The Pharma Closeout | Daily Pharmaceutical & Biotech News in 15 minus

May 14, 2026 | AstraZeneca Imfinzi Phase 3 Win in Bladder Cancer; Gene Therapy Safety Overhang

10 min · 15. maj 2026
episode May 14, 2026 | AstraZeneca Imfinzi Phase 3 Win in Bladder Cancer; Gene Therapy Safety Overhang cover

Beskrivelse

AstraZeneca's VOLGA trial hits EFS and OS incisplatin-ineligible bladder cancer, putting Imfinzi squarely in Keytruda's lane. Plus: Regenxbio's Duchenne gene therapy heads for FDA filing amid safetysignals, a brain tumor linked to a viral vector raises AAV concerns, and biopharma rallies behind Richard Pazdur for FDA commissioner. Also: BMS-Hengrui$15.2B alliance, BeOne's Beqalzi challenges Venclexta, and Taiho's Inqovi expands into AML. visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, AstraZeneca, Imfinzi, durvalumab, bladder cancer, VOLGA, Merck, Keytruda, Padcev, Pfizer,Regenxbio, RGX-202, Duchenne muscular dystrophy, gene therapy, BeOne, Beqalzi, sonrotoclax, Venclexta, Taiho, Inqovi, AML, FDA commissioner, Richard Pazdur,Encoded Therapeutics, Dravet syndrome, ETX101, BMS, Hengrui, Takeda, MacroGenics, BioAge, Isomorphic Labs, Kyverna, Biogen, diranersen, Alzheimer's, ASGCT, Roche, AbbVie

Kommentarer

0

Vær den første til at kommentere

Tilmeld dig nu og bliv en del af The Pharma Closeout | Daily Pharmaceutical & Biotech News in 15 minus-fællesskabet!

Kom i gang

1 måned kun 9 kr.

Derefter 99 kr. / måned · Opsig når som helst.

  • Podcasts kun på Podimo
  • 20 lydbogstimer pr. måned
  • Gratis podcasts

Alle episoder

98 episoder

episode July 10, 2026| GSK Ends Alector Neuroscience Bet: What the $2.2B Unwind Signals cover

July 10, 2026| GSK Ends Alector Neuroscience Bet: What the $2.2B Unwind Signals

GSK walked away from its $2.2 billion Alector alliance,ending its neuroscience re-entry as clinical setbacks piled up. Plus: the FDA resumes releasing rejection letters with fourteen new CRLs, Hengrui and Elevar's PD-1 liver cancer combo is rejected a third time, Sanofi's subcutaneous Sarclisa wins approval, Pfizer/Astellas and Merck expandPadcev-Keytruda in muscle-invasive bladder cancer, Vera Therapeutics scores an IgA nephropathy nod against Otsuka, AstraZeneca and Ionis miss a Phase 3 heart trial, Apnimed files to IPO amid its sleep apnea review, and Moderna sinks in abroad biotech selloff. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, GSKAlector, immuno-neurology, Hengrui Elevar hepatocellular carcinoma, Sarclisa multiple myeloma, Apnimed IPO, Moderna biotech selloff, Padcev-Keytruda bladder cancer

I går9 min
episode July 09, 2026| Wainua Fails Pivotal ATTR-CM Trial; Ionis Sinks 20% cover

July 09, 2026| Wainua Fails Pivotal ATTR-CM Trial; Ionis Sinks 20%

AstraZeneca and Ionis's Wainua missed its Phase 3 ATTR-CMendpoint — Ionis fell ~20% while BridgeBio surged ~17%. We break down the CARDIO-T Transform failure and what it means for Alnylam's Amvuttra and BridgeBio's Attruby, plus Roche scrapping tominersen in Huntington's, GSKexiting its Alector pact, Ipsen's Dysport dual Phase 3 migraine wins, Vera Therapeutics' IgA nephropathy approval versus Otsuka, NICE rejecting Amgen'sLumakras, and Sino Biopharm's China deals with AstraZeneca and GSK. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals,eplontersen Wainua, Ionis Pharmaceuticals, AstraZeneca, BridgeBio Attruby, ATTR-CM, Ipsen Dysport migraine, Roche tominersen

10. juli 202613 min
episode July 08, 2026| FDA Halts Drug Rejection Letters — What It Means for Competitive Intel cover

July 08, 2026| FDA Halts Drug Rejection Letters — What It Means for Competitive Intel

The FDA quietly paused publishing complete response letters after a citizen petition — reversing the Makary-era transparency push and closing a live window into rival drug failures. Plus: Sino Biopharmaceutical's dual respiratory deals with AstraZeneca ($200M upfront, TQC3721 in COPD) and GSK (Trelegy and Anoro Ellipta China rights), Vera Therapeutics' Trutakna approval in IgA nephropathy, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Kailera's oral GLP-1 Phase 3 obesity data, Tampa General's 340B suit against Lilly over Mounjaro, and Biohaven's taldefgrobep push into muscle-sparing obesity. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, complete response letters, Sino Biopharmaceutical, AstraZeneca, GSK, Vera Therapeutics, IgA nephropathy, obesity

9. juli 202610 min