Clinical Research Informer

Donanemab: FDA AdCom will put spotlight on tau enrolment and ARIA concerns

Pharmaceutical Technology

MARCH 21, 2024

Lilly says that the FDA wants to look closer at efficacy implications of the Phase III donanemab trial design before giving the green light.

Trials

Merck to invest €300m in South Korean bioprocessing centre

Pharmaceutical Technology

MARCH 21, 2024

Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.

Production

Delivery tech remains challenging with gene therapies for brain disorders

Pharmaceutical Technology

MARCH 21, 2024

Biotech executives discuss why developing gene therapies for central nervous system disorders remains difficult at a recent conference.

Gene Therapy

Gene Therapy Gene Development

Delivery and manufacturing hurdles remain in the cell and gene therapy

Pharmaceutical Technology

MARCH 21, 2024

Panellists discuss opportunities and challenges in cell and gene therapies at the Advanced Therapies conference in London, UK.

Gene Therapy

Gene Therapy Gene Manufacturing

Capstan secures $175m Series B funds for CAR-T therapy

Pharmaceutical Technology

MARCH 21, 2024

Capstan Therapeutics has secured $175m Series B financing to advance its lead in vivo CAR-T candidate, CPTX2309, for autoimmune disorders.

In-Vivo

BMS’ cell therapy Abecma gains EC approval for multiple myeloma

Pharmaceutical Technology

MARCH 21, 2024

The EC has approved BMS' Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed and refractory multiple myeloma (RRMM).

Automation, risk management, and the manufacture of medical devices

Pharmaceutical Technology

MARCH 13, 2024

As the demand for medical devices continues to rise, manufacturers are increasingly turning to automation during the assembly process to get their products to market faster. But how can the risks involved be mitigated?

Manufacturing

Manufacturing Production Marketing

Quality versus quantity in T-cell production: Why it doesn’t have to be a trade-off

Pharmaceutical Technology

MARCH 13, 2024

In T-cell manufacturing, the historical issue of maintaining the quality of materials when scaling up production is changing.

Production

Production Manufacturing

Lamassu Bio secures US NIH grant for sarcoma treatment

Pharmaceutical Technology

MARCH 13, 2024

Lamassu Bio has received a $2.05m grant from the US National Institutes of Health (NIH) and National Cancer Institute (NCI) for the development of SA53, a new therapeutic for p53 wild-type sarcomas.

Development

Allumiqs and Prolytix collaborate for drug discovery

Pharmaceutical Technology

MARCH 13, 2024

Allumiqs has entered into a long-term strategic collaboration with Prolytix to expedite the discovery and development of new drugs.

Drugs

Drugs Development

Pearl Bio and Merck partner for discovery of cancer therapies

Pharmaceutical Technology

MARCH 13, 2024

Pearl Bio has signed an agreement with Merck for the discovery of biologics that incorporate non-standard amino acids to treat cancer.

Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

MARCH 13, 2024

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

Production

Production Drugs

Tierra raises $11.4 in Series A round for predictive AI protein maker

Pharmaceutical Technology

MARCH 12, 2024

The US company is part of a burgeoning artificial intelligence (AI) market in early-stage drug development.

Protein

Protein Marketing Development Drugs

J&J seeks label expansion for Tremfya in ulcerative colitis

Pharmaceutical Technology

MARCH 12, 2024

Johnson & Johnson’s Tremfya is approved for plaque psoriasis and active psoriatic arthritis, with a label for ulcerative colitis now on the horizon.

Jaguar Health balances ambitions for human and animal pharmaceuticals

Pharmaceutical Technology

MARCH 12, 2024

In an exclusive interview, Jaguar Health’s CEO discussed plans for the investigation of crofelemer in human and animal studies.

Enanta Pharmaceuticals files patent for 17ß-HSD13 inhibitors for treating metabolic disease

Pharmaceutical Technology

MARCH 12, 2024

Discover Enanta Pharmaceuticals' groundbreaking patent for Formula (I) compounds as 17ß-HSD13 inhibitors, targeting metabolic diseases and liver conditions. Learn about the potential therapeutic applications and pharmaceutical compositions covered in the patent application.

Bayer files patent for method for screening chemical substances using plant material

Pharmaceutical Technology

MARCH 12, 2024

Discover Bayer AG's innovative patent for screening chemical substances using plant material. Learn about the process involving phenotypical characteristics, site of action, and sensor technology. Publication Number: US20240036034A1.

Bristol-Myers Squibb files patent for inhibitors of KRAS G12d

Pharmaceutical Technology

MARCH 12, 2024

Discover Bristol-Myers Squibb's groundbreaking patent for compounds inhibiting KRas G12D activity, offering hope for treating various cancers. Explore the potential therapeutic applications and dosages outlined in the patent application.

AbbVie files patent for treatment of rheumatoid arthritis with specific pharmaceutical composition

Pharmaceutical Technology

MARCH 12, 2024

Discover AbbVie Inc.'s innovative patent for an extended-release tablet to treat rheumatoid arthritis. Learn about the specific compound and unique features of this groundbreaking pharmaceutical product.

Production

Dr. Reddy’s Laboratories files patent for 6-substituted pyridazine compounds for treating diseases dependent on SMARCA2/SMARCA4

Pharmaceutical Technology

MARCH 12, 2024

Discover how Dr. Reddy's patent for innovative pyridazine compounds offers promising treatments for diseases dependent on SMARCA2 and SMARCA4 proteins, including various cancers. Explore detailed chemical structures and potential therapeutic benefits.

Protein

AstraZeneca files patent for improved production of aav vectors using specific plasmid sequence

Pharmaceutical Technology

MARCH 12, 2024

Discover how AstraZeneca's new patent revolutionizes AAV vector production with specific polynucleotide sequences, excluding cap genes.

Production

Production Gene

Zealand Pharma files patent for pharmaceutical composition with GLP-1/GLP-2 dual agonist and preservatives

Pharmaceutical Technology

MARCH 12, 2024

Discover Zealand Pharma's innovative patent for GLP-1/GLP-2 dual agonist compositions with specific preservatives. Learn about the unique formula and formulation details for this groundbreaking pharmaceutical composition.

Selecta Biosciences files patent for enhanced gene therapy using viral vectors and immunosuppressants

Pharmaceutical Technology

MARCH 12, 2024

Enhance gene expression and reduce immune responses with Selecta Biosciences' patented method using viral vectors and nanocarriers attached to immunosuppressants. Learn more about this innovative approach for improved therapeutic outcomes.

Gene Expression

Gene Expression Gene Gene Therapy Immune Response

Terns scores FDA orphan designation for CML therapy

Pharmaceutical Technology

MARCH 12, 2024

TERN-701 is a BCR-ABL tyrosine-kinase inhibitor being studied in a Phase I study, with data expected in H2 this year.

Indena’s CDMO services: Full manufacturing capabilities for pharma ingredients

Pharmaceutical Technology

MARCH 12, 2024

In a challenging CDMO framework, Indena has acquired the experience and the equipment to handle high potent NCEs and commercial…

Manufacturing

AD/PD 2024: Eli Lilly’s donanemab hit with FDA delay

Pharmaceutical Technology

MARCH 11, 2024

The FDA is still likely to approve donanemab, however, the delay will benefit Eisai and Biogen in allowing Leqembi to gain greater traction in the Alzheimer's market.

Marketing

The key products you need to trust your host-cell protein analysis and other process related impurity results

Pharmaceutical Technology

MARCH 11, 2024

Market-leading HCP analysis, as well as other process-related impurity analysis, is becoming smoother

Protein

Protein Production Marketing

AD/PD 2024: BioVie’s novel NE3107 shows promise but confirmatory trial needed

Pharmaceutical Technology

MARCH 11, 2024

However, a significant limitation of the early data is that the majority of trial participants were excluded from the analysis following GCP violations at multiple trial sites.

Trials

Mesoblast eyes accelerated approval filing for heart failure cell therapy

Pharmaceutical Technology

MARCH 11, 2024

The race for the first FDA-approved cell therapy for patients with heart failure heats up.

FDA Approval

Novo expands Wegovy’s US label to reduce cardiovascular events

Pharmaceutical Technology

MARCH 11, 2024

Wegovy can now be used to reduce the risk of major cardiovascular events in obese or overweight patients with heart disease.

Decibel Therapeutics files patent for cell lines expressing crispr sam complex for gene activation

Pharmaceutical Technology

MARCH 11, 2024

Discover the groundbreaking patent by Decibel Therapeutics Inc. for CRISPR SAM complex cell lines targeting specific genes. Learn about methods to measure vector efficiency and the potential applications of this innovative technology.

Gene

Codiak BioSciences files patent for extracellular vesicles for repolarizing macrophages in cancer treatment

Pharmaceutical Technology

MARCH 11, 2024

Transform cancer treatment with Codiak BioSciences' patent on extracellular vesicles targeting tumor-associated macrophages. Learn how immunomodulating components repolarize macrophages for enhanced therapy.

Ovid Therapeutics files patent for cancer treatment using (s)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid

Pharmaceutical Technology

MARCH 11, 2024

Discover how Ovid Therapeutics Inc. is revolutionizing cancer treatment with a patented method using (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid to inhibit proliferation and metastasis.

4D Molecular Therapeutics files patent for gene therapy for fabry disease using optimized alpha-galactosidase a sequence

Pharmaceutical Technology

MARCH 11, 2024

Discover how 4D Molecular Therapeutics Inc. is revolutionizing gene therapy with a patent for delivering nucleic acids to treat disorders like Fabry disease.

Gene Therapy

Gene Therapy Gene

Spruce Biosciences files patent for treatment of congenital adrenal hyperplasia using CRF1 receptor antagonist

Pharmaceutical Technology

MARCH 11, 2024

Discover Spruce Biosciences' innovative patent for treating Congenital adrenal hyperplasia (CAH) with a unique pharmaceutical composition. Reduce hormone levels effectively with CRF1 receptor antagonists and lower doses of glucocorticoids.

Hormones

Revolution Medicines files patent for inhibiting RAS proteins for cancer treatment

Pharmaceutical Technology

MARCH 11, 2024

Discover how Revolution Medicines Inc. is revolutionizing cancer treatment with their patented macrocyclic compounds targeting Ras proteins. Learn more about their potential impact on various types of cancer and Ras mutations.

Protein

Protein Medicine

Affimed files patent for trispecific antibody construct for targeting immune effector and target cells

Pharmaceutical Technology

MARCH 11, 2024

Discover the groundbreaking trispecific antibody construct patent by Affimed NV targeting CD16A, various antigens, and target cell antigens. Revolutionizing therapy for diseases with lower fratricide levels.

Antibody

Biora Therapeutics files patent for ingestible device for delivering therapeutic agents

Pharmaceutical Technology

MARCH 11, 2024

Discover the groundbreaking patent by Biora Therapeutics Inc. for ingestible devices revolutionizing drug delivery with precision and efficiency. Explore the innovative technology now!

Drug Delivery

Drug Delivery Drugs

Intellia Therapeutics files patent for genetic modification to reduce HLA-a protein expression in cells

Pharmaceutical Technology

MARCH 11, 2024

Discover how Intellia Therapeutics Inc. is revolutionizing adoptive cell transfer therapies with patented methods to reduce HLA-A protein expression in engineered human cells. Explore the potential for treating cancer, infectious diseases, and autoimmune disorders.

Protein

Protein Genetics Engineer

Eagle Pharmaceuticals files patent for stable pemetrexed formulations for cancer treatment

Pharmaceutical Technology

MARCH 11, 2024

Discover Eagle Pharmaceuticals Inc.'s innovative patent for stable pemetrexed formulations, offering effective treatment for pleural mesothelioma and non-squamous lung cancer. Learn about the unique composition and storage options designed for patient convenience and efficacy.

Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study

Pharmaceutical Technology

FEBRUARY 22, 2024

US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.

Ono Pharmaceutical partners with EME for antibody drug discovery

Pharmaceutical Technology

FEBRUARY 22, 2024

Ono Pharmaceutical has partnered with EME to advance the drug discovery of VHH antibodies to develop new therapeutic agents.

Antibody

Antibody Drugs Development

MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease

Pharmaceutical Technology

FEBRUARY 22, 2024

The UK MHRA has revoked a conditional marketing authorisation for Novartis' Adakveo 10mg/ml to treat sickle cell disease patients.

Marketing

FDA accepts Regeneron’s BLA for linvoseltamab for review

Pharmaceutical Technology

FEBRUARY 22, 2024

The FDA has accepted Regeneron’s biologics licence application (BLA) for linvoseltamab to treat multiple myeloma for priority review.

Pharmaceutical Technology

Donanemab: FDA AdCom will put spotlight on tau enrolment and ARIA concerns

Merck to invest €300m in South Korean bioprocessing centre

Trending Sources

Delivery tech remains challenging with gene therapies for brain disorders

Delivery and manufacturing hurdles remain in the cell and gene therapy

Capstan secures $175m Series B funds for CAR-T therapy

BMS’ cell therapy Abecma gains EC approval for multiple myeloma

Automation, risk management, and the manufacture of medical devices

Quality versus quantity in T-cell production: Why it doesn’t have to be a trade-off

Lamassu Bio secures US NIH grant for sarcoma treatment

Allumiqs and Prolytix collaborate for drug discovery

Pearl Bio and Merck partner for discovery of cancer therapies

Bright Green invests $250m to expand facility in New Mexico, US

Tierra raises $11.4 in Series A round for predictive AI protein maker

J&J seeks label expansion for Tremfya in ulcerative colitis

Jaguar Health balances ambitions for human and animal pharmaceuticals

Enanta Pharmaceuticals files patent for 17ß-HSD13 inhibitors for treating metabolic disease

Bayer files patent for method for screening chemical substances using plant material

Bristol-Myers Squibb files patent for inhibitors of KRAS G12d

AbbVie files patent for treatment of rheumatoid arthritis with specific pharmaceutical composition

Dr. Reddy’s Laboratories files patent for 6-substituted pyridazine compounds for treating diseases dependent on SMARCA2/SMARCA4

AstraZeneca files patent for improved production of aav vectors using specific plasmid sequence

Zealand Pharma files patent for pharmaceutical composition with GLP-1/GLP-2 dual agonist and preservatives

Selecta Biosciences files patent for enhanced gene therapy using viral vectors and immunosuppressants

Terns scores FDA orphan designation for CML therapy

Indena’s CDMO services: Full manufacturing capabilities for pharma ingredients

AD/PD 2024: Eli Lilly’s donanemab hit with FDA delay

The key products you need to trust your host-cell protein analysis and other process related impurity results

AD/PD 2024: BioVie’s novel NE3107 shows promise but confirmatory trial needed

Mesoblast eyes accelerated approval filing for heart failure cell therapy

Novo expands Wegovy’s US label to reduce cardiovascular events

Decibel Therapeutics files patent for cell lines expressing crispr sam complex for gene activation

Codiak BioSciences files patent for extracellular vesicles for repolarizing macrophages in cancer treatment

Ovid Therapeutics files patent for cancer treatment using (s)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid

4D Molecular Therapeutics files patent for gene therapy for fabry disease using optimized alpha-galactosidase a sequence

Spruce Biosciences files patent for treatment of congenital adrenal hyperplasia using CRF1 receptor antagonist

Revolution Medicines files patent for inhibiting RAS proteins for cancer treatment

Affimed files patent for trispecific antibody construct for targeting immune effector and target cells

Biora Therapeutics files patent for ingestible device for delivering therapeutic agents

Intellia Therapeutics files patent for genetic modification to reduce HLA-a protein expression in cells

Eagle Pharmaceuticals files patent for stable pemetrexed formulations for cancer treatment

Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study

Ono Pharmaceutical partners with EME for antibody drug discovery

MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease

FDA accepts Regeneron’s BLA for linvoseltamab for review

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