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Operation Warp Speed’s top doctor says coronavirus vaccine likely won’t be approved until after November

The Pharma Data

Dr Moncef Slaoui, the leading doctor involved with Operation Warp Speed, has said it is unlikely a vaccine for the US will be ready by November. . Vaccines usually are in trial for years, so getting an effective treatment out by mid-2021 will break most norms of vaccine development. Air Force photo/Senior Airman Areca T.

Doctors 52
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine

The Pharma Data

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

Trials 52
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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog: Drug Discovery

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Scaling Phage Therapy

Codon

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 125
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Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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Researchers identify cheap and effective biomarkers for DCIS tumor stage

Broad Institute

While doctors generally recommend treatment, they lack the appropriate evidence to reliably decide which tumor will remain benign and which might turn into a life-threatening invasive ductal carcinoma (IDC), resulting in high rates of overtreatment. Adapted from a story published by the Eric and Wendy Schmidt Center.