// Biotech and Pharma Therapeutics
After spending $6.5B for Momenta, J&J readies ‘pipeline in a product’ for pivotal year
February 27, 2023 / Janssen Pharma / Myasthenia Gravis / Rheumatoid Arthritis / Neurology – With over 10 indications already being explored and the promise of more to come, it’s no surprise that Johnson & Johnson’s nipocalimab has been dubbed a “pipeline in a product.” It’s a good thing, too, because the monoclonal antibody didn’t come cheap. Read Full Article on Fierce Biotech >>
February 27, 2023 / Janssen Pharma / Myasthenia Gravis / Rheumatoid Arthritis / Neurology – With over 10 indications already being explored and the promise of more to come, it’s no surprise that Johnson & Johnson’s nipocalimab has been dubbed a “pipeline in a product.” It’s a good thing, too, because the monoclonal antibody didn’t come cheap. Read Full Article on Fierce Biotech >>
Lilly Bets $630M on Pain Target Novartis Failed
March 2, 2023 / Eli Lilly / Novartis / Licensing / Confo Therapeutics – Eli Lilly is expanding its pain management pipeline with a new asset from Belgium-based Confo Therapeutics. The two announced a licensing agreement for neuropathic pain candidate CFTX-1554 Thursday. Read Full Article on Biospace >>
March 2, 2023 / Eli Lilly / Novartis / Licensing / Confo Therapeutics – Eli Lilly is expanding its pain management pipeline with a new asset from Belgium-based Confo Therapeutics. The two announced a licensing agreement for neuropathic pain candidate CFTX-1554 Thursday. Read Full Article on Biospace >>
Dr. Reddy’s Expands in Women’s Health With $90M Deal for Mayne’s U.S. Meds
February 27, 2023 / Dr. Reddy / Women’s Health / Mayne Pharma – In acquiring Mayne Pharma’s U.S. portfolio, Dr. Reddy’s gains a birth control pill whose rapid sales growth is attributed to a direct-to-consumer marketing strategy. The deal also includes pipeline products and approved products that are not yet on the market. Read Full Article on MedCity News >>
February 27, 2023 / Dr. Reddy / Women’s Health / Mayne Pharma – In acquiring Mayne Pharma’s U.S. portfolio, Dr. Reddy’s gains a birth control pill whose rapid sales growth is attributed to a direct-to-consumer marketing strategy. The deal also includes pipeline products and approved products that are not yet on the market. Read Full Article on MedCity News >>
Eli Lilly’s Insulin: Cheaper for Patients Without Much Financial Hit to the Firm
March 1, 2023 / Eli Lilly / Patients / New Drugs / Insulin / Drug Pricing – Eli Lilly is slashing prices for its insulin products and capping a patient’s monthly out-of-pocket costs at $35. But a financial analyst notes that the company can afford to cut prices on older medicines like insulin because the strategy will help it maintain pricing power for innovative new drugs. Read Full Article on MedCity News >>
March 1, 2023 / Eli Lilly / Patients / New Drugs / Insulin / Drug Pricing – Eli Lilly is slashing prices for its insulin products and capping a patient’s monthly out-of-pocket costs at $35. But a financial analyst notes that the company can afford to cut prices on older medicines like insulin because the strategy will help it maintain pricing power for innovative new drugs. Read Full Article on MedCity News >>
Pfizer, Tempus collaborate on cancer drug development
March 2, 2023 / Pfizer / Cancer / Drug Development – Multinational pharmaceutical and biotech company Pfizer and AI-powered data company Tempus announced a multiyear strategic alliance to utilize AI and machine learning to inform drug discovery and development in oncology. Read Full Article on Mobi Health News >>
March 2, 2023 / Pfizer / Cancer / Drug Development – Multinational pharmaceutical and biotech company Pfizer and AI-powered data company Tempus announced a multiyear strategic alliance to utilize AI and machine learning to inform drug discovery and development in oncology. Read Full Article on Mobi Health News >>
// 4th Industrial Revolution
How life sciences benefits from broader healthcare transformation
February 27, 2022 / Healthcare / Life Sciences / Biopharma – Life sciences and healthcare are often considered adjacent but not adjoined worlds: Biopharma enables everyday care, while unmet needs at bedside can, in turn, inform new research. Read Full Article on Biopharma Dive >>
February 27, 2022 / Healthcare / Life Sciences / Biopharma – Life sciences and healthcare are often considered adjacent but not adjoined worlds: Biopharma enables everyday care, while unmet needs at bedside can, in turn, inform new research. Read Full Article on Biopharma Dive >>
Healthcare AI and Automation: Good or Bad?
February 27, 2023 / AI / Healthcare / Automation – So let’s talk this out: is AI automation a good thing that will help or will it cause more problems? We reached out to the beautiful Healthcare IT Today Community to hear the different lines of thinking on automation. Read Full Article on Healthcare IT News >>
February 27, 2023 / AI / Healthcare / Automation – So let’s talk this out: is AI automation a good thing that will help or will it cause more problems? We reached out to the beautiful Healthcare IT Today Community to hear the different lines of thinking on automation. Read Full Article on Healthcare IT News >>
AI Tools Can Support Early Cardiovascular Disease Diagnosis
March 2, 2023 / AI / Cardiovascular / CDC – Recent research from Rutgers, the State University of New Jersey, described how artificial intelligence (AI) and machine learning (ML) could be used to examine genes within DNA, information that can help clinicians predict cardiovascular diseases such as atrial fibrillation and heart failure. Read Full Article on Health IT Analytics >>
March 2, 2023 / AI / Cardiovascular / CDC – Recent research from Rutgers, the State University of New Jersey, described how artificial intelligence (AI) and machine learning (ML) could be used to examine genes within DNA, information that can help clinicians predict cardiovascular diseases such as atrial fibrillation and heart failure. Read Full Article on Health IT Analytics >>
Telehealth trends in 2023: Virtual-first, health equity and more
February 27, 2023 / Telehealth / Virtual / Recuro Health – The technology-enabled form of healthcare delivery has huge momentum coming out of the COVID-19 pandemic. But at the same time, the pandemic public health emergency is scheduled to end in May, which means action is needed by lawmakers to keep reimbursement going in 2023. There’s lots going on, to say the least. Read Full Article on Healthcare IT News >>
February 27, 2023 / Telehealth / Virtual / Recuro Health – The technology-enabled form of healthcare delivery has huge momentum coming out of the COVID-19 pandemic. But at the same time, the pandemic public health emergency is scheduled to end in May, which means action is needed by lawmakers to keep reimbursement going in 2023. There’s lots going on, to say the least. Read Full Article on Healthcare IT News >>
ConcertAI’s TeraRecon Inks Distribution Deals with Seven AI Developers Alongside EU Launch of Eureka Clinical AI Platform at #ECR23
February 27, 2023 / TeraRecon / AI / Healthcare – ConcertAI’s TeraRecon, advanced visualization and AI Clinical SaaS category leader, has announced its Eureka Clinical AI platform is now available to European healthcare providers. The company initiated distribution agreements with seven leading CE-marked AI software developers —Cercare Medical, Combinostics, Coreline Soft, Imaging Biometrics (CE pending), Infervision, Radiobotics, and Riverain Technologies. Eureka Clinical AI is now one of the leading unified solutions for clinical AI algorithms in Europe, providing clinical and diagnostic benefits across radiology, neurology, oncology, pulmonology, and cardiology. Read Full Article on Biospace >>
February 27, 2023 / TeraRecon / AI / Healthcare – ConcertAI’s TeraRecon, advanced visualization and AI Clinical SaaS category leader, has announced its Eureka Clinical AI platform is now available to European healthcare providers. The company initiated distribution agreements with seven leading CE-marked AI software developers —Cercare Medical, Combinostics, Coreline Soft, Imaging Biometrics (CE pending), Infervision, Radiobotics, and Riverain Technologies. Eureka Clinical AI is now one of the leading unified solutions for clinical AI algorithms in Europe, providing clinical and diagnostic benefits across radiology, neurology, oncology, pulmonology, and cardiology. Read Full Article on Biospace >>
// Business & Markets
OpenText Partners with Bayer to Digitize B2B Operations
March 1, 2023 / B2B / Bayer / OpenText – Global tech anchor, OpenText™ announced its collaboration with healthcare and agricultural leader, Bayer, to simplify its digital operations. This partnership echoes the current trend which sees legacy companies adopting more robust digital solutions to elevate their businesses and free up time to focus on other priorities. Read Full Article on HIT Consultant >>
March 1, 2023 / B2B / Bayer / OpenText – Global tech anchor, OpenText™ announced its collaboration with healthcare and agricultural leader, Bayer, to simplify its digital operations. This partnership echoes the current trend which sees legacy companies adopting more robust digital solutions to elevate their businesses and free up time to focus on other priorities. Read Full Article on HIT Consultant >>
Confo hands baton to Lilly for non-opioid pain med development in $40M upfront deal
March 2, 2023 / Eli Lilly / Confo Therapeutics / Development Deals / Pain Drugs – Eli Lilly will take the baton on developing a peripheral pain candidate from Confo Therapeutics, handing off $40 million upfront and a potential $590 million total down the track if all goes well. Read Full Article on Fierce Biotech >>
March 2, 2023 / Eli Lilly / Confo Therapeutics / Development Deals / Pain Drugs – Eli Lilly will take the baton on developing a peripheral pain candidate from Confo Therapeutics, handing off $40 million upfront and a potential $590 million total down the track if all goes well. Read Full Article on Fierce Biotech >>
Lilly to lower insulin prices by 70%
March 1, 2023 / Eli Lilly / Insulin / Drug Prices – Eli Lilly is cutting the price of its insulin products, announcing Wednesday a plan to reduce the cost of its branded drug Humalog and set a $25-per-vial cap on a non-branded Humalog alternative. The company is also launching a copycat version of Sanofi’s long-acting insulin Lantus at a 78% discount. Read Full Article on Biopharma Dive >>
March 1, 2023 / Eli Lilly / Insulin / Drug Prices – Eli Lilly is cutting the price of its insulin products, announcing Wednesday a plan to reduce the cost of its branded drug Humalog and set a $25-per-vial cap on a non-branded Humalog alternative. The company is also launching a copycat version of Sanofi’s long-acting insulin Lantus at a 78% discount. Read Full Article on Biopharma Dive >>
Novo Nordisk to create Boston R&D hub
March 2, 2023 / Novo Nordisk / R&D / Boston – Danish drugmaker Novo Nordisk announced Thursday plans to expand its research and development operations in the greater Boston area by adding new facilities and creating hundreds of jobs. Read Full Article on Biopharma Dive >>
March 2, 2023 / Novo Nordisk / R&D / Boston – Danish drugmaker Novo Nordisk announced Thursday plans to expand its research and development operations in the greater Boston area by adding new facilities and creating hundreds of jobs. Read Full Article on Biopharma Dive >>
Seagen reportedly in sales talks again, this time with Pfizer
February 27, 2023 / Seagen / Pfizer / Cancer – Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said. Read Full Article on Biopharma Dive>>
February 27, 2023 / Seagen / Pfizer / Cancer – Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said. Read Full Article on Biopharma Dive>>
// Legal & Regulatory
After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS
February 27, 2023 / ALS / Hemophilia B / uniQure – 2022 was a big year for uniQure with the U.S. and European approval of world’s first gene therapy for hemophilia B. In its 2022 financial report Monday, the Lexington, Mass. and Amsterdam-based company provided updates on the progress of its Huntington’s disease and ALS programs. Read Full Article on Biospace >>
February 27, 2023 / ALS / Hemophilia B / uniQure – 2022 was a big year for uniQure with the U.S. and European approval of world’s first gene therapy for hemophilia B. In its 2022 financial report Monday, the Lexington, Mass. and Amsterdam-based company provided updates on the progress of its Huntington’s disease and ALS programs. Read Full Article on Biospace >>
FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv
February 28, 2023 / Cytokinetics / FDA / Bristol Myers Squibb / Heart Failure – The thumbs down was not a surprise. In December, the FDA’s Cardiovascular and Renal Drug Advisory Committee voted 8-3 against recommending omecamtiv for approval for patients with heart failure with reduced ejection fraction (HFrEF). Read Full Article on Fierce Pharma >>
February 28, 2023 / Cytokinetics / FDA / Bristol Myers Squibb / Heart Failure – The thumbs down was not a surprise. In December, the FDA’s Cardiovascular and Renal Drug Advisory Committee voted 8-3 against recommending omecamtiv for approval for patients with heart failure with reduced ejection fraction (HFrEF). Read Full Article on Fierce Pharma >>
Anixa Biosciences Announces Notice of Allowance of Additional Key Patent on Breast Cancer Vaccine Technology
February 27, 2023 / Anixa / Cancer / Breast Cancer / Vaccine – The patent is titled, “Vaccine Adjuvants and Formulations,” and the lead inventor is the late Dr. Vincent Tuohy, of Cleveland Clinic. This patent covers additional intellectual property related to the formulation of Anixa’s breast cancer vaccine. Read on Biospace >>
February 27, 2023 / Anixa / Cancer / Breast Cancer / Vaccine – The patent is titled, “Vaccine Adjuvants and Formulations,” and the lead inventor is the late Dr. Vincent Tuohy, of Cleveland Clinic. This patent covers additional intellectual property related to the formulation of Anixa’s breast cancer vaccine. Read on Biospace >>
FDA Rejects Cytokinetics’ Heart Failure Drug, Requests Another Trial
March 1, 2023 / FDA / Heart Failure / Crytokinetics – In its Complete Response Letter, the regulator said a single Phase III trial was not enough to establish clinical benefit for Cytokinetics’ candidate in adult patients with chronic heart failure with reduced ejection fraction (HFrEF). Read on Biospace >>
March 1, 2023 / FDA / Heart Failure / Crytokinetics – In its Complete Response Letter, the regulator said a single Phase III trial was not enough to establish clinical benefit for Cytokinetics’ candidate in adult patients with chronic heart failure with reduced ejection fraction (HFrEF). Read on Biospace >>
GSK’s RSV vaccine wins FDA panel backing, matching Pfizer
March 2, 2023 / GSK / Vaccine / FDA / Pfizer – A group of advisers to the Food and Drug Administration on Wednesday backed a respiratory syncytial virus vaccine developed by GSK for use in older adults, increasing the chances the agency decides in favor of the shot’s approval later this year. Read on Biopharma Dive >>
March 2, 2023 / GSK / Vaccine / FDA / Pfizer – A group of advisers to the Food and Drug Administration on Wednesday backed a respiratory syncytial virus vaccine developed by GSK for use in older adults, increasing the chances the agency decides in favor of the shot’s approval later this year. Read on Biopharma Dive >>
// Research & Development
Ultra-Rare Orphan Drugs: Advocates Begin Laying Groundwork For New Incentive, Special Pathway
March 2, 2023 / Orphan Drugs / New Drug / Ultragenyx – Rare disease advocates push for National Academies of Sciences, Engineering and Medicine study on how or whether ultra-rare should be defined, which could create legislative pressure. In an interview, Ultragenyx CEO Emil Kakkis suggests patient thresholds, accelerated approval triggers. Read Full Article on Pink Sheet >>
March 2, 2023 / Orphan Drugs / New Drug / Ultragenyx – Rare disease advocates push for National Academies of Sciences, Engineering and Medicine study on how or whether ultra-rare should be defined, which could create legislative pressure. In an interview, Ultragenyx CEO Emil Kakkis suggests patient thresholds, accelerated approval triggers. Read Full Article on Pink Sheet >>
Hope for Parkinson’s disease and Lewy body dementia patients
February 28, 2023 / Parkinson’s / Dementia / RNA – Toxic proteins within the brain that cause Parkinson’s disease and Lewy body dementiahave the potential to help develop new targeted therapies. Read Full Article on Pharma Times >>
February 28, 2023 / Parkinson’s / Dementia / RNA – Toxic proteins within the brain that cause Parkinson’s disease and Lewy body dementiahave the potential to help develop new targeted therapies. Read Full Article on Pharma Times >>
Vital update for Valneva’s COVID-19 vaccine
March 2, 2023 / Covid-19 / Vaccine / Valneva – Valneva has also provided an update on its pivotal phase 3 Study COV-Compare. During this study, neutralising antibodies – six months after the second dose of the primary vaccination with VLA2001 – were non-inferior compared to the active comparator AZD1222 (an adenoviral vector vaccine).Read Full Article on Pharma Times >>
March 2, 2023 / Covid-19 / Vaccine / Valneva – Valneva has also provided an update on its pivotal phase 3 Study COV-Compare. During this study, neutralising antibodies – six months after the second dose of the primary vaccination with VLA2001 – were non-inferior compared to the active comparator AZD1222 (an adenoviral vector vaccine).Read Full Article on Pharma Times >>
Alzheimer’s meds are here. But for the Down syndrome community, it’s still the 1980s
March 1, 2023 / Alzhemier’s Disease / Down Syndrome / Neurodegenerative Disease / Clinical Reasearch – Thirty years ago, the Down syndrome community helped scientists uncover critical learnings about the genetic basis of Alzheimer’s disease. Now, in 2023, we stand on the cusp of new treatments reaching the market, and yet this population has never been included in the clinical research that has underpinned regulatory approvals for these medicines. Read Full Article on Fierce Biotech >>
March 1, 2023 / Alzhemier’s Disease / Down Syndrome / Neurodegenerative Disease / Clinical Reasearch – Thirty years ago, the Down syndrome community helped scientists uncover critical learnings about the genetic basis of Alzheimer’s disease. Now, in 2023, we stand on the cusp of new treatments reaching the market, and yet this population has never been included in the clinical research that has underpinned regulatory approvals for these medicines. Read Full Article on Fierce Biotech >>
FDA clears Intellia to start US tests of ‘in vivo’ gene editing drug
March 2, 2023 / FDA / Intellia / Gene Editing – The Food and Drug Administration has cleared Intellia Therapeutics to start human testing in the U.S. of an experimental CRISPR medicine for a rare swelling disorder, a sign the agency could be getting more comfortable with medicines that edit genes inside the body. Read Full Article on Biopharma Dive >>
March 2, 2023 / FDA / Intellia / Gene Editing – The Food and Drug Administration has cleared Intellia Therapeutics to start human testing in the U.S. of an experimental CRISPR medicine for a rare swelling disorder, a sign the agency could be getting more comfortable with medicines that edit genes inside the body. Read Full Article on Biopharma Dive >>
// Politics
California Lawmaker Introduces Bill to Keep Rural Hospitals From Closing as They Work to Meet Seismic Compliance
March 1, 2023 / California / New Bill / Healthcare Access – A California lawmaker recently introduced legislation designed to keep the state’s small and rural hospitals from closing as they work to meet seismic safety compliance requirements. The bill would require California’s Department of Health Care Access and Administration to provide grant funding to small and rural hospitals so they can achieve compliance amid times of severe financial distress. Read Full Article on MedCity News>>
March 1, 2023 / California / New Bill / Healthcare Access – A California lawmaker recently introduced legislation designed to keep the state’s small and rural hospitals from closing as they work to meet seismic safety compliance requirements. The bill would require California’s Department of Health Care Access and Administration to provide grant funding to small and rural hospitals so they can achieve compliance amid times of severe financial distress. Read Full Article on MedCity News>>
Advocates, lawmakers warn that Biden telehealth rule will worsen opioid crisis
March 2, 2023 / Lawmakers / Biden / Telehealth / Opiod Crisis – The proposal would curtail access via telehealth to buprenorphine, a common and highly effective drug used to treat opioid use disorder. While doctors can currently give out both new buprenorphine prescriptions and refills after telemedicine visits, the new rule would require an in-person examination for telehealth patients who want to stay on the medication for longer than 30 days. Read Full Article on STAT News >>
March 2, 2023 / Lawmakers / Biden / Telehealth / Opiod Crisis – The proposal would curtail access via telehealth to buprenorphine, a common and highly effective drug used to treat opioid use disorder. While doctors can currently give out both new buprenorphine prescriptions and refills after telemedicine visits, the new rule would require an in-person examination for telehealth patients who want to stay on the medication for longer than 30 days. Read Full Article on STAT News >>
How policymakers could tweak HIPAA to better protect abortion records
March 2, 2023 / Policymakers / HIPAA / Abortion Records – “I think it’s important to know that right now, your health records aren’t necessarily protected. And that is because HIPAA privacy protections weren’t prepared for this moment,” said Rep. Sara Jacobs (D-Calif.), referring to the Health Insurance Portability and Accountability Act, which protects patient medical records. Jacobs recently worked with Rep. Anna Eshoo (D-Calif.) to author the Secure Access for Essential Reproductive (SAFER) Health Act, which would prohibit lawmakers from sharing personal health information related to abortion or pregnancy loss without patient consent. Read Full Article on STAT News >>
March 2, 2023 / Policymakers / HIPAA / Abortion Records – “I think it’s important to know that right now, your health records aren’t necessarily protected. And that is because HIPAA privacy protections weren’t prepared for this moment,” said Rep. Sara Jacobs (D-Calif.), referring to the Health Insurance Portability and Accountability Act, which protects patient medical records. Jacobs recently worked with Rep. Anna Eshoo (D-Calif.) to author the Secure Access for Essential Reproductive (SAFER) Health Act, which would prohibit lawmakers from sharing personal health information related to abortion or pregnancy loss without patient consent. Read Full Article on STAT News >>
Congress investigates how pharma middlemen affect drug prices
March 1, 2023 / Congress / Biden / Drug Prices – The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group’s Express Scripts and UnitedHealth Group Inc.’s OptumRx – the largest pharmacy-benefit managers (PBM) – seeking documents about the drug-price rebates they negotiate and fees they charge. Read Full Article on Fox Business >>
March 1, 2023 / Congress / Biden / Drug Prices – The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group’s Express Scripts and UnitedHealth Group Inc.’s OptumRx – the largest pharmacy-benefit managers (PBM) – seeking documents about the drug-price rebates they negotiate and fees they charge. Read Full Article on Fox Business >>
Joe Biden’s Insulin Fictions
March 1, 2023 / Biden / Insulin – The drug maker Eli Lilly said Wednesday that it will cut the sticker price of some insulin products by 70%, and Democrats are taking a victory lap. Well, yes, government coercion can work. But the supposed pricing triumph here is far less than meets the press releases, and the truth is worth noting for the future of drug innovation for Americans with diabetes and other diseases. Read Full Article on Wall Street Journal >>
March 1, 2023 / Biden / Insulin – The drug maker Eli Lilly said Wednesday that it will cut the sticker price of some insulin products by 70%, and Democrats are taking a victory lap. Well, yes, government coercion can work. But the supposed pricing triumph here is far less than meets the press releases, and the truth is worth noting for the future of drug innovation for Americans with diabetes and other diseases. Read Full Article on Wall Street Journal >>
