// Biotech and Pharma Therapeutics

Astellas keeps the big buyouts rolling, inking $5.9B Iveric takeover ahead of FDA eye disease ruling
May 1, 2023 / Astella Pharma / Iveric bio / Mergers and Acquisitions / Eye Disease – The multibillion-dollar biotech buyouts keep on coming. Astellas Pharma is the latest drugmaker to get in on the act, agreeing to pay $5.9 billion to buy Iveric Bio and establish itself as a player in an emerging eye disease niche. Read Full Article on Fierce Biotech >>
Lilly’s hotly anticipated Alzheimer’s data set a new high score in slowing cognitive decline
May 3, 2023 / Eli Lilly / Donanemab / Alzheimer’s Disease / Clinical Trial Data – Eli Lilly’s Alzheimer’s disease candidate has achieved a 35% slowing of cognitive decline and a 39% lower risk of advancing to the next stage of the disease when compared to placebo. Read Full Article on Fierce Biotech >>
AbbVie weathers first months of biosimilar challenge to top-selling Humira
April 28, 2023 / AbbVie / Humira / Amgen – While substantial, the 26% decline AbbVie reported in year-over-year Humira sales is mainly due to the company’s negotiations with U.S. insurers to keep the drug’s access equal to the incoming biosimilars. The sales numbers just about tracked with what analysts had forecast for the first quarter. Read Full Article on Biopharma Dive >>
Pfizer turns focus to new drugs as COVID vaccine revenue falls
May 2, 2023 / Pfizer / Covid / Vaccine / Drugmakers – The revenue windfall Pfizer gained from its COVID vaccine and Paxlovid has diminished as the pandemic has gone on. Investors, once laser-focused on the pharmaceutical company’s coronavirus work, are now paying closer attention to what else the company can do to sustain its momentum. Read Full Article on Biopharma Dive >>
Lilly’s Donanemab Data Energizes Alzheimer’s Sector, Safety Concerns Remain
May 4, 2023 / Eli Lilly / Alzheimer’s / Prothena – Prothena, which has two Phase I Alzheimer’s disease (AD) candidates, added 28% to its share price by market close Wednesday following Lilly’s donanemab data drop. Meanwhile, Annovis Bio, whose lead compound buntanetap is in Phase II/III assessments for AD, was trading 6% higher. Read Full Article on Biospace >>

// 4th Industrial Revolution

AI May Improve Clinician Decision-Making Within ICUs
May 4, 2023 / AI / ICUs / Healthcare – According to the Centers for Disease Control and Prevention (CDC), about 1.7 million US adults develop sepsis annually, at least 350,000 of whom die in the hospital or wind up in hospice. Read Full Article on Health IT Analytics >>
The Promise of ChatGPT Will Be Buried Inside Health Care
May 3, 2023 / Chat GBT / Healthcare / AI / Amwell – The stunning achievements of chatGPT (along with the enormous work that remains to be done) raise the questions of how generative AI will change industries and interactions. As the term “generative AI” indicates, these technologies use AI to communicate, not to do predictive analytics or alter events. Thus, according to Murray Brozinsky, Chief Strategy Officer at Amwell, generative AI will automate peripheral aspects of communication rather than affect health care directly. Read Full Article on Healthcare IT Today >>
Does ChatGPT really outshine doctors? Or just on social media?
May 4, 2023 / ChatGBT / AI / Social Media / Healthcare – A team of licensed healthcare professionals compared physicians’ and the chatbot’s responses to patients’ questions asked publicly on the social media forum Reddit’s r/AskDocs in October 2022, but were summarily won over by the answers to the questions entered into ChatGPT in late December. Read Full Article on Healthcare IT News >>
Women’s hybrid care provider Tia adds mental health offerings
May 3, 2023 / Women’s Health / Mental Health / Healthcare – Tia combines virtual and in-person care for various women’s health needs, including primary and gynecological care and wellness services. The company offers mental health assessments through its primary care visits. Read Full Article on Mobi Health News>>
AI outplays physicians at informing patients and feeling their pain too
May 2, 2023 / AI / ChatGBT / US San Diego – Virtually going toe-to-toe with medical doctors taking questions from real-world patients, a generative AI chatbot gave superior medical advice almost 80% of the time. What’s more, response evaluators consistently scored the technology—yes, a ChatGPT model—higher than the doctors for empathy and, with it, bedside manners. Read Full Article on AI in Healthcare >>

// Business & Markets

Silence Therapeutics Achieves $10 Million Milestone Payment from AstraZeneca Collaboration
May 4, 2023 / Silence Therapeutics / AstraZeneca / Cardiovascular – Regina Fritsche Danielson, SVP, Early Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca said, “This is a very exciting first milestone in our long-term collaboration with Silence Therapeutics and we look forward to continued successes across our ongoing projects to address cardiovascular, renal and metabolic diseases.” Read Full Article on Biospace >>
Astellas to acquire eye drug developer Iveric Bio for $5.9B
May 1, 2023 / Astellas / Iveric Bio / Eye Drug – Japanese drugmaker Astellas Pharma on Sunday agreed to acquire Iveric Bio for about $5.9 billion, betting that a medicine the biotechnology company has developed for a common type of vision loss can help it build an eye drug business. Read Full Article on Biopharma Dive >>
J&J, building on CAR-T success, strikes another cell therapy deal
May 2, 2023 / Johnson & Johnson / CAR-T / Cell Therapy – Once a latecomer to cell therapy research, J&J has established itself as a major player in recent years. A 2017 licensing deal with Chinese drug developer Legend Biotech yielded Carvykti, which has since become one of only two cell therapies approved in the U.S. for multiple myeloma. Read Full Article on Biopharma Dive >>
Telehealth giant Amwell posts nearly $400M loss in Q1
May 4, 2023 / Telehealth / Amwell – Amwell reported a significantly larger net loss in the first quarter due to a noncash goodwill impairment charge related to a lasting decline in the company’s share price. The telehealth company posted a $398.5 million loss compared with $70.3 million in the prior-year period and a $61.6 million loss in the fourth quarter. The impairment charge was $330.3 million. Read Full Article on Mobi Health News >>
AbbVie says Botox rival Revance recruited its employees in bid to steal trade secrets
May 3, 2023 / AbbVie / Revance / Trade Secrets / Lawsuit – The pharma giant is accusing Revance of recruiting key employees as part of a strategy to get its hands on proprietary information. Revance is launching cosmetic treatment Daxxify to challenge AbbVie’s blockbuster Botox. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

Novo Nordisk’s Hemlibra rival faces another approval setback as FDA raises dosing, manufacturing questions
May 4, 2023 / Novo Nordisk / Hemophilia / Complete Response Letter / FDA – Three years after the FDA forced Novo Nordisk to pause a trial of its potential Hemlibra rival over reports of blood clots, the U.S. regulator has placed further barriers in front of the drug—even as it secures approval in other territories. Read Full Article on Fierce Biotech >>
Beating its rivals, GSK nabs world-first approval for adult RSV vaccine Arexvy
May 3, 2023 / GSK / FDA / Arexvy / Respiratory Syncytial Virus – In landing an FDA approval for its highly anticipated respiratory syncytial virus (RSV) vaccine, GSK has both beat out its market rivals and initiated its next major launch. Read Full Article on Fierce Pharma >>
Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy
May 1, 2023 / MedinCell / Teva Pharmaceuticals / FDA / Schizophrenia –In combination with Teva, MedinCell has scored an FDA nod for Uzedy (risperidone), an extended-release injectable suspension treatment for adults with schizophrenia. Read on Fierce Pharma >>
First FDA Approval of an RSV Vaccine Goes to GSK
May 3, 2023 / FDA / RSV Vaccine / GSK / Vaccine – The FDA has approved the first vaccine for respiratory syncytial virus, a pathogen that typically circulates in the fall and winter months, leading to serious and potentially deadly infections, particularly in infants and the elderly. Read on Med City News >>
Eli Lilly Alzheimer’s Drug Meets Phase 3 Goals, Teeing Up Plans for FDA Filing
May 3, 2023 / Eli Lilly / Alzheimer’s Drug / FDA / Phase 3 –Patients treated with Eli Lilly Alzheimer’s disease drug donanemab showed a 35% slowing in decline compared to those given a placebo. Based on the Phase 3 results, Lilly said it would seek FDA approval for the drug by the end of June. Read on Med City News >>

// Research & Development

Lilly’s new Alzheimer’s data may both help and hinder rival Biogen
May 3, 2023 / Eli Lilly / Alzheimer’s / Biogen / Wall Street – Wall Street analysts expect Eli Lilly’s new, positive Alzheimer’s disease data to be a double-edged sword for one of the company’s main rivals, Biogen. Read Full Article on Biopharma Dive >>
Novo reveals another setback in obesity drug’s launch
May 4, 2023 / Novo Nordisk / Obesity Drug / Drugmakers – U.S. supply of Novo Nordisk’s weight loss drug Wegovy will be “reduced temporarily,” the company said Thursday, revealing the latest setback to a launch that’s been slowed by manufacturing issues over the last year and a half. Read Full Article on Biopharma Dive >>
Moderna Announces Phase 1/2 Data on mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia (PA) to be Presented at the 2023 ASGCT Annual Meeting
May 3, 2023 / Moderna / mRNA Therapy / Propionic Acidemia – The ongoing global, Phase 1/2, open-label, multicenter, dose-optimization trial evaluates the safety, pharmacodynamics, and pharmacokinetics of mRNA-3927 in participants aged 1 year and up with genetically confirmed PA. The trial uses a dose-escalation approach to evaluate the intravenous administration of mRNA-3927. Read Full Article on Biospace >>
Novartis spruces up Sandoz—again—by bringing 6 new US generics into the fold
May 4, 2023 / Novartis / Sandoz / Generics / Licensing Deals – In a new deal unveiled Thursday, Sandoz obtained exclusive rights to sell six small-molecule generic candidates in the U.S. from Malta-based pharmaceutical company Adalvo. Read Full Article on Fierce Pharma >>
CVS Health: 60% of Mental Health Physicians See Patients’ Conditions Declining
May 1, 2023 / CVS Health / Mental Health – One in 10 Americans believe their mental health has worsened over the last year, new CVS Health data shows. But six in 10 physicians say they’ve noticed their patients’ mental health deteriorating, revealing a disconnect between what patients think about their health and what their physician thinks. Read Full Article on Med City News >>

// Politics

For­mer Covid test­ing czar dish­es on the pol­i­tics that in­ter­rupt­ed the ear­ly pan­dem­ic re­sponse
May 1, 2023 / Covid / White House / FDA – In his new memoir, to be published next Tuesday by Texas A&M, Giroir explains what went down behind some of the most politically-charged scenes, with two political appointees — the economist Peter Navarro, who rallied for the use of hydroxychloroquine even after the randomized controlled trials failed, and Scott Atlas, Trump’s only political appointee to be added to the federal coronavirus task force — both of whom featured prominently in some of the more contentious meetings. Read Full Article on Endpoints News >>
Medicare Negotiation And The Politics Of Drug Pricing
May 3, 2023 / Medicare / Negotiation / Politics / Drug Pricing – Medicare pricing decisions will become ‘highly politicized,’ Scott Gottlieb predicts. The former FDA commissioner and CMS official also believes the program should rely on outside health technology assessment groups, and he offers his opinions on how negotiation will (or won’t) change patent litigation. Read Full Article on Pink Sheet >>
A Marine Corps vet’s battle to breathe is part of a fight against ‘Big Pharma’
April 29, 2023 / Big Pharma / Marine Corps / Congress – If Congress acts quickly enough, Kevin Jackson just may survive the disease that is trying to suffocate him. Each month he has to come up with $3,000, his co-pay for a 90-day supply of nintedanib. The cost without insurance lands somewhere near $20,000. Sold under the name Ofev, the oral medication treats people with pulmonary fibrosis, a lung disease affected by severe scarring. Read Full Article on AFRO News >>
New European pharmaceutical rules met with scepticism in Switzerland
May 1, 2023 / Switzerland / European Pharma Rules – Switzerland is keeping a close eye on a major overhaul to rules governing pharmaceutical products in Europe that have become a showdown between industry calls for more incentives for innovation and member state demands to make medicine more affordable. Read Full Article on Swissinfo.ch >>
Gov. DeSantis signs ‘Prescription Drug Reform Act’ targeting pharmacy benefit managers
May 3, 2023 / U.S. Congress / AI / Disease Prediction – At a news conference Wednesday morning in Jupiter, Gov. Ron DeSantis signed a bill that will increase regulations on pharmacy benefit managers — the middlemen of the pharmaceutical industry. DeSantis was joined at the news conference by Agency for Health Care Administration Secretary Jason Weida and Department of Elder Affairs Secretary Michelle Branham. Read Full Article on News4Jax >>