BioSpace

Beyond equity: Why venture debt is reshaping European biotech

Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more

The race for access: How the FAIR Act could reclaim U.S. biotech leadership

Clinical trial access in the United States faces a growing competitiveness crisis as other nations, including China, accelerate their biomedical innovation pipelines. The FAIR Act addresses this by establishing a harmonized, accelerated 30-day review pathway for clinical trials and therapies already approved by trusted...

AstraZeneca buys into Summit, UniQure drops on 4-year data, FDA on a roll

How radioligand therapy is rewriting cancer care

Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz

When vision fades: Rethinking wet AMD and the durability gap

Wet age-related macular degeneration (AMD) represents a leading cause of irreversible vision loss, characterized by the growth of abnormal blood vessels in the macula. While anti-VEGF therapies have revolutionized care by converting wet AMD back to a dry state, these treatments necessitate frequent, burdensome eye inje...

FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival

The FDA recently solidified its leadership by appointing permanent directors for CBER and CDER, aiming to restore institutional stability following recent regulatory controversies. Concurrently, the agency is prioritizing the regulation of psychedelic therapies and the reshoring of early-stage clinical trials through t...

The supply chain fault lines of modern pharma

Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease

Breaking borders: Building biotech scale in Benelux

Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals

Novartis and Bristol-Myers Squibb have paused several CAR T trials for autoimmune conditions following patient deaths and safety concerns, highlighting potential risks associated with rapid manufacturing processes. Meanwhile, the White House has expanded its Most Favored Nation drug pricing initiative to include nine m...

Fragile X at a turning point: Breaking through the clinical bottleneck

Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed

The biopharmaceutical sector faces significant shifts as companies navigate regulatory hurdles and pipeline transitions. Capricor Therapeutics received a three-month FDA review extension for its Duchenne muscular dystrophy cell therapy, deramiocel, amid intense scrutiny and shareholder demands for strategic changes. Me...

Rewriting the rules of CMV prevention

Amylyx’s redemption story, Summit’s survival woes, Definium’s anxiety win, more

The biotech industry faces a mix of clinical breakthroughs and regulatory challenges, headlined by Amylyx’s positive Phase 3 data for its GLP-1 blocker, Avexitide, which demonstrated a 55% reduction in hypoglycemic events following bariatric surgery. Conversely, Summit Therapeutics faces mounting pressure regarding its...

The Italian inflection point: Clinical strength, culture and capital

Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight

Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms

The next treatment-resistant depression paradigm

Treatment-resistant depression (TRD) stems from the inherent biological heterogeneity of major depressive disorder, rendering traditional monoaminergic therapies ineffective for a significant patient subset. Current treatment paradigms rely on repetitive, daily medication, which often fails to address the underlying co...