// Biotech and Pharma Therapeutics
FTC targets ‘junk patents’ on Ozempic, other top drugs
May 1, 2024 / Ozempic / FDA / Drug Pricing / FDA
The FTC is targeting over 300 patents associated with top-selling drugs like Ozempic, aiming to reduce “”junk patents”” that prevent generic competition, according to allegations of abuse in the FDA’s Orange Book.
Chasing Novo and Lilly: The obesity drugs that could challenge Wegovy and Zepbound
April 30, 2024 / Obesity / Drug Development / GLP-1 / Weight Loss
Novo Nordisk and Lilly lead the obesity drug market with Wegovy and Zepbound, inspiring competitors to develop alternatives that match their efficacy and offer improvements in safety and convenience. Over 120 drugs are currently being tested.
Astellas hitches a ride in Poseida’s convertible for $50M cell therapy collaboration
May 1, 2024 / Astellas / Poseida / Collaboration / Cell Therapy
Astellas collaborates with Poseida Therapeutics, investing $50M upfront in a deal to develop two cell therapy candidates for solid tumors using Poseida’s CAR-T technology and Xyphos’ ACCELTM.
Lilly counts on manufacturing scale-up to unstick obesity drug supply
April 30, 2024 / Eli Lilly / Obesity / Diabetes / New Drug / Drug Development / GLP-1
Eli Lilly is expanding production of its obesity and diabetes drugs, Zepbound and Mounjaro, expecting a 50% increase in output to meet rising demand and improve U.S. supply issues, enhancing its 2023 revenue projections.
Pharma firm Shield Therapeutics targets cashflow positive date amid US progress
April 30, 2024 / Shield Therapeutics / Anaemia
Shield Therapeutics, focusing on its lead drug Accrufer for iron deficiency anaemia, aims to become cashflow positive in the second half of 2025, following strong U.S. sales growth and increased prescriptions.
// 4th Industrial Revolution
AI Model Predicts Heart Disease and Heart Failure, Identifies $1.4B in Potential Savings
May 1, 2024 / Cedar Gate / Machine Learning / AI / Heart Diease / Healthcare Cost
Cedar Gate Technologies employs machine learning to identify patients at high risk for coronary artery disease and congestive heart failure, potentially saving $1.4 billion by enabling early intervention and reducing hospitalizations.
TeleRare Health launches to offer virtual care to rare disease patients
May 1, 2024 / TeleRare Health / Virtual Care / Rare Diease Treatment / Patient Care
TeleRare Health introduces a virtual care platform for rare disease patients, providing expert consultations, molecular diagnostics, and support with treatment access and clinical trial enrollment to expedite diagnosis and improve management.
Ransomware was used in 72% of network intrusions last year, says BakerHostetler
May 1, 2024 / Healthcare / Ransomware Attacks / Data Security / Cybersecurity
BakerHostetler reports that 72% of network intrusions last year involved ransomware, with the healthcare, biotech, and pharma sectors most affected, comprising 28% of incidents. Effective prevention included the use of endpoint detection and response tools, patch management, and robust backup strategies.
Prioritizing Patient Care: Medical Technology Innovations on the Horizon
May 1, 2024 / MedTech / FDA Approval / AI / Healthcare / Patient Monitoring / Digital Healthcare
2023 marked a significant year for MedTech, highlighted by a record number of FDA approvals for innovative medical devices, including AI-enabled technologies, improving personalized care and digital health delivery.
Risklick debuts new AI software that writes clinical trial protocols
April 25, 2024 / AI / Clinical Trials
Risklick has introduced Protocol AI, an AI software designed to expedite clinical trial protocol development, potentially reducing time and costs by 35% using natural language processing and generative AI.
// Business & Markets
Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb
April 30, 2024 / Eli Lilly / Revenue / GLP-1 / Drug Sales / Obesity / Zepbound
Eli Lilly has increased its annual revenue forecast by $2 billion, driven by strong demand for its GLP-1 diabetes and obesity drugs, Mounjaro and Zepbound, despite production constraints and drug shortages.
GE HealthCare stock falls 14% after release of its first quarter earnings
May 1, 2024 / GE HealthCare / Stock Price / Medical Imaging
GE HealthCare’s stock fell 14% after reporting nearly flat organic growth and a slight revenue decline in Q1 2024, despite stable net income and a positive outlook on innovations and acquisitions, including MIM Software.
GSK raises forecasts on strong vaccine, HIV drug sales
May 1, 2024 / GSK / Vaccine / Arexvy / Market Share / HIV Drug
GSK has upgraded its financial forecasts for 2024, buoyed by robust vaccine and HIV drug sales, particularly from its shingles vaccine Shingrix and RSV vaccine Arexvy, despite anticipating potential seasonal slowdowns later in the year.
Pfizer sets up DTC marketing platform as Q1 sales beat expectations
May 1, 2024 / Eli Lilly / Pfizer / Growth
Pfizer plans to launch a direct-to-consumer platform by year-end, following Eli Lilly’s model, to sell medicines like Paxlovid online directly to consumers, aiming to streamline distribution and reduce intermediary costs.
Novartis, PeptiDream Ink Potential $2.7B Deal to Expand Radioligand Discovery Partnership
April 30, 2024 / Novartis / PeptiDream / Partnership / Oncology
Novartis has expanded its collaboration with PeptiDream, focusing on the discovery of new peptide radioligand therapies. The deal, potentially worth over $2.7 billion in milestones, strengthens their position in the growing radiopharmaceutical sector.
// Legal & Regulatory
FDA finalizes lab developed test rule over industry opposition
April 29, 2024 / FDA / Medical Device / Healthcare
The FDA finalized a rule to enhance oversight of laboratory developed tests (LDTs), categorizing them as medical devices and requiring pre-market reviews to ensure accuracy and safety, despite strong opposition from the healthcare industry.
Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm
May 1, 2024 / H5N1 Bird Flu / FDA / Dairy Products
FDA and academic studies confirm that pasteurization effectively inactivates the H5N1 bird flu virus in milk, with extensive testing across 38 states showing no evidence of viable virus in dairy products, ensuring consumer safety.
Neurocrine Wins FDA Approval for ‘Sprinkle’ Formulation of Ingrezza for Huntington’s Disease
May 1, 2024 / FDA / Neurocrine Biosciences
The FDA approved a new sprinkle capsule formulation of Neurocrine Biosciences’ Ingrezza for treating tardive dyskinesia and chorea in Huntington’s disease, offering easier administration for patients who struggle with swallowing.
Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits
April 30, 2024 / Lawsuit / Bristol Myer Squibb / Johnson & Johnson / Inflation Reduction Act
A U.S. federal judge dismissed lawsuits by Bristol Myers Squibb and Johnson & Johnson challenging the Inflation Reduction Act’s drug price negotiation measures, asserting the companies voluntarily choose to sell to Medicare.
FDA approves Utility Therapeutics’ Pivya tablets for UTIs
April 25, 2024 / UTI / Pivya / FDA Approval
The FDA has approved Utility Therapeutics’ Pivya tablets for treating uncomplicated urinary tract infections in adult females, offering a new option against pathogens like E. coli and Proteus mirabilis based on solid clinical trial outcomes.
// Research & Development
HiberCell Announces First Patient Dosed in Clinical Collaboration with Merck, Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in patients with advanced ccRCC
May 1, 2024 / HiberCell / Clinical Trials / Cancer / New Study
HiberCell has begun a Phase 1b clinical trial combining its cancer therapy HC-7366 with Merck’s WELIREG® in treating advanced clear cell renal cell carcinoma, aiming to evaluate safety, tolerability, and preliminary efficacy.
Cost of developing new drugs may be far lower than industry claims, trial reveals
April 25, 2024 / Clinical Trials / Tuberculosis / Research & Development
Médecins Sans Frontières (MSF) disclosed a €34 million expenditure for a tuberculosis drug trial, challenging the pharmaceutical industry’s claims of high development costs. MSF advocates for transparency in trial costs to address high drug pricing.
Doctors Without Borders challenges pharma by releasing costs for a key clinical trial
April 29, 2024 / Doctors Without Borders / Clinical Trials / Tuberculosis
Doctors Without Borders disclosed the $36 million cost of a tuberculosis treatment trial to challenge the pharmaceutical industry’s justification for high drug prices based on undisclosed research expenses.
FSD Pharma starts trial for alcohol intoxication supplement
April 30, 2024 / Clinical Trial / FSD Pharma
FSD Pharma has initiated a clinical trial for unbuzzd™, a dietary supplement aimed at mitigating alcohol intoxication. This randomized, double-blind, placebo-controlled trial will test the supplement’s ability to enhance alcohol metabolism and cognitive function.
GSK and Genomics collab to explore using genetics in clinical trial design
April 30, 2024 / GSK / Drug Development / Clinical Trial
GSK and Genomics plc are partnering to explore using polygenic risk scores in clinical trial design, potentially reducing participant numbers and study duration while enhancing outcomes through better patient selection.
// Politics
Lawmakers, as part of ‘lab leak’ Covid inquiry, press to bar EcoHealth from federal research funds
April 23, 2024 / EcoHealth / Covid
A House panel is pushing to debar EcoHealth Alliance from federal funding and seek criminal investigation due to alleged misconduct in reporting risky viral research, highlighting deep political divides on the issue.
Momentum builds for House bill cracking down on Chinese biotechs
April 26, 2024 / Biosecure Act / China / House Bill
The House is set to review the BIOSECURE Act, which aims to restrict U.S. biotech firms from partnering with Chinese companies involved in producing critical drug ingredients, due to concerns over national security and data privacy.
State bill aims to protect local pharmacies with tougher oversight of pharmacy benefit managers
April 24, 2024 / PBM / Drug Pricing / Legislation / Oversight Bill
Pennsylvania state legislators have proposed a bill to increase oversight of pharmacy benefit managers (PBMs) to support local pharmacies and ensure fair drug pricing, citing PBMs’ significant influence on drug costs and market practices.
Federal judge rules against two drugmakers challenging Medicare drug price negotiation program
April 29, 2024 / Medicare / Drug Price / Price Negotiation / Inflation Reduction Act / Lawsuit / Johnson & Johnson
A federal judge in New Jersey ruled that the Medicare drug price negotiation program established by the Inflation Reduction Act is constitutional, rejecting challenges from Bristol Myers Squibb and Johnson & Johnson.
Inflation Reduction Act to have knock on effect on R&D, say biotech experts
April 25, 2024 / Inflation Reduction Act / Lawsuit / Innovation
The Inflation Reduction Act, set to impact in 2026, is causing concern among biotech experts for potentially stifling R&D innovation, with experts at the BioTrinity conference noting its unintended consequences on drug development timelines and investment strategies.