// Biotech and Pharma Therapeutics
Phage therapy: Researchers sharpen another arrow in the quiver against antibiotic resistance
February 20, 2024 / Antibiotic Resistance / New Drug
“It just got so frustrating over the years because we couldn’t find the source, so we couldn’t figure out how to treat it and prevent it from happening,” said Mya Cole, Lynn’s daughter. Lynn would be in and out of the hospital. And because she had Sjogren’s syndrome — an autoimmune disease — her health continued to deteriorate.
Rick Gonzalez, longtime AbbVie CEO, to step down in July
February 20, 2024 / AbbVie / CEO
Gonzalez will be succeeded by current company president and Chief Operating Officer Robert Michael. Once the transition occurs, Gonzalez will become AbbVie’s executive chairman and Michael will join the board of directors, AbbVie said.
MedCity FemFwd: What Male Birth Control Means for Women’s Health
February 19, 2024 / MedCity / Women’s Health / Birthcontrol
In this episode, we’re joined by Régine Sitruk-Ware, a distinguished scientist at the Population Council’s Center for Biomedical Research (CBR), and Chelsea Polis, senior scientist of epidemiology at CBR. They talk about the effect upcoming male birth control products could have on women’s health.
As FDA takes up Dato-Dxd, AstraZeneca’s David Fredrickson places next ADC bet on in-house pipeline
February 21, 2024 / AstraZeneca / Antibody Drug / Lung Cancer / ESMO 2023
When he sat down with Fierce Biotech back in August 2022, David Fredrickson made no secret of the fact that AstraZeneca’s antibody-drug conjugates (ADCs) excited him most about the Big Pharma’s oncology pipeline.
GSK’s Injectable HIV Drug Bests Pills in Patients with Medication Adherence Issues
February 21, 2024 / GSK / HIV Drug / Injectable / ViiV Healthcare
HIV-focused biotech ViiV Healthcare, which is majority owned by GSK, on Wednesday posted interim findings from the Phase III LATITUDE trial demonstrating that its long-acting injectable HIV drug Cabenuva (cabotegravir plus rilpivirine) is better than oral daily antiretroviral treatment in patients who have trouble sticking to their medication schedule.
// 4th Industrial Revolution
Microsoft life sciences leader on what makes for successful disruptors
February 19, 2024 / Microsoft / Life Science Leaders
Market forces shape health tech innovation, but the most transformative startups have a keen understanding of adoption patterns and change management at the organizational level, says Sally Ann Frank in advance of her HIMSS24 presentation.
Hartford HealthCare Launches Center for AI Innovation
February 21, 2024 / AI / Hartford Healthcare
Hartford HealthCare has launched its Center for Artificial Intelligence (AI) Innovation in Healthcare, one of a handful of such centers in the United States set to pursue AI research and development in an effort to improve clinical care.
AI Predicts Heart Attacks by Measuring Fat Around Your Heart, Study Finds
February 14, 2024 / AI / Heart Attacks
Investigators included 8,781 patients from four clinical sites in their study. None of the patients had coronary artery disease–a type of heart disease–at the time of the study, and all underwent heart imaging. Key findings of the study include:
Bioptimus launches with $35M to create an AI foundation model for biology
February 20, 2024 / Bioptimus / AI / Startup
French startup Bioptimus, which aims to create an AI foundation model for biology to drive research and innovation, announced its launch with $35 million in seed funding.
Curing MedTech’s Cybersecurity Contagion
February 20, 2024 / MedTech / Cybersecurity / Medical Devices
There is growing and coordinated momentum behind the goal of ensuring connected medical devices improve people’s lives without introducing them to cybersecurity threats and associated safety risks. There also is a proven playbook for implementing the type of multi-layered, security-by-design strategies these initiatives advocate.
// Business & Markets
Sanofi’s planned consumer health spinoff picks up interest from multiple firms: Bloomberg
February 21, 2024 / Sanofi / Consumer Health / Spinoff
Bloomberg lists Advent International and Blackstone as some of the interested parties, citing people familiar with the matter. Bain Capital, CVC Capital Partners, EQT AB and KKR & Co. are also eyeing the consumer health unit, which could be valued at “about $20 billion in any deal,” according to the publication’s sources.
Industry seeks clarity on India’s 2024 tech investment in health
February 12, 2024 / India / Healthcare / AI
Ahead of the upcoming election of the 18th Lok Sabha (lower house of India’s bicameral parliamentary), Nirmala Sitharaman, union minister of Finance, announced the government’s interim 2024-2025 budget.
Lilly Edges Out J&J to Top 20 BioPharma Market Cap List for 2023
February 20, 2024 / Eli Lilly / Johnson & Johnson / Drug Pricing
Amidst a tenuous market, increasing government drug pricing scrutiny and patent cliffs, the top 20 global biopharma companies experienced vastly different shifts in market capitalization in 2023. A report from data analytics firm GlobalData Tuesday reveals an aggregated 1.5% upturn to $3.67 trillion compared to 2022.
Menopause Startup Raises $3.3M in Funding Led By UPMC
February 21, 2024 / Menopause / Startup / Elektra Health
Elektra Health, a virtual provider for menopause care, has secured $3.3 million in financing. With the funding, the company is focused on two areas: partnering with more payers and expanding its footprint to provide clinical care to more patients.
Trace Genomics Raises Oversubscribed $10.5 Million Series B, Expanding Reach of Pioneering DNA Soil Intelligence Platform
February 20, 2024 / Trace Genomics / DNA
Trace Genomics (Trace), the industry leader in DNA-based soil intelligence, today announced its successful Series B funding round at $10.5 million led by existing investors S2G Ventures and Ajax Strategies, as well as new investor Rabo Ventures. The round exceeded expectations and demonstrated strong investor confidence in Trace’s trajectory and growth strategy. With this additional funding, Trace plans to expand its commercial growth, making its offerings available to more farmers and agronomists.
// Legal & Regulatory
United Therapeutics, in unusual step, sues FDA over rival’s drug application
February 21, 2024 / United Therapeutics / FDA / Liquidia / Lawsuit
United Therapeutics sued the Food and Drug Administration on Wednesday, saying the agency made a mistake in allowing a rival to amend a pending application to sell a competing medicine instead of starting over with a new submission.
FDA approves Roche, Novartis’ Xolair to prevent severe outcomes from common food allergies
February 16, 2024 / Novartis / Roche / Genetech / Peanut Allergy
The FDA has blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. The drug is approved for people ages 1 year and older with certain allergies.
FDA to review expanded use of Sarepta Duchenne gene therapy
February 16, 2024 / FDA / Gene Therapy
The announcement is a boost for Sarepta, which has been able to bring multiple Duchenne drugs to market without definitive evidence they can change the course of the disease. Elevidys was among them, and the FDA’s willingness to consider expanding use without first asking outside experts to weigh in is a “positive sign for expansion and conversion to full approval,” wrote William Blair analyst Tim Lugo, in a note to investors.
X-trodes’ Smart Skin Earns FDA Clearance for Home-Based Electrophysiological Monitoring
February 20, 2024 / FDA / New Tech / xtrofrd
X-trodes, a pioneer in wireless monitoring solutions, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Smart Skin solution, marketed as the X-trodes System M.
FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor
February 17, 2024 / FDA Approvals / Cell & Gene Therapy / Melanoma / Lovance Biotherapeutics
The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.
// Research & Development
FDA puts hold on Rapt trials of drug for eczema, asthma
February 20, 2024 / FDA / Eczema / Asthma / Liver Failure
Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range of inflammatory diseases. Sales are expected to increase further still; Sanofi recently forecast the eczema market as likely to grow as fast as that of psoriasis.
Predict-PD study to identify those at high risk of PD before symptoms appear
February 19, 2024 / Parkinson’s Disease / New Study
A study led by researchers at Queen Mary University and University College London aims to identify those at high risk of developing Parkinson’s disease (PD) before symptoms appear and understand the risk factors for the condition.
NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease
February 21, 2024 / NEJM / CAR-T / Autoimmune Diease
The paper, which was published in The New England Journal of Medicine on Wednesday, comes from a team of scientists at the Friedrich Alexander University, Erlangen-Nurnberg in Germany. They detail how 15 people with severe autoimmune conditions experienced either disease remission or a sharp reduction in symptoms after an infusion of a kind of cell therapy known as CAR-T.
Inventiva pauses phase 3 MASH study over patient’s raised liver enzymes
February 16, 2024 / NASH / Fatty Liver Diseases
Inventiva has paused enrolling new patients into a phase 3 trial of its lead liver disease drug after one participant experienced raised enzyme levels.
Elicio’s vaccine shows promise as potential cancer treatment in phase 1 trial
February 21, 2024 / Elicio / Vaccine / Cancer / Phase 1
Elicio Therapeutics has announced positive phase 1 clinical data suggesting that its cancer vaccine could be a viable option for the treatment of pancreatic and other cancers.
// Politics
In the House, a new bipartisan push to get arms around AI
Februry 21, 2024 / AI / Bipartisan
The U.S. House of Representatives is assembling a new task force on AI. As announced Feb. 20 by Speaker Mike Johnson (R-LA) and Minority-party Leader Hakeem Jeffries (D-NY), the move will bring together 24 representatives—12 from each party—who will work to stimulate American AI innovation while mitigating AI-related threats.
Will banning cultivated meat leave a bad taste in biotech investors’ mouths?
Februry 21, 2024 / Biotech Industry
Biotech investors from across America sent a letter to Gov. Ron DeSantis and legislative leaders opposing a cultivated meat ban. A total of 30 venture fund leaders sounded alarms on agriculture legislation advancing through the House (HB 1071) and Senate (SB 1084).
U.S. lawmakers are trying to bar Chinese biotech companies over fears about America’s failure to compete with China in the industry
February 19, 2024 / Lawmakers / China
U.S. lawmakers are raising alarms about what they see as America’s failure to compete with China in biotechnology, warning of the risks to U.S. national security and commercial interests. But as the two countries’ rivalry expands into the biotech industry, some say that shutting out Chinese companies would only hurt the U.S.
Opioid cravings were reduced by anti-obesity drug in small study
February 17, 2024 / Opioid / Obesity Drug
The GLP-1 medication liraglutide significantly reduced opioid cravings in a small analysis presented on Saturday. It is the first randomized controlled trial to test anti-obesity drugs against opioid addiction, which kills around 80,000 people in the U.S. each year.
Pakistan increases prices of 146 life-saving drugs
February 20, 2024 / Pakistan / DRAP
The Drug Regulatory Authority of Pakistan (DRAP) recommended an increase in the prices of 262 medicines about two years ago. However, the government enhanced the costs of 146 drugs, including MMR and typhoid vaccines, oral antibiotics and the ones used for anaesthesia and treating cancer, inflammation, cardiovascular diseases, fungal illness, allergies, diabetes and epilepsy.