// 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.
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.
Healthcare Marketing – How agencies are leaning into data and influencers
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.
Pharmaceutical companies could lose billions to cannabis
September 6, 2022 / Cannabis / Opioids / THC
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.
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.
// 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.
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
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.
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.
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.
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.
// 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.
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.
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.
GoodRx to lay off 16% of its workforce
September 2, 2022 / Digital Health / Health Tech
Gameto, a biotech company using cell engineering to develop therapeutics for diseases of the female reproductive system, has added $17M in funding from Insight Partners, Future Ventures, Arcadia Investment Partners, Bold Capital Partners, Plum Alley, Myelin VC, TA Ventures, Gaingels, Korify Capital, and other existing investors. The new financing brings the total capital raised since inception to $40M. Gameto’s last funding round was announced in January 2021.
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.
// 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).
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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// Politics
Senate GOP delivers early blow to Biden’s Covid and monkeypox request
September 7, 2022 / COVID / Monkeypox / Biden
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.
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.
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.
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.
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.
$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.