// Biotech and Pharma Therapeutics

Bayer, Regeneron’s eye drug shown to work at higher dose, longer intervals
September 8, 2022 / Age-related Macular Degeneration / Diabetic Macular Oedema – Bayer (BAYGn.DE)said on Thursday its anti-blindness treatment Eylea, jointly developed with Regeneron (REGN.O), has been shown to work as well when given at a higher dose at a longer interval between injections. Two late-stage trials showed that Eylea, which is normally given in doses of 2 milligrams every eight weeks, was as effective when given at 8 mg at longer intervals, without any additional safety issues, the German company said in a statement. Read Full Article on Reuters >>
Drugging RNA with pills: small molecules for a big frontier
September 6, 2022 / RNA Interferance / Small Molecule / Biotech – Infused or injectable medicines that interfere with RNA, the messenger molecules that turn genetic instructions into proteins, have taken the spotlight in recent years, winning approvals for several rare diseases. A group of biotechnology startups are trying to find similar success by targeting RNA with pills instead. Merck & Co. discovered an experimental antibiotic it was developing blocked a type of bacterial RNA. Pfizer inadvertently found one of its drug prospects affected translation of a protein that regulates cholesterol. Now, drugmakers are doing it intentionally. Helped by better sequencing technologies, screening methods and a broader understanding of RNA, researchers can more easily capture how the information molecules look and design drugs that attach to them. Read Full Article on BioPharma Dive >>
September 6, 2022 / Data / Social Media Influencers – Agencies are helping health-focused clients in pharmaceuticals and other categories reach patients where they are in their ‘health journey.’ Health care brands are navigating a pandemic-era marketplace that is requiring them to create experiences that are as easy and enjoyable to use as Amazon and Netflix. Read Full Article on AdAge >>
Pharmaceutical companies could lose billions to cannabis
September 6, 2022 / Cannabis / Opioids / THC – A new study led by the California Polytechnic State University and the University of New Mexico (UNM) has found that stock market investors predict that cannabis legalization may reduce conventional pharmaceutical sales by billions of dollars. By analyzing how the stock market returns of publicly traded pharmaceutical firms responded to medical and recreational cannabis legalization events, the experts discovered that stock market returns were 1.5 to two percent lower at ten days following a cannabis legalization event, and that the implication for the annual sales from this reduction were in the billions of dollars. Read Full Article on Earth >>
Can biosimilars, after years of limited impact, finally make a mark in the US?
September 7, 2022 / Humira / Remicade / Herceptin / Biosimilars – Copycat biologic drugs have had limited impact despite high expectations. The next few years could prove important. The launch of the first lookalike biologic drug in 2015 was heralded as a shift in large pharmaceutical companies’ pricing power, holding the promise of deep discounts on expensive, injectable treatments like Humira, Remicade and Herceptin. Yet years of disappointment followed, as the new competitors were either blocked from entering the market or unable to gain traction once they got there. Read Full Article on BioPharma Dive >>

// 4th Industrial Revolution

Players In The Pharmaceutical API Manufacturing Market Are Developing AI-Based Platforms For The Manufacturing Of APIs
September 8, 2022 / Artificial Intelligence / Active Pharmaceutical Ingredients / Small-molecule Drugs – The use of artificial intelligence in API manufacturing is gaining popularity among the pharmaceutical API manufacturing market trends. Players in the API manufacturing market are deploying artificial intelligence (AI) for the continuous manufacturing of critical APIs necessary for producing crucial small-molecule drugs. Artificial intelligence is a machine-based learning which makes use of human intelligence functionalities like reasoning and problem-solving abilities to obtain insights and provide useful information. Companies in the market are developing an AI-based technology platform for the manufacturing of APIs. Read Full Article on Yahoo! Finance >>
P360 Adds Four New Modules to the BirdzAI Data and Analytics Platform for Pharmaceutical Commercial Operations
September 8, 2022 / Artificial Intelligence / Data Management / Insights & Analytics – P360, a leading technology developer for pharmaceutical companies, today unveiled that its BirdzAI data and analytics platform has been enhanced with four powerful new pre-built modules for Master Data Management, Insights & Analytics, Sales Operations and Marketing Operations. With these enhancements, BirdzAI’s next-generation ecosystem supports pharmaceutical commercial operations with rapid, end-to-end data management capabilities, including the ingestion, storage, processing and analysis of data derived from commonly used sources like first and third-party prescription data, specialty pharmacy data feeds, CRM systems, marketing interactions reports and more. Full Article on Businesswire >>
Viz.ai receives FDA clearance for pulmonary embolism-related algorithm
September 6, 2022 / Artificial Intelligence / Subdural Hemorrhage / Cerebral Aneurysms – The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with the left ventricle. That can help indicate pulmonary embolism severity. AI-backed imaging and care coordination company Viz.ai received FDA 510(k) clearance for an algorithm that could help determine the severity of a pulmonary embolism. Read Full Article on MobiHealth News >>
Breaking the bias in women’s healthcare
September 8, 2022 / Research / Data Bias / Innovation – Although women make up half the world’s population, women’s health issues are often considered niche. In writer Caroline Criado-Perez’s words, they are being overlooked by healthcare systems, leaving women “misunderstood, mistreated and misdiagnosed.” Bias in research data itself is holding back development of safe and effective medical devices and treatments for women. The first step to overcome this challenge is awareness of the data gap. Women’s health is a term that is often misunderstood – it does not only cover female-specific conditions. It encompasses a much broader spectrum, including conditions that disproportionately or more severely affect women, and ones that have different symptoms, outcomes or treatment options and efficacies. Read Full Article on Med-Tech Innovation News >>
3 care categories that matter in connected health care
September 7, 2022 / Internet of Things / Cardiovascular / Glucose Monitoring / Diabetes – Medical IoT is forecast to grow from $41 billion in 2020 to $188 billion by 2028. The growth is for a good reason: Connected medical devices, combined with the right software, can improve conditions and delivery, optimize care and devices, and save lives. Global shipping companies attach smart IoT tags to monitor and transmit the state of each of their pallets, trucks, ships, and containers, right down to their exact location, temperature, humidity, and exposure to light. Interstate gas pipelines deploy hundreds of sensors that feed a predictive maintenance regime. Across industries, IoT networks are saving billions of dollars in direct costs (inventory, labor, security) and indirect efficiencies through prevented maintenance and greener operations. Healthcare is no exception. Read Full Article on MedCity News >>

// Business & Markets

Cardinal Health Announces Pharmaceutical Segment Organizational Changes
September 8, 2022 / Pharmaceutical / Specialty Distribution – Cardinal Health (NYSE: CAH) today announced Debbie Weitzman, current President of Pharmaceutical Distribution, will become CEO of the Company’s Pharmaceutical Segment. Weitzman will replace Victor Crawford, who will be stepping down as Pharmaceutical Segment CEO effective September 19, but will remain with the company until November 13 to help with the transition. The role of President of Pharmaceutical Distribution will be eliminated. Read Full Article on Yahoo! Finance >>
Roche to acquire biopharma firm Good Therapeutics for $250m
September 08, 2022 / Immuno-therapeutics / Oncology / Acquisition – Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics. Read Full Article on Pharmaceutical Technology >>
CVS Health advances healthcare strategy in acquiring Signify Health for $8 billion
September 7, 2022 / Home Health / Health Screenings – CVS Health has acquired Signify Health, besting Amazon, UnitedHealth Group and others in acquiring the home health platform. CVS has entered a definitive agreement to acquire Signify Health for $30.50 per share in cash, representing a total transaction value of approximately $8 billion, CVS announced on Monday. Signify was reportedly for sale by auction, with board members holding a meeting on Labor Day to discuss the bids. Read Full Article on Healthcare Finance >>
GoodRx to lay off 16% of its workforce
September 2, 2022 / Digital Health / Health Tech – GoodRx, a company best known for its prescription price transparency tools, will lay off approximately 140 employees, making up about 16% of its workforce. According to a filing with the Securities and Exchange Commission, the reduction will primarily affect its technology-focused and marketing segments. “The company is focused on efficiently growing its core prescriptions business, accelerating its pharma manufacturer solutions business and doubling down on consumer engagement,” Karsten Voermann, GoodRx’s chief financial officer, wrote in the SEC filing. “As the company focuses on these goals, it is consolidating functions and eliminating or reducing investment in areas of lower focus.” Read Full Article on MobiHealth News >>
Walmart, UnitedHealth Group form 10-year value-based care partnership
September 7, 2022 / Partnerships / Collaboration / Patient Care – Through the collaboration, UnitedHealth Group’s Optum will use its analytics and support tools to help Walmart Health clinicians deliver value-based care to Medicare Advantage beneficiaries. The partnership is starting at 15 locations in Florida and Georgia with the potential to grow in the future. Walmart and UnitedHealth Group announced a 10-year collaboration Wednesday that will help several Walmart Health facilities transition into value-based care. The retail company has been working to expand its presence in healthcare, launching Walmart Health in 2019, which offers primary and urgent care, labs, X-ray and diagnostics, behavioral health, dental, optometry and hearing services. Walmart Health currently has 27 locations in Arkansas, Florida, Georgia and Illinois. Read Full Article on MedCity News >>

// Legal & Regulatory

Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
September 7, 2022 / FDA / Neurology / CENTAUR Trial – Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). Read on Yahoo! Finance >>
FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome
September 6, 2022 / FDA / Health Canada / Chronic Inflammatory Diseases – AFSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces that it received “Study May Proceed” letter for the Investigational New Drug (“IND”) application from the U.S. Food and Drug Administration (“FDA”) and “Notice of Authorization” from Health Canada for its Phase 2 clinical trial of FSD201. The corresponding study protocol is titled “A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder)”. Read on Businesswire >>
FDA’s drug shortage prevention guidance draws fire from PhRMA, BIO and Bristol Myers
September 6, 2022 / Biotechnology Innovation Organization / Pharmaceutical Research and Manufacturers of America – Several months after the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent. Late last week, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) lobbed comments at the FDA’s draft guidance, issuing similar rebukes as those made by outfits like Civica and the Biosimilars Forum. Read on Fierce Pharma >>
Vaccine Myocarditis Update
September 7, 2022 / European Medicines Agency / Vaccines / Myocarditis – The European Medicines Agency decided on July 19, 2021 that myocarditis and pericarditis be added to the list of adverse effects of both messenger RNA (mRNA) based vaccines (BNT162b2 [Pfizer-BioNTech] and mrna-1273 [Moderna]) against COVID-19. This advice was based on numerous reports of myocarditis that followed a clinical pattern that strongly suggested a causal link between these particular vaccines and myocarditis/pericarditis. The adverse events that appeared to be predominantly in young men typically occurred within a week after injection, and were clustered after the second dose of the vaccine series. A recent national database from France sheds some light on the approximate rates of mrna vaccine related myocarditis. Read on The Health Care Blog >>
FTC reviewing Amazon’s $3.9B One Medical acquisition
September 6, 2022 / Digital Health / Telehealth / Alexa / Wearables – The Federal Trade Commission is investigating Amazon’s $3.9 billion acquisition of primary care provider One Medical. According to a filing with the Securities and Exchange Commission, One Medical parent 1Life Healthcare and Amazon both received requests from the FTC for more information regarding the deal on Sept. 2. The planned acquisition was first announced in late July. In the filing, 1Life said both companies plan to “promptly respond to the second request and to continue to work cooperatively with the FTC in its review of the merger.” Amazon declined to comment. Read on MobiHealth News >>

// Research & Development

Dizlin Pharmaceuticals publishes data from pharmacokinetic study (PK) (IPO-001) with Infudopa SubC (DIZ102) and Infudopa IntraV (DIZ101) in Neurology
September 7, 2022 / Parkinson’s Disease / Levodopa Carbidopa Monotherapy – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system (CNS), announces that an article has been published in Neurology®, from the American Academy of Neurology®, describing data from the company’s IPO-001 pharmacokinetic cross-over study. “The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson´s disease”, says principal investigator Filip Bergquist, MD, senior consultant in neurology and professor of pharmacology. Read Full Article on PR Newswire >>
Gilead says its breast cancer drug helped patients live longer in study
September 8, 2022 / Chemotherapy / Cancer – Gilead on Wednesday said its breast cancer medicine Trodelvy helped patients whose tumors have spread live roughly three months longer than those given chemotherapy in a clinical trial, an improvement that analysts argue could help persuade physicians to use the drug. Patients on Trodelvy, who were previously treated with hormone therapy and chemotherapy, lived a median of 14.4 months following enrollment in the trial, while those randomized to receive another round of chemotherapy lived 11.2 months. Gilead disclosed detailed survival data ahead of a medical conference, following an August announcement that researchers had observed a benefit. Read Full Article on BioPharma Dive >>
Users more likely to embrace AI-enabled preventive health measures with human touch, study finds
September 7, 2022 / Artificial Intelligence / HIMSS / Mobile Health Study – A study led by researchers from the Nanyang Technological University Singapore has revealed that individuals are more likely to accept preventive health interventions suggested by AI with the involvement of human health experts. It also found lesser trust in AI-powered preventive care than in interventions led by human experts. The study inquired into users’ perceptions of preventive health interventions, such as health screening and physical activity prompts, proposed by AI as compared to those recommended by humans. It involved about 15,000 participants in South Korea using an undisclosed mobile health application. Read Full Article on MobiHealth News >>
Mayo Clinic to use blockchain for hypertension clinical trial
September 7, 2022 / Blockchain-integrated Document Management / Electronic Health Records – Beginning this month, Mayo Clinic will onboard a blockchain-integrated platform by Triall for a two-year multicenter pulmonary arterial hypertension trial that includes 10 research sites and more than 500 patients. By building an immutable blockchain-registered audit trial with Triall’s Veritable Proof API, Mayo Clinic will test end-to-end clinical data integrity – from startup to post-study evaluations. The platform will provide secure, decentralized data capture, document management, study monitoring and electronic consent for the clinical trial, according to the tech company’s announcement. Read Full Article on Healthcare IT News >>
Most Consumers Are Health and Wellness Consumers Even in Hard Financial Times, Accenture Finds
September 8, 2022 / Consumer Electronics / Social Health – Consumers consider health and well-being as an “essential” household spending category based on new research from Accenture. Accenture polled over 11,000 consumers in 17 countries, considering how people are faring amid “widespread uncertainty and personal financial strains,” in the firm’s words. While two in three consumers feel financially stressed, 4 in 5 intend to grow or hold their personal spending on health and fitness steady in the next year. In the U.S., more granularly, 26% of consumers intend to increase spending on health and wellness significantly more or more; 50% plan to hold spending even for H&W; and 24% would spend significantly less or less. Net-net for U.S. consumers, 76% of people would plan to spend more or maintain their spending on health and wellness over the next twelve months. Read Full Article on Health Populism >>

// Politics

Senate GOP delivers early blow to Biden’s Covid and monkeypox request
September 7, 2022 / COVID / Monkeypox – Senate Republicans are signaling early resistance to attaching billions of dollars for Covid and monkeypox aid in a must-pass government funding bill, a troublesome sign for a White House that says vaccine money is rapidly running out. In interviews Wednesday, GOP senators said they were skeptical of the Biden administration’s $22.4 billion request for Covid money, as well as its $4.5 billion request for combating monkeypox — citing unspent money and frustration with what they view as Democrats’ previous spending largesse. Read Full Article on Politico >>
10 years after a landmark health care law, the push to contain costs may be stalling
September 6, 2022 / Massachusetts / Health Policy Commission – Ten years ago, as medical costs soared, Massachusetts passed landmark legislation to tackle the problem. The law created the Health Policy Commission, a first-of-its-kind watchdog agency to monitor rising costs. And it set a target to limit spending growth. A decade later, that experiment in cost control has had mixed success. Health care spending has grown less rapidly — yet consumers and businesses are still grappling with higher costs each year. Now, many health industry insiders and observers say, progress is stalling. They say the Health Policy Commission needs more power to hold the industry accountable for high spending and make care more affordable for all. Read Full Article on WBUR Boston >>
The next round in the fight over prescription drug prices
September 8, 2022 / Medicare / Drug Industry / Inflation Reduction Act – On Aug. 16, President Joe Biden signed into law a sweeping climate, tax and health care package known as the Inflation Reduction Act. “With this law, the American people won and the special interests lost,” Biden proudly announced at the bill’s signing ceremony. Democratic leaders like U.S. Sen. Chuck Schumer (D-NY) took victory laps at the event, touting what they see as one of the law’s most historic achievements. Read Full Article on NPR / WFYI Indianapolis >>
Republicans Try to Jump-Start Probes Into Biden’s Covid Response
September 7, 2022 / Wuhan Institute of Virology / HHS Secretary Becerra / COVID Response – House Republicans aren’t waiting for next year to demand documents from the Biden administration about the federal response to the Covid pandemic and the role of key presidential advisers. Republicans want to use a procedural tool—known as a resolution of inquiry—in the coming weeks to advance investigations into areas ranging from Health and Human Services Secretary Xavier Becerra’s role as a Covid adviser to oversight of research conducted in China at the start of the pandemic. Read Full Article on Bloomberg Law >>
$1 billion in federal economic grants headed coast to coast
September 2, 2022 / Biotech / Regenerative Medicine / Artificial Intelligence – The government will send $1 billion worth of federal grants for manufacturing, clean energy, farming, biotech and more to 21 regional partnerships across the nation, President Joe Biden and Commerce Secretary Gina Raimondo announced Friday. The 21 were chosen from 529 initial applicants vying for grants that were part of last year’s $1.9 trillion coronavirus relief package. The Biden administration has repeatedly laid out a vision for the economy that is more self-sufficient and driven by high-tech manufacturing and the development of renewable energy. Read Full Article on NBC KARE 11 >>