// Biotech and Pharma Therapeutics
New Day For Diabetes Patients As FDA Approves First-Ever Interchangeable Biosimilar
July 29, 2021 / Diabetes / FDA / Biologics
The U.S. Food and Drug Administration (FDA) approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection), which they’re calling the first interchangeable biosimilar product.
Enyo Pharma’s NASH Results Show Boost in Kidney Function, Differentiating Vonafexor From Busy Field
July 28, 2021 / Biotech / NASH / Renal
Enyo Pharma’s liver disease drug reduced liver fat and boosted kidney health during a mid-stage clinical trial, meeting its main and secondary goals while supporting the design of next stage pivotal studies.
Biogen, Ionis Tout Data From Early Study Of RNA-Based Alzheimer’s Drug
July 27, 2021 / Biotech / Alzheimers / RNA
Biogen and Ionis Pharmaceuticals said Monday that one of their experimental drugs for Alzheimer’s disease has shown early signs of being safe and effective. Results from the first part of a small, placebo-controlled study found the drug, known as BIIB080, to be safe and tolerable, with no serious adverse events seen among any patient who received it.
BMS, Bridgebio Partner To Study Drug Combo For Lung Cancer
July 27, 2021 / Oncology / Lung Cancer / Clinical
The two pharma firms will partner to study the efficacy of Opdivo, paired with a SHP2 inhibitor, to treat non-small cell lung cancer with KRAS mutations.
Catalent Biologics Launches New Cell Line Expression Technology
July 22, 2021 / Diabetes / Chronic Kidney Disease – CKD
Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.
// 4th Industrial Revolution
New Elearning Program Aimed At Enabling Faster Clinical Adoption And Improving Patient Access To Atmps
July 26, 2021 / 4IR / Elearning / ATMPs
A new UK eLearning program is targeted at healthcare and academic professionals to support their learning on advanced therapy medicinal products (ATMPs).
Deepmind Says It Will Release The Structure Of Every Protein Known To Science
July 22, 2021 / 4IR / Data / Artificial Intelligence – AI
Back in December 2020, DeepMind took the world of biology by surprise when it solved a 50-year grand challenge with AlphaFold, an AI tool that predicts the structure of proteins. Last week the London-based company published full details of that tool and released its source code.
AI-Driven Deep Genomics Gets $180M To Turn Biology Into Informational Medicines
July 28, 2021 / 4IR / Artificial Intelligence / Genetic Data
Deep Genomics uses artificial intelligence to analyze genetic data. The technology of the Toronto-based company is feeding a pipeline of drug candidates, internal and partnered, that are advancing to clinical testing. Frey is now floating the ambitious goal of making Deep Genomics the world’s leader in producing and selling genetic medicines.
// Business & Markets
Merck to Look for Deals, Prioritize Research, New Executives Say
July 29, 2021 / Deals / R&D / Strategy
Merck & Co. is plotting a course for the company that includes deal-making and sustained investment in research and development, new members of the company’s leadership team said. “There’s broad agreement that investment in R&D should remain our highest strategic priority,” Chief Executive Officer Rob Davis, who took the reins July 1, said Thursday on the company’s second-quarter earnings call.
An AstraZeneca Spinout Scores a Buyout Option from Arena
July 27, 2021 / Mergers & Acquisitions – M&A / Biotech / AstraZeneca
Arena Pharmaceuticals has paid $60 million for an option to acquire Aristea Therapeutics, a private biotech founded in 2018 to develop an experimental inflammatory drug discovered by AstraZeneca.
Pfizer Now Expects COVID Vaccine Sales To Reach $33.5B This Year, A Whopping $7.5B Bump From Its Estimate 3 Months Ago
July 15, 2021 / COVID-19 / Vaccines
Three months after estimating 2021 revenues for its COVID-19 vaccine Comirnaty would reach a whopping $26 billion, Pfizer has jacked up its estimate by an additional $7.5 billion.The company now predicts 2021 sales of $33.5 billion for its BioNTech-partnered mRNA shot as it enters another stratosphere among the most lucrative pharmaceutical products in history.
Deerfield and ARCH Back a New $200M SPAC Run by California VC Firm
July 28, 2021 / SPAC / IPO / Venture Capital
Two prominent life sciences firms have teamed up to sponsor a new SPAC that made its way to Nasdaq on Tuesday evening. Deerfield Management and ARCH Venture Partners are backing the blank check company known as DA32 Life Science Tech Acquisition Corp., which priced at $200 million Monday, the firms announced. The pair is teaming up with California-based VC firm Section 32, whose managing partner Steven Kafka will run the SPAC.
Eli Lilly Teams Up With KRAS Drug Pioneer Yi Liu Targeting Small Molecule I/O With $70M Upfront
July 29, 2021 / SPAC / IPO / Venture Capital / Eli Lilly
Among the major drugmakers, oncology has become a gold rush in recent years with the big dogs hoovering up research partners along the way. One of the pioneers of KRAS drug development will now help Eli Lilly on its search for next-gen I/O therapies.
// Legal & Regulatory
Pfizer Court Fight Could Legalize Medicare Copays And Unleash ‘Gold Rush’ In Sales
July 27, 2021 / Drug Pricing / Medicare / Lawsuits
Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.
Humana Sues Regeneron, Claiming Drugmaker Overpriced Its Popular Drug Eylea
July 28, 2021 / Healthcare Costs / Drug Prices / Pharmaceuticals
Humana has filed suit against Regeneron, alleging that the drugmaker inflated the price of its Eylea drug. According to a complaint, Regeneron inflated the price of the drug, which treats age-related macular degeneration, and then paid kickbacks disguised as donations to the Chronic Disease Foundation (CDF) to cover cost-sharing for patients who may be able to take a cheaper alternative.
Stada Scores Rights To Targeted Oral Steroid Under Review For An Autoimmune Kidney Disease
July 27, 2021 / Kidney Disease / Sustained Release Drug Delivery / Licensing
With Calliditas Therapeutics’ drug formulation, designed to unlock a new use case for the common corticosteroid budesonide, under review in the E.U. and U.S., Stada has struck a deal to bring it to market in certain regions.
// Research & Development
PARIS Farnesylation Prevents Neurodegeneration In Models Of Parkinson’s Disease
July 28, 2021 / Parkinson’s / Neurology / Degeneration
Inactivating Parkin mutations lead to parkin-interacting substrate (PARIS) accumulation and subsequent neurodegeneration in Parkinson’s disease (PD). Inhibiting PARIS accumulation might have therapeutic effect.
Cytokinetics Drug Improves Blood Flow In Patients With Inherited Form Of Heart Disease
July 19, 2021 / Heart Disease / Hypertrophic Cardiomyopathy – HCM
Cytokinetics said Monday that its experimental drug demonstrated statistically significant improvements in blood flow for patients with an inherited form of heart disease — a result that compares favorably to a competing heart drug recently acquired by Bristol Myers Squibb.
Scientists Reverse Age-Related Memory Loss In Mice
July 22, 2021 / Memory Loss / Dementia / Scaffolding
Scientists at Cambridge and Leeds have successfully reversed age-related memory loss in mice and say their discovery could lead to the development of treatments to prevent memory loss in people as they age.
Improving Air Quality Reduces Dementia Risk, Multiple Studies Suggest
July 26, 2021 / Memory Loss / Dementia / Scaffolding
Improving air quality may improve cognitive function and reduce dementia risk, according to several studies reported today at the Alzheimer’s Association International Conference® (AAIC®) 2021 in Denver and virtually.
// Politics
President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector
July 28, 2021 / Patient Healthcare / Executive Order
Access On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”.
‘CON laws’ limit the health care competition Biden aims to deliver
July 24, 2021 / Affordable Care Act / Healthcare Costs
CON laws vary from state to state but generally require health care providers to seek a government permission slip to add or expand facilities and services. In turn, existing health care facilities maintain government-approved monopolies of health care services by restricting supply, which can limit patient access and suppress innovation.
BB Healthcare Trust: The Impact of US President Joe Biden’s Administration on the Healthcare Sector
July 26, 2021 / US Drug Pricing / Healthcare Costs
More than six months in, Darke explains how his expectations of a Biden reign compare to the reality of what has already been achieved and takes viewers through the key areas currently being actively debated. In regards to the potential US drug-pricing reform, Darke explains how he thinks this could impact the BBH portfolio.