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.

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week.

The post Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause appeared first on MedCity News.

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer.

The post Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease appeared first on MedCity News.

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion.

The post Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program 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.

Novo Nordisk’s focus on diabetes and obesity shape its business development work, but the company is also exploring other areas. Top Novo Nordisk M&A executive John McDonald discussed his company’s strategy during a session at the BIO conference in San Diego.

The post At BIO, Novo Nordisk’s Top Dealmaker Talks M&A Strategy and What’s Next After GLP-1s 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.

GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.

The post GSK’s Quest to Bring Myeloma Drug Back to the Market Stops for a Data Drop at ASCO appeared first on MedCity News.

AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology.

The post At ASCO, AstraZeneca Adds Data Supporting Expanded Use of Its Drugs in Lung Cancer 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.

A group of 24 novel startups were selected to pitch at MedCity News’ INVEST conference in Chicago. Here’s four that VC judges chose as the winners in their respective tracks.

The post Here’s Why VC Judges Chose These 4 Startups as INVEST Pitch Perfect Winners 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.

Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug.

The post Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition appeared first on MedCity News.

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders.

The post Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies 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.

Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro.

The post Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro 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.

Biogen’s acquisition of Human Immunology Biosciences brings a drug candidate with potential applications in multiple immune-mediated disorders. The deal comes just prior to the scheduled presentation of clinical data in two of them.

The post Biogen Immunology Strategy Comes Into Focus With $1B HI-Bio Acquisition 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.