// Biotech and Pharma Therapeutics

Bayer-Ionis’ anti-thrombotic med doesn’t increase bleeding in phase 2, setting stage for a new type of anticoagulant
July 28, 2022 / Bayer / Ionis Pharma / Blood Clots Patients with kidney disease taking Ionis Pharmaceuticals and Bayer’s anti-thrombotic therapy did not experience an increase in major bleeding events as compared to those taking placebo, meaning patients may someday have a new anticoagulant option that does not come with a risk of bleeding. Read Full Article on Fierce Pharma >>
Kazia dropped from global umbrella trial to treat aggressive form of brain cancer
August 1, 2022 / Brain Cancer / Kazia / Oncology The company—formerly known as Novogen—says that although enrollment is now completed, the paxalisib arm did not meet “predefined criteria” for moving on to the second stage of development, according to an announcement Monday. Those criteria were decided by the Global Coalition for Adaptive Research, a collaboration between an evolving number of pharmas and biotechs to simultaneously test treatments for glioblastoma, an aggressive brain cancer. Other participants include Bayer, Biohaven, Kintara and Vigeo. Read Full Article on Fierce Biotech >>
Onwards! Novo Nordisk’s once-weekly insulin marches on after hitting goals in pair of phase 3 trials
July 29, 2022 / Insulin / Novo Nordisk / clinical trial data Novo Nordisk has added more threads to the data tapestry it is weaving in support of the once-weekly insulin icodec, dropping positive top-line results from two phase 3a studies in its six-part ONWARDS program. Read Full Article on Fierce Pharma >>
J&J is not the first name in Alzheimer’s these days, but Janssen is charting the ‘sweet spot’ behind the scenes
August 1, 2022 / J&J / Alzhemer’s / Anti-Tau Johnson & Johnson has not been a name associated with the recent rush to find an effective Alzheimer’s disease treatment. But the pharmaceutical unit of the largest healthcare company in the world has a two-pronged approach going on in the background that could someday give it a foothold. The strategy includes pursuing precision medicines while at the same time working on biomarkers that can identify patients who will benefit most, and it recently helped attract a neuroscience veteran to Janssen Pharmaceuticals to drive the clinical program. Read Full Article on Fierce Biotech >>
Pfizer Cancels Phase III Drug Trial for Cardiovascular Disease
August 4, 2022 / Pfizer / Cardiovascular Pfizer is no longer continuing its Phase III trial on a potential drug for symptomatic dilated cardiomyopathy (DCM) as it is unlikely to achieve its primary endpoint. PF-07265803 is being tested in the REALM-DCM trial on DCM patients who have developed the disease because of a mutation of the gene encoding the lamin A/C protein. The investigational compound, formerly called ARRY-371797, is a selective, oral, small-molecule inhibitor of the p38α mitogen activated protein kinase pathway. Read Full Article on BioSpace >>

// 4th Industrial Revolution

Natural Cycles partners with Oura Ring to monitor temperature for birth control app
August 2, 2022 / Womens Health / Birth Control / 4IR  Oura, maker of a health tracking ring, announced a partnership with birth control app Natural Cycles to use its wearable to monitor body temperature changes. Users will be able to sync temperature data recorded from the Oura Ring into the Natural Cycles app instead of taking their temperature manually each morning. Natural Cycles, which received FDA De Novo clearance in 2018, uses temperature data and menstrual cycle information to determine a user’s fertile window and prevent pregnancy. Read Full Article on Mobi Health >>
Addressing Mobile Device Security Risks in Healthcare
August 2, 2022 / 4IR / HealthCare / Security  Mobile device security risks have become a more prominent threat along with the rise of remote work. In fact, nearly half of more than 600 security professionals surveyed by Verizon in its new Mobile Security Index (MSI) report said that their organizations had suffered a compromise involving a mobile device in the past 12 months. Full Article on Health IT Security >>
ResMed Acquires Digital Therapeutics App for Insomnia
August 2, 2022 / 4IR / Digital Therapeutics / Insomnia somnio closes a gap in care for insomnia patients and complements ResMed’s efforts to increase both awareness of this disease—which impacts 1 in 10 Germans—and access to effective home treatments, while laying the foundation to further build on ResMed’s digital sleep health portfolio. Through the acquisition, mementor can leverage ResMed Germany’s broader network to increase adoption of its approved digital therapy alternative for insomnia; somnio is available today in Germany via “app on prescription.” The clinical effectiveness of somnio has been demonstrated in two randomized controlled trials, showing a sustained improvement in users’ sleep after two and twelve months. Read Full Article on Hit Consultant >>
Google AI lab can predict the structure of all proteins
August 2, 2022 / 4IR / Google / AI Researchers at DeepMind, a subsidiary of Google parent company Alphabet, have said they can predict the three-dimensional structure of nearly all known proteins using artificial intelligence, The Wall Street Journal reported July 28. Read Full Article on Becker’s Hospital Review >>
3D Bioprinting Market To Register Explosive Growth and Detailed Analysis

August 4, 2022 / 4IR / Google / AI The 3D Bioprinting Market comprises a detailed study of the latest industry trends as well as new developments in the industry across various regions and countries. The report is an admirable effort to offer a thorough investigation of many important aspects of the global 3D Bioprinting Market industry, including a transparent picture of the current and future conditions based on facts and accurate data. Read Full Article on Shanghaiist >>

// Business & Markets

Ochsner Health closes merger with 7-hospital Rush Health Systems, pledges higher minimum wages to new employees
August 1, 2022 / Mergers / Ochsner and Ruush Health Systems / Nonprofit Hospitals Ochsner Health and Rush Health Systems have wrapped up a planned merger that sees the smaller southern organization rebranded as Ochsner Rush Health, according to a Monday morning release. First announced in June 2021, the deal adds seven hospitals and more than 30 clinics in eastern Mississippi and western Alabama to Ochsner, already the largest health system in the Gulf South region. Read Full Article on Fierce Healhcare >>
Digital health company Pear Therapeutics lays off 9% of staff
August 2, 2022 / Digital Health / Pear Therapeutics Pear Therapeutics, a company that offers digital therapy programs by prescription, has let go of 9 percent of its workforce, according to a recent filing with the Securities and Exchange Commission. Read Full Article on Becker’s Hospital Review >>
Brave Health & MedArrive Partner to Power Virtual Mental Health
August 2, 2022 / Virtual Mental Health / MedArrive Brave Health, a virtual-first behavioral health provider focused on serving Medicaid and Medicare populations, today announced an innovative referral partnership with MedArrive.Through this collaboration, if MedArrive identifies an eligible health plan member in need of mental health support, MedArrive’s field providers can immediately refer that member to Brave Health’s behavioral health providers in real time and schedule care within 72 hours. Conversely, if Brave Health identifies an eligible health plan member that may benefit from MedArrive’s home health services, then Brave Health will work with that health plan’s case management team to align support. Read Full Article on Beacker’s Health IT >>
InnovationRx: Gates, Bezos Back Alzheimer’s Diagnostics; Plus, Biden’s Long Covid Office
July 3, 2022 / Alzheimer’s Drug Discovery Foundation Atrio of billionaires are re-upping their philanthropic commitments to speed the development of diagnostic tests for Alzheimer’s disease. Microsoft cofounder Bill Gates, Amazon founder Jeff Bezos and former Estee Lauder chair Leonard Lauder are each donating another $11.25 million to the Alzheimer’s Drug Discovery Foundation, Forbes’ Kerry Dolan reports. In total, the foundation has raised a fresh $50 million from funders that also include pharmaceutical companies Biogen and Lilly. It has raised $100 million for the effort to date. Around 6 million Americans have Alzheimer’s, with around half of cases going undiagnosed, according to the foundation. The aim is to create new diagnostics similar to the blood tests known as liquid biopsy that are currently being used for early cancer detection, as well as eye scans and smartphone-based detection tools. Read Full Article on Forbes >>
Forbion Co-leads $70 Million Financing of F2G to Advance Development and Commercialization of New Antifungal Agent Olorofim
August 4, 2022 / Forbion / Financing / F2G Ltd Naarden, The Netherlands, 4 August 2022 – Forbion, a leading European life sciences venture capital firm, today announces the $70 million financing of F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections with a high unmet medical need. Read Full Article on Biospace >>

// Legal & Regulatory

Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering Potentiated Intranasal Oxytocin (TNX-1900) for the Treatment of Pain
August 1, 2022 / U.S. Patent / Oxytocin / Tpnix Pharma Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the United States Patent and Trademark Office (USPTO) issued U.S. Patent 11,389,473 to the Company on July 19, 2022. The patent, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use” claims methods and compositions for treating pain, including that incident to migraine headaches, using intranasal magnesium-containing oxytocin formulations. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until January 2036. Read on Bio Space >>
Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023
August 1, 2022 / U.S. Senate / Center for Drug Evaluation and Research Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 Read Full Article on Pink Sheet >>
Senate passes bill to root out conflicts of interest in federal contracting
August 2, 2022 / U.S. Senate / Federal Contracting The Senate passed a bill on Tuesday that aims to root out conflicts of interest in federal contracting by including new disclosure requirements and updating how agencies determine whether contractors have potential conflicts of interest. The Preventing Organizational Conflicts of Interest in Federal Acquisition Act would require federal contractors to disclose business relationships that oppose the services they provide to the American public or otherwise interfere with the work they have been hired to perform by federal agencies. It comes after the management consulting corporation McKinsey & Company drew nationwide legal challenges and criticism last year over its involvement in the U.S. opioid crisis while simultaneously working with the Food and Drug Administration, later paying a reported $600 million to settle charges. Read Full Article on Federal Computer Week (FCW) >>
FDA drafts guidance on patient labeling information for LASIK devices
August 1, 2022 / FDA / LASIK  In a draft guidance document issued July 28 by the U.S. Food and Drug Administration, content and formatting recommendations are presented for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices. Read Full Article on The Medical Press >>
Negotiations? AbbVie CEO says current Senate proposal brings ‘price controls’ instead
August 3, 2022 / U.S. Senate / AbbVie CEO / Price Controls While lawmakers are busy debating details of the reconciliation bill that may take a serious stab at drug prices, pharmaceutical companies are hustling out a defense. On earnings calls over the last two weeks, the leaders of Gilead Sciences, Johnson & Johnson, Novartis, AbbVie and more have voiced concern—and some optimism—about the developing drug pricing package. Read Full Article on Fierce Pharma >>
FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should ‘move into a new phase’
July 29, 2022 / FDA / Oncology / Robert Califf The biotech industry has been resistant to a policy reform that would limit single-arm trials for drug approvals and it appears that even FDA Commissioner Robert Califf, M.D., thinks they’re necessary in some circumstances. But Califf, in a briefing with reporters Thursday, backed proposals by the agency’s cancer czar to limit single-arm trials to nab accelerated approvals. He said that while the pathway remains valuable for certain kinds of cancers, diseases with existing treatments should take a more “mainstream” regulatory route. Single-arm trials involve only dosing the treatment, rather than an additional control arm, requiring fewer patients in the trials, which subsequently makes them cheaper and easier to run. Read Full Article on Fierce Pharma >>
US Agencies Publish Guidance To Ensure Telehealth Access Equality
August 2, 2022 / Telehealth Access / U.S. Agencies The US Departments of Health and Human Services and Justice have published guidance on protections in federal laws to help Americans with disabilities or limited English proficiency to access telehealth. The guidance coincides with the 32nd anniversary of the American with Disabilities Act. Read Full Article on Medtech Insight >>

// Research & Development

Ionis announces positive topline results from Phase 2b clinical study of fesomersen, a potential novel anti-thrombotic treatment
July 28, 2022 / Ionis / Fesomersen / Anti-thrombotic treatment R&D CARLSBAD, Calif., July 28, 2022 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today announced positive topline results of the Phase 2b RE-THINC ESRD study of fesomersen, formerly IONIS-FXI-LRx, in patients with end-stage renal disease (ESRD) on hemodialysis. In the study, fesomersen achieved its primary outcome measure of no increase in incidence of major bleeding and clinically relevant non-major bleeding as compared to placebo. Data from the study show that fesomersen, administered monthly at 40 mg, 80 mg and 120 mg for up to 48 weeks, was safe and well-tolerated. Read Full Article on Biospace >>
Three Months After Covid-19, Individuals Are More Prone To Diabetes & Cardiovascular Disease
July 30, 2022 / Diabetes / Cardiovascular In a recent study published in the journal PLOS Medicine, researchers warn that three months after recovering from a Covid-19 infection, hospitalized patients are at a greater risk of developing cardiovascular disease and diabetes. Read Full Article on Forbes >>
Spray Coating Fights Viruses and Bacteria
August 1, 2022 / Spray Coating / Viruses and Bacteria Researchers at the University of Sydney in Australia engineered a new spray coating for surfaces that provides long-term protection against bacterial and viral contamination. The material is intended as a long-term alternative to disinfectant sprays and combines hydrophobic properties with antimicrobial nanoparticles to reduce microbial contamination. Read Full Article on Medgadget >>
US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas
August 1, 2022 / FDA / Cancer Trials Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence’s new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide. Read Full Article on Pink Sheet >>
AstraZeneca axes Moderna-partnered, phase 2 heart disease drug plus a Wee inhibitor
July 29, 2022 / Cardiovascular / Pipeline / AstraZeneca & Moderna AstraZeneca has axed a Moderna-partnered cardiovascular disease candidate from its phase 2 pipeline. Months after reporting positive trends on exploratory efficacy endpoints, the Big Pharma has pushed the mRNA candidate out the door while also dropping its Wee1 inhibitor after many years of development. Read Full Article on Fierce Biotech >>
Telehealth study among 26 to be funded through $258M from nonprofit
August 2, 2022 / Telehealth / Research and Development R&D The Patient-Centered Outcomes Research Institute is spending $258 million on 26 new studies investigating mental health, heart health and chronic conditions; several of the studies will be designed to evaluate the effectiveness of telehealth services. Read Full Article on Beaker’s Hospital Review >>
GDIT Awarded $10B Medical Research & Development Contract by the Defense Health Agency
July 28, 2022 / GDIT / Defense Health Agency R&D GDIT was awarded a position to compete for task orders in all four market segments: Research and Development; Research and Development Support Services; Regulatory Processes; and Translational Science Support and Services. These four market segments encompass a broad range of program areas, including medical simulation technologies; infectious diseases; military health, performance, and recovery; clinical and rehabilitative medicine; and emerging science and technology. Read Full Article on Hit Consultant >>

// Politics

Senate Deal Could Mean Big Boost to New York Climate Efforts
August 2, 2022 / U.S. Senate / New York Climate Efforts U.S. Senate Majority Leader Chuck Schumer of New York and Senator Joe Manchin of West Virginia on Thursday announced a surprise deal on a massive budget reconciliation bill that, if passed, is likely to have major implications for New York. Read Full Gotham Gazette >>
Democrats Try to Go Big on Insulin Changes for Drug-Pricing Bill
August 2, 2022 / Drug Pricing / Insulin Members of Congress continue to push a misguided drug pricing proposal under the guise of negotiation as part of the reconciliation package. Democrats want to make insulin a major part of drug-pricing legislation set for a vote this week, but face a Senate rules hurdle, senators said. Democratic leaders want to reinstate two major provisions of their drug-pricing language, Sen. Jeanne Shaheen (D-N.H.), said Tuesday. One would automatically subject insulin products to government negotiations for lower prices and the other would cap what people pay out of pocket for insulin at $35 per month. Insulin can cost almost $100 per vial in the US, more than five times the average cost in Canada. Read Full Article on Bloomberg Law >>
Senate Democrats race to ready Inflation Reduction Act for vote this week
August 2, 2022 / Inflation Reduction Act / U.S. Senate Senate Democrats on Tuesday raced to ready their health-care, climate and tax legislation for a grueling floor fight as soon as this week, even as some in the party remained fearful about the potential for last-minute political disruptions. Read Article on Stars and Stripes >>
Critics Decry Drug Pricing Provisions In Inflation Reduction Act, Say They Will Stifle Innovation
August 2, 2022 / Drug Pricing / Inflation Reduction Act The push back against the prescription drug pricing provisions in the Inflation Reduction Act is relentless and hyperbolic. It’s not uncommon to hear detractors suggest that the measures will “stifle innovation” and “devastate” the pharmaceutical industry. Certainly, imposing rebates on list prices of drugs that exceed an inflation index, restructuring Medicare Part D (outpatient), and requiring Medicare negotiations for certain drugs, will challenge the industry in unprecedented ways. Read Full Article on Forbes >>
Another CA city votes to increase healthcare wages stirring controversy about where the funds will come from
August 3, 2022 / Healthcare / California On Monday, the city council of Monterey Park, about seven miles from downtown Los Angeles, voted in favor of a $25 minimum wage for healthcare workers in the city, just two weeks after the city of Downey did the same. The wave of wage increases follows the lead of Los Angeles Mayor Eric Garcetti who signed an ordinance on July 8 establishing a $25 minimum hourly wage for workers at eligible privately owned healthcare facilities. Read Full Article on MedCity News >>