// 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. A biosimilar is a generic version of a biologic drug. Unlike a generic, which is typically an exact copycat, biosimilars are similar to the branded drug, which means they typically have to undergo a clinical trial process. Semglee is a biosimilar for the reference drug, Sanofi’s Lantus, long-acting insulin to treat adults with type 2 diabetes and adults and pediatric patients (children six years and older) with type 1 diabetes. It is sold in a pre-filled disposable pen. Semglee is not indicated for diabetic ketoacidosis. It has an identical amino acid sequence to Lantus. Read Full Article on Biospace >>
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. Vonafexor, also known as EYP001, is being trialed in patients with nonalcoholic steato-hepatitis (NASH), a liver disease that causes excess fat to build up in the liver, leading to damage or even failure. The phase 2a study, called Livify, featured 96 patients who received either vonafexor or placebo. The therapy reduced liver fat by 5% or greater in 58% of patients, compared with 22% seen in the placebo group. Vonafexor also reduced other important biomarkers that can signal damage to the organ and improved kidney function, while patients on placebo saw a deterioration of kidney function. Read Full Article on Fierce Biotech >>
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. Additionally, patients treated with BIIB080 had reductions in a protein called tau that’s been linked to Alzheimer’s. Read Full Article on BIOPHARMA DIVE >>
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. Read Full Article on Outsourcing Pharma >>
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. On July 22, 2021, Catalent announced the launch of its next-generation cell-line development technology, GPEx Lightning, which combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines. Read Full Article on BioPharm International >>
Annovis Touts Alzheimer’s Drug As Better Than Biogen, But Failed Data Makes For A Bleak Day At The Stock Market
July 28, 2021 Alzheimers / Biotech / Clinical Study Annovis Bio wants its Alzheimer’s disease therapy to be better than Biogen’s Aduhelm, but the latest data shows the drug did not improve dementia symptoms, problem-solving, orientation or judgment, among other data points. The company revealed a mixed—and confusing—bag of results from a small phase 2a study Wednesday night at the 2021 Alzheimer’s Association International Conference in Denver. Annovis said Posiphen, also known as ANVS401, improved cognition by 30% in 25 days, but the conference presentation appeared to show the drug did not beat placebo on many—if any—points. Read Full Article on Fierce Biotech >>

// 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). Read Full Article on BioPharma Reporter >>
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. Now the firm has announced that it has used its AI to predict the shapes of nearly every protein in the human body, as well as the shapes of hundreds of thousands of other proteins found in 20 of the most widely studied organisms, including yeast, fruit flies, and mice. The breakthrough could allow biologists from around the world to understand diseases better and develop new drugs. Read Full Article on MIT Technology Review >>
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. “Medicines are information now,” Frey said. “How do we convert the complex biology to a way to design new medicines? To dominate this entire area, we need a way to convert this complex biology to this informational medicine.” Read Full Article on MedCIty News >>

// 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. “While we are on the right path, we need to work with more speed, urgency and agility, more closely matching the pace of change in the broader environment.” Read Full Article on Bloomberg >>
An AstraZeneca Spinout Scores a Buyout Option from Arena
July 27, 2021 Mergers & Acquisitions – M&A / Biotech 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. Arena’s option deal was accompanied by a $63 million Series B fundraising round for Aristea that included contributions from Fidelity Management & Research, Aristea’s original lead investor Novo Holdings and others. Arena added $10 million to the equity round, according to a statement. Read Full Article on BIOPHARMA DIVE >>
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. Pfizer’s revised estimate comes along with its second quarter earnings report. Based on contracts the company has signed through mid-July, Pfizer and BioNTech now expect to deliver 2.1 billion doses of Comirnaty worldwide this year and manufacture 3 billion. Read Full Article on Fierce Pharma >>
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. Read Full Article on Endpoints News >>
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 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. Lilly will pay $70 million in upfront cash and equity with an additional $2 billion in biobucks for a slate of immuno-oncology small molecule drugs from San Diego’s Kumquat Biosciences, a private oncology player led by Kevan Shokat acolyte and KRAS pioneer Yi Liu, the partners said Thursday. Read Full Article on Endpoints News >>

// 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. By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.
Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago—a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices. A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day. Read Full Article on Fortune >>
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. Humana said in the suit that the scheme has been critical to the drug’s success. Read Full Article on Fierce Healthcare >>
FDA Under Pressure to Restore “Normal” Drug Inspections
July 27, 2021 FDA / Safety / Inspections Congressional leaders, as well as regulated industry, want more information from FDA on its strategy for resuming inspections of manufacturing facilities to better assure the quality, safety and efficacy of medical products. The suspension of in-person field inspections in March 2020 has resulted in a huge backlog of delayed site visits, as FDA sent investigators only to those operations deemed “mission critical.” Read Full Article on Pharma Exec >>
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. Budesonide, the corticosteroid found in products including Pulmicort, is already administered in a wide range of dosage forms including oral capsules to treat conditions such as asthma and Crohn’s disease. Calliditas spied an opportunity to use its drug delivery technology to develop a formulation for use in the chronic autoimmune kidney disease IgA nephropathy patients. Read Full Article on Fierce Pharma >>

// 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. Here, Jo et al. tested this hypothesis in preclinical PD models. The authors showed that farnesol inhibited PARIS by promoting its farnesylation. In vivo, in multiple rodent PD models, farnesol reduced histological and behavioral abnormalities, and PARIS farnesylation was reduced in brain samples from patients with PD, suggesting that promoting PARIS farnesylation might have therapeutic effects in PD. Read Full Article on Science Magazine >>
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. In a small, mid-stage clinical trial, 13 of 14 patients, or 93%, treated with a higher dose of the Cytokinetics drug, called CK-274, achieved improvement in blood flow to a target level where they no longer met the threshold for being diagnosed with their disease — obstructive hypertrophic cardiomyopathy, or HCM. No concerning or unexpected side effects were reported. Read Full Article on STAT >>
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. In a study published today in Molecular Psychiatry, the team show that changes in the extracellular matrix of the brain — ‘scaffolding’ around nerve cells — lead to loss of memory with ageing, but that it is possible to reverse these using genetic treatments. Read Full Article on Science Daily >>
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. Previous reports have linked long-term air pollution exposure with accumulation of Alzheimer’s disease-related brain plaques, but this is the first accumulated evidence that reducing pollution, especially fine particulates in the air and pollutants from the burning of fuel, is associated with lower risk of all-cause dementia and Alzheimer’s disease. Read Full Article on Science Daily >>

// 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”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies. Read Full The National Law Review >>
‘CON laws’ limit the health care competition Biden aims to deliver
July 24, 2021 Affordable Care Act / Healthcare Costs On July 9, Biden signed a wide-ranging executive order aimed at promoting more competition in the American economy by urging federal agencies to crack down on anti-competitive practices in various sectors, including health care. 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. By limiting competition, CON laws, not surprisingly, are associated with higher health care costs and fewer medical services per capita. Read Full Article on The Hill >>
BB Healthcare Trust: The Impact of US President Joe Biden’s Administration on the Healthcare Sector
July 26, 2021 US Drug Pricing / Healthcare Costs / Video BB Healthcare Trust’s (LON:BBH) Brett Darke joins Proactive London’s Katie Pilbeam to discuss the impact of US President Joe Biden’s administration on the healthcare sector so far. 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. Watch on YouTube >>