// Biotech and Pharma Therapeutics
Sanofi, Regeneron’s Dupixent tops TV spending again, with AbbVie’s Rinvoq close behind
September 9, 2021 / Big Pharma / DTC advertising / TV ads / AbbVie
Back on the list was Botox with ads for both migraine and aesthetic use. Botox got a boost from a new migraine ad that asks, and answers, potential questions people have about the neurotoxin’s use for migraine.
Biogen CEO blames Aduhelm’s rocky launch on ‘too much confusion, misinformation and controversy’
September 9, 2021 / Alzheimer’s / Reimbursement / Aduhelm / Biogen
Before Biogen scored an FDA approval for Alzheimer’s drug Aduhelm, the company probably hoped its launch would go much smoother than the last three months have been. It turns out Biogen’s CEO Michel Vounatsos is willing to say so publicly.
Eli Lilly to donate nearly $1M to Type 1 diabetes initiative
September 7, 2021 / Eli Lilly / Diabetes
According to a news release, the commitment between Lilly and the Helmsley Trust aims to create inclusive opportunities for members of the community and to make camperships accessible for all children with Type 1 diabetes.
Boehringer Ingelheim and Twist Bioscience Enter Therapeutic Antibody Discovery Collaboration
September 9, 2021 / Boehringer Ingelheim / Twist Bioscience / Antibody
Twist will receive an upfront payment for each program entry. In addition, Twist has the potential to earn up to a total of $710 million in success-based clinical, regulatory and commercial milestone payments for the multiple target discovery programs.
Decibel Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations for DB-OTO for the Treatment of Otoferlin-Related Congenital Hearing Loss
September 9, 2021 / Orphan Drug / Rediatric Disease / Hearing Loss
Decibel Therapeutics, a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for the company’s lead gene therapy product candidate, DB-OTO, for the treatment of patients with otoferlin-related congenital hearing loss.
// 4th Industrial Revolution
Utilizing machine learning to improve clinical trial design for acute respiratory distress syndrome
September 9, 2021 / Machine Learning / Clinical Trail / Respiratory Distress Syndrome
Although great progress in pharmaceutical therapies has been achieved over the last decades, some diseases, especially in the intensive care unit (ICU), are still characterized by high mortality, and efficient therapies would be well-received. However, clinical trials in the ICU are highly complex and prone to failure.
Wearable fitness company WHOOP acquires sports tech startup PUSH
September 3, 2021 / WHOOP / Startup / PUSH
Digital health and fitness company WHOOP announced the acquisition of sports technology startup PUSH Thursday in an undisclosed cash and stock transaction. The news comes days after WHOOP said it had secured $200 million in Series F funding, boosting its valuation to $3.6 billion.
AI trial for prostate cancer expanded across five hospitals
September 15, 2021 / AI / Prostate Cancer / Healthcare
Its artificial intelligence (AI) Galen Prostate technology aims to reduce diagnostic errors by using clinical-grade solutions to help pathologists detect and grade cancer.
Clinova launches health and wellness search engine with Caidr 3.0
September 9, 2021 / Clinova / Health and Wellness / Caidr 3.0 / New Tech
UK-based digital healthcare company Clinova has launched Caidr 3.0, the latest version of its health and wellness search engine for smart self-care. Key features include a search tool for health topics, treatments and products and messages and content on wellbeing and local advice on health while travelling abroad.
How entrepreneurs can meet the moment in digital healthcare innovation
September 6, 2021 / Digital Health / Healthcare / Innovation
As the popularity of digital healthcare only continues to grow, the innovative entrepreneurs who balance all factors of the ‘consumer’ patient experience will find the highest adoption.
// Business & Markets
Mammoth Biosciences Raises $195 Million, Vaulting Its Crispr Tech To Unicorn Status
September 9, 2021 / Mammoth Biosciences / Unicorn Status / Gene Therapy
Investors are betting the protein toolbox of the four-year-old startup can solve one of gene therapy’s trickiest problems: getting treatments into the patient’s body.
How CVS Health Drives Cardinal Health’s Distribution Financials
September 9, 2021 / CVS Health / Financials
In Cardinal’s 2021 fiscal year, CVS purchased more than $42 billion in pharmaceuticals from the wholesaler—about double the figure from 10 years ago.
Baxter, looking to accelerate connected care, will acquire Hillrom for $10.5B
September 3, 2021 / Bexter / Hillrom
The medical products company Baxter International announced this week that it would acquire Hillrom, a connected care and collaboration tool vendor. The acquisition aims to expand digitally enabled connected care, especially beyond hospital settings, and provide a broader array of services to clinicians and patients.
RNA Editor ProQR Lines Up $1.5 Billion Deal with Eli Lilly
September 9, 2021 / RNA / Eli Lilly / ProQR
ProQR Therapeutics is collaborating with Eli Lilly to bolster the former’s Axiomer RNA editing platform and create new medicines that could treat a range of genetic disorders.
// Legal & Regulatory
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
September 9, 2021 / Covid-19 / Vaccine / MIS
MIS is a serious inflammatory condition affecting many parts of the body and symptoms can include tiredness, persistent severe fever, diarrhoea, vomiting, stomach pain, headache, chest pain and difficulty breathing. MIS has previously been reported following COVID-19 disease. The Danish patient, however, had no history of COVID-19.
Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy
September 7, 2021 / Cancer / BioMarin / Gene Therapy / FDA
A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed cancer.
Settling lawsuit, AstraZeneca and European Commission agree on coronavirus vaccine delivery
September 3, 2021 / Lawsuit / AstraZeneca / European Commission / Covid-19 / Vaccine
AstraZeneca said Friday that 140 million doses in total have been delivered so far. The company’s shot is given across two doses, much like the messenger RNA vaccines developed by Moderna and partners Pfizer and BioNTech.
// Research & Development
Science 37 teams up with Roche’s Foundation Medicine to boost home-based oncology trials
September 9, 2021 / Clinical Trial / Foundation Medicine / Science 37 / Cancer
Cancer trials typically have to be done within a hospital or community healthcare setting, but Science 37 and Roche’s genomics unit Foundation Medicine are teaming up to move some of this to an at-home setting.
WHO calls for coordinated dementia research efforts, looks to drive innovation in the field
September 7, 2021 / WHO / Dementia Research / Clinical Trials / R&D
Previously a series of unsuccessful clinical trials for treatments, combined with the high costs of R&D in the area, led to declining interest in dementia research but a new publicaion from the WHO notes a definite uptick in the funding of such work in more recent times.
Increasingly savvy patients call for shift in trial approach: Illingworth
September 7, 2021 / Patient Centricity / Patient Recruitment / Patient Engagement / Decentralized Trials
A leader from the home trial services provider say s patients’ increasing awareness of clinical research has how trial teams should consider their approach.
Building a biotech hub: Switzerland puts the focus on personalized medicine, mRNA , CGT and more
September 8, 2021 / Biotech / Switzerland / mRNA / CGT / Innovation
Switzerland wants to build on the momentum of recent years to get ahead in key aras for the future.
Autism drug fails in late-stage trials, Servier says
September 8, 2021 / Autism / Late-stage Trials / Neurochlore
Autism spectrum disorders affects about 1 out of every 54 children in the U.S. But while there are drugs available for some of the symptoms patients experience, there are no approved treatments for the underlying condition.
// Politics
Biden Administration Announces National Cybersecurity Initiatives
September 7, 2021 / Biden / Cybersecurity
The Administration has been ramping up its cybersecurity efforts and encouraging private companies to do the same, especially since a malicious ransomware attack on US critical infrastructure company Colonial Pipeline in May.
Florida nursing home group fears staffing challenges after Biden issues COVID vaccine requirement
September 10, 2021 / Biden / Medicare / Negotiation
After President Biden announced the plan for COVID vaccinations for healthcare worers, the Florida Health Care Association, the state’s largest nursing-home group, quickly raised concerns that the requirement would worsen staffing shortages and apply only to nursing homes.
Pharma’s uphill messaging battle over drug prices
September 8, 2021 / Pharma / Drug Prices / Medicare
The success of Democrats’ attempt to allow Medicare to negotiate prescription drug prices hinges on whether the drug industry can persuade voters — particularly seniors — that the policy would result in fewer new drugs, an endeavor that experts say is an uphill battle.