// Biotech and Pharma Therapeutics
J&J shines light on key role in multiple myeloma care team, vowing to raise awareness and offer support
Johnson & Johnson’s multiple myeloma team wants to “Make It HAPPen.” Working with a professional society, the drugmaker is stepping up its support for advanced practice providers (APPs) in light of survey data showing the key role they play in the multiple myeloma care pathway.
Health News Roundup: Cough syrup deaths overseas prompt US crackdown on toxic testing; Britain’s first supervised drug-injection site approved and more
The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products for the toxins ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers. Exclusive-Edwards Lifesciences cooperating with EU antitrust regulators Edwards Lifesciences is working with EU antitrust regulators after they raided one of its facilities in an EU country a week ago, the U.S. medical device maker said on Tuesday.
Weight Loss Drugs May Be Riskier For Older Adults, Experts Say
That’s true for weight loss from GLP-1 medications like Ozempic and Wegovy, too. For younger adults, the loss of muscle may not cause problems right away, but in people over 65, it’s critical for maintaining strength and mobility. Muscle weakness is a risk factor in falls among older adults, one of the leading causes of injury death for that age group, according to the US Centers for Disease Control and Prevention.
Obesity drug success sparks biotech buying spree
These new drugs belong to a class of medications called GLP-1 analogs (or incretin-based therapies), which work by activating GLP-1 – a critical hormone produced by the gut – receptors in the body. GLP-1 analogs help people lose weight through several mechanisms, including slowing down stomach emptying, reducing appetite by acting on the brain, and boosting the release of insulin.
AbbVie axes Caribou CAR-T deal, continuing cascade of punted cancer pacts
AbbVie has decided it can do without Caribou Biosciences. The Big Pharma is terminating its off-the-shelf CAR-T pact with the biotech, depriving Caribou of the chance to pocket up to $350 million in milestones per program.
// 4th Industrial Revolution
Mercy & Microsoft Form Generative AI Collaboration to Advance Patient Care
The Microsoft Cloud, chosen as Mercy’s primary platform for continuous innovation, offers a reliable and comprehensive solution. It enhances efficiency, facilitates data connectivity and governance, enhances both patient and staff experience, extends reach to new communities, and establishes a foundation for ongoing innovation.
FDA finalizes guidance on cybersecurity for medical devices
Late last year, Congress empowered the FDA to issue “refuse to accept” decisions to applicants that fail to include the information it needs to ensure medical devices meet cybersecurity requirements. The FDA said it “generally intends” not to use that power before Oct. 1. After that, the agency expects sponsors “will have had sufficient time to prepare premarket submissions that contain [the] information required.”
Galen robot gets FDA de novo clearance for ENT surgeries
Galen is among a burst of new companies eyeing niches in the growing robot-assisted surgery market, which remains dominated by Intuitive Surgical and is a key focus for deep-pocketed challengers such as Medtronic and Johnson & Johnson.
AstraZeneca and SAS link up on AI and analytics
The SAS and AstraZeneca collaboration will enable teams across the organisation to increase clinical research innovation using SAS’s cloud-based software and technologies.
Adela scores $48M to grow genomic cancer detection platform
Cancer detection technology startup Adela announced it secured $48 million in funding, bringing its total raise to $108 million. Labcorp joined the round as a new investor alongside existing investors OrbiMed, Decheng Capital, F-Prime Capital, Deerfield Management and RA Capital Management. Adela also named Lisa Alderson as its interim CEO. Alderson has served on the company’s board of directors since 2022. Former CEO Scott Bratman will move to the position of president and join the company’s board of directors.
// Business & Markets
Merck KGaA goes again in AI, expanding Quris toxicity prediction pact days after inking 2 deals
The artificial intelligence deals keep coming at Merck KGaA. Days after the pharma put out news of two new AI pacts, Quris-AI has shared details of the expansion of the drug toxicity prediction project it’s working on with the German drugmaker.
Generative AI-focused biotech startup Evozyne raises $81m
OrbiMed and Fidelity Management & Research Company led the round, with the investment companies joining previous investors Paragon Biosciences and Valor Equity Partner. NVIDIA, a company considered a leader in generative AI software development, also participated through its venture capital arm NVentures.
Novo Nordisk, Evotec partner in metabolic disease drug discovery pact
The companies announced Tuesday a new drug discovery accelerator dubbed LAB eN², which will incubate research from academic institutions in hopes of creating new medicines. Harvard University, Mass General Brigham, Yale University, and Beth Israel Deaconess Medical Center are all set to work with the companies as part of the collaboration.
Roche bets on Ionis RNA medicines with neuroscience deal
Roche and Ionis have worked together for years. The two are currently collaborating on tominersen, a type of drug called an antisense oligonucleotide that blocks the expression of a protein mutated in Huntington’s disease. That drug is in a Phase 2 trial measuring biologic signs of disease as well as patient function.
Intercept, once a biotech trailblazer, sells itself for less than $1 billion
Alfasigma, an Italian pharmaceutical firm, will pay $19 a share for Intercept, in a roughly $800 million cash deal that represents an 80% premium to the company’s recent trading price. Intercept expects the deal to close by the end of the year.
// Legal & Regulatory
J&J’s Rybrevant combo bests AstraZeneca’s established Tagrisso in key lung cancer study
A highly anticipated head-to-head matchup between a Johnson & Johnson combination and AstraZeneca’s star Tagrisso as a first-line treatment in a subset of non-small cell lung cancer (NSCLC) has yielded a winner.
Bionomics’ midphase PTSD trial hits primary endpoint, briefly tripling its battered share price
Bionomics’ bid to bounce back from its stock-crushing anxiety trial failure has finally gained some momentum, with investors sending the share price up almost 200% on the strength of phase 2 data in post-traumatic stress disorder (PTSD).
GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns
When Scynexis won FDA approval for its antifungal drug ibrexafungerp back in 2021, some analysts predicted the drug could eventually surpass the $1 billion annual sales threshold. But now the drug’s launch is taking a serious detour.
Item of Interest: NIH and partners launch public-private effort to advance pediatric medical device development
The National Institutes of Health today announced the launch of the design phase of a public-private partnership addressing the lack of medical devices designed and approved for children in the United States. In this initial phase, NIH and partners will develop a detailed plan to build and launch a partnership that will bring together the resources of U.S. government agencies and private sector organizations, including industry and non-profits.
JBS to Build Cultivated Protein Research Facility in Brazil
The center will include labs, a pilot plant and, eventually, a commercial-sized plant. JBS says it has invested $22 million in the project with plans to add another $40 million. Expected to open in late 2024, the facility will be staffed by a team of 25 post-doctoral researchers as well as support staff.
// Research & Development
New RSV vaccines can be powerful tools, but rollout poses test
Their arrival in the U.S., alongside a new antibody drug, gives public health officials and physicians powerful new tools to combat respiratory syncytial virus, or RSV, which causes thousands of deaths among young children and older adults each year.
Pfizer’s Vydura recommended by NICE for acute migraines
The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults.
Startup AIRNA emerges from stealth to bring RNA editing to a rare disease
Scientists have touted RNA editing as a safer derivation of early gene editing methods. Unlike CRISPR-based therapies, RNA editing can target specific sites in an RNA transcript without permanently changing a patient’s genome.
Broken birth control: Growing calls for research into popular IUD after 6,000+ breakage reports
The initial investigation found that the Paragard IUD had broken thousands of times, sometimes leading to serious health complications for women; both of those concerns continue to persist about the device.
RetinalGeniX Technologies focuses on prevention of blindness, early detection of multiple systemic diseases
RetinalGeniX Technologies Inc. released to the public via OCT Markets a video webinar regarding the retinal screening medical device technology being developed by the company to help prevent blindness and multiple systemic diseases, the company’s business opportunities and the professional background of the company’s management team.
As Biden plans to ban medical debt from credit scores, advocates press for more change
Anti-debt advocates have long highlighted the injustices of medical debt, a major cause of personal bankruptcy in the U.S. The burden of medical debt weighs on people in various financial situations: some may be uninsured, while others may be insured but have high deductibles or coinsurance policies that result in costly bills, said Patricia Kelmar, the director of health care campaigns for the U.S. at PIRG, a public interest advocacy.
Federal regulation of AI: What the likely framers and innovators are saying now
Last week brought the latest in an occasional series of conversations on AI between governmental leaders and Big Tech honchos. For months, the No. 1 topic on the table has been regulation. Businesses are counterintuitively clamoring for it, and the political parties are—for the moment, anyway—united over it.
With Novo Nordisk, Denmark Wants to Avoid the Nokia Trap
CDenmark has long been known as the home of Lego toys and Carlsberg beer, but it’s enjoying newfound fame in weight-loss medicine. Now, the economy’s increasingly heavy dependence on the stunning success of a single company — Novo Nordisk — is driving fears the Scandinavian country could be falling into the so-called Nokia trap.
Bipartisan battle over prescription intermediaries heats up
Members across the aisle have introduced at least a dozen bills so far this year that would address the impact of increasing consolidation among PBMs and lack of transparency into prescription drug access and pricing.
Low rural healthcare getting the attention of Congress
The committee also wants to increase federal reimbursement rates to Medicare and Medicaid providers. But rather than increasing spending, members want that money to come by cutting other government programs.