified a campaign to increase the planting of yellow corn, which is used to feed livestock. This is intended to ensure that Mexico imports less grain from the USA. Read Full Article on Nation World News >>
Republicans love RFK Jr. What does that tell us about their health platforms in 2024?
August 22, 2023 / GOP / RFK Jr. / Health Platforms – Republican presidential candidates are polishing off their best barbs and attack lines for each other, President Biden and even elephant-in-the-room Donald Trump during their first debate this week. But one increasingly popular candidate isn’t likely to catch any flak. Read Full Article on Stat News >>
Boehringer Latest to Sue US Over Drug Price Negotiation Plan
August 21, 2023 / Boehringer / Drug Price / Negotiation – Boehringer Ingelheim sued the U.S. government in an attempt to block a program that gives the Medicare health insurance plan the power to negotiate lower drug prices, joining other drugmakers and business groups claiming that it would stifle development of new medicines. Read Full Article on US News >>
Why are Congress’s budget experts failing to address the rise of climate-related health care spending?
August 21, 2023 / Congress’s Budget / Healthcare / Climate Control – Beyond its role of scoring the budgetary and economic effects of proposed legislation, the Congressional Budget Office (CBO) independently publishes reports and working papers addressing more than two dozen topics intended, in part, to enhance the office’s transparency and encourage external review and comment. Under the topic of “climate and the environment,” the CBO has since 2015 published nine reports, the two most recent from last December addressing transportation and electric power sector greenhouse gas (GHG) emissions. Read Full Article on The Hill >>