// Biotech and Pharma Therapeutics

Clearmind Medicine Collaboration with CTS Ltd., a Leading Pharmaceutical/Consumer Products Company
August 14, 2023 / Clearmind Medicine / Pharmaceuticals / Consumer Products –
As part of the collaboration, Clearmind Medicine will have access to the CTS’ state-of-the-art facilities, allowing it to expand its research and development capabilities. Furthermore, the collaboration provides Clearmind access to CTS’ global networks and industry connections, the ability to leverage CTS’ expertise in manufacturing and marketing, as well as benefit from CTS’ vast industry experience and guidance, ensuring that the Company’s treatments meet the highest standards of quality, safety, and efficacy. Read Full Article on Yahoo! Finance >>
Radiopharmaceuticals for cancer: Making radiation precise
August 15, 2023 / Pluvicto / Zevalin / Bexxar / Idec / Novartis / GSK – More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching. When the Food and Drug Administration approved a new prostate cancer drug last year, it validated a bet made by Novartis to acquire the drug’s maker, Endocyte. The decision was also another step forward for a long-studied research field that appears to finally be coming of age. Read Full Article on BIOPHARMA DIVE >>
GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies
August 17, 2023 / Vaccines / RSV / Arexvy – As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. Read Full Article on Fierce Pharma >>
Selecta Biosciences Halts Pipeline Investments, Focuses on Gout Treatment
August 17, 2023 / Gout / Selecta – Selecta Biosciences is freezing further investments in its pipeline and will focus company efforts on a candidate treatment for chronic refractory gout, the biotech announced Thursday in its second-quarter financial results. The Mass.-based company said that it made the strategic decision “to stop or discontinue non-essential activities” in an effort “to preserve capital.” The cost-saving measures focused on “maximizing the value of its pipeline through potential licensing and corporate development activities” are expected to extend Selecta’s cash runway into 2027. Read Full Article on BioSpace >>
Health and Pharma Wrap Up from the Wall Street Journal
August 16, 2023 / FDA / Ozempic / Disease Treatment – The latest news on health and wellness, including the healthcare industry, pharmacuticals and more from the Wall Street Journal. Read Full Article on WSJ.com >>

// 4th Industrial Revolution

Clinician burnout – where’s technology when you need it?
August 14, 2023 / Technology / Health Systems / Leadership – Administrative burden is a huge challenge, and technology often exacerbates it. But is there a better way forward? IT is underleveraged as a way to help clinicians spend more time with their patients, says one expert. Hospital and health system executives are all too familiar with clinician burnout, an industry-wide problem that threatens healthcare quality and accessibility. Forward thinking execs are on the hunt for strategies and technologies that can help combat burnout and improve the daily lives of their caregivers. Read Full Article on Healthcare IT News >>
MedArrive, Heartbeat Health Connects Medicaid Members with Virtual Cardiology Care
August 15, 2023 / Cardiovascular Disease / Longitudinal Care / Heart Health – Collectively, the U.S. spends more than $320 billion – or 15 percent of the total health expenditure – treating or managing cardiovascular disease (CVD). More than one in four Medicaid beneficiaries have some form of CVD, rates that are often much higher than in other populations. People on Medicaid also have high rates of the common risk factors that contribute to CVD, including hypertension and high cholesterol. Read Full Article on HIT Consultant >>
Abridge inks Epic partnership, Emory Healthcare tie-up for its generative AI tech
August 16, 2023 / Emory Healthcare / Epic / AI / EHRs – As the generative artificial intelligence race in healthcare continues with big tech companies jumping into the space, startup Abridge nabbed several notable partnerships to expand the use of its gen-AI-powered medical note-taking service. Epic will integrate the company’s generative AI for clinical documentation into its electronic health record (EHR) workflow as part of the tech giant’s new “Partners and Pals” program. That program will be introduced during the company’s annual users’ group meeting in Wisconsin next week. Read Full Article on Fierce Healthcare >>
Generative AI in healthcare: Google Cloud’s Amy Waldron on the tech giant’s health ambitions
August 17, 2023 / Partnerships / Google / Mayo Clinic / Generative AI – Google has been keeping busy in the healthcare industry, announcing partnerships with organizations to implement generative artificial intelligence. The search giant announced partnerships this year with health systems like Mayo Clinic to use generative AI, or algorithms that can be used to create new content like text, to improve clinician workflows. The company is also tackling billing, with financial engagement platform Cedar announcing an agreement with Google Cloud earlier this month to use its generative AI tools to help patients understand their healthcare bills. Read Full Article on HEALTHCARE DIVE >>
YouTube cracks down on misinformation on cancer treatment
August 15, 2023 / Healthcare / Cancer Treatment – YouTube’s health division is stepping up its effort to combat medical information, with a particular focus on cancer treatment and prevention. The Google-owned video sharing company unveiled a new plan Tuesday to remove content that promotes harmful or ineffective cancer treatments, or discourages viewers from getting professional medical treatment. Read Full Article on STAT News >>

// Business & Markets

Best of biotech can bounce back from dotcom-style slump
August 17, 2023 / Early-stage Therapeutics / Healthcare Stocks / AI / Computational Biology – The healthcare sector is one of dynamism – where global demographic trends, breakthrough drug developments, and M&A activity can offer diverse sources of alpha. Historically, the sector has provided access to secular long-term growth and has outperformed broader market indices over full market cycles since the late 1990s. Innovation is modernising the industry, as technology adoption is improving the patient experience and contributing to lower costs. Patients have become more tech-savvy and more aware of their own health. At the same time, advancements in the ability to diagnose, monitor, and treat diseases with personalised therapeutics are creating a broad set of investment opportunities. The current wave of consumerisation and innovation is paving the way for a select group of healthcare companies with access to data to generate durable, outsized growth over the next decade. In our view, moves to replace legacy approaches and provide more impactful and efficient care should parallel the evolution of the technology sector from 2010 to 2020. Read Full Article on Trustnet >>
Agnelli family’s Exor buys $2.8 bln stake in Philips
August 14, 2023 / Healthcare / Technology / John Elkann – Exor NV (EXOR.AS), the investment arm of Italy’s Agnelli family, has become the top investor in Philips (PHG.AS) by buying 15% of the healthcare technology group for about 2.6 billion euros ($2.8 billion), the companies said. The deal is a welcome vote of confidence in the Dutch company, which is in the late stages of a huge product recall that began in 2021 and that knocked two thirds off its share price. Read Full Article on Reuters >>
How Biogen outbid a rival ‘large-cap’ pharma to claim Reata for $7.3B

August 15, 2023 / Mergers & Acquisitions / Biogen / Reata Pharmaceuticals – Biogen’s $7.3 billion buyout of Skyclarys-maker Reata Pharmaceuticals surprised some industry watchers last month. But it turns out Biogen wasn’t the only drugmaker jockeying for the Texas-based rare disease outfit, a new securities filing shows. Back in May, before Biogen entered the picture, a separate “large-cap pharmaceutical company,” identified only as “Party A,” set up an introductory meeting with Manmeet Soni, Reata’s president, COO and CFO, to discuss collaboration opportunities in Europe, the filing says. Read Full Article on Fierce Pharma >>
Zealand Pharma Announces Financial Results for the First Half of 2023

August 17, 2023 / Zealand / Amalyn Analog / Survodutide – Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: “The first six months of 2023 have been phenomenal for Zealand Pharma, with impressive clinical data readouts from our obesity portfolio, including presentations at ADA for survodutide and our amylin analog ZP8396, regulatory submissions for dasiglucagon, and a strengthened balance sheet. “We look forward to an eventful second half of the year as well, which we expect among other events will include the regulatory submission to the FDA for glepaglutide in SBS, a potential partnership agreement for dasiglucagon in CHI, and initiation by Boehringer Ingelheim of the Phase 3 program with survodutide in obesity.” Read Full Article on Global Newswire >>
In a year with few biotech IPOs, ‘crossover’ financings are hard to find
August 16, 2023 / Crossover Funds / Venture Capital / Innovation Banking – Cancer drug startup CG Oncology ticks many of the criteria biotechnology companies need to pull off an initial public offering in today’s market. Its lead drug candidate is in a Phase 3 trial, as well as a mid-stage study together with the Merck & Co. immunotherapy Keytruda, for a stubborn form of bladder cancer. Through the end of last year, the Irvine, California-based company had raised more than $200 million in private financing. Read Full Article on BIOPHARMA DIVE >>

// Legal & Regulatory

Family of Henrietta Lacks sues biotech company Ultragenyx​ over HeLa cells
August 11, 2023 / HeLa cells / Gene Mapping / Vaccines – Attorneys for the family of Henrietta Lacks have filed a lawsuit against a second large biopharmaceutical company. This time, the family is asking billion-dollar biotech company Ultragenyx for compensation and for control over the valuable HeLa cells that were taken, without permission, from their ancestor. The family of Lacks wants to take back control of her legacy. Read on CBS News >>
How 5th Circuit Court of Appeals mifepristone ruling pokes holes in wider FDA authority
August 17, 2023 / FDA / Supreme Court / Mifepristone – By interfering with the Food and Drug Administration’s authority to regulate an abortion drug, the courts have undermined its authority over all medications, legal and medical experts told USA TODAY. “The meaning of FDA approval will always be unclear now,” said Dr. Peter Lurie, a former FDA associate commissioner for Public Health Strategy and Analysis. “Is (approval) just something that has not yet been reversed? Will it be subject to some extended legal process, which will be called into question in all kinds of ways?” “From the agency’s point of view,” he said, “its very essence is at stake.” Read Full Article on USA Today >>
Breaking News: FDA Approves Niraparib + Abiraterone for Metastatic Castration-Resistant Prostate Cancer
August 14, 2023 / Cancer Treatment / BRCA1 Gene / BRCA2 Gene – The FDA has approved a new medication, niraparib, in combination with abiraterone acetate for patients with metastatic castration-resistant prostate cancer (mCRPC) who also have mutations in specific genes called BRCA1 and BRCA2. This means that patients with mCRPC (prostate cancer that has spread beyond the prostate and continues to grow despite low testosterone) have an additional treatment option. To determine whether a patient is eligible for and may benefit from this therapy, a doctor first orders a test of the patient’s tumor tissue to look for specific mutations. Read Full Article on Prostate Cancer Foundation >>
FDA’s Dietary Supplements Program Remains a Critical Priority
August 14, 2023 / FDA / New Drug / Mapi Pharma / Viatris – Under the new proposed HFP structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. The reporting of ODSP to the OFCSDSI director is similar to its current reporting to an individual managing several Offices; however, the current individual reports to the CFSAN Center Director while the OFCSDSI director is proposed to report to a Deputy Commissioner. Read on FDA.gov >>
Viz.ai gets FDA De Novo approval for AI-enabled heart disease detection
August 16, 2023 / Machine Learning / AI / Hypertrophic Cardiomyopathy –The developer’s Viz HCM algorithm can be used to assess electrocardiograms. When findings are suspicious of hypertrophic cardiomyopathy, the app alerts cardiology specialists to provide further triage. Read on Healthcare IT News >>

// Research & Development

Global $49.3+ Artificial Intelligence (AI) in Biopharmaceuticals Market Report 2023-2033: Surge in Collaborations Among Organizations for Drug Development Enabled by AI – ResearchAndMarkets.com
August 16, 2023 / Automation / Data / Patent Expiration – The report forecasts strong revenue growth in the market, with the overall world revenue surpassing US$49.3 billion in 2023. The study identifies organizations with the greatest potential in the field, outlining their capabilities, progress, and commercial prospects. Read Full Article on Businesswire >>
Thin Film Drugs Market: Rising Interest in Advanced Drug Delivery Methods Drives Growth 2030
August 18, 2023 / Innovation / Drug Delivery / WHO – The global thin film drugs market is experiencing significant growth due to increasing research and development activities in drug delivery systems. Pharmaceutical companies are investing in thin film drug technology to harness its benefits, such as faster absorption and enhanced therapeutic effects. Moreover, thin film drugs are being explored as a superior alternative to conventional delivery methods, spurring manufacturers to develop these systems to address critical ailments. The rising cases of schizophrenia worldwide and the demand for efficient drug delivery systems are also contributing to the market’s growth. Read Full Article on Digital Journal >>
Boehringer Initiates Phase III Obesity Trials, Seeks to Challenge Novo and Lilly
August 9, 2023 / Boehringer Ingelheim / Phase II / Phase III / Survodutide – Boehringer Ingelheim is looking to challenge Novo Nordisk and Eli Lilly in the lucrative obesity market, advancing its weight-loss injectable into pivotal studies. The company announced Thursday it will initiate three Phase III trials for its glucagon/GLP-1 receptor dual agonist with patient enrollment planned before the end of the year. In a Phase II trial, overweight or obese participants on survodutide saw close to 19% weight loss after 46 weeks of treatment. Weight reduction had not plateaued at the 46-week mark, suggesting additional weight loss could occur with longer treatment, the company said. Read Full Article on BioSpace >>
Phenobarbital Market is Anticipating Outstanding Surge of US$ 2.23 Billion by 2030 | Sanofi, Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Mylan N.V.
August 18, 2023 / Epilepsy / Seizures / Sedatives / Anticonvulsants – The global Phenobarbital market size was valued at US$ 1.58 billion in 2023 and is expected to reach US$ 2.23 billion by 2030, grow at a compound annual growth rate (CAGR) of 5% from 2023 to 2030. A medication called phenobarbital is used to treat or prevent seizures. It controls the aberrant electrical activity that leads to seizures in the brain. It belongs to a group of drugs known as sedatives and anticonvulsants. When someone is uncomfortable or nervous, it may also be taken briefly to help them unwind or fall asleep. Only a doctor’s prescription is required to purchase this drug. Read Full Article on Medgadget >>
Lilly revolutionizes clinical trials with intelligent sensor cloud
August 18, 2023 / Digital Biomarkers / Passive Data Collection / Wearables / Remote Monitoring – The pharmaceutical giant has developed a cloud solution d믭 MagnolAI for continuously ingesting, visualizing, and transforming digital biomarker data into meaningful medical insights. Digital biomarkers are increasingly playing an important role in improving our understanding of disease and health. Defined as quantifiable and objective behavioral and physiological data collected and measured by digital devices such as implantables, wearables, ingestibles, or portables, digital biomarkers enable pharmaceutical companies to conduct studies remotely without the need for a physical site. This innovative approach is revolutionizing the way pharmaceutical firms conduct research and determine treatment effectiveness. Read Full Article on CIO >>

// Politics

We’re on the cusp of another psychedelic era. But this time Washington is along for the ride
August 12, 2023 / Psychedelics / Depression / FDA – There’s a new cause in Washington that’s uniting Republicans, Democrats and Biden health officials: psychedelics as a cure for America’s mental health crisis. Long derided as counterculture party drugs, psychedelics are gaining new resonance 56 years after psychologist Timothy Leary urged 30,000 hippies in San Francisco’s Golden Gate Park to “turn on, tune in and drop out.” This time, it’s not about breaking free of staid convention, as Leary urged, but healing intractable psychic wounds. Read Full Article on Politico >>
GOP hopefuls try to shine in Trump-DeSantis shadow
August 12, 2023 / GOP / Donald Trump / Vivek Ramaswamy / Ron DeSantis – Participating in chats with the Iowa governor, surveying cattle and hogs across the fairgrounds and rapping an Eminem song, Republican candidates fought for air Saturday as a showdown between Donald Trump and Ron DeSantis largely stole the spotlight. Ohio biotech entrepreneur Vivek Ramaswamy, former U.N. Ambassador Nikki Haley and Texas pastor Ryan Binkley toured the fair and spoke to voters. Read Full Article on QC Times >>
Congressman Launches Investigation into Medicaid Prior Authorization Denials
August 17, 2023 / Senator / Medicaid Managed Care Organizations (MCOs) – U.S. Representative Frank Pallone, Jr. (D-New Jersey) announced that he is looking into high prior authorization denial rates by Medicaid managed care health plans. It follows a report by the Office of Inspector General that found that Medicaid MCOs denied one out of every eight prior authorization requests in 2019. Read Full Article on Medcity News >>
Drug pricing concerns cross party lines to become ‘core value’ for voters, pollsters say
August 16, 2023 / Healthcare Costs / Drug Prices / Inflation Reduction Act – Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines. That’s the conclusion reached by Democrat Celinda Lake, president of Lake Research Partners, after a recent survey commissioned by the Campaign for Sustainable Rx Pricing, which found that a “vast majority” of voters (almost 70%) are worried about the cost of their medicines. The live-caller interview tracked responses from 900 registered voters in the U.S., who were polled toward the end of July. Read Full Article on Fierce Pharma >>
Americans’ biggest fears: Opioids surge past guns in Axios-Ipsos poll
August 14, 2023 / Polls / Insights – The summertime rise in COVID cases and hospitalizations is making some Americans rethink if the pandemic is over, but it isn’t persuading them to start wearing masks again or test for the virus, according to the latest Axios-Ipsos American Health Index. The big picture: Economic and political turmoil, along with unease about developments like AI, have left many Americans numb to public health threats, though issues like the opioid crisis and shortage of cancer drugs are still registering. Gun violence, which ranked as the top threat to public health when we asked the question in May, has dropped to No. 3 behind opioids and obesity, with noticeably fewer Democrats listing it as their top concern. Read Full Article on Axios >>