// Biotech and Pharma Therapeutics
ChemoCentryx’s drug gets U.S. FDA nod for treating rare autoimmune disease
October 8, 2021 / ChemoCentryx / FDA / Autoimmune Disease
ChemoCentryx Inc. said on Friday the U.S. health agency approved its lead drug for treating a rare, fatal autoimmune disease, sending the biopharmaceutical company’s shares up by more than 70%.
Supporting Patient Adherence Through Electronic Prior Authorization and First Fill Copay Programs
With 51% of physicians reporting that prior authorizations (PAs) for prescribed branded and specialty medications have significantly expanded over the last five years, PA requirements continue to be a major hurdle for patients and healthcare providers (HCPs) alike.
Biohaven’s Nurtec, with dual migraine approvals, hits $136M in quarterly sales and leads the pack in market share
October 5, 2021 / CGRP / Drug Launch / Migraine / Biohaven Pharmaceuticals
Biohaven’s migraine drug Nurtec ODT has been on a roll since becoming the first medicine to win a dual FDA approval to both treat and prevent migraines. Now, the company is posting sales figures that might make some of its Big Pharma rivals in the migraine field jealous.
1 In 10 Americans Turn To Social Media For Health Information, New Survey Shows
October 6, 2021 / Social Media
Amid culture wars over masking, Covid-19 treatments, and vaccine mandates, many Americans are at a loss for who to trust when it comes to healthcare information.
Voyager Therapeutics’ strategy shift to gene therapy tech leads to a Pfizer alliance
November 6, 2021 / Voyager Therapeutics / Pfizer / Cardiovascular
The gene therapy pipeline of Voyager Therapeutics has hit several setbacks in the past year, but a strategy shift to its capsid technology is now showing promise. Pfizer has signed on as partner in a wager that Voyager’s tech holds the key to delivery of gene therapies for cardiovascular and neurological disorders.
// 4th Industrial Revolution
Contributed: Technology is helping physicians and pharma to better coexist
October 8, 2021 / Healthcare / Accenture
Healthcare is undoubtedly one of the most complex and nuanced industries there is, especially in the U.S. So, it is no surprise that the relationship between physicians and pharma is complicated at best.
Teladoc’s latest primary care offering, Primary360, available to payers
October 6, 2021 / Teladoc Health / Primary360 /
Primary360 allows members to choose a primary care provider and work with a care team, which can also help them find in-person providers if necessary. Members can make personalized healthcare plans and schedule phone or video telehealth appointments.
A Visual Guide to Investing in Psychedelics
October 4, 2021 / Psychedelics / Investing
This graphic provides a visual guide to investing in psychedelics, breaking down each sector and the companies that operate within them.
Why Healthcare IT Must Embrace Full-Stack Observability for an Increasingly Digital Future
October 8, 2021 / Healthcare / Digital Future / Covid-19
Applications can assist with scheduling appointments, virtual doctor visits, accessing medical records and conducting tests down to the most complex AI-powered technologies such as medical imaging. As COVID-19 fundamentally transformed the way industries operate, healthcare has been the world’s focus as physicians, nurses, EMTs, and other healthcare practitioners have stepped up to provide routine as well as critical care amid chaos and a period of transformation.
The ‘patient of the future’ is driving radical innovation in healthcare
October 5, 2021 / Innovation / Healthcare / Digital Data
The healthcare industry is also changing as its ‘customers’ move from ‘boomer’ patients to digital natives. These individuals no longer accept the patient role of past generations. They want to be involved, proactive contributors to their own health, with access to their own health information.
// Business & Markets
Xeris Pharmaceuticals Completes Acquisition of Strongbridge Biopharma
October 5, 2021 / Xeris Pharmaceuticals / Acquisition / Strongbridge Biopharma
Xeris Pharmaceuticals, Inc. (“Xeris”), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that it has successfully completed the previously announced acquisition of Strongbridge Biopharma plc (Nasdaq: SBBP) (“Strongbridge”).
Poolbeg Pharma launches AI programme with Eurofins Genomics
October 8, 2021 / Poolbeg Pharma / Eurofins Genomics / AI
CEO of Poolbeg Pharma, Jeremy Skillington, says that the aim of this partnership is to complete the next-generation RNA sequencing of respiratory syncytial virus (RSV) disease progression samples from human viral challenge studies.
Xenon Pharma secures $300M capital raise via equity offering
October 5, 2021 / Xenon Pharma / Equity
Xenon Pharmaceuticals (XENE) has priced its public offering of 8,474,577 common shares and, pre-funded warrants to purchase up to 1,694,915 common shares. The common shares and…
Gene therapy developer gets chance at a comeback with Pfizer deal
October 6, 2021 / Gene Therapy / Pfizer / Voyager Therapeutics
Voyager’s first generation of gene therapies for ALS, Parkinson’s and Huntington’s disease, all now discontinued, relied on a direct infusion into brain tissue, an invasive procedure. The company claims its new technology, dubbed TRACER, is more cell- and tissue-specific and can penetrate the blood-brain barrier, allowing it to be infused through a less invasive intravenous procedure.
Three New Nasdaq Tickers and MPM Capital Secures $850 Million to Impact Oncology
October 8, 2021 / Nasdaq / Oncology / Cognition Therapeutics
Cognition is developing small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system. Compounds within its pipeline target the σ-2 (sigma-2) receptor, which is a key regulator of the cellular damage response. The receptor is expressed in multiple call types, including neuronal synapses.
// Legal & Regulatory
FDA offers best practices for patient-facing alerts on medical device vulnerabilities
October 8, 2021 / FDA / Patient / Radiological Health
The U.S. Food and Drug Administration released a new best practices document this week to help healthcare actors and government agencies design a communication approach regarding cybersecurity vulnerabilities. The agency’s Center for Devices and Radiological Health notes that the document is not a guidance and doesn’t create any regulatory expectations.
FDA halts all Allogene cell therapy trials after chromosome problem detected
October 8, 2021 / FDA / Chromosome / Cell Therapy / Allogene
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most advanced study developed what the company described as a “chromosomal abnormality.”
Health Privacy and Our Ambivalent Tech-Embrace – Lessons for Digital Health Innovators
October, 2021 / Health / Digital Health / Innovator
This ambivalence will flavor how health citizens will adopt and adapt to the growing digitization of health care, and challenge the healthcare ecosystem’s assumption that patients and caregivers will universally, uniformly engage with medical tools and apps and technologies.
Pharmalittle: FDA scientists uncertain about Moderna vaccine boosters; pharma may face stricter rules for supplying meds in the EU
October 13, 2021 / FDA / Moderna / Vaccine
Drug makers may face stricter rules to ensure the supply of medicines in the European Union as the bloc tries to reduce its imports of pharmaceutical products from China and other foreign “autocracies,” Reuters explains. At the onset of the Covid-19 pandemic last year, the 27-country bloc encountered protracted problems in obtaining a wide range of medicines and their ingredients from India and China, as supplies tightened amid lockdowns and export restrictions.
// Research & Development
Researchers demonstrate vaccination approach in mice that could prevent future coronavirus outbreaks
October 8, 2021 / Vaccine / Covid-19 / SARS-CoV-2
The SARS-CoV-2 virus responsible for COVID-19 enters human cells by using its spike protein to bind to a cell surface receptor called ACE2.
Nanotechnology offers alternative ways to fight COVID-19 pandemic with antivirals
October 7, 2021 / Nanotechnology / Covid-19 / Antiviral
A flurry of recent papers highlights growing interest in approaches that employ nanomaterials as antiviral countermeasures. Compared with traditional small molecules or antibodies that inhibit viral replication or cellular entry, nanotechnology offers drug developers virus binders, cell-membrane decoys or viral-envelope inhibitors that may complement conventional antiviral therapies. With the help of an influx of funding spurred by the COVID-19 pandemic, some researchers hope that these materials could soon move towards clinical translation.
Yale spinout shows how targeting cancer cells’ acidic environment might enhance immunotherapy
October 7, 2021 / Antibody-drug Conjugates / Checkpoint Inhibitors / Combination Therapy / Immuno-oncology
Antibody-drug conjugates such as AstraZeneca and Daiichi Sankyo’s Enhertu have shown unparalleled efficacy in certain biomarker-driven tumor types. But those therapies are not as effective at attacking cancer cells that lack the antigen they are designed to target. Yale University spinout Cybrexa Therapeutics is reporting promising early evidence indicating it may have a solution to that shortcoming.
Algorithmic app could head off suicides of high-risk adolescents
October 2, 2021 / Algorithmic App / Mental Health / AI
While the subjects were simulated patients, the preclinical work also succeeded in showing that Bayesian network modeling is “an accurate and very efficient branch of AI in psychiatry and clinical psychology,” the authors state.
Mirati teams with Sanofi on PhI/II trial for KRAS treatment combo; AbbVie loses in latest Humira biosimilar development
October 8, 2021 / Mirati teams / Sanofi / AbbVie / Humira
Mirati and Sanofi on Friday announced their new non-exclusive, clinical collaboration to evaluate combining Mirati’s investigational KRAS G12C inhibitor adagrasib with Sanofi’s investigational SHP2 inhibitor RMC-4630 in an upcoming Phase I/II study.
// Politics
Why Sweden Is Suspending The Moderna Shot For Those Under 30
October 6, 2021 / Moderna / Sweden / Covid-19
The Swedish Public Health Agency identified this group as particularly susceptible to side effects that include an increased risk of “inflammation of the heart muscle or the pericardium,” a membrane close to the heart and blood vessel roots. The chance of experiencing side effects, it noted, was found mainly in boys and men.
Study shows Medicaid expansion increased access to bariatric surgery for obesity
October 8, 2021 / Medicaid / Obesity / Affordable Care Act
Following the Affordable Care Act (ACA) Medicaid expansion, access to bariatric surgery as a treatment for obesity increased by 31% annually for lower-income Medicaid-covered and uninsured white adults age 26 to 64 but not for Hispanic and Black adults, according to research conducted by scientists at Wake Forest School of Medicine.
California makes it illegal to remove condom without consent
October 8, 2021 / California Bill / Consent
Under the bill, a person commits sexual battery who “causes contact between a sexual organ, from which a condom has been removed, and the intimate part of another who did not verbally consent to the condom being removed.”
Feds OK health plan discounts for coronavirus vaccination
October 7, 2021 / OK Health / Covid-19 / Vaccine
Monday’s guidance came from HHS, the U.S. Department of Labor and the U.S. Department of the Treasury and discussed compliance with the Coronavirus Aid, Relief, and Economic Security Act, HIPAA and the Affordable Care Act.