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.

The voluntary removal of ALS drug Relyvrio from the market comes with a corporate restructuring that turns Amylyx Pharmaceuticals’ focus to other neurodegenerative diseases. But the company also has another ALS drug candidate set to begin clinical testing this year.

The post Amylyx Withdraws ALS Drug From Market; Restructuring Will Slash 70% of Staff appeared first on MedCity News.

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein.

The post Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells appeared first on MedCity News.

Amylyx Pharmaceuticals co-CEO Justin Klee previously said the company would withdraw ALS drug Relyvrio from the market if it failed its Phase 3 clinical trial. The biotech has set an eight-week timeline to evaluate its next steps.

The post After ALS Drug Fails in Phase 3, Amylyx Weighs Pulling the Product From Market appeared first on MedCity News.

FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets.

The post Cancer Biotech Lands $145M for First-in-Class Drug to Block Elusive Tumor Target appeared first on MedCity News.

Evelo Biosciences’ vision of using microbes to engage the gut and modulate immune responses remains unrealized. With financing prospects dim and no one willing to take on its assets, Evelo is dissolving its business.

The post Evelo Bio Shutdown Follows a Series of Microbiome Therapy Trial Failures appeared first on MedCity News.

Theseus Pharmaceuticals discontinued its former lead program in July following the report of dose-limiting toxicities in two patients. Though Theseus has other assets in its pipeline, it has decided to explore strategic alternatives with the goal of “maximizing shareholder value.”

The post Theseus Pharma Lays Off Staff, Explores Options Months After Toxicity Scuttles Lead Drug appeared first on MedCity News.

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease. Analysts say prospects of the therapy, Elevidys, rest on FDA willingness to exercise flexibility it has already shown to rare disease drugmakers, including Sarepta.

The post Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility appeared first on MedCity News.

Sickle cell disease is among the Beam Therapeutics programs spared, and here the company needs to show differentiation from genetic medicines under FDA review from Vertex Pharmaceuticals and Bluebird Bio. Meanwhile, Beam aims to find partners for its research in allogeneic cancer cell therapies and hepatitis B.

The post Base-Editing Biotech Beam Restructures, Narrowing Pipeline & Cutting 20% of Staff appeared first on MedCity News.

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.

The post FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder appeared first on MedCity News.

Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.

The post Moderna Puts Up $120M to Start Cancer Drug R&D Alliance With Immatics appeared first on MedCity News.

Flagship Pioneering-founded Alltrna is developing tRNA therapies to address genetic diseases driven by truncated versions of proteins. By addressing an aberrant genetic instruction underpinning many diseases, the startup is developing what it describes as a potential “universal solution.”

The post Alltrna Unveils $109M to Make tRNA a Universal Therapy for Genetic Diseases appeared first on MedCity News.

Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.

The post Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression appeared first on MedCity News.

Biogen’s Reata Pharmaceuticals acquisition brings Skyclarys, the first and only FDA-approved therapy for the rare neuromuscular disease Friedreich’s ataxia. Biogen says Skyclarys complements the other neuromuscular drugs in its portfolio.

The post Biogen Bulks Up in Rare Disease With $7.3B Reata Pharmaceuticals Acquisition appeared first on MedCity News.

Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal.

The post Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug appeared first on MedCity News.

Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations.

The post Pfizer, Flagship Team Up in $100M R&D Pact: 10 New Drugs for Unmet Needs appeared first on MedCity News.

Eli Lilly is expanding its diabetes prospects by acquiring cell therapy developer Sigilon Therapeutics. The two companies are already partners in the development of a type 1 diabetes cell therapy currently in preclinical development.

The post Eli Lilly to Buy Sigilon, Betting the Biotech Can Overcome a Cell Therapy Limitation appeared first on MedCity News.

Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.

The post FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy appeared first on MedCity News.

Scientists at Empress Therapeutics say molecules that co-evolved with humans over millennia are a promising source of new drugs. With its AI-driven technology platform, the Flagship Pioneering-founded startup finds them.

The post Flagship Startup Emerges to Find Drugs in Promising Hunting Ground—Our Bodies appeared first on MedCity News.

Massachusetts Institute of Technology Bioengineering Professor Ram Sasisekharan and his lab have been cleared of research misconduct allegations following a lengthy university investigation.

The post MIT Clears Bioengineering Professor of Research Misconduct Allegations appeared first on MedCity News.

For the second time in three months, Mersana Therapeutics is dealing with an FDA clinical hold. The partial hold on tests of its experimental ovarian cancer drug follows a full hold placed on an early-stage test of a different Mersana therapy in various types of solid tumors.

The post Bleeding Problems Prompt FDA Partial Hold on Tests of Mersana Cancer Drug appeared first on MedCity News.

2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.

The post Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia appeared first on MedCity News.

Metaphore Biotechnologies leverages the concept of biomimicry for developing new drugs with potential applications in autoimmune diseases, metabolic disorders, and cancer. Flagship Pioneering is backing the startup with $50 million.

The post New Flagship Startup Metaphore Mimics Mother Nature for Drug R&D appeared first on MedCity News.

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy.

The post Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy appeared first on MedCity News.

ARCH Venture Partners-backed Orbital Therapeutics’ is researching next-generation RNA medicines that offer advantages over currently available therapies. The startup’s three areas of focus are vaccines, protein replacement, and immunomodulation.

The post Orbital Therapeutics Raises $270M to Bring RNA-Based Medicines to New Heights appeared first on MedCity News.

The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS.

The post Biogen Drug Wins Accelerated FDA Nod for Treating Rare Genetic Form of ALS appeared first on MedCity News.

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

The post Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold appeared first on MedCity News.

Novartis is partnering with Bicycle Therapeutics to see if the biotech’s technology can be used to develop better, more targeted radiopharmaceuticals. The deal covers two targets that were not disclosed.

The post Novartis Puts Up $50M to Steer Bicycle Therapeutics’ Tech Into New Cancer Meds appeared first on MedCity News.

Alzheimer’s disease research at MIT spawned Cognito Therapeutics, a startup whose medical device uses light and sound to modulate electrical activity that supports brain health. The company’s Series B financing will support a Phase 3 test of its technology in patients with mild-to-moderate disease.

The post Neuro Startup Cognito Corrals $73M as Alzheimer’s Device Commences Key Test appeared first on MedCity News.

Ampersand Biomedicines emerged from stealth with technology for site-specific drug delivery that avoids toxic effects throughout the body. The Flagship Pioneering-founded startup is backed by $50 million in financing.

The post Flagship Startup Emerges With $50M to Send Drugs to the Right Biologic Address appeared first on MedCity News.