// Biotech and Pharma Therapeutics
Focusing on smaller biotechs to have a big impact on society
Marcus Delatte spent over 10 years as a senior pharmacology and toxicology reviewer with the U.S. Food and Drug Administration (FDA). Today, he leverages his expertise to help small and mid-sized biotech companies develop scientific, technical and regulatory strategies at the specialized Clinical Research Organization (CRO) leader, Allucent. Here he discusses how and why he focuses his expertise on counseling smaller companies and mentoring the next generation of technical experts.
Nektar pins comeback hopes on Lilly collab and cancer combinator following bempeg blowup
Nektar Therapeutics is kicking through the rubble left months after the demolition of the company’s lead asset bempeg. It’s now pinning hopes on two clinical-stage assets set for critical milestones in the next two years.
Lilly has a full plate, as CMO jokes, ‘we need to leave J.P. Morgan and get back to work’
Before the sun has even risen on the first day of J.P. Morgan’s 2023 annual healthcare conference, two Eli Lilly execs already have their plates full, dubbing 2023 the year of new modalities and new medicines for the Big Pharma. “It’s an exciting time,” Patrik Jonsson, president of Lilly’s U.S. arm, EVP, president of immunology and chief customer officer, said early this morning, pointing to anticipated launches and the company’s next wave of innovation. “The impact we can make on patients has never been bigger than this right now. We just need to continue to get it right.”
Roche offers up to $554M in biobucks to in-need Kronos for small-molecule discovery pact
Kronos Bio had a rough end to 2022 after having to toss away a late-stage acute myeloid leukemia asset. But 2023 is already looking a bit brighter thanks to a new small-molecule drug discovery pact with Roche’s Genentech. The companies will collaborate on an initial two drug discovery programs in oncology, with each one focused on a transcription factor chosen by Genentech. Transcription factors are believed to provide the seeds for cancer initiation, progression, spread and resistance, so scientists want to develop inhibitors of these proteins that can turn off the mechanism.
Lilly, Biogen and more gear up for blockbuster launches in 2023: report
With many of the world’s top-selling drugs speeding toward patent expirations over the next few years, pharmaceutical companies are hurrying to identify replacements. In its 11th annual list of Drugs to Watch, data analytics company Clarivate highlights 15 that were launched in the U.S. last year or are likely to be approved in 2023.
// 4th Industrial Revolution
OR Health System to Test AI App That Tracks Blood Sugar Levels
After receiving a grant from the Leona M. and Harry B. Helmsley Charitable Trust, Oregon Health and Science University (OHSU) researchers developed an artificial intelligence (AI)-based app to evaluate and track type 1 diabetes patients’ glucose levels and plan to test the app in a clinical trial. According to the press release, about 1.45 million Americans are living with type 1 diabetes, and these patients generally find regulating their blood sugar level and evaluating the need to take insulin challenging.
Researchers Investigate When, How Healthcare AI Models Will Fail
Researchers from the Carle Illinois College of Medicine (CI MED) at the University of Illinois are investigating when and how medical artificial intelligence (AI) and machine learning (ML) models will fail or not perform as expected in an effort to improve these models. Many healthcare AI models perform well in certain settings but can experience drops in performance once they are deployed elsewhere, the researchers explained.
Blockchain Could Save Healthcare Billions Every Year
In recent years, blockchain has been one of the most-hyped technologies: A public ledger that lives on a network of computers, each validating any changes in real-time. Unlike traditional distributed databases with centralized management, blockchain offers a shared database, providing security, transparency, traceability, and speed. While the shared ledger idea can be traced back to the 80s, blockchain technology emerged in 2008 as the foundation for decentralized currency, namely Bitcoin.
Why direct primary care may be the future, and what technology is needed to support it
Homebound patients often struggle with complex medical conditions among the most costly in healthcare. Further, they typically face health equity issues related to social determinants of health, including the ability to visit a clinic, hospital or doctor’s office. Many in healthcare believe patients tend to be happiest and healthiest when they’re in the home. This increasing awareness could potentially fuel a trend toward shifting direct primary care into the home.
Why ML Monitoring is Essential to AI Success in Healthcare
Artificial intelligence (AI) adoption in the healthcare sector has grown significantly over the last decade, with no signs of slowing down. According to a 2021 report from HIMSS, 62% of clinicians are interested in using AI/ML tools. From front-line workers to back-office staff, every stakeholder in the healthcare continuum can leverage AI technology to enhance healthcare quality. In fact, ML models are already being used to collect and analyze patient data at scale, thereby allowing healthcare organizations to reduce human error and streamline physician workflows. The significant benefit of this technology is that clinicians have more time for hands-on patient engagement.
// Business & Markets
Looking past Humira, AbbVie boosts sales forecasts for successor drugs
As competition looms for AbbVie’s best-selling drug Humira, company CEO Richard Gonzalez on Tuesday laid out ambitious forecasts for sales of two successor drugs that, when combined, could exceed Humira’s peak. Speaking to investors at the J.P. Morgan Healthcare Conference, Gonzalez said AbbVie’s medicines Skyrizi and Rinvoq will together earn the pharmaceutical company at least $17.5 billion in 2025 and more than $21 billion in 2027. The new forecasts represent a big bump: as recently as last February, the company was predicting $15 billion in 2025 sales, which was already an increase for the $10 billion AbbVie had estimated back in 2020.
JPM23: Bayer hikes sales targets for Kerendia, Nubeqa to $3B each
For Bayer’s splashy reveal at the J.P. Morgan Healthcare Conference, the drugmaker raised its peak sales projection for heart medication Kerendia and prostate cancer treatment Nubeqa to 3 billion euros ($3.2 billion) each. The duo lead the company’s fleet of new growth drivers, which now have a peak sales potential of more than 12 billion euros ($12.9 billion) combined, Bayer said (PDF) Tuesday ahead of pharma chief Stefan Oelrich’s presentation.
Bristol Myers, Bayer forecast blockbuster future for rival blood thinners
Bristol Myers Squibb and Bayer this week said they expect rival blood thinners they’re each developing could exceed $5 billion in peak annual sales later this decade, if clinical testing shows them to be better than current top-selling treatments. The forecasts are indicative of the companies’ confidence in the experimental drugs. Known as Factor XIa inhibitors, they are meant to have lower risk of bleeding than Factor Xa-targeting medicines like Eliquis and Xarelto, but have shown mixed results in mid-stage trials.
Microsoft Strikes Partnership with Paige To Advance Cancer Diagnostics and Treatment
New York City-based Paige’s mission is to transform cancer diagnostics through AI and tissue pathology. It works with healthcare systems, hospitals and laboratories to digitize pathology and workflow, as well as use AI to help pathologists diagnose cancer faster. It has two approvals from the Food and Drug Administration: the Paige Platform, which allows pathologists to make a diagnosis on a digital slide, and Paige Prostate Detect, an AI application for detecting cancer in prostate samples.
AbbVie, following in footsteps of Lilly and Takeda, pays Anima $42M to go after undruggable targets
Eli Lilly helped put Anima on the map in 2018 when it paid $30 million upfront to collaborate with the biotech on translation inhibitors of several protein targets. The deal gave Lilly a way to target proteins that lack accessible binding sites. Lilly and Anima are hitting ribosomes that read mRNA to modulate the production of the target molecules rather than trying to engage the undruggable proteins directly. Takeda allied with Anima three years later, committing $120 million in upfront and preclinical research milestone payments to go after Huntington’s disease and other indications. Along the way, Anima caught the eye of AbbVie.
// Legal & Regulatory
Claiming Insulin Price Conspiracy, CA Sues Lilly, Novo Nordisk, Sanofi & PBMs
Eli Lilly, Novo Nordisk, and Sanofi, are the three drug companies named in the complaint. Together they account for more than 90% of the global insulin supply. The three additional defendants are CVS Caremark, Express Scripts, and Optum Rx, which are all pharmacy benefit managers (PBMs), companies that manage prescription benefits for insurers.
AstraZeneca, Avillion Land FDA Approval for First of Its Kind Asthma Inhaler
An asthma rescue inhaler from partners AstraZeneca and Avillion has won FDA approval, giving patients the option of a single product that both manages symptoms and controls underlying inflammation. For AstraZeneca, the new product could breathe new life into the pharmaceutical giant’s respiratory portfolio.The regulatory decision announced Wednesday follows the affirmative recommendation of an FDA advisory committee, which voted 16-1 in November that the inhaler’s benefits outweigh its risks in adults.
AstraZeneca’s first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use
As AstraZeneca fights to defend its aging two-drug inhaler Symbicort against generics, the company has a new approval to bolster its respiratory business. Wednesday, the British drugmaker said the FDA has approved Airsupra, formerly known as PT027, as the first and only rescue medication for as-needed use to reduce the risk of asthma exacerbations. Importantly, the drug is only approved in adults after the company and its partner Avillion sought approval in patients 4 and older.
Lilly rides TRex into regulatory T-cell space, paying $55M upfront for 3 immune-mediated disease drugs
Johnston Erwin has persuaded some old friends to up their bet on TRexBio. Twenty months after taking over as CEO of the biotech, the Eli Lilly veteran has landed a deal with his former employer that sees the trade of $55 million for exclusive rights to three regulatory T-cell (Treg) programs. TRexBio broke cover in the summer of 2021, simultaneously disclosing the appointment of Erwin, a pact with Lilly and the closing of a $59 million series A round. The San Francisco-based biotech attracted the attention on the strength of a platform for discovering ways to modulate Tregs, a subset of T cells that play a key role in tissue inflammation. Johnson & Johnson struck a deal with TRexBio one year ago.
AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma
Airsupra is part of a growing portfolio of new drugs that are helping offset wilting sales of older AstraZeneca respiratory medicines such as Pulmicort. It’s an essential therapeutic area for the British drugmaker; in the third quarter, respiratory and immunology drugs accounted for 14% of overall revenue. The company’s current top-selling respiratory medicine, an inhaler called Symbicort, brought in $630 million in the third quarter. But it’s facing increased competition as patents expire, leaving AstraZeneca to depend more on products such as Fasenra, an asthma drug approved in 2017 that had revenue of $353 million in the third quarter.
// Research & Development
Previously unachievable drug discovery insights created by Cardea’s BPU platform
Protein-protein interactions represent a significant proportion of functionally relevant biological interactions, and therefore, manipulating these interactions is an important therapeutic strategy. The main focus of the Qvit lab is the identification of molecular modulators of protein-protein interaction using bioinformatics analysis, peptide and protein chemistry, as well as system-wide biological assays. The lab goal is the development of compounds capable of modulating protein complexes that will allow a better understanding of the role of specific protein-protein interactions in cells and will be a starting point for the development of therapeutic compounds.
Oramed’s oral insulin flunks phase 3 diabetes test, sending stock down 70%
Oramed Pharmaceuticals’ dream of developing an oral insulin for type 2 diabetes looks to be over. With the candidate failing to beat placebo in a phase 3 trial, the biotech outlined plans to stop development and sent its share price tumbling in the process. For years, Oramed has plugged away at the idea that its protein oral delivery technology can transform the treatment of type 2 diabetes. By protecting insulin from the pH and proteases encountered after oral delivery, the biotech aimed to make it easier for patients with diabetes to take their medication—and improve blood glucose control and prevent weight gain into the bargain.
Alto’s hopes for brain biomarker strategy rise on phase 2 antidepressant data
Alto Neuroscience has pointed to the success of its antidepressant therapy in a phase 2a trial as proof that its precision psychiatry platform can identify the patients most likely to benefit from its treatment. The therapy, dubbed ALTO-100, hit the study’s primary endpoint of demonstrating a change in depression severity compared to baseline after six weeks in patients with major depressive disorder. Specifically, the 59 patients that Alto identified as having a relevant brain biomarker saw a mean 15.5 point reduction in their severity score, while the 64 patients without the biomarker saw a more modest 10.6 point decrease.
JPM23: After hiatus, Teva looks to amp up research collaborations, CEO says
Faced with a question on dealmaking at the J.P. Morgan Healthcare Conference, Francis said he wants to push Teva toward more research collaborations. The CEO, a veteran of Biogen and Novartis’ Sandoz, said there’s been an “explosion of science” in biopharma over the last five years. “It’s not contained in Big Pharma anymore,” he added. “Research is moving fast everywhere, and I think we’ve seen that. And so I think that creates opportunities for companies to partner with Teva because of our global capability.”
Cash-strapped Calithera closes down in shadow of enrollment delays to cancer trials
Calithera Biosciences has kept its head down since a phase 2 fail in 2021 caused layoffs for a third of its workforce. But in the wake of enrollment delays for two lead cancer therapies, the cash-strapped biotech has given up the fight and announced it’s liquidating the business. “The board of directors and management devoted substantial time and effort in identifying and pursuing various opportunities, but we were unable to complete a transaction that would allow us to continue the development of our clinical programs and enhance shareholder value,” CEO Susan Molineaux, Ph.D., said in a release Monday.
Pfizer gives $1 million to Republican Party of Kentucky to expand its headquarters
In what may be the largest political contribution ever given to a political party in Kentucky, the drug maker Pfizer Inc. gave $1 million last month to the building fund of the Republican Party of Kentucky. A report filed by Republican Party of Kentucky Building Fund last week with the Kentucky Registry of Election Finance listed the $1 million from Pfizer along with five other big corporation contributions in the final quarter of 2022 totalling $1.65 million.
California Attorney General Sues Drugmakers Over Inflated Insulin Prices
The 47-page civil complaint alleges three pharmaceutical companies that control the insulin market — Eli Lilly and Co., Sanofi, and Novo Nordisk — are violating California law by unfairly and illegally driving up the cost of the drug. It also targets three distribution middlemen known as pharmacy benefit managers: CVS Caremark, Express Scripts, and OptumRx. “We’re going to level the playing field and make this life-saving drug more affordable for all who need it, by putting an end to Big Pharma’s big profit scheme,” Bonta said at a news conference after filing the lawsuit in a state court in Los Angeles. “These six companies are complicit in aggressively hiking the list price of insulin, at the expense of patients.”
Patient access is political, say CGT experts
DeSantis unveils plan to lower drug prices, increase transparency with ‘Big Pharma’
Gov. Ron DeSantis unveiled a proposal on Thursday to increase transparency in the pharmaceutical world and ultimately lower prescription drug costs for Floridians. According to the governor, a key part of the plan is checking the power of “Big Pharma.” At a news conference in The Villages, DeSantis said he’s already working with the legislature to do “the most comprehensive, transparency legislation in Florida history with respect to prescription drugs.”
Health care lobbyists are bracing for Chair Bernie Sanders
Health care lobbyists representing insurers, drugmakers and a range of powerful industry interests are steeling themselves for a Senate chair immune to their usual charms — Bernie Sanders. The Vermont independent is set to take over the Senate’s Health, Education, Labor and Pensions Committee next month. Leading the panel gives the Medicare-for-All proponent oversight authority over some of his policy priorities — drug pricing, workers’ rights and income inequality, and student and medical debt.