// Biotech and Pharma Therapeutics
AACR 2024: Getting older younger may be driving rise in early-onset cancers
April 8, 2024 / Cancer / AACR
As with most common diseases of the developed world, aging is the major risk factor for developing cancer. Most of the half-dozen hallmarks of precancer that were published last week by investigators from Vanderbilt University and the Fred Hutchinson Cancer Research Center are also hallmarks of aging.
Pfizer’s plot to win the RSV vaccine race
April 9, 2024 / Pfizer / Vaccine / RSV / Chronic Health
The company said Tuesday that topline data from its MONeT trial — a safety and immunogenicity trial involving 681 volunteers — showed that the vaccine generated as strong an immune response in adults under the age of 60 who have chronic conditions as it does in adults 60 and older. The vaccine was well tolerated in the younger adults, the company said.
How biotech startup Seadling is turning seaweed into a high-impact crop for smallholder farmers
April 9, 2024 / Startup / Seadling / Enviornment
Seaweed is a billion-dollar industry just in Malaysia, Indonesia and Philippines, but a tough one to access, Davis tells AgFunderNews. Seaweed farms are usually located in remote places where language is a barrier and communities are slow to embrace change.
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med
April 8, 2024 / AstraZeneca / FDA / Enhertu / Cancer
Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment.
Advanced therapy CDMO Ascend nabs Florida manufacturing site and team from ocular gene therapy outfit Beacon
April 9, 2024 / CDMO / Cell & Gene Therapy / Manufacturing
Though gene therapy manufacturing specialist Ascend Advanced Therapies just launched a little more than a year ago, the CDMO is already on the hunt to expand.
// 4th Industrial Revolution
Which Health Tech Startups Will Present in the Payer/Provider Track of INVEST Pitch Perfect?
April 9, 2024 / New Teach / Startup / Payers
At the MedCity INVEST conference, healthcare startups take center stage in the Pitch Perfect contest. The finalists for the Payer/Provider track are applying their health tech solutions to burnout and operational efficiency. Their health tech solutions span a wide range of areas such as physical therapy, critical illness, health data privacy and more.
The rise of subscription-based AI platforms for drug discovery
April 6, 2024 / AI / Subscription Based / Drug Discovery / Startups
As soon as pharmaceutical companies recognized the potential of artificial intelligence tools for drug discovery, they rushed in with big money. After all, traditional drug discovery methods are painstakingly time-consuming, and the promise of AI platforms to trim timelines holds much appeal. Nearly all pharma giants have partnered with start-ups or well-established companies at the forefront of drug discovery AI.
PureTech launches Seaport, hoping to create Karuna 2.0
April 9, 2024 / PureTech / Karuna 2.0 / ARCH / Sofinnova / Third Rock / Startup
Hoping to repeat a recent success story, the biotechnology startup creator PureTech Health has launched a new company aimed at developing psychiatric medicines.
Clinical deterioration AI contributes to reduced care escalation risk
April 5, 2024 / AI / New Research
Researchers have demonstrated that an artificial intelligence (AI) model designed to detect clinical deterioration was associated with a significantly decreased risk of inpatient escalations in care, according to a study recently published in JAMA Internal Medicine.
Machine learning predicts hospitalization during cancer treatment
April 8, 2024 / Machine Learning / Cancer Treatment / Wearables / Chemoradiotherapy
Machine learning tools can accurately forecast an unplanned hospitalization event during concurrent chemoradiotherapy (CRT) using patient-generated health data from wearable devices, according to a study published recently in JAMA Oncology.
// Business & Markets
J&J to acquire Shockwave Medical for $13.1B
April 5, 2024 / Johnson & Johnson / Shockwave Medical / Merger
J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
3 Pharma Stocks Delivering Exciting April Returns
April 10, 2024 / Innovation / Economy / Stock Market
Given the industry’s bright prospects, investors could consider buying fundamentally strong pharmaceutical stocks such as Dr. Reddy’s Laboratories Limited (RDY – Get Rating), Teva Pharmaceutical Industries Limited (TEVA – Get Rating), and AbbVie Inc. (ABBV – Get Rating).
Genmab Buys ProfoundBio for $1.8B to Boost Oncology Portfolio
April 3, 2024 / Genmab / Oncology / ProfoundBio
Danish drugmaker Genmab A/S (GMAB) said Wednesday that it is buying privately held U.S. biotech firm ProfoundBio Inc. for $1.8 billion in cash as it expands its pipeline of cancer treatments.1
AbbVie’s Humira Loses Only 4% of Market Share to Biosimilars: Report
April 9, 2024 / AbbVie / Humira / Market Share / Samsung Bioepis
Despite hitting the market more than a year ago with steep discounts, biosimilars for AbbVie’s blockbuster arthritis treatment Humira (adalimumab) have managed to take only 4% of the market share away from the branded reference product, according to the latest quarterly report from Samsung Bioepis.
Costco, Sesame expand weight loss partnership program
April 9, 2024 / Costco / Weight Loss / Sesame / Partnership
Warehouse retailer Costco is expanding its healthcare footprint by offering a comprehensive weight loss service to its members across all 50 states with a three-month subscription starting at $179.
// Legal & Regulatory
J&J’s Medos withdrawing neurovascular guide catheters
April 8, 2024 / Johnson & Johnson / FDA / Medos International
The U.S. FDA announced a class I recall of single-use neurovascular guide catheters made by Medos International Sarl SA of Neuchatel, Switzerland, because of fractures in the device’s distal catheter shaft. The FDA stated that the issue, seen in the company’s Cerebase DA line of guide sheaths, has led Medos to recommend that customers quarantine any of the affected devices, although a root cause has not yet been identified.
Novartis Sues Teva to Block Copies of Tasigna Leukemia Drug
April 5, 2024 / Novartis / Leukemia Drug / Teva / Lawsuit
Novartis AG alleged in a federal lawsuit that Teva Pharmaceutical Industries Ltd.’s proposed copy of Tasigna infringes six patents for the leukemia treatment.
Astellas wins first approval of Vyloy in gastric cancer in Japan
April 2, 2024 / Astellas / Drug Approval / Cancer / Japan
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake
April 9, 2024 / Multiple Myeloma / Minimal Residual Disease / FDA / Accelerated Approval
About 15 years ago, Carl Ola Landgren, M.D. Ph.D., noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. Drugs had become so increasingly efficacious that they could induce tumor responses in nearly 90% of newly diagnosed patients.
Sanofi to settle 4,000 Zantac cancer lawsuits in US state courts
April 4, 2024 / Sanofi / Zantac / Lawsuit / US State Courts
Sanofi did not disclose the financial terms of the deal. The agreement, which still needs to be finalized, will resolve most of the lawsuits against the French pharmaceutical company in U.S. state courts, with the exception of Delaware where the majority of the cases are pending.
// Research & Development
Women want to participate in clinical trials. Lack of flexibility is still a problem.
April 8, 2024 / Women’s Health / Clinical Trials
Exclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness. But the drug caused serious birth defects, including missing or deformed limbs.
Pfizer plots Abrysvo expansion with positive study in wide pool of adults at risk from RSV
April 9, 2024 / Pfizer / Abrysvo / Respiratory Syncytial Virus / Vaccine Development
As Pfizer races to grow the respiratory syncytial virus (RSV) vaccine market along with rival GSK, the company has been looking to expand its vaccine’s reach. Now, armed with fresh data for Abrysvo in adults at higher risk of disease, the New York drugmaker is plotting a new approval filing.
US researchers reveal positive results of personalised vaccine for liver cancer
April 9, 2024 / Liver Cancer / Vaccines / Clinical Trials
Researchers from the Johns Hopkins Kimmel Cancer Center and its Convergence Institute have revealed promising results of a personalised vaccine for liver cancer in a clinical trial.
Results from the study were published in Nature Medicine and were recently presented at the American Association for Cancer Research’s annual meeting.
Bristol Myers Squibb Schizophrenia Drug Reduces Symptoms Without Weight Gain
April 8, 2024 / Bristol Myers Squibb / Weight Gain / Schizophrenia
Bristol Myers Squibb have announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
Amylyx axes ALS drug from market after Phase III failure
April 5, 2024 / Amylyx / ALS / FDA
Amylyx Pharmaceuticals has formally announced the removal of its amyloid lateral sclerosis (ALS) drug Relyvrio (AMX0035) from the market following disappointing Phase III results.
// Politics
Biden touts inhaler price drops with Bernie Sanders: “Finally, finally we beat big Pharma”
April 3, 2024 / Biden / Bernie Sanders / Asthma / Congress / Drug Costs
Sen. Bernie Sanders and President Biden joined forces Wednesday at the White House, championing the progress they’ve made on lowering the cost of inhalers and other expenses for Americans with asthma.
Medicare coverage of weight loss drugs could save the U.S. billions of dollars
April 3, 2024 / Medicare / Weight Loss / Obesity / Clinical Trials
Individuals with obesity participating in a clinical trial of Wegovy safely lost 15% or more of their body weight, with similar results for other medications like Zepbound. The benefit of these drugs extends beyond weight loss. For example, the FDA recently approved the use of Wegovy to treat people with heart disease.
US takes next step in Medicare drug price negotiations with pharma companies
April 3, 2024 / Medicare / Drug Price Negotiations / Biden
The Biden administration said on Tuesday it has responded to offers from the manufacturers of 10 high-cost drugs selected for the U.S. Medicare program’s first-ever pricing negotiations, but provided no details.
US National Security, China and Biotechnology in 2024
April 5, 2024 / China / National Security / Congress
If it hasn’t become painfully obvious yet with the BIOSECURE Act in the news, China is aggressively pursuing a strategy to become the world’s leader in biotechnology, which poses a significant threat to U.S. national security. In recent months, members of Congress and U.S. intelligence officials have warned that Chinese biotech companies may be collaborating with Beijing, with the latest example being WuXi AppTec, a China-based biotech reported to have allegedly transferred a U.S. client’s intellectual property (IP) to the Chinese government without consent.
Driving down health care costs: Independent pharmacies, patients and lawmakers take steps to rein in PBMs
April 3, 2024 / Healthcare Costs / Lawmakers / Drug Costs
Even as prescription drug costs have skyrocketed in recent years, Hart Pharmacy in Cincinnati is getting less money per prescription, costing the pharmacy tens of thousands of dollars each year. Third-generation pharmacist and owner Sarah Priestly said costs associated with PBMs forced her to cut back hours for her staff of 16.