International, Licensing, Pharmacokinetics and Therapies

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. Susan Audino is ISO Assessor and Instructor, Scientific Advisor at AOAC International CASP, and Chemistry Laboratory Consultant at SA Audino & Associates, LLC. deletion syndrome. 15 References [link] [link] [link].

Clinical Trials

Clinical Trials Regulations Production FDA

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

1] [9] [10] Names Etrasimod is the international nonproprietary name. [11] “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 11] SYN ACS Med. twitter +919321316780 call whatsaapp EMAIL. 401 (10383): 1132–1133.

FDA

FDA FDA Approval International Pharmacokinetics

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA

FDA Trials Regulations Therapies

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data.

Disease

Disease Pharmacokinetics Treatment FDA

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. ” In June 2021, AbbVie Inc.

Production

Production Clinical Trials Government Disease

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA

FDA Production Licensing Licensing

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., and Canada) or (484) 365-2865 (International) five minutes prior to the start time.

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Small Molecule

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

LifeSciVC

APRIL 24, 2024

Suggested resources for this first pass genetics diligence include OMIM, GWAS Catalog, DisGeNET, OpenTargets, Genebass, and the International Mouse Phenotyping Consortium. with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)? with antibodies), or correction (e.g.,

Production

Production Small Molecule Regulations Trials

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. Elsewhere around the world: Avacta Group – U.K.-based Shanghai Haini Pharmaceutical — China’s Shanghai Haini Pharmaceutical Co.,

Licensing

Licensing Licensing Vaccine Compliance

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Vaccine

Vaccine Therapies Trials Clinical Trials

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. 50 c/mL, meeting noninferiority criteria.

FDA Approval

FDA Approval Treatment RNA FDA

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

Disease

Disease Clinical Trials Small Molecule Trials

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

The Pharma Data

NOVEMBER 26, 2020

an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Protalix has licensed to Pfizer Inc.

Disease

Disease Treatment Clinical Trials FDA

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well). We have tried to sort guidance documents by topic area. Priority B List.

FDA

FDA Science Biosimilars Production

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. Protalix has licensed to Pfizer Inc. Galactosidase-A enzyme.

Clinical Trials

Clinical Trials Disease Treatment Trials

Drug Discovery Digest

Eplontersen

Where is the promise for plant-based medicines? Part 1: Cannabis

Trending Sources

Etrasimod

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Advances in the Battle Against Autoimmune Disease

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

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