// Biotech and Pharma Therapeutics

Pfizer drops sickle cell disease collab with Syros inherited from GBT takeover
July 24, 2023 / Pfizer / Syros Pharmaceuticals / Sickle Cell Disease / Beta Thalassemia – At tail-end of 2019, GBT agreed to pay Syros $20 million upfront and bankroll at least three years of research funding up to $40 million to discover, develop and commercialize new therapies for sickle cell disease and beta thalassemia. The plan was for Syros to use its gene control platform to identify potential drugs that could induce fetal hemoglobin, with GBT having first choice to pick up the worldwide license to take any resulting candidates through development and on to market. Read Full Article on Fierce Biotech >>
Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug
July 24, 2023 / Roche / RNAi / Hypertension Drug / Alnylam / Cardiometabolic Disease – Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. Read Full Article on Med City News >>
ImmunoGen Inks Cancer ADC Partnership with ImmunoBiochem
July 25, 2023 / ImmunoGen / ImmunoBiochem / Cancers / Partnerships – ImmunoGen has entered into a multi-target license and option partnership with privately-held ImmunoBiochem to advance novel and first-in-class antibody-drug conjugates against unique cancer targets, the companies announced Monday. Read Full Article on BioSpace >>
Roche buys into Alnylam heart drug in cardiovascular research bet
July 24, 2023 / Roche / Alnylam / Cardiovascular / High Blood Pressure – Roche will partner with Alnylam Pharmaceuticals to study a promising new treatment for high blood pressure, becoming the latest large drugmaker to commit in a big way to the often lengthy and expensive process of developing new medicines for the heart. Read Full Article on Biopharma Dive >>
Kodiak Sciences Scraps Late-Stage Vision Loss Biologic
July 24, 2023 / Kodiak Sciences / Diabetes Macular Edema / Tarcocimab Tedromer – Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further. Read Full Article on BioSpace >>

// 4th Industrial Revolution

AWS Launches Generative AI Solution That Auto Generates Clinical Notes
 July 26, 2023 / Amazon Web Services / AI / Clinical Notes – Amazon Web Services, Inc. (AWS) launches AWS HealthScribe, a new HIPAA-eligible service that empowers healthcare software providers to build clinical applications that use speech recognition and generative AI to save clinicians time by generating clinical documentation. With AWS HealthScribe, healthcare software providers can use a single API to automatically create robust transcripts, extract key details (e.g., medical terms and medications), and create summaries from doctor-patient discussions that can then be entered into an electronic health record (EHR) system. 3M Health Information Systems, Babylon Health, and ScribeEMR are among customers and partners using AWS HealthScribe. Read Full Article on HIT Consultant >>
Whole Foods Co-Founder Launches Health & Wellness Company, Love.Life
 July 26, 2023 / Love.Life / Health and Wellness / Virtual Health – Whole Foods Market co-founder, John Mackey today announced the launch of an integrated new health and wellness company, Love.Life. The company’s virtual health optimization programs and plans for its first flagship location in El Segundo, CA is slated to open in the summer of 2024. Read Full Article on HIT Consultant >>
When physicians and health IT leaders embrace an ‘AI as an ally’ mindset
 July 24, 2023 / AI / Health IT / Virtual Care – Dhruv Suyamprakasam is CEO and founder of virtual healthcare company iCliniq. Its physician panel consists of more than 3,500 doctors from more than 80 specialties in the U.S., UK, UAE, India, Singapore and Germany. He believes ChatGPT and other artificial intelligence models like it are not a threat to healthcare but an enhancement. And he says the benefits are only beginning. Read Full Article on Healthcare IT News >>
How Generative AI Can Transform Healthcare Contact Centers
 July 26, 2023 / AI / Healthcare / ChatGPT – Generative artificial intelligence (AI) arguably is the hottest topic today in the world of business and technology. With the ability to create content such as text, images, audio, and video, generative AI algorithms are being tested for use cases in marketing, finance, education, and healthcare. Read Full Article on HIT Consultant >>
Pager’s Virtual Care Platform Now Available on Google Cloud Marketplace
 July 24, 2023 / Pager / Virtual Care – Pager Inc. today announced that its virtual care navigation and collaboration platform, which serves 23 million members, is now available on Google Cloud Marketplace, effective immediately. This new offering includes additional benefits for Pager clients who have a Google Cloud account. Purchases made on Google Cloud Marketplace count toward a dollar-for-dollar drawdown on any Google Cloud committed spend. Read Full Article on HIT Consultant >>

// Business & Markets

After consumer split, Johnson & Johnson plans to drop 80% of Kenvue stake through exchange offer
July 24, 2023 / Johnson & Johnson / Kenvue / Joaquin / Pharma CEO – With Johnson & Johnson’s consumer health spinoff in the rearview, J&J is taking its hands off the Kenvue steering wheel to focus on its own business—and offering investors an incentive to take ownership in the new company. Read Full Article on Fierce Pharma >>
Humanigen mulls bankruptcy after reverse merger falls through
July 25, 2023 / Humanigen / Bankruptcy – Humanigen is running out of options. Talks over a reverse merger have collapsed and, with efforts to find another deal or raise funding failing, the biotech is considering filing for bankruptcy in the third quarter. Read Full Article on Fierce Biotech >>
Astellas notches another protein degrader pact with $21M upfront for PeptiDream
 July 25, 2023 / Astellas / PeptiDream / Protein Degradion – Is there anything Astellas likes more than a protein degrader pact? The Japanese pharma has followed up agreements with the likes of Cullgen and Generian Pharmaceuticals by tapping PeptiDream for its latest partnership. Read Full Article on Fierce Biotech >>
Lilly Announces Extension of Tender Offer to Acquire DICE
 July 25, 2023 / Eli Lilly / DICE Therapeutics – Eli Lilly and Company (NYSE: LLY) today announced the extension of the expiration of the tender offer to acquire all of the issued and outstanding shares (“Shares”) of common stock of DICE Therapeutics, Inc. (NASDAQ: DICE), for a purchase price of $48 per share in cash, without interest and less any applicable tax withholding. Read Full Article on BioSpace >>
Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan
July 25, 2023 / Biogen / FDA Approval / Alzheimer’s – With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. Read Full Article on BioSpace >>

// Legal & Regulatory

Verrica notches long-awaited FDA nod but shares plummet after loan revelation
July 24, 2023 / FDA / Complete Response Letter / Sterling Pharma Solutions / Ycanth – After two rejections from the FDA—both related to manufacturing—Verrica Pharmaceuticals has scored approval for Ycanth (cantharidin/VP-102), which becomes the first therapeutic sanctioned in the United States for molluscum, a viral skin infection. Read Full Article on Fierce Pharma >>
Pfizer, FDA work to ease shortage concerns as tornado relief efforts pick up at NC injectables plant
July 24, 2023 / Pfizer / U.S. FDA / Sterile Injectables / Drug Supply Plan – Pfizer and the U.S. FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week. Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage. Read Full Article on Fierce Pharma >>
Further blow for Biohaven as FDA refuses to consider failed rare disease drug for approval
July 27, 2023 / Biohaven Pharmaceuticals / FDA / Failed Trials / Regulatory Affairs – Biohaven’s attempts to redefine itself as a post-migraine company are continuing to encounter headaches, with the company expressing “deep disappointment” at the FDA’s refusal to review the brain disorder drug troriluzole. Read on Fierce Biotech >>
Lawsuit says Cigna illegally denies claims in bulk, sticking patients with unexpected bills
July 24, 2023 / Lawsuit / Cigna / PXDX – A new lawsuit accuses Cigna of using an algorithm to automatically deny claims in bulk instead of individually reviewing each case, putting patients on the hook for bills the health insurer otherwise would have paid. Read on STAT News >>
British billionaire used insider info to spur lovers to trade in Solid Bio and Mirati, DOJ claims
July 26, 2023 / Mirati Therapeutics / Solid Biosciences / U.S. Department of Justice –According to an indictment unsealed in Manhattan federal court, and uploaded by Bloomberg, Lewis allegedly “engaged in multiple schemes to violate the securities laws through insider trading and submitting false and misleading filings” to the U.S. Securities and Exchange Commission. Read on Fierce Biotech >>

// Research & Development

AstraZeneca links up with Qureight on lung disease research
July 25, 2023 / AstraZeneca / Qureight / Lung Disease / AI – Under the terms of the agreement, AstraZeneca will utilise Qureight’s artificial intelligence (AI) technology and proprietary platform to undergo studies across a variety of complex lung diseases. In doing so, the pharma giant will be able to leverage imaging data analytics and incorporate AI models to improve its understanding of how patients with rare lung conditions respond to novel treatments. Read Full Article on Pharma Times >>
Gilead Ends Late-Stage Trial for Magrolimab in Blood Cancer Treatment
July 24, 2023 / Gilead / Late-Stage Trial / Magrolimab / Blood Cancer – Gilead has discontinued the Phase III ENHANCE study of its investigational anti-CD47 antibody magrolimab for the treatment of patients with higher-risk myelodysplastic syndromes, the company announced Friday. Read Full Article on BioSpace >>
Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial
July 25, 2023 / Elevar / Liver Cancer – A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday. Read Full Article on BioSpace >>
Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop
July 24, 2023 / Bavarian Nordic / Phase II / RSV Vaccine – Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. Read Full Article on BioSpace >>
Merck’s next-gen pneumococcal vaccine strides forward after two phase 3 wins
July 27, 2023 / Merck & Co. / Pneumococcal Vaccine / Vaccines – Merck & Co.’s next-generation pneumococcal vaccine has secured success in a pair of phase 3 trials, bringing the Big Pharma within touching distance of getting the first pneumococcal conjugate shot specifically designed for adults to market. Read Full Article on Fierce Biotech >>

// Politics

OPINION – How do doctors’ personal political affiliations affect how they care for their patients?
July 24, 2023 / Patients / Political Affiliations / Healthcare – A 2016 survey study, conducted by the Tufts University political scientist Eitan Hersh and the Yale psychiatrist Matthew Goldenberg, asked about 230 Democratic and Republican primary care physicians to read a short vignette about a hypothetical patient and rate the “seriousness” of various medical issues the patient presented. The researchers purposely included both politically charged and nonpolitically charged issues. For example, one vignette focused on tobacco use, a non-charged issue. It described a patient who “acknowledges engaging in social smoking, consuming ~15–20 cigarettes per week (2-3 per day), a habit that began at age 18.” Read Full Article on STAT News >>
Roche Drops Hemophilia A Candidate, Prepares for the Impacts of IRA
 July 27, 2023 / Roche / Hemophilia A Candidate / IRA – Roche is discontinuing the development of the mid-stage gene therapy candidate RG6358, or SPK-8016, which was previously being assessed as a treatment for hemophilia A patients with inhibitors to factor VIII, the company announced Thursday in its second-quarter earnings report. Read Full Article on BioSpace >>
White House unveils plan to make insurers cover mental health care
July 25, 2023 / White House / Mental Health / Insurers – If the plan is enacted, it could help end decades of whack-a-mole between government regulators and insurance companies. While insurers have been legally required to cover mental health and addiction treatment since the 1990s, many have never truly complied, forcing patients to jump through bureaucratic hoops, or even pay out-of-pocket, to obtain care. Read Full Article on STAT News >>
Key House panel proposes lowering out-of-pocket drug costs in Medicare
July 24, 2023 / Key House Panel / Drug Costs / Medicare – A key House committee announced its own plans to increase health care transparency and reduce some health care costs for patients on Monday, according to bill text obtained by STAT. Read Full Article on STAT News >>
A new lobby shop looks to remind Congress about NIH’s translational research arm
July 24, 2023 / Congress / NIH – Christopher Austin was the first director of a then-tiny National Institutes of Health department with an opaque name, the National Center for Advancing Translational Sciences. Now, a few years out of the job, he’s got a new task: Make sure Congress doesn’t forget about it. Read Full Article on STAT News >>