Clinical Research Informer

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

Astellas wins FDA orphan drug status for approved antifungal Cresemba

Pharmaceutical Technology

MARCH 11, 2024

Cresemba will enjoy seven years and six months of market exclusivity for the treatment of invasive aspergillosis and invasive mucormycosis.

Drugs

Drugs Marketing

The state of oligonucleotide therapeutic manufacturing: what biopharmaceutical players need to know

Pharmaceutical Technology

MARCH 11, 2024

In the genomic medicine toolbox, oligonucleotide therapeutics offer highly specific and effective treatments

Genome

Genome Genomics Manufacturing Medicine

Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis

Pharmaceutical Technology

MARCH 11, 2024

Sanofi presented the data as part of a late-breaking session at the American Academy of Dermatology (AAD) 2024 conference in San Diego, US.

Dermatology

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.

Digital transformation of the supply chain will make data more valuable – are you prepared?

Pharmaceutical Technology

FEBRUARY 22, 2024

One common factor can help make supply chains more comprehensible, resilient and valuable: data

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.

Charles River and Wheeler Bio partner on therapeutic discovery

Pharmaceutical Technology

FEBRUARY 22, 2024

Charles River has entered into a partnership with Wheeler Bio to expedite the progression from therapeutic discovery to manufacturing.

Manufacturing

Psilocybin by Filament Health for Treatment Resistant Depression: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Psilocybin is under clinical development by Filament Health and currently in Phase I for Treatment Resistant Depression.

Clinical Development

Clinical Development Development

Squaric acid dibutyl ester by Squarex Pharmaceutical for Herpes Labialis (Oral Herpes): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Squaric acid dibutyl ester is under clinical development by Squarex Pharmaceutical and currently in Phase I for Herpes Labialis (Oral Herpes).

Clinical Development

Clinical Development Development

Vorolanib by Betta Pharmaceuticals for Thymic Carcinoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Vorolanib is under clinical development by Betta Pharmaceuticals and currently in Phase II for Thymic Carcinoma.

Clinical Development

Clinical Development Development

Sarilumab by Regeneron Pharmaceuticals for Polyarticular Juvenile Idiopathic Arthritis (PJIA): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Sarilumab is under clinical development by Regeneron Pharmaceuticals and currently in Pre-Registration for Polyarticular Juvenile Idiopathic Arthritis (PJIA).

Clinical Development

Clinical Development Development

23ME610 by 23AndMe Holding for Metastatic Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

23ME610 is under clinical development by 23andMe Holding and currently in Phase II for Metastatic Renal Cell Carcinoma.

Clinical Development

Clinical Development Development

23ME610 by 23AndMe Holding for Merkel Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

23ME610 is under clinical development by 23andMe Holding and currently in Phase II for Merkel Cell Carcinoma.

Clinical Development

Clinical Development Development

Denosumab biosimilar by Lupin for Post Menopausal Osteoporosis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Denosumab biosimilar is under clinical development by Lupin and currently in Phase III for Post Menopausal Osteoporosis.

Clinical Development

Clinical Development Development

Apilimod mesylate by OrphAI Therapeutics for Amyotrophic Lateral Sclerosis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

Apilimod mesylate is under clinical development by OrphAI Therapeutics and currently in Phase II for Amyotrophic Lateral Sclerosis.

Clinical Development

Clinical Development Development

Bavarian Nordic’s revenue soars post-mpox outbreaks

Pharmaceutical Technology

FEBRUARY 21, 2024

Bavarian Nordic reported a preliminary revenue of $1bn for 2023, driven by sales of JYNNEOS, its moneypox/smallpox vaccine.

Sales

Sales Vaccination Vaccine

MHRA bans OTC sale of codeine after recreational abuse reports

Pharmaceutical Technology

FEBRUARY 21, 2024

Codeine linctus has been reclassified from a pharmacy-only medicine to a prescription-only medicine in the UK.

Sales

Sales Pharmacy Medicine

Pharmaceutical Technology

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

J&J seeks label expansion for Tremfya in ulcerative colitis

Trending Sources

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

Astellas wins FDA orphan drug status for approved antifungal Cresemba

The state of oligonucleotide therapeutic manufacturing: what biopharmaceutical players need to know

Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis

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

Digital transformation of the supply chain will make data more valuable – are you prepared?

FDA accepts Regeneron’s BLA for linvoseltamab for review

Charles River and Wheeler Bio partner on therapeutic discovery

Psilocybin by Filament Health for Treatment Resistant Depression: Likelihood of Approval

Squaric acid dibutyl ester by Squarex Pharmaceutical for Herpes Labialis (Oral Herpes): Likelihood of Approval

Vorolanib by Betta Pharmaceuticals for Thymic Carcinoma: Likelihood of Approval

Sarilumab by Regeneron Pharmaceuticals for Polyarticular Juvenile Idiopathic Arthritis (PJIA): Likelihood of Approval

23ME610 by 23AndMe Holding for Metastatic Renal Cell Carcinoma: Likelihood of Approval

23ME610 by 23AndMe Holding for Merkel Cell Carcinoma: Likelihood of Approval

Denosumab biosimilar by Lupin for Post Menopausal Osteoporosis: Likelihood of Approval

Apilimod mesylate by OrphAI Therapeutics for Amyotrophic Lateral Sclerosis: Likelihood of Approval

Bavarian Nordic’s revenue soars post-mpox outbreaks

MHRA bans OTC sale of codeine after recreational abuse reports

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