PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

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PharmaShots

FEBRUARY 24, 2023

Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive

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PharmaShots

JANUARY 27, 2023

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

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Chemotherapy FDA 59

pharmaphorum

AUGUST 25, 2022

The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

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pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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pharmaphorum

JANUARY 11, 2022

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Breakthrough designations can speed up the development of new therapies, making them available to patients sooner.

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pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. After EGFR therapy fails, platinum-based chemo has limited efficacy, generally preventing disease progression or death for between four and six months.

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pharmaphorum

NOVEMBER 24, 2021

Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on. Photo by thom masat on Unsplash.

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pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. That status goes to Johnson & Johnson’s Spravato (esketamine), which was approved in March 2019 and is administered as a nasal spray twice a week for four weeks.

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pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

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pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. Here we go again.

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The Checkup by Singlecare

MARCH 21, 2023

Opioids should not be used as first-line therapy for short-term or chronic pain —with the exception being in end-of-life or palliative care, during active cancer treatment, and with sickle cell disease. Belbuca is a good alternative to opioid treatment that needs to be taken around the clock, but it may come with a hefty price tag.

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The Spirit Pharmacist

DECEMBER 2, 2021

Psychedelic therapies are making headlines due to the unprecedented benefits demonstrated in clinical trials for persons with refractory mental illnesses. However, psychedelic assisted therapy is resource intensive and will likely come with a price tag putting it out of reach of many persons that could benefit from such therapies.

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Health and Personal Care Stores Insurance Coverage Insurance Patient Care 52

European Pharmaceutical Review

DECEMBER 27, 2023

Currently CAR T-cell therapy is approved for three indications: acute lymphoblastic leukaemia (ALL), non-hodgkin lymphoma (NHL), and multiple myeloma (MM) – and the strongest correlation between CAR T-cell efficacy and persistence has been demonstrated in ALL. This is variable and to some extent unpredictable.

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