// Biotech and Pharma Therapeutics
Novo Nordisk follows Eli Lilly’s lead, slashing insulin prices in the US
March 14, 2023 / Novo Nordisk / Eli Lilly / Insulin / Novolog – On Tuesday, the Danish company said it would reduce the list price of its NovoLog insulin by 75% and slice the cost of Novolin and Levemir by 65%. The cuts will kick in on Jan. 1 of 2024, the drugmaker said. Read Full Article on Fierce Pharma >>
March 14, 2023 / Novo Nordisk / Eli Lilly / Insulin / Novolog – On Tuesday, the Danish company said it would reduce the list price of its NovoLog insulin by 75% and slice the cost of Novolin and Levemir by 65%. The cuts will kick in on Jan. 1 of 2024, the drugmaker said. Read Full Article on Fierce Pharma >>
Sanofi acquires diabetes drug via Provention buyout
March 13, 2023 / Sanofi / Diabetes / Buyout / FDA – Tzield’s path to FDA approval was long, having been tossed back and forth between one-time developers MacroGenics and Eli Lilly and then overcoming an initial rejection from the FDA. Read Full Article on Biopharma Dive >>
March 13, 2023 / Sanofi / Diabetes / Buyout / FDA – Tzield’s path to FDA approval was long, having been tossed back and forth between one-time developers MacroGenics and Eli Lilly and then overcoming an initial rejection from the FDA. Read Full Article on Biopharma Dive >>
Organon finally offers a larger pharma model for women’s health. But ‘one company can’t do it by itself’
March 16, 2023 / Organon / Merck / Endometriosis / Women’s Health – When it comes to getting women’s health therapies to market, nothing is ever straightforward. From encouraging women to “step forward” for clinical trials to battling for R&D funding, it remains a tough arena—yet Organon is building a pipeline to mount a challenge. Read Full Article on Fierce Biotech >>
March 16, 2023 / Organon / Merck / Endometriosis / Women’s Health – When it comes to getting women’s health therapies to market, nothing is ever straightforward. From encouraging women to “step forward” for clinical trials to battling for R&D funding, it remains a tough arena—yet Organon is building a pipeline to mount a challenge. Read Full Article on Fierce Biotech >>
Vaxart cans oral COVID-19 vaccine plans, lays off 27% of staff to go all in on norovirus program
March 16, 2023 / Vaxart / COVID-19 / Layoffs / Norovirus – San Francisco-based Vaxart landed on the Nasdaq in 2017 in the wake of the publication of phase 2 data on its oral influenza vaccine candidate. The biotech still lists the influenza tablet in its pipeline—and teamed up with Johnson & Johnson to develop an universal flu vaccine in 2019—but, in recent years, its internal focus has shifted to two indications: COVID-19 and norovirus. Read Full Article on Fierce Biotech >>
March 16, 2023 / Vaxart / COVID-19 / Layoffs / Norovirus – San Francisco-based Vaxart landed on the Nasdaq in 2017 in the wake of the publication of phase 2 data on its oral influenza vaccine candidate. The biotech still lists the influenza tablet in its pipeline—and teamed up with Johnson & Johnson to develop an universal flu vaccine in 2019—but, in recent years, its internal focus has shifted to two indications: COVID-19 and norovirus. Read Full Article on Fierce Biotech >>
Novo Nordisk hit with two-year suspension from UK pharma group after online marketing breaches
March 16, 2023 / Novo Nordisk / ABPI / United Kingdom / Drug Marketing – Last month, Novo Nordisk’s general manager in the U.K. stepped down as president of a national pharma group as the company weathered fallout from an ill-fated LinkedIn campaign. Now, the other shoe has dropped. Read Full Article on Fierce Pharma >>
March 16, 2023 / Novo Nordisk / ABPI / United Kingdom / Drug Marketing – Last month, Novo Nordisk’s general manager in the U.K. stepped down as president of a national pharma group as the company weathered fallout from an ill-fated LinkedIn campaign. Now, the other shoe has dropped. Read Full Article on Fierce Pharma >>
// 4th Industrial Revolution
Cerebral says 3M affected by a patient data breach
March 13, 2022 / Cerebral / Data Breach / Telehealth – The telehealth company said data was transmitted to third parties without patient consent through pixel trackers, including online self-assessment responses and some clinical information. Read Full Article on Healthcare IT News >>
March 13, 2022 / Cerebral / Data Breach / Telehealth – The telehealth company said data was transmitted to third parties without patient consent through pixel trackers, including online self-assessment responses and some clinical information. Read Full Article on Healthcare IT News >>
TytoCare Receives FDA Clearance for AI-Powered Tyto Insights for Wheeze Detection
March 15, 2023 / FDA / TytoCare / AI / Wheeze Detection – Tyto InsightsTM for Wheeze Detection is designed to aid in the clinical assessment of lung sound data for adults and children aged two and above, enabling clinicians to accurately diagnose respiratory conditions remotely. Fueled by TytoCare’s own database of lung sounds – the largest of its kind – the AI-powered decision support software automatically analyzes lung sounds recorded by TytoCare’s FDA-cleared handheld remote exam device’s stethoscope to determine whether wheezing is detected. Read Full Article on HIT Consultant >>
March 15, 2023 / FDA / TytoCare / AI / Wheeze Detection – Tyto InsightsTM for Wheeze Detection is designed to aid in the clinical assessment of lung sound data for adults and children aged two and above, enabling clinicians to accurately diagnose respiratory conditions remotely. Fueled by TytoCare’s own database of lung sounds – the largest of its kind – the AI-powered decision support software automatically analyzes lung sounds recorded by TytoCare’s FDA-cleared handheld remote exam device’s stethoscope to determine whether wheezing is detected. Read Full Article on HIT Consultant >>
Almost Half of Health Systems Use AI for Workforce Issues
March 16, 2023 / AI / Workforce Issues / COVID-19 – With support from Outbound AI, the Health Management Academy (the Academy) conducted a survey showing that due to common staffing issues within health systems, many C-suite executives are using artificial intelligence (AI) for back office and clinical operations. Read Full Article on Health IT Analytics>>
March 16, 2023 / AI / Workforce Issues / COVID-19 – With support from Outbound AI, the Health Management Academy (the Academy) conducted a survey showing that due to common staffing issues within health systems, many C-suite executives are using artificial intelligence (AI) for back office and clinical operations. Read Full Article on Health IT Analytics>>
How to Improve Customer Experience in Healthcare with AI
March 16, 2023 / Healthcare / AI – In today’s world, personalized and efficient digital interactions are expected, especially in the healthcare industry. To meet those demands, organizations should prioritize the creation of convenient digital-first environments that satisfy all parties involved in providing health care services. Read Full Article on Healthcare IT Today >>
March 16, 2023 / Healthcare / AI – In today’s world, personalized and efficient digital interactions are expected, especially in the healthcare industry. To meet those demands, organizations should prioritize the creation of convenient digital-first environments that satisfy all parties involved in providing health care services. Read Full Article on Healthcare IT Today >>
FDA: Glucose and Insulin Devices Can Now Work Together
March 13, 2023 / Glucose / Insulin / FDA – The FDA says an iCGMs can link to an AIDs! The U.S. Food and Drug Administration (FDA) has cleared Abbott’s FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. This clearance is a significant step forward in diabetes management technology, and this integration could affect how millions of people around the world administer their insulin. Read Full Article on Health Tech Insider >>
March 13, 2023 / Glucose / Insulin / FDA – The FDA says an iCGMs can link to an AIDs! The U.S. Food and Drug Administration (FDA) has cleared Abbott’s FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. This clearance is a significant step forward in diabetes management technology, and this integration could affect how millions of people around the world administer their insulin. Read Full Article on Health Tech Insider >>
// Business & Markets
AstraZeneca employees fight layoffs in India as drugmaker shifts ‘strategic priorities’
March 16, 2023 /AstraZeneca / India / Layoffs / Job Cuts – Another major pharma company is downsizing its sales and marketing presence in India. This time, though, the staffers are publicly pushing back. Fifty-one AstraZeneca sales staffers in the company’s primary care division in India are fighting what they describe as unlawful terminations, The Hindu reports. Read Full Article on Fierce Pharma >>
March 16, 2023 /AstraZeneca / India / Layoffs / Job Cuts – Another major pharma company is downsizing its sales and marketing presence in India. This time, though, the staffers are publicly pushing back. Fifty-one AstraZeneca sales staffers in the company’s primary care division in India are fighting what they describe as unlawful terminations, The Hindu reports. Read Full Article on Fierce Pharma >>
AbbVie’s Humira, 5 Pfizer drugs among those with price hikes that exceeded inflation rate
March 15, 2023 / Inflation Reduction Act / Pfizer / Seagen / Joe Biden – Among 27 medicines whose price hikes exceeded the rate of inflation in the fourth quarter of 2022, Pfizer had five, which was three more than any other company. The list was released by the White House on Wednesday. Read Full Article on Fierce Pharma >>
March 15, 2023 / Inflation Reduction Act / Pfizer / Seagen / Joe Biden – Among 27 medicines whose price hikes exceeded the rate of inflation in the fourth quarter of 2022, Pfizer had five, which was three more than any other company. The list was released by the White House on Wednesday. Read Full Article on Fierce Pharma >>
<strongSanofi’s site modernization spree rolls on with plan to shift 2,000 staffers to new flexible workspace in New Jersey
March 7, 2023 / Sanofi / Job Satisfaction / Facilities / COVID-19 – Sanofi is moving its flagship New Jersey site in Bridgewater roughly 15 miles northeast to Morristown—and all 1,900 employees are coming along for the ride, a company spokesperson confirmed. The site’s relocation marks the latest stop on a global campaign to modernize Sanofi’s workspaces, he said. Read Full Article on Fierce Pharma >>
Sanofi to Acquire Diabetes Therapy Maker Provention Bio for $2.9B
March 13, 2023 / Sanofi / Diabetes / TZIELD – The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need, and its expertise in diabetes. Read Full Article on HIT Consultant >>
March 13, 2023 / Sanofi / Diabetes / TZIELD – The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need, and its expertise in diabetes. Read Full Article on HIT Consultant >>
Healthcare companies may turn to big banks after SVB’s fall
March 15, 2023 / Healthcare / Silicon Valley Bank / Big Banks – Healthcare startups may turn to traditional large banks and prioritize conserving cash after the collapse of regional lenders Silicon Valley Bank and Signature Bank last week. Read Full Article on Biopharma Dive>>
March 15, 2023 / Healthcare / Silicon Valley Bank / Big Banks – Healthcare startups may turn to traditional large banks and prioritize conserving cash after the collapse of regional lenders Silicon Valley Bank and Signature Bank last week. Read Full Article on Biopharma Dive>>
// Legal & Regulatory
US Sues Rite Aid for Ignoring Glaring ‘Red Flags’ in Opioid Prescriptions
March 14, 2023 / Lawsuit / Opioid / Rite Aid – The Department of Justice filed a lawsuit against Rite Aid, accusing the pharmacy chain of filling hundreds of thousands of opioid prescriptions that had “obvious, and often multiple, red flags.” The DOJ claimed that Rite Aid violated the Controlled Substances Act by filling unlawful prescriptions for addictive drugs, as well as the False Claims Act when the chain sought reimbursement from federal healthcare programs for these prescriptions. Read Full Article on MedCity News >>
March 14, 2023 / Lawsuit / Opioid / Rite Aid – The Department of Justice filed a lawsuit against Rite Aid, accusing the pharmacy chain of filling hundreds of thousands of opioid prescriptions that had “obvious, and often multiple, red flags.” The DOJ claimed that Rite Aid violated the Controlled Substances Act by filling unlawful prescriptions for addictive drugs, as well as the False Claims Act when the chain sought reimbursement from federal healthcare programs for these prescriptions. Read Full Article on MedCity News >>
New Medical Billing Codes You Should Know About
March 16, 2023 / New Medical / Billing Codes – Physicians need to keep their billing and coding right to ensure seamless reimbursements from payers. Similarly, they should stay updated with the latest coding changes to keep their revenue cycle intact. In addition, running a successful medical practice is a daunting task as the providers need to stay updated with the industry guidelines. Read Full Article on HIT Consultant >>
March 16, 2023 / New Medical / Billing Codes – Physicians need to keep their billing and coding right to ensure seamless reimbursements from payers. Similarly, they should stay updated with the latest coding changes to keep their revenue cycle intact. In addition, running a successful medical practice is a daunting task as the providers need to stay updated with the industry guidelines. Read Full Article on HIT Consultant >>
Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
March 16, 2023 / Biogen / Court of Justice – Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection. Read on Biospace >>
March 16, 2023 / Biogen / Court of Justice – Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection. Read on Biospace >>
Pfizer says the FDA has approved its migraine nasal spray Zavzpret
March 11, 2023 / Pfizer / FDA / Zavzpret / Migraine – Zavzpret, a branded formulation of the generic drug zavegepant, is the “first and only” calcitonin gene-related peptide receptor antagonist nasal spray for treating migraines with or without an aura, or sensory disturbances such as flashes of light that can accompany a migraine, the drugmaker said. Read on CBS News >>
March 11, 2023 / Pfizer / FDA / Zavzpret / Migraine – Zavzpret, a branded formulation of the generic drug zavegepant, is the “first and only” calcitonin gene-related peptide receptor antagonist nasal spray for treating migraines with or without an aura, or sensory disturbances such as flashes of light that can accompany a migraine, the drugmaker said. Read on CBS News >>
CMS lays out plans for negotiating drug prices
March 16, 2023 / CMS / Drug Prices / Congress – While Congress laid out the broad principles for Medicare to negotiate “maximum fair” prices for drugs, much of the process and details were left to CMS to develop this year ahead of negotiations starting in 2024 for a first set of 10 medicines. Read on Biopharma Dive >>
March 16, 2023 / CMS / Drug Prices / Congress – While Congress laid out the broad principles for Medicare to negotiate “maximum fair” prices for drugs, much of the process and details were left to CMS to develop this year ahead of negotiations starting in 2024 for a first set of 10 medicines. Read on Biopharma Dive >>
// Research & Development
Acadia’s Daybue wins FDA nod as first treatment for Rett syndrome
March 13, 2023 / Acadia Pharmaceuticals / FDA / Rett Syndrome – Doctors and scientists have been studying Rett syndrome for decades, but up until now, there have been no approved treatments. Enter Acadia’s Daybue. Read Full Article on Fierce Pharma >>
March 13, 2023 / Acadia Pharmaceuticals / FDA / Rett Syndrome – Doctors and scientists have been studying Rett syndrome for decades, but up until now, there have been no approved treatments. Enter Acadia’s Daybue. Read Full Article on Fierce Pharma >>
Johnson & Johnson shelves Carvykti’s UK launch amid manufacturing shortfalls
March 15, 2023 / CAR-T / Carvykti / Johnson & Johnson / Cell & Gene Therapy – As Johnson & Johnson and partner Legend Biotech struggle to meet demand for their CAR-T therapy Carvykti in the U.S., the companies seem to be pacing themselves with launches outside of the key market. Read Full Article on Fierce Pharma >>
March 15, 2023 / CAR-T / Carvykti / Johnson & Johnson / Cell & Gene Therapy – As Johnson & Johnson and partner Legend Biotech struggle to meet demand for their CAR-T therapy Carvykti in the U.S., the companies seem to be pacing themselves with launches outside of the key market. Read Full Article on Fierce Pharma >>
After rejection and appeal, Omeros saddles up for 2nd charge at transplant drug approval
March 14, 2023 / Omeros / Transplants / FDA / Blood clots – A year and a half after its stem-cell-associated blood clot med was rejected by the FDA, Omeros is gearing up to head back to the regulator for another attempt. Read Full Article on Fierce Biotech>>
March 14, 2023 / Omeros / Transplants / FDA / Blood clots – A year and a half after its stem-cell-associated blood clot med was rejected by the FDA, Omeros is gearing up to head back to the regulator for another attempt. Read Full Article on Fierce Biotech>>
UPDATE: Merck’s TIGIT fails in phase 2 Keytruda combo, notching another loss for the class
March 16, 2023 / Merck & Co. / TIGIT / Keytruda / Chemotherapy – Merck & Co.’s TIGIT therapy tacked on to Keytruda did not improve progression-free survival in a phase 2 lung cancer trial, marking the latest failure for the class. Read Full Article on Fierce Biotech >>
March 16, 2023 / Merck & Co. / TIGIT / Keytruda / Chemotherapy – Merck & Co.’s TIGIT therapy tacked on to Keytruda did not improve progression-free survival in a phase 2 lung cancer trial, marking the latest failure for the class. Read Full Article on Fierce Biotech >>
Homology Medicines Announces Presentations on Design of Ongoing Gene Editing and Gene Therapy Trials for PKU and Hunter Syndrome at ACMG Annual Clinical Genetics Meeting
March 15, 2023 / Gene Editing / Gene Therapy / Hunter Syndrome / Homology Medicines- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced two presentations during the ACMG Annual Clinical Genetics Meeting, which highlight the preclinical data that supported initiation of the Company’s Phase 1 pheEDIT gene editing trial for phenylketonuria (PKU) and the Phase 1 juMPStart gene therapy trial for Hunter syndrome (MPS II). Read Full Article on Biospace >>
March 15, 2023 / Gene Editing / Gene Therapy / Hunter Syndrome / Homology Medicines- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced two presentations during the ACMG Annual Clinical Genetics Meeting, which highlight the preclinical data that supported initiation of the Company’s Phase 1 pheEDIT gene editing trial for phenylketonuria (PKU) and the Phase 1 juMPStart gene therapy trial for Hunter syndrome (MPS II). Read Full Article on Biospace >>
// Politics
Here are the healthcare IT spending priorities in President Biden’s new budget
March 14, 2023 / Healthcare IT / Biden / Cybersecurity – Citing the Administration Cybersecurity Priorities for the 2024 Budget Memorandum, the Office of Management and Budget lays out three cyber investment areas for agencies – improving defense, deepening cross-sector collaboration to defend critical Infrastructure and strengthening the government’s digital foundations. Read Full Article on Healthcare IT News>>
March 14, 2023 / Healthcare IT / Biden / Cybersecurity – Citing the Administration Cybersecurity Priorities for the 2024 Budget Memorandum, the Office of Management and Budget lays out three cyber investment areas for agencies – improving defense, deepening cross-sector collaboration to defend critical Infrastructure and strengthening the government’s digital foundations. Read Full Article on Healthcare IT News>>
The abortion pill lawsuit that could change how the FDA approves drugs
March 16, 2023 / Abortion Pill / Lawsuit / FDA / FDA Approval – “To the extent that all of these things become a political question or a judicial question rather than a question of science and medicine, we’re in a very dangerous place,” physician Amanda Banks says. Read Full Article on WBUR >>
March 16, 2023 / Abortion Pill / Lawsuit / FDA / FDA Approval – “To the extent that all of these things become a political question or a judicial question rather than a question of science and medicine, we’re in a very dangerous place,” physician Amanda Banks says. Read Full Article on WBUR >>
Biden tells U.S. to have confidence in banks after 2 collapse
March 13, 2023 / Biden / Banks / Financial System – President Joe Biden on Monday told Americans the nation’s financial systems were safe, seeking to project calm following the swift and stunning collapse of two banks that prompted fears of a broader upheaval. Read Full Article on PBS >>
March 13, 2023 / Biden / Banks / Financial System – President Joe Biden on Monday told Americans the nation’s financial systems were safe, seeking to project calm following the swift and stunning collapse of two banks that prompted fears of a broader upheaval. Read Full Article on PBS >>
Biden unveils submarine pact with U.K., Australia during historic San Diego visit
March 13, 2023 / Biden / San Diego / Submarine Pact – At a historic meeting in San Diego, President Joe Biden and the prime ministers of the United Kingdom and Australia announced Monday that they’re accelerating plans to provide Australia with nuclear-powered submarines to help the nations counter a military build-up by China in the Indo-Pacific. Read Full Article on The San Diego Union Tribune >>
March 13, 2023 / Biden / San Diego / Submarine Pact – At a historic meeting in San Diego, President Joe Biden and the prime ministers of the United Kingdom and Australia announced Monday that they’re accelerating plans to provide Australia with nuclear-powered submarines to help the nations counter a military build-up by China in the Indo-Pacific. Read Full Article on The San Diego Union Tribune >>
US names first drugs to face price hike penalty
March 15, 2023 / Drug Price Hike / Biden – The rebates are some of the first reforms to kick in from last year’s Inflation Reduction Act, which was in part aimed at reducing drug costs. Drugmakers must pay back to Medicare a rebate for price hikes they took that were greater than inflation — limits that started in October for certain self-administered Part D drugs and in January for certain physician-administered Part B drugs. Read Full Article on Biopharma Dive >>
March 15, 2023 / Drug Price Hike / Biden – The rebates are some of the first reforms to kick in from last year’s Inflation Reduction Act, which was in part aimed at reducing drug costs. Drugmakers must pay back to Medicare a rebate for price hikes they took that were greater than inflation — limits that started in October for certain self-administered Part D drugs and in January for certain physician-administered Part B drugs. Read Full Article on Biopharma Dive >>
