// Biotech and Pharma Therapeutics
The worst pharma launch of all time?
It isn’t the first kick-off that went south, but Aduhelm is probably the most hyped drug to have tanked.
Pharma’s reliance on horseshoe crabs is threatening the species
Conservationists say using the prehistoric horseshoe crabs’ blood for bacterial endotoxin testing is no longer justifiable.
Pharma advertisers try new ways to reach doctors during the pandemic
With fewer opportunities for in-person rep visits, the industry ramps up digital approaches.
Pharma VOICE Therapeutic Digest OCT 2021
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 educational and promotional activity.
44% of Healthcare and Pharmaceutical Organizations Have Experienced a Data Breach Caused By a Third Party in the Last 12 Months
SecureLink, a leader in critical access management, has released a new report titled “A Matter of Life And Death: The State of Critical Access Management in Healthcare,” revealing that third-party attacks in healthcare are on the rise and fundamentally threaten not just highly sensitive medical data, but patient care.
// 4th Industrial Revolution
Four big pharma companies team up in AI initiative focused on drug R&D - MedCity News
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 f…
Google gains a sure foothold for building its healthcare AI résumé
In honor of October, which is Breast Cancer Awareness Month, we have listed some of the ways that 3D printing is used in the fight against breast cancer.
AI System Now Has FDA Clearance for Type 2 Diabetes
With an estimated 9.3 percent of the world’s adult population living with diabetes, experts are making remarkable accomplishments to manage diabetes efficiently. DreaMed Diabetes AI LTD. — a …
Using Machine Learning to Study Changes in Tumors After Immunotherapy
Johns Hopkins University engineers are developing a machine learning method to understand changes in tumors after immunotherapy.
// Business & Markets
Ionis Pharma Shares Drop 12% After Tofersen Study Misses Primary Endpoint
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
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
Here’s a roundup of top developments in the biotech space over the last 24 hours. Stocks In Focus Athira Names Chief Operating Officer Mark Litton As Next CEO as Leen Kawas Resigns Athira Pharma, Inc. (NASDAQ: ATHA) announced the appointment of Mark Litton, who was serving as the company’s chief ope…
Downtown San Diego: A New Frontier for SoCal Life Science? - Hughes Marino San Diego
Downtown San Diego commercial real estate market expert Star Hughes-Gorup weighs in on the new frontier for life science in Southern California.
// Legal & Regulatory
Tech, pharma companies divided in PTO patent-eligibility comments
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
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 - MedCity News
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…
FDA approves first interchangeable biosimilar to Humira
Pharmacists can officially swap out the lower-cost biosimilar for Humira without consulting a health care provider.
// Research & Development
Princeton and MIT gene-editing pioneers uncover clues for improving CRISPR and other tools
Scientists at Princeton and MIT, including gene-editing pioneer David Liu, used a new screening method called Repair-seq to identify pathways that affect different outcomes in CRISPR/Cas9, prime editing and base editing. The findings could help design more accurate and efficient gene-editing systems…
Lingering ‘Brain Fog’: Study Finds High Rate Of Cognitive Impairment Months After Covid-19 Infection
High numbers of Covid-19 survivors showed signs of cognitive impairment months after infection, according to tests designed to evaluate memory, language and attention.
Research Roundup: Regrowing Nerve Cells in Spinal Cord Injuries and More
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.
Smooth Sailing for Regeneron and LEO Pharma in Phase III | BioSpace
Skin health logged major wins this week after two companies announced positive clinical trial results.
Biden doubts Medicare benefits expansion could make it into infrastructure package
President Joe Biden conceded that opposition from centrist Democrats could make it doubtful to add dental, vision and hearing benefits to Medicare as part of a major infrastructure package.
U.S. officials caution companies about risks of working with Chinese entities in AI and 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
Almost immediately after Merck & Co. 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.