// 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.
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.
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.
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.
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.
// 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.
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.
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.”
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.
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.
// 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.
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.
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.
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.
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.
// Legal & Regulatory
Bayer, Janssen Pharmaceuticals Sue Mylan for Patent Infringement of Xarelto
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.
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
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.
FDA drafts guidance on patient labeling information for LASIK devices
August 1, 2022 / FDA / LASIK
n 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.
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.
// 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
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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.