Bristol Myers Squibb drug Augtyro now has a tumor-agnostic approval permitting the drug to be used to treat all solid tumors positive for NTRK gene fusions. Augtyro came from BMS’s $4.1 billion acquisition of Turning Point Therapeutics.

The post New FDA Nod Brings Bristol Myers Squibb Cancer Drug to a Wider Range of Solid Tumors appeared first on MedCity News.

A Pfizer gene therapy for Duchenne muscular dystrophy failed its Phase 3 clinical trial. But analysts draw distinctions between that therapy and Sarepta Therapeutics’ Elevidys, which awaits an FDA decision that could grant it full regulatory approval.

The post Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval appeared first on MedCity News.

Three things drug manufacturers and CEs can do to build trust and enable effective collaboration

The post How Covered Entities and Pharma Companies Can Better Collaborate on Drug Discount Programs appeared first on MedCity News.

Despite misconceptions about its use, artificial intelligence (AI), through modalities such as machine learning models, is poised to enable companies to expedite the drug design process. 

The post The Potential for AI in Drug Design appeared first on MedCity News.

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses.

The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

How academia and biotech can team up to bring impactful new drug therapies to patients faster

The post Rapid Translation of Therapeutic Discoveries into the Clinic through Purposeful Collaboration appeared first on MedCity News.

Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine.

The post Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer appeared first on MedCity News.

Rapport Therapeutics’ IPO came with a concurrent private placement that boosted the biotech’s cash haul. The new capital will support clinical development of a lead drug with a novel approach to focal epilepsy, a form of the disorder that affects 1.8 million people in the U.S.

The post Rapport’s Stock Market Debut Reaps $154M as Novel Epilepsy Med Heads for Mid-Stage Test appeared first on MedCity News.

Three upcoming Supreme Court decisions have the potential to radically change FDA regulation of medications.
The cases, which involve “Chevron deference” and the abortion pill mifepristone, were discussed on a panel during the BIO conference in San Diego.

The post Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs appeared first on MedCity News.

By working together to build an ecosystem of support around people with diabetes, the healthcare system as a whole can ensure that no one slips through the cracks.

The post As Interest in GLP-1s Explodes, People Living With Diabetes Need Structured Support To Ensure Effective Use appeared first on MedCity News.

Gameto’s $33 million Series B funding round was led by Two Sigma Ventures and RA Capital. The funding will help with the clinical development of its in vitro maturation product called Fertilo.

The post Gameto Secures $33M To Support Clinical Development of Fertility Treatment appeared first on MedCity News.

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.

The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal. The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021.

The post Gilead Sciences ADC Flunks Its Confirmatory Test in Advanced Bladder Cancer appeared first on MedCity News.

CinRx Pharma’s most prominent spinout is CinCor Pharma, which was acquired by AstraZeneca last year. The startup creator will apply its new capital toward current programs and to expand to additional areas of unmet medical need.

The post CinRx Pharma Corrals $73M to Continue ‘Hub and Spoke’ Model of Startup Formation appeared first on MedCity News.

Johnson & Johnson is acquiring a bispecific antibody that Numab Therapeutics engineered to address two pathways associated with the inflammation and itching of atopic dermatitis. It’s J&J’s second immunology acquisition this month.

The post J&J Adds Another Bispecific Antibody for Atopic Dermatitis With $1.25B Acquisition appeared first on MedCity News.

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes.

The post With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better appeared first on MedCity News.

Tracey James, chief operating officer of Walgreens’ specialty pharmacy business, talked about the retailer’s vision of innovating in the specialty pharmacy world, as well as about affordability and access.

The post MedCity Pivot Podcast: A Conversation With Walgreens’ Head of Specialty Drugs appeared first on MedCity News.

GLP-1 agonists are transforming the weight loss market. Experts weighed in on the changes they’re seeing, speaking in a panel discussion during the MedCity News INVEST Conference in Chicago.

The post Navigating Opportunities and Challenges in the GLP-1 Drug Gold Rush appeared first on MedCity News.

To win the battle against rare diseases, drug developers must work hand-in-hand with patients.

The post Allying With Patients to Make Every Cure Possible appeared first on MedCity News.

The NIH’s SEED office formed to help startups leverage government’s funding programs. Chris Sasiela, director of the SEED office, discussed these programs during the MedCity News INVEST Conference in Chicago.

The post 5 Things to Know About How NIH’s SEED Can Help Life Science Startups Grow appeared first on MedCity News.

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.

The post AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs appeared first on MedCity News.

Rapport Therapeutics’ lead program could offer more targeted epilepsy treatment compared to currently available anti-seizure medications, which introduce many side effects. The IPO will support plans to develop the oral small molecule in focal epilepsy as well as peripheral neuropathic pain and bipolar disorder.

The post CNS-Focused Rapport Therapeutics Preps IPO to Back Phase 2-Ready Epilepsy Drug appeared first on MedCity News.

Johnson & Johnson’s Proteologix acquisition adds a pipeline of bispecific antibodies, including an experimental treatment for asthma and atopic dermatitis. It’s the latest M&A deal involving molecules addressing TSLP, a key signaling protein involved in inflammation.

The post J&J Joins Chase for Hot Immunology Target With $850M Proteologix Acquisition appeared first on MedCity News.

AbbVie’s alliance with Gilgamesh Pharmaceuticals is pursuing next-generation psychiatric medications. The companies aim to bring patients drugs that offer the benefit of psychedelics but with a better side effect profile.

The post AbbVie Expands Psychiatric Drug Prospects, Inking R&D Pact With Neuroscience Startup appeared first on MedCity News.

In part 2 of our Q&A, Okamura addresses the need for biopharma companies to leverage digital technologies in disease management.

The post Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business appeared first on MedCity News.

Eli Lilly-partnered Lycia Therapeutics will use its Series C financing to continue developing its internal pipeline of protein-degrading drugs. The startup is working to reach the clinic with drugs for autoimmune and inflammatory disorders.

The post Lycia Therapeutics Lands $106M for Protein Degraders That Treat Autoimmune & Inflammatory Diseases appeared first on MedCity News.

A new startup launched at the SynBioBeta conference. The company, called CybergenX, is seeking to integrate AI-powered cybergenetic technology into the synthetic biology field. By doing this, CybergenX is seeking to accelerate the potential of engineering biology in drug manufacturing.

The post This Chip Seeks to Transform Drug Manufacturing by Learning More About Intracellular Dynamics appeared first on MedCity News.

Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. 

The post Small Thank You’s Mean a Lot: The Impact of Micropayments in Clinical Trials appeared first on MedCity News.

One irony of personalized or precision medicine (PM) is that it aims, against the advice of Hippocrates and Osler, to treat the disease, not the patient.

The post Why Personalized Medicine Should Not Be Too Personalized appeared first on MedCity News.

Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line. Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression.

The post Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression appeared first on MedCity News.