// Biotech and Pharma Therapeutics
‘Lots of ways for donanemab to win’ in Alzheimer’s, Lilly says. Now, it just needs the data
April 27, 2023 / Eli Lilly / Alzheimer’s Disease / Donanemab / Iecanemab – Analysts are desperately trying to read the tea leaves comparing Eli Lilly’s Alzheimer’s disease med and Eisai/Biogen’s Leqembi before the mug is cool, but executives say there are “lots of ways for donanemab to win.” Read Full Article on Fierce Biotech >>
April 27, 2023 / Eli Lilly / Alzheimer’s Disease / Donanemab / Iecanemab – Analysts are desperately trying to read the tea leaves comparing Eli Lilly’s Alzheimer’s disease med and Eisai/Biogen’s Leqembi before the mug is cool, but executives say there are “lots of ways for donanemab to win.” Read Full Article on Fierce Biotech >>
Johnson & Johnson’s PARP combo nabs first global nod but faces tough fight against AZ, Merck’s Lynparza
April 24, 2023 / Johnson & Johnson / PARP Inhibitors / Prostate Cancer / European Commission – Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Read Full Article on Fierce Pharma >>
April 24, 2023 / Johnson & Johnson / PARP Inhibitors / Prostate Cancer / European Commission – Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Read Full Article on Fierce Pharma >>
Sanofi Cleans House, Cuts Assets from Principia and Ablynx Buyouts
April 27, 2023 / Sanofi / Buyouts / Principia / Ablynx – Sanofi is the latest company to do some spring cleaning of its pipeline. Thursday morning, the pharma announced it will discontinue two acquired programs in its Q1 update. Read Full Article on Biospace >>
April 27, 2023 / Sanofi / Buyouts / Principia / Ablynx – Sanofi is the latest company to do some spring cleaning of its pipeline. Thursday morning, the pharma announced it will discontinue two acquired programs in its Q1 update. Read Full Article on Biospace >>
A startup taking a different approach to Alzheimer’s gets fresh funds, Lilly backing
April 27, 2023 / Startup / Eli Lilly / Alzheimer’s / Therini Bio – Therini Bio, a startup developing a drug for Alzheimer’s disease, has raised $36 million from a group of investors that included Eli Lilly and the venture arms of both Sanofi and Merck & Co. Read Full Article on Biopharma Dive >>
April 27, 2023 / Startup / Eli Lilly / Alzheimer’s / Therini Bio – Therini Bio, a startup developing a drug for Alzheimer’s disease, has raised $36 million from a group of investors that included Eli Lilly and the venture arms of both Sanofi and Merck & Co. Read Full Article on Biopharma Dive >>
Lilly to Divest BAQSIMI to Amphastar
April 27, 2023 / Eli Lilly / Amphastar – In an effort to continue expanding the availability of BAQSIMI® to patients, Eli Lilly and Company (NYSE: LLY) and Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) have entered into a definitive agreement for Lilly to divest BAQSIMI worldwide to Amphastar, a global pharmaceutical company focused on developing, manufacturing, and marketing injectable, intranasal, and inhalation products including experience with a glucagon product. BAQSIMI is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes. Read Full Article on Biospace >>
April 27, 2023 / Eli Lilly / Amphastar – In an effort to continue expanding the availability of BAQSIMI® to patients, Eli Lilly and Company (NYSE: LLY) and Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) have entered into a definitive agreement for Lilly to divest BAQSIMI worldwide to Amphastar, a global pharmaceutical company focused on developing, manufacturing, and marketing injectable, intranasal, and inhalation products including experience with a glucagon product. BAQSIMI is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes. Read Full Article on Biospace >>
// 4th Industrial Revolution
Walmart Health Continues 2024 Expansion into Oklahoma
April 26, 2023 / Walmart Health / Oklahoma – Walmart Health announced its expansion into the state of Oklahoma, with four new health centers in the Oklahoma City area in 2024. This expansion into Oklahoma is a continuation of Walmart Health’s commitment to making quality healthcare more convenient, accessible and affordable for customers in the communities we serve. Read Full Article on Hit Consultant >>
April 26, 2023 / Walmart Health / Oklahoma – Walmart Health announced its expansion into the state of Oklahoma, with four new health centers in the Oklahoma City area in 2024. This expansion into Oklahoma is a continuation of Walmart Health’s commitment to making quality healthcare more convenient, accessible and affordable for customers in the communities we serve. Read Full Article on Hit Consultant >>
Researchers Develop AI Feedback Tool to Improve Surgeon Performance
April 27, 2023 / AI / Surgeon / New Tech – Researchers from the California Institute of Technology (Caltech) and the University of Southern California (USC) Keck School of Medicine have developed an artificial intelligence (AI) system designed to provide surgeons with feedback on the quality of their work and which of their skills need improvement. Read Full Article on Healthcare IT Analytics >>
April 27, 2023 / AI / Surgeon / New Tech – Researchers from the California Institute of Technology (Caltech) and the University of Southern California (USC) Keck School of Medicine have developed an artificial intelligence (AI) system designed to provide surgeons with feedback on the quality of their work and which of their skills need improvement. Read Full Article on Healthcare IT Analytics >>
The fast-growing need for oversight of AI in healthcare
April 27, 2023 / AI / Healthcare / ChatGPT – With artificial intelligence starting to proliferate in healthcare, and getting a lot of attention thanks to recent developments like ChatGPT, it’s becoming critical that healthcare provider organizations understand the risks that come with AI and the subsequent need for oversight. Read Full Article on Healthcare IT News >>
April 27, 2023 / AI / Healthcare / ChatGPT – With artificial intelligence starting to proliferate in healthcare, and getting a lot of attention thanks to recent developments like ChatGPT, it’s becoming critical that healthcare provider organizations understand the risks that come with AI and the subsequent need for oversight. Read Full Article on Healthcare IT News >>
Generative AI: 5 concerns voiced by healthcare thought leaders
April 26, 2023 / AI / Healthcare / ChatGBT – Every industry on earth is buzzing over the promise and potential of ChatGPT and similarly sharp AI models, whether “large language” or another generative form. Healthcare is no exception. But shouldn’t it be? Read Full Article on AI in Healthcare >>
April 26, 2023 / AI / Healthcare / ChatGBT – Every industry on earth is buzzing over the promise and potential of ChatGPT and similarly sharp AI models, whether “large language” or another generative form. Healthcare is no exception. But shouldn’t it be? Read Full Article on AI in Healthcare >>
The rise of AI in pharma: make it work for you
April 24, 2023 / AI / Pharma – You work with biologists on experiments to prioritize leads for further drug development. You do a full analysis of existing data to help define which drug targets have the highest likelihood for therapeutic success. You use an AI-derived knowledge base to pull available ’omics data from a range of dataset repositories, and match that data with your company’s internal data. Read Full Article on Biopharma Dive >>
April 24, 2023 / AI / Pharma – You work with biologists on experiments to prioritize leads for further drug development. You do a full analysis of existing data to help define which drug targets have the highest likelihood for therapeutic success. You use an AI-derived knowledge base to pull available ’omics data from a range of dataset repositories, and match that data with your company’s internal data. Read Full Article on Biopharma Dive >>
// Business & Markets
J&J’s consumer health spinoff seeking $3B stock offering in test of IPO market
April 25, 2023 / Johnson & Johnson / IPO Market / Kenvue – Kenvue’s IPO could boost a stagnant market for initial public offerings in the U.S. The slowdown has been particularly acute among drugmakers, who often account for a substantial share of new listings. Only five biotechs have priced IPOs so far this year, by far the slowest pace to begin any year since 2018, according to data from BioPharma Dive. Read Full Article on Biopharma Dive >>
April 25, 2023 / Johnson & Johnson / IPO Market / Kenvue – Kenvue’s IPO could boost a stagnant market for initial public offerings in the U.S. The slowdown has been particularly acute among drugmakers, who often account for a substantial share of new listings. Only five biotechs have priced IPOs so far this year, by far the slowest pace to begin any year since 2018, according to data from BioPharma Dive. Read Full Article on Biopharma Dive >>
Biogen’s new strategy brings more pipeline cuts, but leaves deal options open
April 25, 2023 / Biogen / Pipeline / New Strategy – Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. Read Full Article on Biopharma Dive >>
April 25, 2023 / Biogen / Pipeline / New Strategy – Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. Read Full Article on Biopharma Dive >>
Lilly sells emergency diabetes drug for $500M
April 24, 2023 / Eli Lilly / Diabetes / Baqsimi – Eli Lilly will sell its emergency diabetes treatment Baqsimi to Amphastar Pharmaceuticals for $500 million upfront, the company said Monday, divesting a drug launched four years ago that had $139 million in sales last year. Read Full Article on Biopharma Dive >>
April 24, 2023 / Eli Lilly / Diabetes / Baqsimi – Eli Lilly will sell its emergency diabetes treatment Baqsimi to Amphastar Pharmaceuticals for $500 million upfront, the company said Monday, divesting a drug launched four years ago that had $139 million in sales last year. Read Full Article on Biopharma Dive >>
ImmunoGen Appoints Isabel Kalofonos as Senior Vice President and Chief Commercial Officer
April 24, 2023 / ImmunoGen – ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Isabel Kalofonos has been appointed Senior Vice President and Chief Commercial Officer. Read Full Article on Biospace >>
April 24, 2023 / ImmunoGen – ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Isabel Kalofonos has been appointed Senior Vice President and Chief Commercial Officer. Read Full Article on Biospace >>
Shared vision for Boehringer Ingelheim and RetinAI
April 21, 2023 / Boehringer Ingelheim / RetinAI – The companies are joining forces to improve patient outcomes in geographic atrophy (GA) by combining Boehringer Ingelheim’s considerable research in retinal diseases with RetinAI’s discovery platform and associated AI tools. Read Full Article on Pharma Times >>
April 21, 2023 / Boehringer Ingelheim / RetinAI – The companies are joining forces to improve patient outcomes in geographic atrophy (GA) by combining Boehringer Ingelheim’s considerable research in retinal diseases with RetinAI’s discovery platform and associated AI tools. Read Full Article on Pharma Times >>
// Legal & Regulatory
FDA Questions Efficacy of Merck-AstraZeneca’s Lynparza Ahead of Adcomm
April 27, 2023 / FDA / AstraZeneca / Lynparza / Adcomm – The pharma partners seek to broaden the indication of their PARP inhibitor in combination with Johnson & Johnson’s Zytiga (abiraterone) and prednisone or prednisolone. The combination is designed to be a first-line therapy in adult mCRPC patients, regardless of BRCA mutation status. Read Full Article on Biospace >>
April 27, 2023 / FDA / AstraZeneca / Lynparza / Adcomm – The pharma partners seek to broaden the indication of their PARP inhibitor in combination with Johnson & Johnson’s Zytiga (abiraterone) and prednisone or prednisolone. The combination is designed to be a first-line therapy in adult mCRPC patients, regardless of BRCA mutation status. Read Full Article on Biospace >>
FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?
April 26, 2023 / Nestle / FDA Approcals / Seres Therapeutics / Clostridium Difficile – There are many over-the-counter probiotic food additions that one can eat, and now the FDA has approved the first oral microbiome to be used as a therapeutic. Read Full Article on Fierce Pharma >>
April 26, 2023 / Nestle / FDA Approcals / Seres Therapeutics / Clostridium Difficile – There are many over-the-counter probiotic food additions that one can eat, and now the FDA has approved the first oral microbiome to be used as a therapeutic. Read Full Article on Fierce Pharma >>
Novartis plant cleared to produce in-demand cancer drug
April 24, 2023 / Novartis / Cancer Drug / Pluvicto –Novartis on Friday said it has received FDA clearance to begin production of its radiopharmaceutical drug Pluvicto out of its factory in Millburn, New Jersey. Read on Biopharma Dive >>
April 24, 2023 / Novartis / Cancer Drug / Pluvicto –Novartis on Friday said it has received FDA clearance to begin production of its radiopharmaceutical drug Pluvicto out of its factory in Millburn, New Jersey. Read on Biopharma Dive >>
What is the Next Chapter for FDA’s Accelerated Approval’s in Oncology?
April 20, 2023 / FDA / Oncology / Approval’s – Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion. Read on MedCity News >>
April 20, 2023 / FDA / Oncology / Approval’s – Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion. Read on MedCity News >>
Defence Granted US Patent with Broad Coverage on Accum(TM)-based Vaccine Enhancer Platform Technology
April 24, 2023 / U.S. Patent / New Tech –The US patent broadly covers Defence’s AccumTM-based vaccine enhancer technology platform as a powerful “drop-in” ingredient to boost immunogenicity and performance of virtually any cell-based or protein subunit vaccine, including both prophylactic and therapeutic vaccines in the fields of cancer and infectious diseases. Read on Biospace >>
April 24, 2023 / U.S. Patent / New Tech –The US patent broadly covers Defence’s AccumTM-based vaccine enhancer technology platform as a powerful “drop-in” ingredient to boost immunogenicity and performance of virtually any cell-based or protein subunit vaccine, including both prophylactic and therapeutic vaccines in the fields of cancer and infectious diseases. Read on Biospace >>
// Research & Development
AbbVie closes cystic fibrosis chapter after combo ‘just did not work’
April 27, 2023 / AbbVie / Cystic Fibrosis / Richard Gonzalez / Pipeline – After analyzing data from a proof-of-concept study of the triple combination cystic fibrosis therapy, AbbVie decided that the interim results “did not meet our criteria” to continue development, Thomas Hudson, M.D., AbbVie’s SVP of R&D and chief scientific officer said on a quarter one earnings call today. Read Full Article on Fierce Biotech >>
April 27, 2023 / AbbVie / Cystic Fibrosis / Richard Gonzalez / Pipeline – After analyzing data from a proof-of-concept study of the triple combination cystic fibrosis therapy, AbbVie decided that the interim results “did not meet our criteria” to continue development, Thomas Hudson, M.D., AbbVie’s SVP of R&D and chief scientific officer said on a quarter one earnings call today. Read Full Article on Fierce Biotech >>
Bristol Myers boosts cell therapy production with Novartis plant
April 26, 2023 / Bristol Myers / Novartis / Cell Therapy / Cancer – Cell therapies are powerful weapons for treating some cancers, but the manufacturing required is complex and time-consuming. Bristol Myers has previously had difficulties producing enough of its two CAR-T cancer therapies to keep up with demand. Read Full Article on Biopharma Dive >>
April 26, 2023 / Bristol Myers / Novartis / Cell Therapy / Cancer – Cell therapies are powerful weapons for treating some cancers, but the manufacturing required is complex and time-consuming. Bristol Myers has previously had difficulties producing enough of its two CAR-T cancer therapies to keep up with demand. Read Full Article on Biopharma Dive >>
Lilly drug Mounjaro succeeds in second weight loss study
April 27, 2023 / Eli Lilly / Weight Loss / Mounjaro – Eli Lilly’s new medicine Mounjaro helped overweight people with diabetes lose about 30 pounds on average over an 18-month clinical trial, a significant result that boosts the drug’s chances of winning approval as a weight loss treatment. Read Full Article on Biopharma Dive >>
April 27, 2023 / Eli Lilly / Weight Loss / Mounjaro – Eli Lilly’s new medicine Mounjaro helped overweight people with diabetes lose about 30 pounds on average over an 18-month clinical trial, a significant result that boosts the drug’s chances of winning approval as a weight loss treatment. Read Full Article on Biopharma Dive >>
Ionis, AstraZeneca’s polyneuropathy med improved patients’ quality of life in phase 3, teeing up battle with Alnylam
April 24, 2023 / Ionis / AstraZeneca / Alnylam / ATTR – Ionis and AstraZeneca are finally cracking open the hood to phase 3 data of eplontersen, a burgeoning competitor to Alnylam’s ATTR polyneuropathy franchise. Read Full Article on Fierce Biotech >>
April 24, 2023 / Ionis / AstraZeneca / Alnylam / ATTR – Ionis and AstraZeneca are finally cracking open the hood to phase 3 data of eplontersen, a burgeoning competitor to Alnylam’s ATTR polyneuropathy franchise. Read Full Article on Fierce Biotech >>
Ionis and AstraZeneca Seek to Challenge Alnylam with New ATTR Data
April 24, 2023 / Ionis / AstraZeneca / Alnylam / ATTR Data – With a potential $2.9 billion on the line, Ionis Pharmaceuticals and AstraZeneca announced new results from the Phase III study of eplontersen in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The results will be presented Monday at the American Academy of Neurology (AAN) 2023 Annual Meeting in Boston. Read Full Article on Biospace >>
April 24, 2023 / Ionis / AstraZeneca / Alnylam / ATTR Data – With a potential $2.9 billion on the line, Ionis Pharmaceuticals and AstraZeneca announced new results from the Phase III study of eplontersen in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The results will be presented Monday at the American Academy of Neurology (AAN) 2023 Annual Meeting in Boston. Read Full Article on Biospace >>
// Politics
‘Can’t tie our own hands’: Presidential candidate warns an AI pause for US means ‘China running with it’
April 28, 2023 / Presidential Candidate / AI / China – “A temporary pause amongst U.S. companies — if China is actually running forward with it — that doesn’t do anything in alleviating the risks of AI,” Ramaswamy said in an exclusive interview. “It exacerbates them because Americans are at an even greater risk instead.” Read Full Article on Fox News >>
April 28, 2023 / Presidential Candidate / AI / China – “A temporary pause amongst U.S. companies — if China is actually running forward with it — that doesn’t do anything in alleviating the risks of AI,” Ramaswamy said in an exclusive interview. “It exacerbates them because Americans are at an even greater risk instead.” Read Full Article on Fox News >>
Could Government Drug-Price Negotiations Sound The Death Knell For Biotech Stocks
April 28, 2023 / Drug Price / Negotiations / Medicare – People have griped about prescription drug prices for years. Soon, Medicare plans to do something about them. But experts following pharmaceutical and biotech stocks warn of unintended consequences. They’re sounding the death knell for drug company profits, innovation — and patient care. Read Full Article on Investor’s Business Daily >>
April 28, 2023 / Drug Price / Negotiations / Medicare – People have griped about prescription drug prices for years. Soon, Medicare plans to do something about them. But experts following pharmaceutical and biotech stocks warn of unintended consequences. They’re sounding the death knell for drug company profits, innovation — and patient care. Read Full Article on Investor’s Business Daily >>
House offers new bipartisan IT modernization bill as VA halts EHRM rollout
April 26, 2023 / U.S. House / Bipartisan / IT Mondernization / New Bill – On Monday, Rep. Mike Takano, D-Calif., ranking member of the House Committee on Veterans’ Affairs, and the committee’s Chairman Mike Bost, R-Ill., introduced companion legislation to the EHR Program RESET Act of 2023 that had been offered by Sens. Jon Tester, D-Mont., Patty Murray, D-Wash., and Sherrod Brown, D-Ohio, on March 30. Read Full Article on Healthcare IT News >>
April 26, 2023 / U.S. House / Bipartisan / IT Mondernization / New Bill – On Monday, Rep. Mike Takano, D-Calif., ranking member of the House Committee on Veterans’ Affairs, and the committee’s Chairman Mike Bost, R-Ill., introduced companion legislation to the EHR Program RESET Act of 2023 that had been offered by Sens. Jon Tester, D-Mont., Patty Murray, D-Wash., and Sherrod Brown, D-Ohio, on March 30. Read Full Article on Healthcare IT News >>
Biopharma feels momentary relief as Supreme Court preserves abortion drug access—for now
April 26, 2023 / Abortion / Mifepristone / U.S. Supreme Court / FDA – The Supreme Court has for now preserved access to the abortion medication mifepristone—a win for the biopharma world that rallied to support the FDA’s authority to approve drugs. But the women behind the unprecedented letter campaign and amicus brief are not yet breathing a sigh of relief. Read Full Article on Fierce Biotech >>
April 26, 2023 / Abortion / Mifepristone / U.S. Supreme Court / FDA – The Supreme Court has for now preserved access to the abortion medication mifepristone—a win for the biopharma world that rallied to support the FDA’s authority to approve drugs. But the women behind the unprecedented letter campaign and amicus brief are not yet breathing a sigh of relief. Read Full Article on Fierce Biotech >>
Congress gives $10M to DoD, Philips to advance AI-driven disease predictionApril 27, 2023 / U.S. Congress / AI / Disease Prediction – New funding from Congress’s Accelerate the Procurement and Fielding of Innovative Technologies initiative will enable the Department of Defense Rapid Assessment of Threat Exposure project with additional investment, based on its success in demonstrating that the use of artificial intelligence to leverage data from wearables could predict COVID-19 and other infections 2.3 days prior to diagnostic testing. Read Full Article on Healthcare IT News >>
