// Biotech and Pharma Therapeutics

Eli Lilly touts early demand for high-stakes diabetes launch Mounjaro: analysts
September 14, 2022 / Mounjaro / Tirzepatide / Type 2 Diabetes – After snaring approval in May, Eli Lilly’s closely watched diabetes med tirzepatide—now christened Mounjaro—is said to be “tracking at the highest end” of the company’s demand expectations. That’s the word from a team of analysts at Morgan Stanley, who recently met with Lilly’s chief financial officer Anat Ashkenazi. When it comes to meeting that demand, Lilly is “prepared to fully supply Mounjaro” in the U.S., the team wrote to clients Wednesday in a summary of remarks from Ashkenazi. Read Full Article on Fierce Pharma >>
Weight-Loss Drugs: This Time It May Be a Different Story | 2022 PBMI Annual National Conference
September 14, 2022 / Weight Loss / Pharmacy Benefit Managers / Wegovy – The history of medications to help people lose weight does not inspire a lot of confidence. Amphetamines, the fen-phen (fenfluramine-phentermine), sibutramine (sold under the brand name Meridia) — they helped people lose weight. But they also had dangerous, sometimes fatal, side effects. But in June 2021, FDA approved the repurposing of a diabetes drug, semaglutide, as a weight-loss drug that Novo Nordisk is selling under the brand-name Wegovy. And at the 2022 Pharmacy Benefit Management Institute (PBMI) Annual National Conference today in Orlando, Florida, a pharmacy benefits management (PBM) executive and Novo Nordisk executive said the good safety track record of semaglutide as a diabetes drug and the class of drugs to which it belongs, called glucagon-like peptide 1 (GLP-1) agonists, should be reassuring. Read Full Article on Managed Healthcare Executive >>
Pharma leans into telehealth, Flo’s anonymous mode arrives, and clever digital deals
September 15, 2022 / Health Tech / Telehealth – Drug ads have long tried to influence patient’s medical choices, directing them to “ask your doctor” if a marketed medication is right for them. But when a patient sees an ad or visits a manufacturer’s website today, many will find buttons to “talk to a doctor now.” Clicking through will take them to a third-party site that asks questions about their health — and eligibility for that particular drug — before letting them schedule a virtual visit. Read Full Article on Stat >>
Novartis to spend $300m on biotherapeutics drive
September 12, 2022 / Cancer / Autoimmune Diseases – Swiss pharmaceutical company Novartis is investing $300 million ($288 million) in biotherapeutics development, which includes a new $100 million biologics hub at its home base in Basel. A further $110 million will be spent on research and production at a Novartis site in Slovenia and $60 million in Austria, the company announcedExternal link on Monday. Biotherapeutics is a growing class of medicaments which are extracted or synthesized from biological material, including proteins, cells and genes to treat such conditions as cancer and autoimmune diseases. Read Full Article on Swiss Info >>
Fierce Biotech Names ReCode Therapeutics as One of its “Fierce 15” Biotech Companies of 2022
September 12, 2022 / mRNA / SORT / Biotech – ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, announced today that Fierce Biotech has named it as one of 2022’s Fierce 15 biotechnology companies, designating it as one of the most promising early-stage biotechnology companies in the industry. ReCode is differentiated by its first-in-class modular genetic medicines delivery platform. The company’s selective organ targeting (SORT) lipid nanoparticle technology (LNP) platform is the foundation for its pipeline. Pioneered by co-founder Professor Daniel J. Siegwart, Ph.D., of the University of Texas, and described by Nature as one of the “Seven Technologies to Watch in 2022,” ReCode’s SORT LNP platform is an innovation beyond the lipid delivery system used by the mRNA COVID vaccines and novel RNA and gene correction therapeutics. Read Full Article on Yahoo!Finance >>

// 4th Industrial Revolution

A new x-ray technique for detecting explosives could also identify tumors
September 9, 2022 / Artificial Intelligence / X-Ray / Cancer / Tumors – A new x-ray technique that works alongside a deep-learning algorithm to detect explosives in luggage could eventually catch potentially deadly tumors in humans. Concealing explosives inside electronics and other objects can make it difficult to detect them using conventional x-ray techniques. But the new method was able to detect explosives with 100% accuracy under test conditions, according to researchers. While the most obvious application would be to scan for bombs and other dangerous items and substances at airports, the findings, described in Nature Communications today, could also help detect cracks and rust in buildings, and eventually it could be used to identify early-stage tumors. Read Full Article on MIT Technology Review >>
How AI And Machine Learning Will Impact The Future Of Healthcare
September 14, 2022 / Artificial Intelligence / Healthcare / Insights – Our modern healthcare system is currently facing huge challenges exacerbated by the pandemic, a rise in lifestyle-related diseases, and an exploding world population. The good news is that using AI to create intelligent processes and workflows could make healthcare cheaper, more effective, more personalized, and more equitable. Full Article on Forbes >>
A Prescription for the Future of Healthcare: AI, Databases and Video Games
September 14, 2022 / Artificial Intelligence / Databases / Research – An AI that can instantly detect genetic diseases. A giant search engine containing all the medical research in the world. A virtual nurse on your phone that tells you exactly what treatments you need. In the 21st century digital world, medicine must keep up with the times. Hundreds of technology and computing researchers at USC’s Information Sciences Institute (ISI) have developed innovations like these designed to streamline medical research and jumpstart life-saving treatments. Read Full Article on USC Viterbi School of Engineering >>
How Digital Medicine Is Shaping The Future Of Healthcare
September 13, 2022 / Technology / Healthcare / Communication – There are many benefits to using technology in healthcare. For example, technology allows for fewer errors, improves communication between clinicians and patients, and makes data interoperability possible. It also gives patients more options when it comes to diagnosing ailments and liberty to choose other ways to source alternative medicines like red vein indo capsules and other natural compounds. It also reduces costs and empowers individuals. Read Full Article on We All Want Someone To Shout For >>
Smart hospital solution to reshape the future of healthcare
September 15, 2022 / Internet of Things / Smart Hospital / Healthcare – Hong Kong-based AI company, SenseTime recently launched its Smart Hospital Solution – a full-stack solution to facilitate the digital and intelligent transformation of hospitals and reshape the future landscape of healthcare. Based on deep learning algorithms, the AI diagnostic assistance software helps doctors quickly detect lesions, analyse the patient’s conditions, and plan for future treatments. Doctors can also simulate and assess a surgical plan through 3D visualized models, to better communicate with patients and their families. Read Full Article on Future IOT >>

// Business & Markets

AmerisourceBergen to purchase German pharmaceutical company
September 14, 2022 / Portfolio / Emerging Biotech / Global Pharma – Conshohocken-based AmerisourceBergen Corp., a global healthcare company, recently signed an agreement to purchase Germany-based PharmaLex Holding GmbH for $1.28 billion in cash. PharmaLex provides strategic guidance and regulatory support services to the life sciences industry throughout a product’s lifecycle, including clinical development consulting and marketing authorization. It has a large presence in Europe and the United States, with a growing presence worldwide. Read Full Article on Pennsylvania Business Report >>
PurpleLab, Inc. Raises $40M in Funding from Primus Capital
September 12, 2022 / Data Assets / Product Development / Human Resources – PurpleLab, Inc. today announced a $40 million Series B funding round led by Primus Capital, which joins existing investor Edison Partners. TripleTree served as the exclusive financial advisor to PurpleLab for this transaction. The investment highlights PurpleLab’s growing role in simplifying the access to and interpretation of Real-World Data (RWD) across the healthcare continuum. Read Full Article on Businesswire >>
Are biotech SPACs back? Cancer-focused Apollomics next to take blank-check route
September 15, 2022 / Special Purpose Acquisition Company (SPAC) / Mergers – Are we witnessing the return of biotech SPACs? It’s worth considering as Apollomics merges with Maxpro Capital Acquisition Corp.—the second such transaction in recent weeks. The deal with special purpose acquisition corporation (SPAC) Maxpro is set to close in the first quarter of 2023 and means California-based Apollomics will become a public traded company. Apollomics is valued at pre-money equity value of $899 million, according to a Sept. 14 release. Read Full Article on Fierce Biotech >>
Biotech Company Gameto Adds $17M in Funding to Develop Therapeutics for Diseases in the Female Reproductive System
September 15, 2022 / IVF / Digital Health / Health Tech / Ovarian Hyperstimulation Syndrome – Gameto, a biotech company using cell engineering to develop therapeutics for diseases of the female reproductive system, has added $17M in funding from Insight Partners, Future Ventures, Arcadia Investment Partners, Bold Capital Partners, Plum Alley, Myelin VC, TA Ventures, Gaingels, Korify Capital, and other existing investors. The new financing brings the total capital raised since inception to $40M. Gameto’s last funding round was announced in January 2021. Read Full Article on Femtech Insider >>
Capstan Therapeutics debuts with $165 million financing
September 14, 2022 / Venture Capital / In Vivo – Continuing this year’s trend of new venture capital-backed biotechs springing up, today sees the launch in the USA of Capstan Therapeutics, which says it is dedicated to developing and delivering precise in vivo cell engineering to patients, and has a bicoastal presence with operations in San Diego and Philadelphia. Capstan has received $165 million in financing to build on the foundational insights of world-renowned leaders in mRNA… Read Full Article on The Pharma Letter >>

// Legal & Regulatory

AMA, 2 state medical societies join class-action suit against Cigna
September 13, 2022 / Cigna / American Medical Association / Lawsuits – The American Medical Association (AMA) has joined a class-action lawsuit against Cigna, alleging the insurer underpaid for claims filed by providers in the contracted MultiPlan network. MultiPlan is the country’s largest third-party network, and Cigna contracts with it to access providers. According to the lawsuit, which was initially filed in June, Cigna reimbursed for claims from providers in MultiPlan’s network at its non-participating providers rate rather than at the rate expected for a MultiPlan contract. Read on Yahoo! Finance >>
FDA Finally OKs First Drug for Hepatorenal Syndrome — Pivotal trial data showed terlipressin nearly doubled reversal of the condition
September 15, 2022 / FDA / Kidney / Liver Disease – The FDA approved terlipressin (Terlivaz), the first drug for treating patients with hepatorenal syndrome (HRS). A synthetic vasopressin analog, terlipressin is an injectable drug indicated for patients with HRS experiencing rapid deterioration of kidney function (type 1 HRS). The disease affects patients with advanced liver disease, most commonly those with advanced cirrhosis and ascites, and has a poor prognosis without liver transplantation. Read on Medpage Today >>
Moderna v. Pfizer: What the Patent Infringement Suit Means for Biotech
September 16, 2022 / COVID-19 / mRNA / Lawsuit – Moderna, the maker of one of the Covid-19 vaccines, once was the underdog, the startup that rose to the occasion during the 2020 pandemic. It might be hard to remember that given all that’s happened since. The company has enjoyed massive growth and recognition. Its name is plastered on the walls at Fenway Park and Arthur Ashe stadium, home to the U.S. Open. In size and public profile, Moderna is more Goliath than David these days, a point underscored by its recent filing of a patent infringement lawsuit against Pfizer. Read on Harvard Business Review >>
After FDA rejection, Vanda sues agency over regulatory rebuffs on jet lag med
September 15, 2022 / FDA / Lawsuit – Once again, Vanda Pharmaceuticals is challenging the FDA in court. This time, the company says the agency failed to give its application for Hetlioz in jet lag disorder a proper hearing after the FDA issued a complete response letter more than three years ago. Since 2014, Hetlioz has been approved to treat a circadian rhythm condition called non-24-hour sleep-wake disorder. The company submitted its application for the jet lag disorder indication back in October 2018. The following year, the FDA handed back a complete response letter, saying it couldn’t approve Vanda’s application “in its present form” and directed the company to resubmit its application. Read on Fierce Pharma >>
FDA accepts Otsuka, Lundbeck filing for long-acting schizophrenia drug, teeing up April decision date
September 13, 2022 / Schizophrenia / FDA / Injectable – Otsuka and Lundbeck have taken a step toward approval of their two-month, ready-to-use, long-acting injectable treatment for schizophrenia and bipolar I disorder, securing FDA acceptance of the filing and an April 27 PDUFA date. The approval application covers the same patient populations as indicated for Abilify Maintena, Otsuka and Lundbeck’s existing once-monthly treatment. In a phase 1/2 clinical trial, Otsuka compared its new two-month long-acting injectable to its one-month depot therapy in 266 patients, emerging with data to show the formulations yield similar aripiprazole plasma concentrations. Read on Fierce Pharma >>

// Research & Development

IT’S ALIVE!!! Well, Kind of…
September 14, 2022 / Adipose / Brain – These firm but quasi-gelatinous “1 pound of fat” models create the perception that adipose is simply a slumberous, rubbery, and unwanted squatter that seems to have something personal against the waistband of my favorite pair of old jeans (and for some odd reason, every time I see one of these things I get the child-like urge to chuck it like a football). Having said that, the blob does impart a rather indelible repulsiveness that we would rather forget as we look in the mirror. But therein lies the problem: we think of adipose chiefly in terms of what we see on our exterior. Read Full Article on Vault Bioventures >>
Researchers Discover a Gene That Makes Your Muscles Significantly Stronger
September 15, 2022 / C18ORF25 Gene / Cancer / Diabetes / Cardiovascular Disease – The study found that the gene promotes muscle strength during exercise. Researchers have discovered a gene that increases muscle strength when activated by exercise, opening the door to the creation of therapeutic treatments that replicate some of the benefits of working out. The University of Melbourne-led research, which was published in Cell Metabolism, demonstrated how various forms of exercise alter the molecules in our muscles and led to the identification of the new C18ORF25 gene, which is activated by all forms of exercise and is responsible for enhancing muscle strength. Animals lacking C18ORF25 have weaker muscles and worse exercise performance. Read Full Article on Scitech Daily >>
New Heart Disease Therapeutic Target Identified
September 15, 2022 / CRISPR / LDLR / mRNA / CSDE1 Regulator – Using a CRISPR-based screen, researchers have identified a key regulator of LDLR, which reduces cholesterol concentrations and lowers the risk of heart attacks. The regulator, CSDE1, coordinates the decay of LDLR mRNA, and knockdown of Csde1 in mice protected against cholesterol accumulation. Thus, CSDE1 may be a therapeutic target for lowering cholesterol in humans. Heart disease is the leading cause of death in the United States, and high blood cholesterol is a major risk factor. LDLR (low-density lipoprotein receptor) removes cholesterol from the bloodstream. Drugs such as statins boost the activity of LDLR and can lower the risk of heart attacks and atherosclerosis, so scientists are pursuing drugs that can grant even stronger anti-cholesterol effects. Read Full Article on Genetic Engineering & Biotechnology News >>
A New Drug Could Treat Type 2 Diabetes
September 14, 2022 / GLP-1 / Type 2 Diabetes – Scientists develop a new drug candidate to treat diabetes. A novel hormone combination has been created by a research team from Helmholtz Munich, the German Center for Diabetes Research (DZD), and Novo Nordisk for the potential treatment of type 2 diabetes in the future. The researchers combined the blood sugar-lowering actions of the medications tesaglitazar and GLP-1 (Glucagon-like peptide-1) to create a new and extremely effective drug. The benefit of combining Tesaglitazar with GLP-1 is that the Tesaglitazar only penetrates the tissue with GLP-1 receptors. This increases the effects on sugar metabolism while lessening the side effects of tesaglitazar. Scientists have already successfully tested the new drug in animal studies. The study was recently published in the journal Nature Metabolism. Read Full Article on Scitech Daily >>
Onset of Type 2 Diabetes in Adults Aged 40 or Younger Increases Risk of Cardiovascular Disease
September 15, 2022 / Type 2 Diabetes / Cardiovascular Disease – Patients aged 40 years or younger who are diagnosed with type 2 diabetes (T2D) were found to have a greater risk of developing cardiovascular disease (CVD) than the general population of the same age, according to a study published in Diabetologia. Patients with early-onset diabetes were found to have be 5 times more likely to develop heart disease or die from CVD compared to non-diabetics. They were also found 7 times more likely to be diagnosed with heart failure. Read Full Article on Pharmacy Times >>

// Politics

Chutes & Ladders—Biden lands on leader for new agency that will oversee ‘cancer moonshot’ initiatives
September 16, 2022 / FDA / Cancer Moonshot – President Joe Biden has landed on a leader for his new federal biotech agency aimed at overseeing his ambitious “cancer moonshot” initiatives. Renee Wegrzyn, a veteran of the federal government and current executive at Ginkgo Bioworks, is slated to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is the manifestation of Biden’s larger ambitions for reducing the cancer death rate—shaving it 50% over the next 25 years, to be exact. For comparison, from 2001 to 2020, the cancer death rate dropped 27%. Top brass from Rome Therapeutics are committing themselves to a new venture, launching Pretzel Therapeutics to build out a slate of mitochondrial-focused medicines. Led by Jay Parrish, Ph.D., the company is hitting the biotech scene armed with $72.5 million in initial cash. Parrish co-founded Rome Therapeutics and most recently was chief business officer at Vir Biotechnology, the latter of which was able to nab FDA authorization for its GSK-partnered COVID-19 treatment. Read Full Article on Fierce Biotech >>
Amgen CEO Robert Bradway warns Biden’s Inflation Reduction Act could blunt future biotech success stories
September 15, 2022 / Mergers and Acquisitions / Inflation Reduction Act – In an era of abundant pharma buyouts, small and midsized biotechs may find it increasingly difficult to go their own way, Amgen’s CEO Robert Bradway figures. And new drug cost legislation in the U.S. certainly won’t help, the helmsman added. Reflecting on the state of the industry in the wake of the Inflation Reduction Act (IRA), Bradway voiced confidence in Amgen’s position during a recent interview with Bloomberg News. But newer companies may have a tougher path to travel, he told the news service. Read Full Article on Fierce Pharma >>
Biden looks to beef up US biomanufacturing amid pressure from China
September 13, 2022 / Biomanufacturing / China / Drug Manufacturing – The Biden Administration, after setting its sights on America’s pharmaceutical supply chains last winter, is telegraphing its next move to restore the United States’ drugmaking prowess. President Joe Biden penned an executive order Monday to boost biotechnology and biomanufacturing across a range of areas in the U.S. To help the U.S. biotech sector reach its full potential, the U.S. needs to funnel cash toward development of genetic engineering tech, use approaches like artificial intelligence to “unlock the power of biological data,” and “scale-up production,” whilst simultaneously breaking down obstacles to commercialization so that innovative products can hit the market faster, Biden said in a White House release. Read Full Article on Fierce Pharma >>
Senators question how HHS plans to roll out new drug pricing reforms
September 15, 2022 / US Drug Pricing / R&D / CBO – While CMS drug price negotiations won’t actually kick off until 2026, a group of more than two dozen Republican senators is already raising questions about how this new law will be implemented. The partisan law (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations but mandatory inflation-related rebates that will begin next year, as well as million-dollar fines for noncompliance. In a letter sent earlier this week to both HHS Secretary Xavier Becerra and CMS administrator Chiquita Brooks-LaSure, the group of 25 Republican senators expressed “concerns with the disruptive and distortive administrative undertaking that the implementation of this far-reaching federal expansion will inevitably represent.” Read Full Article on
Endpoints >>
Inflation uptick comes at a bad time for Biden
September 15, 2022 / Inflation / Supply Chain / Inflation Reduction Act – Fresh inflation data and a subsequent stock market tumble have come at a bad time for President Biden and Democrats, who were just appearing to be getting comfortable framing the economy as an asset for their party’s pitch to voters in November. Tuesday provided a split screen that illustrated the problem Democrats face. Biden and scores of congressional and administration allies gathered at the White House to celebrate the passage of the Inflation Reduction Act, which Democrats argue will help lower the cost of health care, energy and prescription drugs. Read Full Article on
The Hill >>