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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

Avita Recell device

Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

June 21, 2023
By Tamra Sami
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
Read More
Coin inserted into Australian map
Newco news

Argenica raises AU$4M to advance neuroprotective agent in ischemic stroke

June 20, 2023
By Tamra Sami
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
Read More
Squamous cell carcinoma.

Sirnaomics advances siRNA skin cancer candidate to late-stage trials

June 20, 2023
By Tamra Sami
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Read More
Coin inserted into Australian map
Newco news

Argenica raises AU$4M to advance neuroprotective agent in ischemic stroke

June 19, 2023
By Tamra Sami
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
Read More
Yen-Yuan symbols

Cellusion raises ¥2.83B series C round to progress iPS cell-derived corneal substitute

June 13, 2023
By Tamra Sami
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy.
Read More
Tracey Duffy speaking at podium

Consumer and industry engagement guide Australia’s device reforms

June 8, 2023
By Tamra Sami
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
Read More
Yen-Yuan symbols

Cellusion raises ¥2.83B series C round to progress iPS cell-derived corneal substitute

June 7, 2023
By Tamra Sami
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy.
Read More
Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 6, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Read More
Australian coins and bills

Immutep to raise AU$80M to advance LAG-3 immunotherapy pipeline

June 6, 2023
By Tamra Sami
Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer.
Read More
William Cao, founder and CEO, Gracell Biotechnologies

Gracell enters autoimmune space with its dual-targeting CAR T

June 6, 2023
By Tamra Sami
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T. 
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View All Articles by Tamra Sami

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