// Biotech and Pharma Therapeutics

Is This Vertex Pharmaceuticals’ Biggest News Yet?
July 25, 2022 Pain / VX-548 / Pharma It’s been a big year for Vertex Pharmaceuticals (VRTX -1.85%) so far. The biotech company has grown its main cystic fibrosis (CF) business — reporting billions of dollars in revenue from its portfolio of products. It’s getting ready to apply for approval of its blood-disorders candidate. And Vertex shares have managed to gain 27% year to date — even as the rest of the market moved into bear territory. Read Full Article on The Motley Fool >>
The NASH curse strikes again. Pfizer dumps early-stage asset for liver condition
July 28, 2022 NASH / Liver  Another NASH drug bites the dust. This time it’s Pfizer’s early-stage asset danuglipron, which the drugmaker has dumped for the liver condition. The GLP1 agonist, also known as PF-06882961, will no longer be pushed forward as a potential treatment for non-alcoholic steatohepatitis, according to Pfizer’s pipeline website and second quarter earnings report. The 22-person phase 1 trial wrapped up in January, according to ClinicalTrials.gov, but Pfizer has yet to post the results. Trials for the GLP1 agonist to treat obesity and diabetes appear to be ongoing, according to the earnings documents. Read Full Article on Fierce Biotech >>
Get ready for the biotech market rebound
July 28, 2022 Nasdaq / Biotech  Investors are still feeling the burn from biotech’s flameout. And with rising interest rates and increasingly strict regulatory scrutiny, it’s no wonder they remain wary of being singed by the sector.Just look at the numbers — as of June 10, only 23 biotechs had gone public globally in 2022 versus 68 in the same period in 2021. The Nasdaq Biotech index is down by nearly 19 percent. Only a handful of biotech companies that went public last year in the U.S. are trading above their debut price. Full Article on Reuters >>
Living Biotherapeutics Explore New Niches
August 2, 2021 Biotherapeutics / CNS / Oncology In the not-too-distant future, diseases of the central nervous system (CNS) may be treated by therapies derived from living gut bacteria. Such therapies are in development at 4D pharma, a company that is also working toward more immediate goals, such as microbiome therapeutics for autoimmune diseases, respiratory diseases, and forms of cancer. The most immediate applications are, of course, in gastrointestinal diseases. Read Full Article on GEN & Biotechnology News >>
Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
July 27, 2022 Lexicon / Treating Heart Failure THE WOODLANDS, Texas, July 27, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and filed its New Drug Application (NDA) for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of heart failure. The FDA assigned a standard review for the NDA filing with a Prescription Drug User Fee Act (PDUFA) target action date in May 2023. Read Full Article on BioSpace >>
After failed Alzheimer’s launch, Biogen writes off the remaining value of its Aduhelm inventory
July 22, 2022 Alzheimer’s / Biogen Biogen is trying to escape the dark Aduhelm cloud hanging over its Alzheimer’s disease drug launch. So far, the launch has triggered layoffs, a CEO switch and much more. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Telehealth platform doxy.me taps Lokalise to automate localisation efforts in APAC
July 21, 2022 4IR / Telehealth / APAC New York-based telehealth company doxy.me has recently automated its localisation efforts to further make its platform accessible to more patients and providers in Asia-Pacific and beyond. Read Full Article on Mobi Health News >>
Only 22% of Health Systems Have A Custom Mobile Engagement Platform
July 20, 2022 4IR / Digital Platforms in Healthcare A survey of 272 health system executives was commissioned by Gozio and conducted by Eliciting Insights in June 2022. Eliciting Insights also interviewed five directors of patient experience and marketing. The research was conducted to determine health systems’ top challenges around mobile app engagement and digital health success. Read Full Article on Hit Consultant >>
Calderdale and Huddersfield uses predictive analytics for mortality data
July 26, 2022 4IR / Mortality Data / Predictive Analytics Calderdale and Huddersfield NHS Foundation Trust is using predictive analytics to accelerate the understanding of mortality ratios, which will give the trust the data it needs to help determine which cases it needs to review in light of a death. Read Full Article on Digital Health >>
Digital health company snags FDA clearance for atrial fibrillation algorithm
July 25th, 2022 4IR / FDA Clearance / Cardiac Cardiac-focused digital health company iRhythm has received FDA 510(k) clearance for an algorithm that monitors atrial fibrillation and will be paired with wearable technology. Read Full Article on Beaker’s Hospital Review >>
The Blueprint for Success with Custom-Tailored Healthcare Access
July 27, 2022 4IR / Healthcare Access Our world today is more personalized than ever. Most industries are now characterized by customization, with consumers expecting experiences and outcomes exactly how they want them, when they want them. If retail, hospitality, food services, and most other industries can custom-tailor experiences based on the wants and needs of their target audiences, why can’t healthcare do the same? Read Full Article on Health IT >>
The Evolving Role of Telehealth
August 2, 2021 4IR / Telehealth / Healthcare Telehealth is poised to see continued growth as the health care industry experiences the benefits of telehealth models, specifically supporting patient care delivery and closing care gaps.On this episode of Value-Based Care Insights, host Daniel J. Marino and Dr. Alan Kumar, Senior Vice President of Medical Affairs and Chief Medical Officer at Community Healthcare System, to discuss the key factors for a successful rollout and how to increase adoption during the ongoing evolution of telehealth. Read Full Article on Health IT >>

// Business & Markets

FemTec Health scoops up nutrition platform Nutrimedy
July 25, 2022 Deals / FemTec / Womens Health FemTec Health announced Monday it had acquired nutrition platform Nutrimedy, the latest in a spate of deals from the women’s health startup. Nutrimedy allows users to take photos of their food to log their meals and offers nutrition recommendations. FemTec said it will integrate the tool into its Awesome Woman direct-to-consumer platform, which sends products like at-home tests and supplements to customers’ homes and provides telehealth visits. Read Full Article on Mobi Health News >>
Amazon to acquire primary care company One Medical for $3.9B
July 21, 2022 Deals / Amazon Amazon has signed a definitive agreement to acquire hybrid primary care provider One Medical in an all-cash deal worth approximately $3.9 billion. One Medical is a membership-based primary care organization that offers virtual care as well in-person visits. The companies said the deal’s close is subject to regulatory approval and clearance by One Medical shareholders. CEO Amir Dan Rubin is slated to remain in his position after the acquisition is complete. Read Full Article on Mobi Health News >>
3 views on Amazon’s $3.9B acquisition of One Medical
July 23, 2022 Deal / Amazon / One Medical After it was rumored to be in play earlier this month, it shouldn’t come as a huge surprise that One Medical has found a new home. After a torrid public offering, the value of the American consumer healthcare and technology company had fallen below its IPO price, and it was an obvious target for the right buyer. But after CVS left the table, it wasn’t a healthcare entity that snapped up the former venture darling, and nor was it turned into a platform play by private equity. Instead, Amazon nabbed it up in a deal that comes to around $3.9 billion. At $18 per share, One Medical is exiting the public markets with a price tag that’s higher than when it IPO’d — a win of sorts for the unprofitable company. Read Full Article on TechCrunch >>
Marketing mergers and acquisitions show record growth
July 25th, 2022 Deal / Marketing Mergers Marketing industry mergers and acquisitions have continued their record growth, despite budget cuts and layoffs at some firms, the Wall Street Journal reported. The first half of 2022 saw 789 marketing industry deals, compared to the then record-setting 571 deals in the first half of 2021. Analysts have suggested the stability within marketing mergers and acquisitions is due to a rise in online shopping and the growth of venture capital within the industry, according to the July 20 Wall Street Journal report. Read Full Article on Beacker’s Health IT >>
College women-focused digital health startup snags $10.5M to offer integrated care
July 27, 2022 Deal / Women’s Health / Startup A new women-focused health tech startup for college students, Caraway, has announced a $10.5 million seed round. The startup will offer integrated mental, reproductive and physical health care and aims to be inclusive of different gender identities and sexual orientations. Founding partners 7wireVentures and OMERS Ventures led a $10.5 million seed round alongside participation from Hopelab Ventures and other angel investors. Read Full Article on Fierce Healthcare >>
Heart attack prediction startup Cleerly scores $192M and more digital health fundings
July 26, 2022 Deal / Cardiovascular / Digital Health Cardiovascular disease-focused Cleerly scored $192 million in Series C financing, a little more than a year after the company launched with a $43 million Series B. The latest round, led by T. Rowe Price and Fidelity Management and Research Company, brings Cleerly’s total raise to $248 million. Other participants in the round include Sands Capital, Piper Sandler’s Merchant Banking and Heartland Healthcare Capital funds, Mirae Asset Capital, Peter Thiel, Breyer Capital, Novartis, Vensana Capital, LRVHealth, New Leaf Ventures, Cigna Ventures and DigiTx Partners. Read Full Article on Mobi Health News >>
FDA setback leads women’s health biotech ObsEva to give up on uterine fibroids drug
Jul 27, 2022 FDA / Womens Health / ObsEva Women’s health pharmaceutical company ObsEva recently welcomed two regulatory approvals in Europe for its uterine fibroids drug, but that pill has hit a wall at the FDA so the biotech has decided to walk away from the drug altogether. The drug, linzagolix, was set for regulatory decision by Sept. 13. ObsEva said Wednesday that the FDA has flagged deficiencies in the small molecule’s new drug application. The company did not describe the agency’s concerns but said that it believes it might not be possible to resolve them by the September target date. Read Full Article on MedCity News >>
Teladoc takes hefty impairment charge in Q2 with losses mounting to nearly $10B
Jul 27, 2022 Digital Health / Teladoc Telehealth giant Teladoc Wednesday reported a hefty loss of $3.1 billion that dragged down its second-quarter earnings. The company’s share price tumbled in after-hours trading as management set lower expectations for its 2022 outlook. The company took a $3 billion hit from an impairment charge that pushed the company to a loss of $19.22 per share in the second quarter compared to a loss of $133.8 million, or a loss of 86 cents per share, for the same period a year ago. Read Full Article on Fierce Healthcare >>

// Legal & Regulatory

FDA Awards 510(k) Clearances for ZEUS System/Zio Watch
July 22, 2022 FDA / ZEUS System The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience. The cleared Zio Watch is a wrist-worn solution that not only detects AFib but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. The Zio Watch uses continuous photoplethysmography (PPG), an AI-based algorithm to detect AFib and calculate an AFib burden estimate. A preliminary report is then sent to the patient’s clinician for review, potentially leading to a diagnosis and clinical intervention. Read Full Article on Hit Consultant >>
FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals
July 22, 2022 FDA / Oncology / Cancer The FDA’s oncology department has lately been tightening its act around accelerated approvals and stressing the importance of patient survival data. Several companies immediately fell in line, withdrawing problematic indications when the agency mounted its pressure. But some companies have decided to put up a fight. Read Full Article on Fierce Pharma >>
J&J escapes $120M verdict after appellate court reverses loss in long-running talc case
July 22, 2022 New York Supreme Court / J&J After Johnson & Johnson hit a setback in a high-profile talcum powder case back in 2019, the company vowed to appeal. Now, that strategy has paid off. Tuesday, the appellate branch of the New York Supreme Court reversed an earlier decision in favor of plaintiff Donna Olson, who claimed her lifelong use of J&J’s talc caused her to develop mesothelioma. With a win in hand, J&J is also off the hook to pay Olson damages of $120 million, a figure that was reduced from an original award of $325 million. Read Full Article on Fierce Pharma >>
AbbVie seeks nod from FDA and EMA for Crohn’s disease drug
July 27, 2022 FDA / Crohn’s Disease / AbbVie U.S. biopharma company AbbVie has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn’s disease. Read Full Article on LabioTech >>
Two sides of ‘historic’ drug pricing bill: Pharma industry blasts ‘mistake’ while advocates plan for ‘first ever’ gains
July 27, 2022 Drug Pricing / Senate / Pharma Industry Both Congressional Democrats and the pharma industry agree that pending drug pricing legislation is “historic” — they just diametrically disagree on the modifier. Trade industry group PhRMA’s CEO Stephen Ubl called it an “historic mistake” on Wednesday, joined by Eli Lilly CEO David Ricks, Atlas Venture partner Jean-Francois Formela along with a hematology oncology-leading physician and a metastatic breast cancer survivor in a press conference. Read Full Article on EndPoints News >>
Adherium gets US FDA 510(k) to connect remote monitoring sensor for Ellipta inhaler users
July 27, 2022 FDA / Respiratory / Adherium Adherium, a New Zealand-based maker of connected respiratory medical devices, has received the US Food and Drug Administration’s 510(k) clearance for connecting its digital monitoring platform with GlaxoSmithKline’s range of Ellipta dry powder inhalers. The ASX-listed firm offers the Hailie sensor which attaches to an inhaler to remotely monitor and capture medication usage parameters and adherence of patients with asthma and chronic obstructive pulmonary disease. It is part of a remote patient monitoring system which includes a software development kit and API integration tools to enable the capture and real-time sharing of health data through mobile and desktop apps. Full Article on Mobi Health News >>
Global regulators look to integrate real-world evidence into regulatory decision-making
July 27, 2022 Decision-making / RWE / RWD / Adherium The International Coalition of Medicines Regulatory Authorities is calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making, with harmonization of real-world data and RWE terminologies, convergence of RWD and RWE guidance, and best practice, readiness and transparency key areas of focus. Read Full Article on BioCentury >>

// Research & Development

Medable Partners with Withings Health Solutions to Integrate Health Devices in Decentralized Clinical Trials
July 21, 2022 Health Devices / Medable With Withings easy-to-use devices, Medable can remotely capture and integrate critical medical-grade measurements, including temperature, heart rate, blood pressure, sleep patterns, and weight. Withings incorporates patient-centered design principles to develop non-invasive devices that are both robust and easy for patients to use in any setting. The convenience can improve patient recruitment and retention – which is significant since 85% of clinical trials fail to retain enough patients and more than two-thirds of sites fail to meet patient enrollment goals. Read Full Article on Hit Consultant >>
New Study Links One Drop’s AI-Powered Blood Glucose Forecasts to Better Engagement and Diabetes Outcomes
July 20, 2022 AI Forecasts / Diabetes According to the Association of Diabetes Care & Education Specialists (ADCES), self-monitoring of blood glucose (SMBG) is an integral component of effective therapy for people with diabetes and is associated with improved glycemic control. It was found that adults with type 2 diabetes who received glucose forecasts and personalized insights were more likely to track health data in the One Drop app and achieved lower average glucose. Read Full Article on Hit Consultant >>
Scientists develop greener, more efficient method for producing next-generation antibiotics
July 27, 2022 Next-gen Antibiotics / Innovation Scientists from the Institute of Organic Chemistry and Chemical Biology at Germany’s Goethe University wondered if the system could be genetically altered to assemble the antibiotic with one additional fluorine atom, which can often improve pharmaceutical properties. “We had been analyzing fatty acid synthesis for several years when we identified a part of a mouse protein that we believed could be used for directed biosynthesis of these modified antibiotics, if added to a biological system that can already make the native compound,” said Martin Grininger, professor for biomolecular chemistry at Goethe University. Read Full Article on Science Daily >>
Alnylam Uncovers Genetic Mutations in INHBE That Protect Against Abdominal Obesity
July 27, 2022 INHBE / Diabetes / Cardiovascular R&D CAMBRIDGE, Mass.–(BUSINESS WIRE)– Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company and collaborators have identified mutations in the INHBE gene associated with protection against abdominal obesity and metabolic syndrome – a condition impacting more than 20 percent of adults worldwide. The discovery leveraged sequencing data from more than 360,000 individuals in UK Biobank, and was published in the 13th issue of Nature Communications. Read Full Article on Biospace >>
Ionis announces positive topline results from Phase 2b clinical study of fesomersen, a potential novel anti-thrombotic treatment
July 28, 2022 Ionis / Fesomersen / Anti-thrombotic treatment R&D CARLSBAD, Calif., July 28, 2022 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today announced positive topline results of the Phase 2b RE-THINC ESRD study of fesomersen, formerly IONIS-FXI-LRx, in patients with end-stage renal disease (ESRD) on hemodialysis. In the study, fesomersen achieved its primary outcome measure of no increase in incidence of major bleeding and clinically relevant non-major bleeding as compared to placebo. Data from the study show that fesomersen, administered monthly at 40 mg, 80 mg and 120 mg for up to 48 weeks, was safe and well-tolerated. Read Full Article on Biospace >>
Novartis-linked startup launches with technology designed to remove ‘destroy’ tags on helpful proteins
July 28, 2022 Drug development R&D Drug development relies on a few key principles, with one being that, to work, medicines must interact with the right molecules in the body. But that requirement is difficult to meet. The helpful ingredients in most pharmaceuticals are microscopic. So, too, are their targets. In the relatively enormous spaces that are tissues or the blood, it’s rarely guaranteed the pieces needed for a therapeutic reaction will come together. Read Full Article on Biopharma Dive >>
FDA, in another test of its flexibility, agrees to review Biogen’s closely watched ALS drug
July 26, 2022 FDA / ALS Drug / Biogen R&D Late last year, Biogen disclosed results from a closely watched study evaluating an experimental drug for Lou Gehrig’s disease, also known as ALS or amyotrophic lateral sclerosis. They showed the drug, called tofersen, wasn’t better than a placebo at slowing progression of the fatal nerve disorder, dealing yet another blow to patients and caregivers, who currently have very limited treatment options. Read Full Article on Biopharma Dive >>

// Politics

The Drug Pricing ‘Slippery Slope’
July 27, 2022 Senate / Drug Pricing Progressives are disappointed with the tentative drug-pricing deal that Senate Majority Leader Chuck Schumer appears to have struck with West Virginia’s Joe Manchin. But no worries, says Vermont Rep. Peter Welch, the price controls are merely the start of what will be a long raid on drug makers to fund Democratic spending ambitions. Read Full The Wall Street Journal >>
The Senate’s latest price setting proposal will undermine: American medical innovation
July 27, 2022 US Senate / Medical Innovation Members of Congress continue to push a misguided drug pricing proposal under the guise of negotiation as part of the reconciliation package. This proposal is nothing short of government price setting and, if implemented, would require the government to dictate prices and choose winners and losers when it comes to which diseases are likely to see new treatments. Instead of addressing a broken insurance system, the most recent proposal doubles down on bad policies that will threaten patient access to medicines and future innovations. This is the second blog in a three-part series where we discuss the very real threats of the proposal. Read Full Article on PhRMA >>
The view on drug pricing from Wall Street, a pharma-friendly Dem holds firm, and what’s next for a big telehealth bill
July 28, 2022 Wall Street / Telehealth bill Pharma has been clear with reporters and Hill staff that Democrats’ drug pricing bill will be catastrophic for the industry. But I always like to listen to what the companies are telling investors, as the story isn’t necessarily the same. Keep in mind that different companies have different exposure here, but I’ve compiled some tidbits from a few recent earnings calls: Read Full Article on STAT News >>
Manchin says he has reached deal with Schumer on economy, climate bill
July 27, 2022 Climate Bill / Manchin Sen. Joe Manchin III (D-W.Va.) on Wednesday reached a deal with Democratic leaders on a spending package that aims to lower health-care costs, combat climate change and reduce the federal deficit, marking a massive potential breakthrough for President Biden’s long-stalled economic agenda. Read Full Article on Bloomberg Law >>
US manufacturing group runs 6-figure ad campaign lambasting Congress’ latest drug pricing bill
July 25, 2022 US Congress / Drug Pricing / US Manufacturing The National Association of Manufacturers (NAM) is spending some serious bucks to fight a sweeping proposal in the Senate that aims to rein in drug pricing and spending in the United States. In a nutshell, the Senate reconciliation package under consideration would allow Medicare to negotiate lower prices for some drugs. The legislation is unsurprisingly proving controversial within the life sciences industry. Read Full Article on Fierce Pharma >>
Merck sees big lift in Keytruda sales, as Senate probes its taxes
July 28, 2022 US Senate / Taxes / Merck Merck & Co has reported record sales of its cancer immunotherapy Keytruda in the second quarter, as members of the Senate Finance Committee continue an investigation into the way the company books profits from the drug. Read Full Article on Pharmaphorum >>