// Biotech and Pharma Therapeutics
European prosecutors take over investigation into deal for Pfizer COVID vaccines: Politico
April 1, 2024 / Pfizer / European Commission / Albert Bourla / Investigation
While the market for COVID-19 vaccines has been shrinking lately, an investigation into text messages between Pfizer CEO Albert Bourla, Ph.D., and the European Commission’s president Ursula von der Leyen remains ongoing.
Gilead bets on Xilio cancer drug as biotech restructures
March 28, 2024 / Gilead Sciences / Cancer / Xilio Therapeutics
XTX301 is a form of the cytokine IL-12 that’s designed to be activated only within the local area surrounding a tumor. IL-12 drugs have been explored for years as a possible cancer immunotherapy, but their track record is mixed. Bristol Myers, for example, paid Dragonfly Therapeutics $475 million in 2020 to license an IL-12 medicine, only to terminate the license and return rights back to Dragonfly three years later. Eli Lilly, AstraZeneca and Merck & Co. have also done IL-12 research.
Merck puts KRAS cancer drug competitor to the test
April 4, 2024 / Merck / KRAS / Cancer Drug / Immunotherapy / Amgen
While sales have been slower than analysts expected, and Amgen has run into confirmatory testing difficulties, the drugs are viewed as building blocks for curbing tumors that resist other treatment. Both Amgen and Bristol Myers Squibb, which bought Mirati last fall, are testing their respective drugs alongside other therapies, as well as in earlier settings.
‘Unprecedented’ demand for Eli Lilly’s Zepbound sparks US supply constraints
March 29, 2024 / Zepbound / Mounjaro / Tirzepatide / Eli Lilly
This time, the drug that pharmacies can’t consistently keep on shelves is Eli Lilly’s GIP/GLP-1 obesity offering Zepbound, thanks to what the company describes as “unprecedented” demand.
The biotech scoreboard for the second quarter: 32 stock-moving events to watch
April 2, 2024 / 2nd Quarter / Drugmakers
Danish drugmaker Zealand Pharma — yes, there’s another Danish drug maker in obesity — is developing a long-acting amylin analog called petrelintide. The experimental medicine has garnered attention for its potential to show incretin-like weight loss with muscle preservation, and a tolerable side-effect profile. A Phase 1 study is expected to read out toward the middle of the year.
// 4th Industrial Revolution
5 tips on AI adoption from a frontline physician champion
March 28, 2024 / AI / Healthcare / New Tech
AI adoption for real-world healthcare settings can’t happen in a vacuum. Behind every successful implementation is a work culture open to innovation, a leadership team supportive of continuous improvement and a PPT framework primed to be built upon.
HD raises $5.6M to build a Sierra AI for healthcare in Southeast Asia
April 2, 2024 / Sierra AI / Healthcare / Southeast Asia / Chatbots
Chatbots have come a long way. For years, they were limited to responding with predetermined replies that followed a simple logic structure. But customers can have complex problems, and no tree-diagram of possible replies can have enough branches to account for all the edge cases that arise. Thankfully, the advent of large language models (LLMs) has finally rendered chatbots useful.
Abridge brings generative AI solution to Sutter Health physicians in California
March 28, 2024 / AI / Sutter Health / California / Abridge / New Tech / Med Tech
Generative AI company Abridge announced a partnership with Northern California-based healthcare system Sutter Health, which will allow Abridge’s clinical documentation software to be available to Sutter clinicians.
AI Adoption Essential for Healthcare Providers Amid Rising Challenges and Patient Options
March 29, 2024 / AI / Healthcare Providers
If you’re not addressing core challenges and improving healthcare experiences to meet people’s needs, you risk losing your competitive edge. Traditional healthcare providers often struggle to innovate and compete due to costly administration and revenue cycle management (RCM) processes, which consume significant amounts of profits.
Openstream.ai notches patent for multimodal AI-driven digital twin
March 29, 2024 / Openstream.ai / Virtual Assistants / Digital Twins
Conversational AI organization Openstream.ai announced a new patent for automated digital twin technology that gives EVA, or enterprise virtual assistant, users the ability to utilize virtual assistants that are digital twins of human experts in their respective fields.
// Business & Markets
Boston Medical Center launches new hospital-at-home program
April 3, 2024 / Boston Medical Center / Clinical Home Visits
Hospital patients with conditions like pneumonia, dehydration and heart failure have been shown to experience shorter recovery times with fewer complications when they receive more cost-effective healthcare at home – and many health systems have been preparing for this future.
Diagonal launches with $128M and a platform slanted toward agonist antibodies
April 3, 2024 / Diagonal Therapeutics / Antibodies / Atlas Venture / RA Capital
Diagonal Therapeutics is taking shape, launching with $128 million and backed by the likes of BVF Partners, Atlas Venture and RA Capital to develop a pipeline of antibody agonists.
Eiger Files for Bankruptcy, Plans to Shutter Operations After Difficult Year
April 2, 2024 / Bankruptcy / Eiger BioPharmaceuticals / California
Eiger BioPharmaceuticals on Monday announced that it has voluntarily filed for bankruptcy and has kicked off the process of selling its assets and winding down the company’s operations.
Providence Spins Out Praia Health Secures $20M for Digitally Driven Health System Transformation
April 2, 2024 / Praia Health / Digital Health / Startup
The new company is spearheaded by Justin Dearborn, a seasoned figure in both the healthcare industry and startup realm, who has been actively involved as an executive-in-residence at the Providence Digital Innovation Group (DIG) since September 2023. The Praia Health platform marks the fourth technology venture incubated at DIG under the guidance of Sara Vaezy, Providence’s chief strategy and digital officer.
Acorda inks $185M asset sale to Merz, files for bankruptcy after years of disappointing sales
April 2, 2024 / Merz / Acorda Therapeutics / Inbrija / Fampridine
After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal to sell off its assets and a bankruptcy filing.
// Legal & Regulatory
New law to speed up clinical trails
March 30, 2024 / Clinical Trials / Germany
The draft Medical Research Act (Medizinforschungsgesetz) presented by Health Minister Karl Lauterbach in Berlin before Easter is the centrepiece of Germany’s pharmaceutical strategy. With this strategy, the federal government wants to make Germany more attractive again as a location for biopharmaceutical production and R&D.
FDA approves new antibiotic for several hard-to-treat infections
April 4, 2024 / FDA Approval / Drugmakers / Basilea
It’s been a long road for Basilea to reach the world’s biggest pharmaceutical market with Zevtera. The company first tried to win approval for Zevtera more than 15 years ago with its former partner, Johnson & Johnson. Setbacks in both the U.S. and European markets followed, with Basilea blaming J&J for faulty management of clinical trials for patients with a different set of skin infections.
AliveCor Isn’t Backing Down from Apple, Its ‘Bully’
March 31, 2024 / AliveCor / Apple / Medical Device / Antitrust Lawsuit
Throughout its storied history, Apple has been no stranger to litigation. While many articles about the Cupertino, California-based tech giant’s legal woes are currently being published given the antitrust lawsuit that the Department of Justice filed over Apple’s alleged monopolization of the smartphone market, this story focuses on its legal wrangling with a smaller rival in the medical device space.
Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod
April 3, 2024 / Vanda Pharmaceuticals / Fanapt / Hetilioz / Johnson & Johnson
The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder. Those with manic or mixed episodes are a subset of the 10 million in the U.S. with bipolar I, which is characterized by mood swings from euphoria to depression.
Acorda Joins Growing Group of Biotechs Filing for Bankruptcy, Divests Assets to Merz
April 3, 2024 / Bankruptcy / Acorda Theraputics
Acorda Therapeutics on Monday announced that it has voluntarily filed for bankruptcy and is seeking Chapter 11 protections to facilitate the orderly transfer of its assets and the winding down of its business operations.
// Research & Development
Amylyx withdraws ALS drug after trial fail, slashes headcount
April 4, 2024 / Cambridge Biotech / ALS / Clinical Trials
The Cambridge biotech has decided to remove its ALS drug from the market after announcing last month it had failed a Phase 3 clinical trial.
Bristol Myers says KRAS drug succeeds in key trial
March 29, 2024 / Bristol Myers / KRAS / Clinical Trials
KRAS mutations are one of the most common in non-small cell lung cancer. People whose tumors are positive for the mutation have poorer prognosis than those who don’t. For years, developers tried and failed to come up with a targeted KRAS therapy, leading some to consider it “undruggable.” That changed when Amgen was able to quickly push Lumakras through clinical trials and onto the market.
Eli Lilly in advanced clinical trials for its weight-loss pill
March 29, 2024 / Eli Lilly / Clincal Trials / Weight Loss / Drug Makers
The race for new weight-loss drugs is heating up. And if you have the scare of the needle, just pop a pill and see your waist size shrink. US drug maker Eli Lilly has initiated its phase three clinical trials in India for an oral drug named orforglipron.
CureVac, chasing Moderna’s mRNA flu vaccine, runs into the same B strain problems
April 4, 2024 / CureVac / GSK / mRNA / Flu Vaccine
CureVac and GSK have been racing behind Moderna to try to get the first mRNA flu vaccine to market. But, now, the European partners have come up against the exact same problem as their U.S. competitor when it comes to the “historically challenging” B strains of influenza.
Vertex moves kidney disease drug into late-stage testing
April 1, 2024 / Vertex / Kidney Disease / Late-stage Testing
Vertex, as it sought to find success outside of the cystic fibrosis drugs that made its name, made a bet a few years ago on targeting APOL1-mediated kidney disease.
// Politics
Federal Government Unveils Draft Health IT Strategy for Public Comment
March 27, 2024 / ONC / Health IT Strategy / Healthcare
The draft 2024-2030 Federal Health IT Strategic Plan focuses on improving access to health data, creating a more equitable healthcare experience, and modernizing public health data infrastructure.
Health Execs Applaud Biden’s Final Rule on ‘Junk’ Health Insurance
April 1, 2024 / Biden / Health Insurance
The American Medical Association, the Association for Community Affiliated Plans and several other organizations came out in support of the Biden administration’s new rule on short-term health plans. The rule limits the plans to shorter time periods and requires them to be clearer about what they do and do not cover.
Lawmakers want to add more Chinese biotechs to defense list
April 2, 2024 / Lawsuit / China / Congress
Members of Congress are asking the Biden administration to add seven more Chinese biotechs to a list of companies suspected of working with Beijing’s military. The concern is that China could “create synthetic pathogens” to win an upper hand, a March 29 letter addressed to Defense Secretary Lloyd Austin said.
White House outlines new rules for AI use in federal agencies
March 29, 2024 / AI / White House / CDC / Biden
The aim of the new policies, which build off President Biden’s sweeping executive order back in October, is to “mitigate risks of artificial intelligence and harness its benefits,” said the White House in a fact sheet.
Sanofi settles 4,000 Zantac state lawsuits, still faces Delaware claims
April 4, 2024 / Sanofi / GSK / Zantac / Lawsuits
Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. state courts besides Delaware, the company confirmed on Thursday.