// Biotech and Pharma Therapeutics
The worst pharma launch of all time?
October 22, 2021 / Pharma Launch / Biogen / Alzheimer’s
Biogen’s Alzheimer’s disease drug Aduhelm has seen slow uptake from the get-go, hampered by inconclusive efficacy data and a $56,000 sticker price. The firm’s third-quarter earnings reveal just how slow its debut has been.
Pharma’s reliance on horseshoe crabs is threatening the species
October 22, 2021 / Pharma / Horseshoe Crabs / Vaccines
The animals’ bright blue blood contains Limulus Amebocyte Lysate (LAL), a substance used by pharmaceutical companies the world over for bacterial endotoxin testing. LAL clots when it encounters bacterial endotoxins, enabling the detection of the potentially deadly contaminants in parenteral drugs, vaccines and medical devices.
Pharma Advertisers Try New Ways to Reach Doctors During the Pandemic
October 21, 2021 / Pharma Advertisers / Pandemic / COVID
Pharma VOICE Therapeutic Digest OCT 2021
October, 2021 / Pharma VOICE / Neurology Therapeutics
Amid the continued effects of the global Covid-19 pandemic, 2021 has been a year of remarkable activity in neurology therapeutics, encompassing treatments for the brain, spinal cord and nerves. New medicines for Alzheimer’s disease migraine, and a host of rare conditions have been prominent in the medical literature and popular news and have been a major focus of industry education and promotional activity.
44% of Healthcare and Pharmaceutical Organizations Have Experienced a Data Breach Caused By a Third Party in the Last 12 Months
October 22, 2021 / Healthcare / Pharma / Medical Devices
With vendors and third parties supplying most of the components that make up the healthcare provider ecosystem, the very structure of the healthcare industry creates a greater attack surface area for data breaches, ransomware, and remote takeover of medical devices.
// 4th Industrial Revolution
Four big pharma companies team up in AI initiative focused on drug R&D
October 17, 2021 / AstraZeneca / Merck / Pfizer / Teva / StartUp / Drug Discovery
A new startup initiative in Israel aims to create and invest in startups that use artificial intelligence to address challenges in drug discovery and development. Called AION Labs, this innovation lab stems from an economic development effort from the Israeli government and will have contributions from AstraZeneca, Merck, Pfizer and Teva Pharmaceutical.
Google gains a sure foothold for building its healthcare AI résumé
October, 2021 / Google / AI / Healthcare
A 17-hospital, 500-site health system in the Northeast is going all in with Google Cloud: It’s migrating clinical and operational data to Google’s Workspace and Chrome Enterprise platforms while also partnering with the Silicon Valley giant on AI and machine learning.
AI System Now Has FDA Clearance for Type 2 Diabetes
October 19, 2021 / AI / FDA / Diabetes
Advisor Pro is the first ever decision support system to get FDA clearance on using data by patients who use insulin pumps and monitor their blood glucose levels using Continuous Glucose Monitoring (CGM) or Self Monitor the Blood Glucose (SMBG). The system was already in action for patients with diabetes type 1, but the new clearance allows to expand Advisor Pro’s target population to patients with type 2 diabetes.
Using Machine Learning to Study Changes in Tumors After Immunotherapy
October 18, 2021 / Machine Learning / Tumors / Immunotherapy
By combining detailed mapping of the biochemical composition of tumors with machine learning, Johns Hopkins University engineers created the first non-invasive optical probe to understand the complex changes in tumors after immunotherapy.
GeniusRx Digital Pharmacy Launches Asynchronous Telehealth Offering
October 22, 2021 / Digital Pharmacy / Telehealth / GeniusRx
With the growing need for on-demand remote care brought on by the COVID-19 pandemic and longer than traditional waiting times, GeniusRx™ knew bringing on telehealth solutions to its current pharmacy platform was an absolute must in the trajectory of its roadmap.
// Business & Markets
Ionis Pharma Shares Drop 12% After Tofersen Study Misses Primary Endpoint
October, 2021 / Ionis / Pharma / Tofersen
By Chris Wack Ionis Pharmaceuticals Inc. shares fell 12% to $30.90 after the company said a study for tofersen missed its primary endpoint. The Company said…
Adamis Pharma Shares Rise 16% After FDA Approves Zimhi for Opioid Overdose
October, 2021 / Adamis / Pharma / FDA / Zimhi / Opioid
Adamis Pharmaceuticals Corp. shares were up 16% in heavy trade to $1.30 after the company said the U.S. Food and Drug Administration has
The Daily Biotech Pulse: Athira CEO Resigns Over Doctored Research, Merck’s Keytruda Snags First Approval For Breast Cancer In Europe, Minerva And Xilio IPOs
October 22, 2021 / Breast Cancer / Merck / Athira Pharma
Athira Pharma, Inc. announced the appointment of Mark Litton, who was serving as the company’s chief operating officer, as its chief executive officer. Litton succeeds Leen Kawas, who has resigned from her position as President and CEO and as a member of the company’s board. Kawas was placed on leave after papers she published as a student were found to contain altered research.
Downtown San Diego: A New Frontier for SoCal Life Science?
October 13, 2021 / San Diego Biotech / Startups / New Tech
Once brimming with the energy of tech startups, marketing agencies and professional service firms—as well as a thriving retail, dining, arts, theater and music scene—Downtown San Diego has a long way to go to achieve its pre-pandemic vitality. Over the past year and half, many downtown companies moved out of tens of thousands of square feet of office space, leaving more than a 40% availability.
23andMe Acquires Lemonaid Health for $400M – Health M&A
October 22, 2021 / 23andMe / Lemonaid Health
For $25 per visit, patients can request prescriptions by filling out a questionnaire and attaching a picture for the doctor to write out the prescription, and then have it automatically sent to a locally preferred pharmacy within a 2-hour turnaround time. The visit cost is much cheaper than a co-pay, and an email summary of the care provided is sent to the patient’s primary care doctor.
// Legal & Regulatory
Tech, pharma companies divided in PTO patent-eligibility comments
October 19, 2021 / Tech / Pharma / PTO / J&J / Patient
Johnson & Johnson and other pharmaceutical companies have told the U.S. Patent and Trademark Office that the unpredictable state of patent law has discouraged investment in important technologies, while tech companies including Google LLC and Dell Inc say the current system safeguards against bad pa…
FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test
October 20, 2021 / Clinical Trial / Oncology / Amgen / AstraZeneca
We found out, via a small and almost unnoticed ClinicalTrials.gov update today, that AstraZeneca suspended trial work on its experimental blood cancer drug AZD5991. Now, we have learned that things are in fact bleaker for the therapy.
FDA refusal of Stealth Bio drug shows challenges of ultra-rare disease studies
October 21, 2021 / FDA / Stealth Bio
The FDA refused to review Stealth BioTherapeutics’ Barth syndrome drug, telling the company results in a study of just eight patients are insufficient to support its submission. The impasse highlights the challenges of testing drugs for ultra-rare diseases. Barth is so rare that Stealth is unsure it can recruit patients to run a new study.
FDA approves first interchangeable biosimilar to Humira
October 19, 2021 / FDA / Humira
Boehringer Ingelheim signed an agreement with AbbVie that would delay U.S. sales of Cyltezo until 2023. And although FDA has also approved Amjevita as a Humira biosimilar, its sale is wedged in lawsuits between its manufacturer, Alvotech, and AbbVie.
During a Global Health Crisis, IP Rights Are Getting a Bad Rap
October 22, 2021 / Global Health Crisis / COVID /
Let’s take a quick look at what patents do. At the heart of every patent is a basic quid pro quo. In exchange for limited exclusivity over manufacturing, use and sales of the medicines, inventors invest sometimes billions of dollars into research and development to concoct lifesaving innovations and share them with the rest of the world. In the case of COVID-19 vaccines, this global innovation incentive has brought about effective inoculations in record time.
// Research & Development
Princeton and MIT gene-editing pioneers uncover clues for improving CRISPR and other tools
October 20, 2021 / Cell & Gene Therapy / CRISPR / Gene Editing / Beam Therapeutics
Gene-editing technologies such as CRISPR have shown promise as both research tools and therapies for a range of diseases. But existing tools don’t always alter the genome as intended, and they can cause unwanted and potentially dangerous mutations.
Lingering ‘Brain Fog’: Study Finds High Rate Of Cognitive Impairment Months After Covid-19 Infection
October 22, 2021 / Brain Fog / Mental Health . Covid-19 / New Study
High numbers of Covid-19 patients show impaired cognitive functioning months after diagnosis, according to a study published Friday in JAMA Network Open, shedding light on “brain fog,” a common complaint among the many survivors experiencing ‘long Covid’—lingering coronavirus symptoms months after infection.
Research Roundup: Regrowing Nerve Cells in Spinal Cord Injuries and More
October 22, 2021 / Nerve Cells / SpinalCord / New Study
Investigators at Washington University School of Medicine in St. Louis identified a compound that can help sensory neurons in the central nervous system to heal. Working with mice with injured sensory neurons, the researchers gave the animals a drug called fenofibrate. The drug is approved by the U.S. Food and Drug Administration (FDA) to treat high cholesterol. In their experiments, fenofibrate activated the support cells that surround sensory neurons, helping them regrow about twice as fast as the control group’s sensory neurons. They published their research in eLife.
Smooth Sailing for Regeneron and LEO Pharma in Phase III
October 22, 2021 / Regeneron / LEO Pharma / Tralokinumab
Week 16 results from the 52-week Phase III ECZTRA 6 trial demonstrated a significant improvement in atopic dermatitis signs and symptoms in teens aged 12 to 17 years, even without rescue therapy. Tralokinumab is a high-affinity antibody that inhibits IL-13, which is the key driver of disease manifestations. It has not yet been approved in the U.S., but the European Commission and Health Canada have already allowed it for use in adults with the same skin condition.
Psychoactive compound to advance research in treatment of depressive disorders
October 20, 2021 / Psychoactive / Depression / Mental Health
Covar Pharmaceuticals has successfully guided an assortment of pharmaceutical products from early development stage to commercialisation. However, drug development efforts of both Lucid and FSD BioSciences for Lucid-PSYCH are at an early stage, and it is not yet certain that Lucid-PSYCH is assured for viable commercial therapeutic application.
// Politics
Biden doubts Medicare benefits expansion could make it into infrastructure package
October 22, 2021 / Centers for Medicare & Medicaid Services / Dental Care / Insurance Benefits / Reimbursement
Biden admitted during a CNN town hall Thursday that key centrist senators have an issue with adding dental, vision and hearing benefits to Medicare. The remarks come as Democrats in Congress start to coalesce around the infrastructure package.
U.S. officials caution companies about risks of working with Chinse entities in AI and biotech
October 22, 2021 / China / AI / Biotech
Collaborate smartly in key emerging technologies and mitigate risks, counterintelligence officials urge businesses
WHO plots multibillion-dollar campaign to buy COVID-19 antivirals for $10 per course: Reuters
October 19, 2021 / Covid-19 / Merck & Co / Molnupiravir / World Health Organization
Almost immediately after Merck reported impressive data for its COVID-19 pill, questions about pricing and access started swirling. It turns out officials at the World Health Organization are already working through those issues with a multibillion-dollar international effort.
Pharmalittle: Four Democratic senators may delay Medicare drug price reform; Western Covid vaccine stockpiles to hit 600M doses by year’s end
October 22, 2021 / Covid / Vaccine / Lawmakers / Drugmakers
The fate of the Democratic party’s ambitious goal of allowing Medicare to negotiate drug prices rests with a handful of key moderate senators, STAT notes. Negotiations on the exact scope of the reforms heated up this week after months of stalemate. But as lawmakers push to compile an outline of the massive domestic spending package that forms a cornerstone of President Biden’s domestic agenda, consensus on drug pricing policies has proved elusive. Besides Sen.