// Biotech and Pharma Therapeutics

ProQR draws line under its eye disease era, offloading 2 assets to Théa for $14M upfront
August 1, 2023 / ProQR Therapeutics / Eye Disease / Asset Sale / Ophthalmology – ProQR Therapeutics has found a buyer for its ophthalmology assets. One year after putting the programs up for sale, the Dutch biotech has offloaded sepofarsen and ultevursen to Laboratoires Théa for 12.5 million euros ($13.7 million) upfront. Read Full Article on Fierce Biotech >>
Bio Startup Tisento Launches With $81M and a Brain-Penetrating Drug in the Clinic
July 31, 2023 / Tisento / Startup / Cyclerion Drug – Cyclerion Therapeutics had taken its lead drug candidate into the clinic, obtaining encouraging data in a rare disease. But the company was running out of cash to support that program and others in its pipeline. A key Cyclerion financial backer stepped in with a deal to acquire that asset and continue its development in a new biotech company. Read Full Article on Med City News >>
Average Healthcare Data Breach Cost Reaches Nearly $11M
July 31, 2023 / Healthcare / Data Breach – Healthcare continues to have the highest data breach costs of all industries, according to a new report from IBM. It revealed that the average cost of a healthcare data breach is now $10.93 million — up from $10.10 million in 2022. Read Full Article on Med City News >>
With OTC birth control approved, access battles have just begun
July 31, 2023 / Women’s Health / OTC Birth Control / FDA Approval / Over the Counter – As a leader at the Paris-based HRA Pharma and now global vice president of women’s health at its parent company Perrigo, Welgryn has worked with U.S. regulators for close to a decade to move the progestin-only Opill onto drugstore shelves. Read Full Article on Biopharma Dive >>
Enhancing Patient Adherence & Improving Treatment Outcomes
August 1, 2023 / Patients / Healthcare – Patients seeking healthcare for their ailments often receive detailed treatment plans tailored to their individual needs. However, the efficacy of these treatment plans relies heavily on patient adherence. Unfortunately, research indicates that only about half of the patients adhere to their prescribed treatments consistently and correctly. This surprising statistic reveals a significant problem in our healthcare system, especially for those with chronic conditions requiring ongoing treatments. Read Full Article on Healthcare It Today >>

// 4th Industrial Revolution

Revolutionizing Biotech and Pharmaceutical R&D by Advancing the PEG Product Supply Chain
July 28, 2023 / PEG Product / Supply Chain / R&D – The newly expanded PEG product catalog ranges from crosslinkers made of branched polyethylene glycol, various derivatives derived from linear methoxy polyethylene glycol with diverse structural and functional characteristics, and multi-arm PEGs with a wide range of molecular weights. Committed to quality, the company ensures that each product exhibits high purity, low polydispersity, and high reactivity levels. Read Full Article on Biopharma Dive >>
Harnessing Generative AI for Advancements in Pharma R&D Value Chain
August 1, 2023 / AI / Healthcare / R&D / Drug Development – Pharmaceutical companies are embracing the revolutionary potential of artificial intelligence (AI), to traverse complex regulatory regimes and efficiently handle industry concerns. The latest developments in the field of Generative AI, a sub field of AI, are fueling even more possibilities in the pharmaceutical Research and Development (R&D) value chain. Generative AI has the potential to speed drug development, optimise clinical trials, and revolutionize personalized medicine by leveraging powerful algorithms and deep learning techniques. Read Full Article on ET Health World >>
OpenAI, Google, Microsoft, Anthropic create forum to ensure responsible AI development
July 31, 2023 / OpenAI / Google / Microsoft / AI Development – The partners are looking for organizations to join the Forum as members. The members must develop and deploy frontier models, show commitment to frontier model safety, and be willing to contribute to advancing the Forum’s efforts. Read Full Article on Mobi Health News >>
Amazon expands telehealth clinic nationwide
August 1, 2023 / Amazon / Telehealth – Amazon has expanded its direct-to-consumer telehealth operation, Amazon Clinic, announcing today that the service is available in all 50 states. True to Amazon’s origins, Clinic is billed as a “virtual health care marketplace” — a place where patients can comparison shop for telehealth visits for discrete conditions, from pink eye to vaginal dryness. When the service launched last November, it had signed up two provider networks for patients to choose from; now that list has expanded to include Curai, Hello Alpha, SteadyMD, and Wheel. Blurring the line between patient and consumer even more: Clinic now also offers users the option to choose between text and video visits — usually, with text at a discount. Read Full Article on STAT News >>
Microsoft strikes partnership with Duke Health to advance AI in medicine
August 1, 2023 / Duke Health / Microsoft / Coalition for Health AI – On Tuesday, Duke Health and Microsoft announced a five-year partnership that will support artificial intelligence applications in medicine, with a focus on building out infrastructure such as cloud-based data platforms. Read Full Article on STAT News >>

// Business & Markets

Femtech: HerMD Raises $18M to Transform Women’s Healthcare
July 31, 2023 / Women’s Health / Healthcare / Femtech / HerMD – HerMD offers comprehensive women’s healthcare under one umbrella via in-person and virtual care offerings, with an emphasis on menopause and sexual healthcare. All appointments last between 20 and 60 minutes and all medical services are insurance and Medicare based. HerMD also prioritizes the provider experience, which is crucial when it comes to addressing the failings of the existing healthcare system. Read Full Article on HIT Consultant >>
Pfizer Misses on Q2 Revenue as COVID-19 Sales Tank, Narrows 2023 Forecast
August 1, 2023 / Pfizer / Q2 – Pfizer’s second-quarter report Tuesday revealed it brought in revenue lower than forecasted as COVID-related sales plummeted more than expected. Looking ahead, the company trimmed the top end of its 2023 revenue range by $1 billion. Read Full Article on BioSpace >>
How the prescription drug supply chain is killing local pharmacies
July 28, 2023 / Supply Chain / Local Pharmacies / Legislatures / Drug Prices – The supply chain that brings pharmaceutical drugs from the factory to the pharmacy is long, complex and unclear. Congress and several state legislatures have proposed or enacted laws to bring more transparency and curb soaring drug prices. As special correspondent Fred de Sam Lazaro reports, many small or independent pharmacies complain the system also hurts them. Read Full Article on PBS >>
MyMD enjoys stock bump as drug shows promise against age-related inflammation in phase 2 trial
July 31, 2023 / Chronic Inflammation / Sarcopenia – The study aimed to enroll 40 participants aged 65 years and older with chronic inflammation associated with sarcopenia—a term for the age-related progressive loss of muscle mass and strength. Over 28 days, they received weekly doses of either 600 mg, 750 mg, 900 mg or 1050 mg of the TNF-α inhibitor, dubbed MYMD-1, or placebo. Read Full Article on Fierce Biotech >>
Revolution to Buy EQRx in All-Stock Deal, Add $1B in Cash to Balance Sheet
August 1, 2023 / Revolution Medicines / EQRx – Revolution Medicines will acquire troubled Massachusetts-based biotech EQRx in an all-stock transaction that will add over $1 billion in net cash to its balance sheet, the California-based oncology company announced Tuesday. Read Full Article on BioSpace >>

// Legal & Regulatory

Henrietta Lacks’ family settles lawsuit with a biotech company that used her cells without consent
August 1, 2023 / Henrietta Lack / Lawsuit / John Hopkins Hospital – More than 70 years after doctors at Johns Hopkins Hospital took Henrietta Lacks’ cervical cells without her knowledge, a lawyer for her descendants said they have reached a settlement with a biotechnology company that they accused of reaping billions of dollars from a racist medical system. Read Full Article on ABC News >>
CDC detects coronavirus, HIV, hepatitis and herpes at unlicensed California lab
July 27, 2023 / CDC / Unlicensed California Lab / Prestige BioTech – According to court documents, city officials inspected the location at 850 I St. on March 3 for building violations and found various chemicals being stored. On March 16, an inspection by county public health officials allegedly turned up medical devices thought to have been developed on-site, such as Covid and pregnancy tests. Read Full Article on NBC News >>
Johnson & Johnson’s $8.9B talc deal in jeopardy as judge shoots down 2nd bankruptcy attempt
July 31, 2023 / Johnson & Johnson / Talc Litigation / Bankruptcy – Johnson & Johnson’s attempt to end its talc litigation with a sweeping $8.9 billion settlement didn’t pass muster at the bankruptcy court, which instead dismissed the company’s latest bankruptcy attempt.Read on Fierce Pharma >>
As opioid settlement money starts to flow in, states debate how best to use it
July 31, 2023 / Opioid Settlement – More than $50 billion in settlement funds from pharmaceutical companies that made and sold opioid painkillers will be paid out over the next 18 years to state and local governments across the country. But the debate around how this money should be spent is just beginning. Special correspondent Cat Wise and producer Mike Fritz report from North Carolina for our ongoing series, “America Addicted.” Read on PBS >>
FDA Approves Harm Reduction Therapeutics’ Over-the-Counter Opioid Overdose Reversal Medication
August 1, 2023 / Opioid Overdose / FDA / Over-the-Counter –Since 2018, Purdue has supported HRT’s mission by contributing millions of dollars, extensive technical expertise, and rights to important data to support the development of this opioid overdose reversal medication. Purdue’s support for HRT is a vital part of the Company’s Public Health Initiatives which, as important elements of its Plan of Reorganization, are intended to help abate the opioid crisis. Read on BioSpace >>

// Research & Development

Takeda’s Exkivity sputters in lung cancer trial, with accelerated approval on the line
July 31, 2023 / Takeda / Exkivity / U.S FDA / Johnson & Johnson – News of Exkivity’s Exclaim-2 trial flop comes just a few days after Johnson & Johnson said its rival drug Rybrevant has succeeded at delaying cancer progression in first-line NSCLC patients. Both drugs used tumor shrinkage data from single-arm trials to win FDA accelerated approvals in 2021 as second-line treatments for NSCLC with EGFR exon20 insertion mutations. Read Full Article on Fierce Pharma >>
Sumitomo Schizophrenia Drug Discovered With AI Tech Fails in Two Phase 3 Trials
July 31, 2023 / Sumitomo Pharma / Otsuka Pharma / Drug Discovery – Schizophrenia drugs mainly go after the same target in the brain, but drug developers are hoping to improve on the efficacy and side effect profile of such medicines by going after new targets. The prospects for one such therapy from Sumitomo Pharma are dimmer after the small molecule discovered with artificial intelligence technology failed in two Phase 3 studies. Read Full Article on Med City News >>
BridgeBio explores path forward for muscular disease drug
July 31, 2023 / BridgeBio / FDA / Muscular Dystrophy – BridgeBio Pharma anticipates it could seek accelerated approval for an experimental muscular dystrophy drug it’s developing, outlining in a statement Monday a path to U.S. regulators in the coming years. Read Full Article on Biopharma Dive >>
NIH launches long COVID clinical trials through RECOVER Initiative, opening enrollment
July 31, 2023 / NIH / Covid / Clinical Trials – Today, the National Institutes of Health launched and is opening enrollment for phase 2 clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven more treatments expected in the coming months. Treatments will include drugs, biologics, medical devices and other therapies. The trials are designed to evaluate multiple treatments simultaneously to identify more swiftly those that are effective.Read Full Article on National Institutes of Health >>
Cybin Initiates Dosing of Final Cohort of its Phase 2 Trial of CYB003 in Major Depressive Disorder
August 2, 2023 / Clinical Stage / Healthcare / Cybin Initiates – The first five cohorts, which dosed 1mg, 3mg, 8mg, 10mg, and 12mg of CYB003, have completed dosing with no serious adverse events and no subject discontinuations due to adverse events. All adverse events reported in the cohorts completed to date were mild to moderate and resolved without the need for any clinical intervention. To date, no unexpected treatment emergent adverse events have been observed. Read Full Article on BioSpace >>

// Politics

Vivek Ramaswamy wants to ‘gut’ the FDA. His claims don’t hold up to scrutiny
July 31, 2023 / Vivek Ramaswamy / FDA – These products were studied in some of the biggest approval trials I’ve ever seen, and Ramaswamy certainly knows that. There were tens of thousands of patients in each pre-approval study, with hard impacts measured on infection and for some vaccines hospitalization. Yes, this was unprecedented, but we were in a global crisis. Read Full Article on STAT News >>
Biden Administration unveils its 4-pillar national cyber workforce strategy
July 31, 2023 / Biden Administration / Cyber Workforce / White House – The White House unveiled its new National Cyber Workforce and Education Strategy on Monday. The goal is to encourage skilled cybersecurity professionals in healthcare and other industries, communicating the benefits of careers in public service to job seekers and lowering barriers associated with hiring and onboarding, according to the Office of the National Cyber Director. Read Full Article on Healthcare IT News >>
Harrell proposes $27 million for Seattle addiction treatment, drug enforcement bill
July 31, 2023 / Harrell / Seattle Addiction / New Bill – Mayor Bruce Harrell is asking Seattle City Council members who voted against adopting the state’s new drug possession and public use law to reconsider, offering a plan that includes additional treatment resources and guidelines to assuage enforcement concerns. Read Full Article on Seattle Times >>
As Medicare Turns 58, It Still Must Be Protected and Expanded
July 31, 2023 / Medicare / Healthcare – Today, life expectancy is longer and healthcare costs have skyrocketed. But traditional Medicare still does not cover hearing, vision, and dental care—leaving beneficiaries to bear the full cost of care for their ears, eyes, and teeth. Hearing aids, dental crowns, and eyeglasses can amount to thousands of dollars in out-of-pocket expenses, which many seniors simply can’t afford. Read Full Article on Common Dreams >>
Cannabis industry scales back its lobbying in Washington
August 1, 2023 / Cannabis Industry / Pullback – Curaleaf, one the largest cannabis companies in the world, spent nearly 40% less on lobbying in the first half of 2023 than it did at its peak in 2019. Others like Columbia Care and Pax Labs got rid of their entire lobbying teams. Of the four major cannabis industry coalitions that have been pushing for federal legalization of marijuana the longest, one has seen its revenue cut in half; two others appear to have folded completely. Together, their spending on advocacy has dipped by more than 50% since 2019, back when federal weed lobbying was at its height. Read Full Article on STAT News >>