// 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.
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.
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.
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.
Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
July 27, 2022 Lexicon / Treating Heart Failure
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.
// 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.
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.
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.
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.
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?
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
Alnylam Uncovers Genetic Mutations in INHBE That Protect Against Abdominal Obesity
July 27, 2022 INHBE / Diabetes / Cardiovascular R&D
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.
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
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.
// 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.
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.
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:
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.
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.