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.

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.

Singling out an industry segment won’t solve the underlying problem of healthcare costs.

The post The Senate Attacks on Pharma Put the Industry in Jeopardy and Consumers at Risk 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.

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.

Here is a selection of recent executive hires, promotions, retirements and layoffs occurring across the healthcare industry.

The post Healthcare Moves: A Monthly Summary of Hires and Layoffs 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.

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.

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.

The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented.

The post European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug 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.

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller.

The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval 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.