// Biotech and Pharma Therapeutics
RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds
March 4, 2024 / RSV / Pfizer / GSK / Arexvy
After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness.
Pfizer, looking for a jumpstart, leans into cancer drug research
March 1, 2024 / Pfizer / Cancer / Drug Research
The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in the wake of Pfizer’s $43 billion buyout of Seagen last year, houses a sprawling portfolio of experimental medicines both companies discovered and acquired through deals. It also includes the marketed drugs Pfizer and Seagen have long been selling for a variety of tumor types.
After tough rightsizing, Biogen looks to newer rare diseases to broaden lens
March 5, 2024 / Biogen / M&A / Reata Pharmaceutical / Business Development
The business development journeyman, with prior stints at Johnson & Johnson and Sanofi, was hired last year as Biogen’s executive vice president and head of corporate development, tasked with using M&A to shore up Biogen’s late-stage pipeline and overseeing a dispiriting 1,000-person downsizing.
New Novo Nordisk Ozempic Data Build Case for Adding Kidney Disease to Label
March 5, 2024 / Novo Nordisk / Ozempic / Kidney Disease / Clinical Trials
Novo Nordisk drug Ozempic, already a blockbuster seller in type 2 diabetes, now has clinical trial results showing it reduced the risk of kidney disease complications by 24%. The company is planning U.S. and European regulatory submissions this year that would expand the drug’s uses to include treating chronic kidney disease in type 2 diabetes patients.
2nd win for Alnylam RNAi blood pressure med strengthens Roche’s $2.8B biobucks bet
March 5, 2024 / Roche / Alnylam Pharmaceuticals / Hypertension / RNAi
In further evidence that Roche’s $310 million metabolic therapy bet will pay off, the Big Pharma’s Alnylam-partnered hypertension drug has notched up another phase 2 win.
// 4th Industrial Revolution
How AI and FHIR can help reduce sepsis mortality rates
February 28, 2024 / AI / FHIR / Innovation
To better – and earlier – identify sepsis cases not present on admission, at a large safety-net hospital, an end-to-end early sepsis prediction and response workflow was created in the inpatient setting. First, a machine learning model was built to predict the risk of a patient becoming septic in real time.
Machine Learning Models Predict Mortality Among Dementia Patients
February 29, 2024 / Machine Learning / Dementia / New Research
Researchers at the Icahn School of Medicine at Mount Sinai have developed machine learning (ML) models to identify mortality predictors in dementia patients, according to a study published this week in Communications Medicine.
Researchers reveal two different subtypes of prostate cancer using AI
March 4, 2024 / AI / Cancer / Prostate
Researchers from the University of Oxford and the University of Manchester have revealed that prostate cancer is not just a single disease and is made up of two different evotypes – subtypes of the disease.
New digital iTalkBetter app significantly improves speech in stroke patients
February 29, 2024 / iTalkBetter / Stroke / Patient Health
Researchers from the Neurotherapeutics Group at University College London’s Queen Square Institute of Neurology have developed a new digital app that significantly improves speech in stroke patients.
Machine Learning Predicts Cancer Risk in Liver Disease Patients
March 5, 2024 / Machine Learning / Cancer Risk / Liver Disease / UC Davis Health
A research team from UC Davis Health developed a machine learning (ML) tool to identify which patients are at increased risk of developing hepatocellular carcinoma (HCC), a common type of liver cancer.
// Business & Markets
Bayer pays $310M for European rights to BridgeBio’s Vyndaqel rival
March 4, 2024 / Bayer / BridgeBio Pharma / Licensing deals / ATTR / FDA
With the FDA currently mulling whether to approve BridgeBio’s acoramidis as a rival to Pfizer’s blockbuster heart disease drug Vyndaqel, Bayer has decided to pay out $310 million to scoop up the European rights.
WebMD acquires Healthwise to bolster patient engagement and growth
March 4, 2024 / WebMD / Healthwise / Patient Care
WebMD Health announced this past week that it acquired the operation assets of the Boise, Idaho-based Healthwise, a nonprofit that develops patient-engagement technology that integrates with care-management platforms through online patient portals, at the point of care or digitally.
Meissa Vaccines’ future in limbo due to current fundraising climate: CEO
March 5, 2024 / Meissa Vaccines / RSV / Layoffs / Covid-19
Meissa Vaccines is putting its portfolio on hold and laying off staff due to the current fundraising environment, the company told Fierce Biotech.
While Meissa touts a phase 2/3-ready RSV intranasal candidate for children, the California-based biotech doesn’t have the financial means to launch the clinical study.
The Cream Of The Crop: 5 Biotechs That Outrank Most Stocks
March 1, 2024 / Stocks / Market
Now, interest appears to be returning. In the first month of 2024, Investor’s Business Daily’s biotech industry group mostly traded sideways. Shares still remain far below a February 2021 high point, but experts say the trend looks positive. The group now has a Relative Strength Rating of 97, according to IBD Digital. This puts it in the top 3% of all industry groups in terms of 12-month performance.
Novo Nordisk’s success with Ozempic in diabetes and kidney disease patients isn’t enough for investors
March 5, 2024 / Novo Nordisk / Wegovy / Ozempic / Kidney Disease
A trial by Novo Nordisk of its GLP-1 blockbuster Ozempic (semaglutide) on diabetes and kidney disease patients was successful enough that it was halted for efficacy five months ago at the interim stage after a recommendation from the Independent Data Monitoring Committee.
// Legal & Regulatory
As Medicare price negotiations roll on, drugmakers counter HHS’ initial offers
March 4, 2024 / Inflation Redution Act / HHS / CMS / Johnson & Johnson
After the U.S. government last month floated its first offers for 10 drugs on Medicare as part of the negotiations process laid out in the Inflation Reduction Act (IRA), the pricing talks are now in full swing.
CDC panel mulls changes to RSV vaccine recommendation
March 1, 2024 / CDC / RSV Vaccine
Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursday that would more forcefully encourage some individuals receive a shot.
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs
March 5, 2024 / FDA / Sandoz / Amgen
A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products.
Iovance receives more good news as FDA lifts hold on lung cancer cell therapy trial
March 4, 2024 / Iovance Biotherapeutics / FDA / Clinical Hold / Cell & Gene Therapy
The agency implemented the hold on the phase 2 trial of tumor-infiltrating lymphocyte therapy LN-145 on Dec. 22 after a grade 5 adverse event—which signifies a patient fatality—was reported. The death was potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, Iovance explained at the time.
J&J Wins Full FDA Approval for Rybrevant, Chemo Combo in NSCLC
March 4, 2024 / Johnson & Johnson / FDA Approval / Cancer
The FDA on Friday approved Johnson & Johnson’s bispecific antibody Rybrevant (amivantamab-vmjw) for the first-line treatment of locally advanced non-small cell lung cancer in combination with carboplatin and pemetrexed.
// Research & Development
BioCardia rejigs phase 3 heart failure data to find a path forward for cell therapy
March 4, 2024 / BioCardia / Failed Trials / Cell & Gene Therapy / Heart Failure
BioCardia’s data safety monitoring board already warned that the phase 3 CardiAMP cell therapy heart failure trial was not going to make the primary endpoint. And so the California biotech is showcasing some other endpoints instead, hoping to persuade investors that the autologous cell therapy has a future.
ICR study reveals new targeted immunotherapy to prevent spread of breast cancer
February 28, 2024 / ICR / Breast Cancer / Immunotherapy
Responsible for around 47,000 new cases in England every year, breast cancer is a disease that occurs when cells in the breast grow out of control.
The new research reveals a new immunotherapy approach that targets a protein known as endosialin to disrupt the tumour’s blood supply and prevent its growth and spread.
Most commonly used to treat cancer, immunotherapy works to help the body’s immune system recognise and eliminate cancer cells.
Akero strengthens MASH drug’s case with new study data
March 4, 2024 / Akero / MASH / New Study / FDA
The first drug for the condition, Madrigal Pharmaceuticals’ resmetirom, could be approved by the Food and Drug Administration this month. Akero is one of several others, including 89bio and Viking Therapeutics, following closely behind. Popular weight-loss medicines are being tested against MASH as well, and two have already shown promise.
With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype
March 4, 2024 / Johnson & Johnson / Rybrevant / FDA Approvals / Non-small Cell Lung Cancer
Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients.
In a first, fetal cell organoids generated from amniotic fluid, new study reports
March 4, 2024 / Amniotic Fluid / Fetus
It’s “a huge shock that there are viable epithelial cells in the amniotic fluid — totally unexpected!” said stem cell researcher Emma Rawlins via email. Senior group leader at the Gurdon Institute at Cambridge University, Rawlins was familiar with the research conducted at University College London and published Monday in Nature Medicine, but was not involved in it. The cells “are a great way of growing fetal organoids from externally exposed organs,” such as the lung, kidney and intestine, she added.
// Politics
What does America’s crackdown on Chinese firms mean for the U.S. biotech sector?
February 26, 2024 / China / Biden
The federal government increasingly is scrutinizing Chinese businesses and their interactions with American companies, including in the biotech sector. Chinese biotechnology companies, the thinking goes, could threaten national security by giving the Chinese government access to the genetic and health information of Americans.
The US bioeconomy is worth $950 billion, and growing, thanks to these federal policies
February 28, 2024 / Federal Policies / Biomanufacturing
Biomanufacturing can affect the efficacy of many things important to a business plan, from “supply chain security, to sustainability, to environmental impacts, to workforce issues, to new technologies, to new chemicals and materials, and really everything in between,” said Friedman.
Biotech investors urge Florida lawmakers to reject lab-grown meat ban
March 5, 2024 / Investors / Florida / Lawmakers
A letter to Florida legislators signed by 38 venture fund leaders signals strong opposition to the restrictions in an Agriculture Department package (SB 1084). The bill would bar the sale or distribution of cultivated meat.
White House touts incremental step in Medicare drug price negotiation: counteroffers
March 4, 2024 / White House / Medicare / Drug Price
The White House on Monday ballyhooed a routine step in Medicare’s new program to negotiate the prices of prescription drugs, its latest effort to draw attention to the program in an election year.
Biden Drug Price Negotiation Policy Survives Key Legal Fight
March 1, 2024 / Biden / Drug Price / AstraZeneca / Drugmakers
The Biden administration secured another major win Friday in its battle to defend a government drug price-setting program after a federal judge struck down administrative and constitutional claims brought by AstraZeneca.