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 (..)

Diabetes 40

Diabetes Biosimilars 40

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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Labelling 40

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: (..)

Biosimilars 40

Biosimilars 40

PharmaShots

JUNE 9, 2023

Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules Astellas and the (..)

Biosimilars 40

Biosimilars Diabetes 40

PharmaShots

APRIL 28, 2023

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

Diabetes 56

Diabetes Biosimilars 56

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

Biosimilars 40

Biosimilars Labelling Diabetes 40

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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Chemotherapy Biosimilars Immunity Immunization 40

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 (..)

Diabetes 40

Diabetes Biosimilars 40

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 (..)

Biosimilars 40

Biosimilars 40

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 (..)

Biosimilars 40

Biosimilars 40

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, (..)

Medical Schools 40

Medical Schools Biosimilars Immunity Immunization 40

PharmaShots

MARCH 31, 2023

PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular (..)

Diabetes 40

Diabetes 40

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 (..)

Diabetes 40

Diabetes Immunity Immunization Biosimilars 40

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 (..)

Biosimilars 40

Biosimilars 40

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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Vaccines Diabetes 40

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 (..)

Biosimilars 40

Biosimilars Vaccines 40

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, (..)

Diabetes 40

Diabetes Immunity Immunization 40

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 (..)

Biosimilars 40

Biosimilars Diabetes Labelling 40

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. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

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RX Note

JUNE 11, 2023

Certain lesions, such as nevi, milia, dermatofibroma, skin tags, pyogenic granuloma, keratosis pilaris, syringoma are more common in children and younger adults. Skin Tag Acrochordons, commonly known as skin tags, are an outgrowth of normal skins (soft and fleshy).

Diabetes 52

Diabetes Community Pharmacies 52

pharmaphorum

JANUARY 5, 2022

Teliso-V is currently in a 233-patient phase 2 study (LUMINOSITY) involving subjects with c-Met-positive, non-squamous NSCLC as a second- or third-line treatment after chemotherapy, immunotherapy with checkpoint inhibitors or drugs targeted at specific mutations. Preliminary results from that study showed a 53.8%

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Chemotherapy 111

European Pharmaceutical Review

JUNE 8, 2023

A study has reported for the first time, an innovative downstream method for mannosylerythritol lipids (MELs), were separated from the crude MEL mixture in a first stage with the other lipid derivatives (free fatty acids, mono- and diacylglycerols) removed by organic solvent nanofiltration (OSN). percent of MELs lost in the first filtration.

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pharmaphorum

AUGUST 25, 2022

Tecvayli’s approval is based on the results of the phase 1b MajesTEC-1 study which found that after the bispecific antibody achieved an overall response rate of 63% at the recommended dose of 1.5 Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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Immunity Immunization 98

European Pharmaceutical Review

MARCH 1, 2023

In a recent study, Massachusetts Institute of Technology (MIT) researchers developed a new purification method to cut the costs of manufacturing protein drugs. The researchers demonstrated their method with lysozyme, an enzyme whose crystallisation properties have been well studied, and insulin.

Vaccines 93

Vaccines 93

Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. was observed in the study. Bimagrumab is of interest in the obesity space as it is a first-in-class therapy for obesity.

Diabetes 52

Diabetes Hospitals 52

Pharmaceutical Technology

NOVEMBER 9, 2022

In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. million price tag. In the Gener8-1 Roctavian study , the modified intent-to-treat (mITT) population had a mean factor VIII activity of 42.8

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Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

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pharmaphorum

JANUARY 24, 2022

IBM said the sell-off is tagged as “a clear next step” as it focuses on its platform-based hybrid cloud and artificial intelligence strategy, but it’s no secret that Watson Health has failed to live up to its early promise.

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Cerner 111

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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pharmaphorum

JANUARY 18, 2022

The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.

Immunity 52

Immunity Immunization Drug Development 52

pharmaphorum

NOVEMBER 24, 2022

Yesterday, the drugmaker added to the evidence behind Spravato – an intranasal formulation of esketamine – with the release of top-line data from a head-to-head study with a long-acting formulation of the antipsychotic quetiapine, which is also used to treat TRD. and 17.6%, respectively, according to J&J’s pharma unit Janssen.

Labelling 52

Labelling Hospitals 52

pharmaphorum

JANUARY 11, 2022

He is the principal investigator for a clinical study that will evaluate the impact of BNT200 on quality of life, mood, and symptoms of patients diagnosed with AML. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. Other DTxs are aimed at people being treated for breast and lung cancers.

Chemotherapy 64

Chemotherapy Hospitals 64

pharmaphorum

APRIL 27, 2022

Enhertu is already approved as a third-line therapy for HER2-positive metastatic breast cancer and a second-line therapy for HER2-positive metastatic gastric cancer, and recent data from the DESTINY-Breast03 study looks set to expand its use into second-line treatment in breast cancer.

Chemotherapy 59

Chemotherapy 59

pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder.

Immunity 52

Immunity Immunization Labelling 52

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.

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Hospitals Documentation 111

pharmaphorum

JULY 25, 2022

J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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pharmaphorum

JUNE 8, 2021

Instead, the FDA granted Aduhelm a conditional approval, allowing it to be prescribed and used while Biogen conducts a post-marketing, phase 4 confirmatory study – which could take years to complete. Phase 4 studies typically require less onerous protocols than phase 3 – for example they can use real-world evidence.

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