PharmaShots

MAY 5, 2023

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease Date: May 05, 2023 | Tags: Chiesi Global Rare Diseases, Protalix BioTherapeutics, PRX-102, pegunigalsidase alfa, Fabry Disease, Regulatory, EC, Marketing Authorization Kinoxis Therapeutics (..)

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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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PharmaShots

JUNE 23, 2023

Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)

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PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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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

APRIL 14, 2023

Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)

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PharmaShots

MAY 26, 2023

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

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PharmaShots

APRIL 21, 2023

Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)

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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

FEBRUARY 17, 2023

Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of (..)

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PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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PharmaShots

JUNE 16, 2023

Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B

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PharmaShots

MARCH 17, 2023

5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted

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PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

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PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

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pharmaphorum

DECEMBER 23, 2021

AZ has already licensed rights to HER2-targeting drug Enhertu (trastuzumab deruxtecan) – which is already on the market for HER2-positive breast and gastric cancers – as well as investigational TROP2 ADC datopotamab deruxtecan in two multibillion-dollar deals. Daiichi Sankyo and AZ are close collaborators in the ADC arena.

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Pharmaceutical Technology

NOVEMBER 9, 2022

CSL Behring has a commercialisation and license agreement to develop EtranaDez. million price tag. The post Can gene therapies for haemophilia defend their high price tags? A fair price for CSL Behring’s haemophilia B treatment etranacogene dezaparvovec would be between $2.93–2.96 million ($1.8 million at the time).

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pharmaphorum

APRIL 27, 2022

billion upfront to license rights to the drug in a deal that could be worth up to $6.9 The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

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pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion in sales in 2028.

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Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. While Vertex and CRISPR submitted the Biologics License Application (BLA) for exa-cel earlier this April, bluebird has yet to do so for lovo-cel.

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pharmaphorum

MAY 10, 2022

The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA could result in an approval before the end of the year.

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Druggist

OCTOBER 25, 2020

Nevertheless, calamine lotion is licensed in the UK for symptomatic relief of skin conditions including itchiness. Both products have the same licensed use: symptomatic relief of mild sunburn and relief from other skin conditions. Liquid antihistamine – chlorphenamine (Piriton syrup) is licensed for this indication.

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Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Already a big player in haemophilia treatments, CSL licensed exclusive global rights to Hemgenix from gene therapy developers uniQure back in 2021.

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PharmaShots

MARCH 10, 2023

Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, (..)

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The Physician Pharmacist

SEPTEMBER 14, 2023

Hosted by licensed pharmacist and now 4th-year medical student Nathan Gartland, this podcast explores the unique pathway of combining pharmacy and medicine. I'm a licensed pharmacist and second year medical student. ️ Podcasts are a great way to learn about a variety of topics, and The Physician Pharmacist Podcast is no exception.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. As alleged by Gilead’s complaint , filed in the Eastern District of New York, licensed U.S. We purchased our products only from state-licensed suppliers who went through an extensive vendor vetting process.”.

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