The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

Pharmaceutical Technology

MAY 24, 2023

The therapy has also received orphan drug and fast-track designations. It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

Drug Discovery World

AUGUST 25, 2023

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

Drugs 52

Drugs Clinical Trials Clinical Trials Trials 52

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. A summary of these new state law developments is included below.

Development 52

Development Drugs Manufacturing Pharmacy 52

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.

Clinical Trials 200

Clinical Trials Clinical Trials Pharmacy Trials 200

pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

Drugs 115

Drugs FDA Approval Trials Licensing 115

Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

Antibody 59

Antibody Drugs Licensing Licensing 59

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. billion takeover of Sativex’ developer GW Pharma earlier this year. Jazz acquired rights to Sativex when it completed its $7.2

Trials 136

Trials Drugs Licensing Licensing 136

The Pharma Data

NOVEMBER 4, 2020

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

Licensing 40

Licensing Licensing Dermatology Production 40

The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.

Licensing 52

Licensing Licensing Development Sales 52

The Pharma Data

MARCH 30, 2021

Expands Novartis Oncology radioligand pipeline with exclusive worldwide rights to develop and commercialize therapeutic applications for a library of FAP assets including FAPI-46 and FAPI-74. Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. Disclaimer.

Protein 52

Protein Licensing Licensing Containment 52

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Food and Drug Administration or any other health authority. About Omidubicel. About GDA-201.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Drug Discovery World

MAY 5, 2023

The acquisition will provide Eterna with a pipeline of allogeneic immuno-oncology products under development for the treatment of haematologic and solid tumours. Eterna plans to use Exacis’ platform to develop engineered cell therapies containing genomic edits designed to enhance their performance.

Gene Editing 52

Gene Editing Engineer DNA Life Science 52

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. . MARSEILLE, France, Jan. Cell 2019 ).

Development 52

Development Antibody Drugs Containment 52

Drug Discovery World

JULY 3, 2023

PrecisionLife and the University of Oxford have signed a data access agreement to license the Oxford Endometriosis Gene (OXEGENE) dataset to develop new personalised treatments for endometriosis patients. We hope that the analysis of our data will lead to the development of precision medicines to improve the lives of patients.”

Genetics 52

Genetics Genotype Medicine Licensing 52

The Pharma Data

DECEMBER 13, 2020

Under the collaboration, Genentech will assume development of RLY-1971 with the potential to expand into multiple combination studies including with Genentech’s investigational inhibitor of KRAS G12C, GDC-6036. RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2).

Licensing 40

Licensing Licensing Clinical Trials Clinical Trials 40

pharmaphorum

APRIL 27, 2021

The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab) – across six types of cancer.

Drugs 90

Drugs Trials FDA Approval Marketing 90

Druggist

JULY 22, 2020

Promethazine: effect on the body Promethazine belongs to a group of drugs called antihistamines. All products listed above are licensed as pharmacy only medicines – ‘P’ products. How much promethazine is contained in Nigh Nurse liquid? Each 20ml of Nigh Nurse contains 20mg of promethazine.

Nurses 52

Nurses Pharmacy Containment Licensing 52

The Pharma Data

AUGUST 17, 2020

Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly received U.S. About Bristol Myers Squibb.

Licensing 52

Licensing Licensing Development Production 52

FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

Production 59

Production Bioequivalency Drugs Containment 59

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Antibody 40

Antibody Development Licensing Licensing 40

The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer. “In

Development 52

Development Clinical Trials Clinical Trials Trials 52

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

Drug Discovery World

AUGUST 9, 2023

The company’s collaboration partner, Cancer Research UK’s Centre for Drug Development, has sponsored and will conduct the Phase I/II clinical trial. ” CD19-directed CAR T therapies Aleta’s lead development programme, ALETA-001, contains the CD19 target protein which is further linked to an CD20 antibody domain.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

World of DTC Marketing

MAY 24, 2022

To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs. Do online mental health apps work? Mental wellness apps are basically the Wild West of therapy.

Licensing 252

Licensing Licensing Scientist Production 252

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

Drugs 40

Drugs Clinical Trials Clinical Trials Trials 40

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Chief Executive Officer of Biohaven, said: “We are excited to enter into this agreement with Sosei Heptares, a world leader in GPCR drug discovery.

Licensing 40

Licensing Licensing Production Development 40

pharmaphorum

JANUARY 20, 2022

The Swiss subsidiary of Glenmark Pharmaceuticals and Lotus International have signed a licensing agreement whereby Glenmark will handle the manufacture and supply of Ryaltris and Lotus will take charge of commercialising the drug, subject to approval. with allergic rhinitis.

Allergies 72

Allergies Marketing Manufacturing Production 72

Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Medicine 52

Medicine FDA Approval Licensing Licensing 52

The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. NEW YORK , Jan. 27, 2021 /PRNewswire/ — Q Biomed Inc.

Drugs 40

Drugs Containment Production Marketing 40

Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. drug pricing, reimbursement, and dispensing system. d/b/a Drug Channels Institute. The 2022 Economic Report on U.S.

Pharmacy 98

Pharmacy Drugs Marketing Licensing 98

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. In this sort of research, scientists try to reproduce the disease in animals and then test new drugs on these animals.

Medicine 59

Medicine Genome Genomics Drugs 59

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. Food and Drug Administration (“FDA”) approval.

Drugs 52

Drugs Containment Development Sales 52

The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development 75

Development Regulation Medicine Containment 75

The Pharma Data

JANUARY 18, 2021

Experienced executive development team from Gilead Sciences. a clinical-stage biotechnology company focused on developing treatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP. SOUTH SAN FRANCISCO, Calif. ,

Development 52

Development Life Science Protein Clinical Development 52