// Biotech and Pharma Therapeutics
Endocrinology company Valendo Health launches with $4M and two provider partners
January 31, 2024 / Endocrinology / Diabetes / Telehealth
Valendo Health, a diabetes-focused, value-based endocrinology company, announced its launch with $4 million in seed funding and two providers.
Sanofi expects RSV antibody to breach blockbuster status in 2024, even as supply hitch drags on
February 1, 2024 / Sanofi / AstraZeneca / Beyfortus / Respiratory Syncytial Virus
As Sanofi strives to become a global immunology leader, it’s also busy making the most of a crucial immunization rollout with partner AstraZeneca. On both fronts, Sanofi expects to see dividends in 2024.
Roche shuffles early stage pipeline as it joins obesity rush
February 1, 2024 / Roche / Obesity / Carmot Therapeutics
Roche is reshaping its early-stage pipeline of experimental drugs, jettisoning eight drug candidates in neurological conditions and oncology as it makes room for a set of obesity treatments it gained with its $2.7 billion acquisition of Carmot Therapeutics.
Novo resumes supplying starter doses of obesity drug Wegovy
January 31, 2024 / Novo Nordisk / Obesity / Wegovy / Drugmaker
Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
Clues from mice could help explain why women face a higher risk of autoimmune disorders
February 1, 2024 / Autoimmune Disorders / RNA
Researchers have long known that women are more likely to develop autoimmune disorders than men, though they’ve struggled to fully understand why. Now a new study in mice suggests a key part of the answer may be that an RNA molecule that’s indispensable for female survival steers the body toward immune friendly fire.
// 4th Industrial Revolution
How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer
January 30, 2024 / AI / Cancer Treatment / Early Detection
Artificial intelligence (AI) is rapidly transforming the healthcare industry, with its ability to process and analyze vast amounts of data. Cancer treatment is one area that could benefit significantly from AI, as it can aid in early detection, precise diagnosis, and personalized treatment plans. With the rise of AI technologies, we could see significant advancements in cancer treatment, making it more efficient and potentially leading to a cure.
Machine Learning, ‘Liquid Biopsy’ to Bolster Early Cancer Detection
January 30, 2024 / Machine Learning / Cancer
Artificial intelligence has the potential to revolutionize the way healthcare is delivered. And many healthcare professionals are exploring exactly what AI can do and deploying systems to help health systems manage care and patients manage their health.
Healthcare should broaden efforts to scale genAI, say IT leaders
January 31, 2024 / Healthcare / AI
The Deloitte 2024 Healthcare Generative AI Outlook study released this week takes a closer look at potential blind spots leaders may have as they implement generative artificial intelligence.
Health tech hazards: At-home medical devices, AI governance on ECRI’s new list
February 1, 2024 / Health Tech / AI / Medical Devices / Patient Data
As part of its safety-focused mission, the nonprofit ECRI conducts independent evaluations of medical devices – and potential risks related to at-home use of devices, by patients and their caregivers alike, top this year’s edition of the list.
If you haven’t met your chief AI officer yet, chances are you soon will
January 30, 2024 / AI / C-Suites / Healthcare
Members of C-suites around the world are making room for a new teammate: the CAIO. In healthcare, some organizations are hiring for the even more specialized position of CHAIO, for chief health AI officer.
// Business & Markets
Roche’s 2024 Strategy Seeks to Fight Low Growth with Pipeline Cuts, M&A
February 1, 2024 / Roche / Cancer / Partnerships
Despite a sharp COVID-19 sales decline, Roche reported 1% group sales growth for 2023 while predicting mid-single digit sales growth in 2024, according to the company’s financial results announced on Thursday.
Merck still in the market for deals in the $1B to $15B range, CEO says
February 1, 2024 / Merck / M&A / Quarterly Sales / Keytruda
Merck made the biopharma industry’s second-largest deal of 2021 when it acquired Acceleron for $11.5 billion. Last year, Merck’s $10.8 billion buyout of Prometheus was the third-largest in the industry.
Pfizer cuts 3 assets as R&D spend drops 24% in Q4
January 30, 2024 / Pfizer / Pipeline / Amplyx Pharma / Antifungal
Pfizer is trimming its pipeline (and team), discarding three assets after R&D spending dropped 24% in the last quarter of 2023.
Takeda pays $300M to license Protagonist drug for blood disorder
February 1, 2024 / Takeda / Protagonist Therapeutics / Peptide Drugs
Protagonist Therapeutics, a biotechnology company focused on peptide drugs, is teaming up with Takeda Pharmaceutical on an experimental, injectable medicine for a rare blood disorder.
After phase 2 fail, cell therapy biotech Atara cuts CMO and lays off 25% of staff
January 31, 2024 / Atara Biotherapeutics / Cell & Gene Therapy / Layoffs / Allogeneic Cell Therapy
After a phase 2 flop late last year, allogeneic T-cell company Atara Biotherapeutics is laying off 25% of staff and sending its chief medical officer out the door.
// Legal & Regulatory
FDA orders new cancer warnings for CAR-T therapies
January 29, 2024 / Cell & Gene Therapy / CAR-T / FDA / Patient Safety
Amid a high-profile CAR-T safety probe, the FDA has released final industry guidance for developers in the space built on the backbone of available information while simultaneously acknowledging a lack of precedent in the space.
AstraZeneca Case Leads Off Busy Year of Challenges to Medicare Drug Pricing Law
February 1, 2024 / AstraZeneca / Medicare / Drug Pricing
A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reports from inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
GSK inks another Zantac settlement ahead of trial in California
February 1, 2024 / GSK / Zantac / Marketing
After GSK spent the latter half of 2023 warding off concerns about the swelling Zantac product liability litigation, the company is back at the settlement table in 2024.
FDA medical device loophole could cause patient harm, study warns
February 1, 2024 / FDA / Medical Device / genAI
Doctors and researchers from the University of Maryland School of Medicine, the UMD Institute for Health Computing and the VA Maryland Healthcare System are concerned that large language models summarizing clinical data could meet the U.S. Food and Drug Administration’s device-exemption criteria and could cause patient harm.
23andMe Scores FDA Clearance for Novel Cancer Immunotherapy Targeting NK Cells
February 1, 2024 / 23andMe / FDA / Immunotherapy / NK Cells / Clinical Trials
23andMe Holding Co. (Nasdaq: ME), a genetics and biopharmaceutical company, announced The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for 23ME-01473 (referred to as ‘1473), paving the way for the first human clinical trial of this promising new therapy.
// Research & Development
Cancer treatment could identify patients most likely to respond to cancer drugs
February 1, 2024 / Cancer / Reaseach / New Drugs
Scientists from the Cancer Research UK Scotland Institute and Memorial Sloan Kettering Cancer Centre have discovered a cancer treatment that can identify patients who are more likely to respond to cancer drugs.
KLAS Research Putting More Focus on Patient Engagement
February 1, 2024 / KLAS Research / Patient / Healthcare
KLAS Research is continuing to expand beyond its traditional focus on healthcare IT buyers and has put a focus on incorporating the voice of patients into their research. Here is why this is important.
Non-opioid drug from Vertex cuts pain in major trial tests
January 30, 2024 / Non-opioid Drug / Vertex / Drug Development / Pain Killer
A closely watched non-opioid painkiller succeeded in two large clinical trials, raising hopes the drug might offer an alternative to powerful but addictive medicines like OxyContin or Vicodin.
New CMS pilot to test payment scheme for pricey sickle cell gene therapies
January 31, 2024 / CMS / Sickle Cell / Gene Therapy / FDA
Two such treatments were recently approved by the Food and Drug Administration after testing showed they can eliminate the crises of pain people with severe sickle cell often experience. However, they respectively cost $2.2 million and $3.1 million, raising alarm about their affordability and impact on the budgets of state Medicaid agencies, which cover an estimated 50% to 60% of people living with sickle cell in the U.S.
Methadone treatment gets first major update in over 20 years
February 1, 2024 / Methadone / New Regulations
The federal government is unveiling new regulations meant to modernize methadone treatment, the first major update to patient care standards at methadone clinics in more than 20 years.
// Politics
Bernie Sanders Has a Plan to Make Big Pharma’s Greedheads Squirm
Februry 1, 2024 / Bernie Sanders / Drug Manufacturers
Since taking the helm of the committee that oversees the nation’s health care system last year, Senator Bernie Sanders has used his perch to take aim at pharmaceutical executives over the cost of prescription drugs. Next week, the CEOs of drug manufacturers Johnson & Johnson, Merck, and Bristol Myers Squibb will appear before the Health, Education, Labor and Pensions Committee to testify at a hearing concerned with the high prices of prescription medication in the United States as compared to other countries. The executives agreed to appear voluntarily last week after Sanders threatened to hold a vote to subpoena them.
Biden administration makes opening offers in Medicare drug price negotiations
Februry 1, 2024 / Biden / Price Negotiations / Medicare
The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
WuXi Bio shares drop as US BIOSECURE bill targets China biotech
January 29, 2024 / China / House of Representatives
“The Government of the People’s Republic of China (PRC) seeks to dominate biotechnology as an industry of the future,” the bipartisan draft bill states. “In recent years, the PRC has pursued a strategy known as ‘military-civil fusion’ that merges public and private industries to enable the military modernization of the People’s Liberation Army (PLA),” it continues, adding this includes collaboration with companies looking to accelerate the development of biotechnology.
Pharma price cut proposals from US government could be steep, analysts say
January 29, 2024 / Drug Price / Drugmakers
Pharmaceutical companies are due to receive by Thursday the U.S. government’s opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program’s first ever price negotiations.
Florida cybersecurity safe harbor bill advances
January 30, 2024 / Florida / Cybersecurity / Cyberattack
Introduced in November by Mike Giallombardo, R-Coral Gables, the chair of the state’s Energy, Communications & Cybersecurity Subcommittee, the law would provide safe harbor to government agencies and a list of entities that acquire, manage and use personal information for cyber incident liability if the entity is “substantially” compliant with a cyber protection framework and the regulations governing the individual entity.