// Biotech and Pharma Therapeutics
Covering Wegovy for heart risk could cost Medicare tens of billions: study
August 27, 2024 / Wegovy / Medicare Cost / Semaglutide Heart Risk / GLP-1 Drug Spending / Obesity Treatment
Covering Wegovy for heart risk could significantly strain Medicare, with annual costs potentially reaching $145 billion, even with narrow eligibility. Expanded coverage of GLP-1 drugs like semaglutide may drive substantial increases in federal healthcare spending.
First Severe plaque psoriasis oral therapy for ages 6-17 available in the US
August 22, 2024 / Plaque Psoriasis / Pediatrics / Psoriasis Therapy
Amgen’s Otezla (apremilast) is now available in the U.S. as the first oral therapy for children aged 6-17 with moderate to severe plaque psoriasis, offering a new treatment option for pediatric patients.
21 cases of little-known Oropouche virus detected in U.S.
August 27, 2024 / CDC / Oropouche Virus
The CDC reports 21 Oropouche virus cases in the U.S., linked to travel in Cuba. This emerging virus is associated with severe illness, potential congenital malformations, and deaths, prompting travel advisories for pregnant women.
Eli Lilly rolls out direct patient access to weight loss star Zepbound—at a deep discount
August 27, 2024 / Zepbound / Weight-loss / Eli Lilly / Lilly Direct / GLP-1 Obesity Treatment
Eli Lilly introduces discounted direct-to-patient access for its weight-loss drug Zepbound through LillyDirect, offering significant savings and addressing issues like high costs, supply chain, and off-label use, aiming to improve access and authenticity.
A Revolution in Military Medical Staffing is Afoot and Private Sector Firms are Playing a Big Part
August 27, 2024 / Military Healthcare Staffing / Defense Health Agency
The U.S. Defense Health Agency’s $43 billion MQS2-NG contract engages private firms to improve healthcare staffing at military facilities, addressing challenges like physician shortages, remote locations, and competitive pay, enhancing military healthcare access and quality.
// 4th Industrial Revolution
Why Pfizer Is Dipping Into DTC Telehealth With PfizerForAll
August 28, 2024 / PfizerForAll / TeleHealth
Pfizer launches PfizerForAll, a direct-to-consumer telehealth platform, to simplify healthcare access for conditions like migraines and COVID-19. The platform offers telehealth consultations, medication delivery, and vaccination scheduling, addressing the complexity of navigating healthcare.
MUSC Health Deploys AI to Automate Patient Self-Service Tasks
August 28, 2024 / MUSC Health AI Agent / Patient Engagement / AI / Healthcare
MUSC Health has implemented “Emily,” an AI-powered patient engagement agent, to enhance self-service capabilities. Integrated with Epic, this AI tool helps patients manage appointments, make payments, and access information, improving patient satisfaction and operational efficiency.
Elation Health Launches AI-Powered Note Generation Tool
August 27, 2024 / Elation Health Note Assist / AI / Primary Care / HER Solutions / Clinician Burnout
Elation Health introduces Note Assist, an AI-powered tool for its EHR platform, automating real-time note-taking during primary care visits. This solution reduces documentation time, enhances patient interactions, and helps alleviate clinician burnout.
Spectral AI hits enrollment goal at burn centres for AI-powered assessment tech
August 27, 2024 / AI DeepView System / AI / Burn Assessment Techonology / FDA / Market Growth
Spectral AI completes adult enrollment for a pivotal study on its DeepView AI wound diagnostics platform, targeting FDA De Novo classification. The platform aims to enhance burn assessment accuracy and reduce unnecessary surgeries.
Dexcom launches over-the-counter continuous glucose sensors in the US
August 26, 2024 / Dexcom Stelo Glucose Monitor / Non-Insulin Users / Glucose Tracking App
Dexcom launches Stelo, the first over-the-counter continuous glucose monitor in the U.S., available for non-insulin-using adults. Priced at up to $99, Stelo continuously measures glucose levels via a wearable sensor paired with a smartphone app.
// Business & Markets
PatientPay and ClearGage Merge to Improve Patient Payment Experience
August 28, 2024 / PatientPay / ClearGage / Merger / Healthcare
PatientPay and ClearGage merge to enhance healthcare billing efficiency, offering an advanced digital platform that simplifies payment processes, reduces administrative costs, and improves revenue collection for medical groups and hospitals.
Novartis taps Lindy to turn biologic drugs into at-home injectables, puts nearly $1B on the line
August 28, 2024 / Novartis / Lequio / LDL-C Reduction Therapy / Heart Disease Treatment / Cardiovascular Disease
Novartis’ phase 3 trial shows Leqvio, a cholesterol-lowering drug, significantly reduces LDL-C levels as a monotherapy, potentially broadening its use for patients at risk of atherosclerotic cardiovascular disease (ASCVD).
AstraZeneca remembers roots with $135 million Swedish spend
August 28, 2024 / AstraZeneca / Investment / Biomanufacturing Center
AstraZeneca invests $135 million in its Södertälje, Sweden biologics facility, enhancing biologics R&D capabilities, creating jobs, and supporting local economic growth, marking the company’s largest investment there since 2021.
Bayer partners with RNA drugmaker to develop new cancer therapies
August 28, 2024 / Bayer / Partnership / NextRNA / Cancers / Oncology
Bayer partners with NextRNA Therapeutics to develop small molecule drugs targeting dysregulated long non-coding RNA in cancer, in a deal worth up to $547 million. The partnership focuses on cancers with high unmet needs.
UPDATE: Genentech telegraphs 93 layoffs in California after sharing plans to shutter cancer immunology research unit
August 28, 2024 / Genentech / Layoffs / Cancer Immunology Unit / San Francisco
Genentech will lay off 93 employees in South San Francisco as part of restructuring, following the closure of its cancer immunology research unit. Roles affected include scientists, quality professionals, and project managers.
// Legal & Regulatory
EyePoint dinged with FDA warning letter over manufacturing shortfalls tied to eye implant
August 27, 2024 / EyePoint / FDA Warning / Manufacturing Issues / Regulatory Action
EyePoint Pharmaceuticals received an FDA warning for manufacturing issues at its Watertown facility, primarily concerning its Yutiq eye implant. Problems include production inconsistencies, facility maintenance, and inadequate written procedures.
Feds killed plan to curb medicare advantage overbilling after industry opposition
August 28, 2024 / Medicare Advantage / United Health / Lawsuit / Healthcare Fraud Prevention
CMS dropped a 2014 proposal to curb Medicare Advantage overbilling due to industry pressure. This decision is central to a DOJ lawsuit against UnitedHealth Group, alleging fraudulent overcharges by not correcting invalid billing codes.
Basilea announces new EC approval for Cresemba
August 28, 2024 / Cresemba Pediatric Approval / Antifungal Therapy
The European Commission has approved Basilea’s antifungal drug Cresemba (isavuconazole) for pediatric use, treating invasive aspergillosis and mucormycosis, triggering a milestone payment from Pfizer.
In key win for GSK, Delaware court will review decision to allow expert testimony in Zantac cases
August 28, 2024 / GSK Zantac Lawsuits / Delaware Supreme Court Review / Zantac Cancer Claims
The Delaware Supreme Court will review a decision allowing expert testimony in Zantac lawsuits, potentially impacting 75,000 personal injury claims against GSK. This follows similar rulings in Florida challenging the drug’s alleged cancer risks.
EC approves Astellas’ Padcev for added indication
August 28, 2024 / Padcev Keytruda Approval / Astellas / Cancer Treatment / Cancer Therapy
The European Commission approved Astellas’ Padcev combined with Keytruda for first-line treatment of unresectable or metastatic urothelial cancer, based on Phase III trial results showing improved overall and progression-free survival over chemotherapy.
// Research & Development
myTomorrows and Pancreatic Cancer Europe partner on clinical trials
August 28, 2024 / Pancreatic Cancer / Clinical Trials / myTomarrows / Partnership / Cancer Treatment
myTomorrows and Pancreatic Cancer Europe partner to provide pancreatic cancer patients, caregivers, and healthcare professionals with access to a comprehensive database of clinical trials, aiming to improve awareness and access to potential pre-approval treatment options.
Neurocrine’s KarXT rival hits in phase 2 schizophrenia trial—but only at lowest dose
August 28, 2024 / Neurocrine / Schizophrenia Trial / Drug Development
Neurocrine Biosciences’ phase 2 trial for schizophrenia drug NBI-1117568 showed efficacy only at the lowest dose, with a significant 7.5-point improvement on PANSS and fewer adverse events than KarXT, leading to plans for phase 3 trials.
With phase 3 win, Novartis pads case for broader use of heart med Leqvio
August 28, 2024 / Novartis / Lequvio / Cholesterol Drug / siRNA Cardiovascular Therapy
Novartis’ phase 3 trial confirms Leqvio’s efficacy in significantly lowering LDL-C levels as a monotherapy, supporting its broader use for atherosclerotic cardiovascular disease prevention, and bolstering its potential as a key cholesterol-lowering drug.
NIH launches $270 million anti-overdose research program for, and led by, Native Americans
August 28, 2024 / NIH / Native American Overdose Reasearch / Anti-Overdose
The NIH is launching a $270 million program focused on addiction and overdose research led by Native Americans, addressing the severe impact of drug overdoses on indigenous communities.
Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
August 27, 2024 / Fezolinetant / Phase3 Trial / Vasomotor Symptoms Breast Cancer / Astellas / Endocrine Therapy
Astellas begins the Phase 3 HIGHLIGHT 1 study of fezolinetant to treat vasomotor symptoms in breast cancer patients on adjuvant endocrine therapy. The nonhormonal drug aims to reduce hot flashes and night sweats.
// Politics
Patent Thickets in Federal Government’s Crosshairs as Election 2024 Looms
August 28, 2024 / Big Pharma / Prescription Drug Price / Price Reduction / Generic Drug Competition / Affordable Prescription for Patients Act
U.S. government bodies are targeting Big Pharma’s use of “patent thickets” to extend drug exclusivity and hinder generic competition, aiming to lower prescription drug prices. This effort involves legislative and regulatory actions as the 2024 election approaches.
SCOTUS overturn of Chevron doctrine opens a Pandora’s box for biopharma industry, expert says
August 27, 2024 / Supreme Court / Chevron Doctrine / FDA Regulatory Challenges
The Supreme Court’s overturning of the Chevron doctrine removes judicial deference to federal agencies like the FDA, opening the door for increased legal challenges to regulatory decisions in the biopharma industry, potentially causing regulatory uncertainty.
For pharma, Trump vs. Harris is a showdown between two industry foes
August 26, 2024 / Drug Prices / Medicare / Price Negotiations / Big Pharma Regulations
Both Donald Trump and Kamala Harris are targeting high drug prices, with Harris advocating for broader Medicare negotiations and caps on drug spending. Trump seeks to increase competition and lower costs, signaling bipartisan pressure on Big Pharma.
Craig Injects Oxy Issue into NHDem Gov Primary, Warmington Hits Back
August 26, 2024 / New Hampshire / Purdue Pharma
In the New Hampshire Democratic gubernatorial primary, Joyce Craig targets opponent Cinde Warmington’s past work as a Purdue Pharma lobbyist. Warmington counters, defending her record and accusing Craig of running a divisive campaign.
Government working on a scheme to strengthen Indian Medical Device sector: Pharma Secretary
August 22, 2024 / Medical Devices / Clinical Trials
India’s government is developing a scheme to bolster the medical device sector post-PLI, focusing on reducing import dependence, enhancing clinical trial support, capacity building, and promoting medical devices, aiming for a self-reliant industry by 2047.