The Pharma Data

JANUARY 17, 2021

Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. SHANGHAI , Jan. In addition, no evidence of nephrotoxicity was observed in the study. ” About SPR206. About Everest Medicines.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

New Drug Approvals

APRIL 19, 2025

This is then added with 10 100 equivalents of starting product (S)-(2,2-dimethyl-1,3-dioxolan-4-yl)methyl 3-(4-hydroxyphenyl)propanoate 3, preferably 20 50 equivalents, then with a polar aprotic solvent, preferably methyl tert -butyl ether (MTBE). The resulting Landiolol hydrochloride 2 has very high enantiomeric purity. 20 November 2023.

FDA 62

FDA Clinical Trials Treatment Trials 62

The Pharma Data

MARCH 22, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. said Levi Garraway, M.D.,

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs. Our experts are ready to assist you with your next adaptive oncology MRCT.

Trials 80

Trials Clinical Trials Regulations FDA 80

The Pharma Data

NOVEMBER 26, 2020

NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University. Food and Drug Administration cleared Investigational New Drug Application. BOSTON, Jan.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes. switching studies).

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

DECEMBER 29, 2020

NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A., Galactosidase-A enzyme.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

New Drug Approvals

APRIL 18, 2025

gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Prete A, Auchus RJ, Ross RJ: Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia. Eur J Endocrinol. 2021 Nov 30;186(1):R1-R14. doi: 10.1530/EJE-21-0794. 2023 Oct 30;70(10):945-957. doi: 10.1507/endocrj.EJ23-0075. Epub 2023 Jun 29.

FDA 62

FDA FDA Approval Drugs Trials 62

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

JANUARY 4, 2021

About the Innate-Sanofi agreement: The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multispecific antibody formats engaging natural killer (NK) cells to kill tumor cells and secrete cytokines through the activating receptor NKp46.

Drugs 40

Drugs Cell Biology Pharmacokinetics Clinical Trials 40

The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. COPENHAGEN, Denmark, Jan.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

OCTOBER 27, 2020

“As our core business continues to perform well, we have a solid footing to enter 2021 with several key product launches including the potential INCREASE product label expansion for Tyvaso, the Remunity Pump for Remodulin, and the Implantable System for Remodulin,” said Martine Rothblatt , Ph.D., SILVER SPRING, Md.

FDA 40

FDA Production Licensing Licensing 40

Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. 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. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. Warnings and Precautions.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease 40

Disease FDA Clinical Trials Licensing 40

New Drug Approvals

SEPTEMBER 29, 2024

gingivalis infection led to the appearance of bacterial DNA in the brain, increased brain Aβ42 production, neuroinflammation, and hippocampal degeneration. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In the same study, they show that in mice, oral P. All volunteers with AD had P.

Small Molecule 62

Small Molecule DNA Disease Trials 62

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Ricciardi M.J. Science Translational Medicine. Will Bedingfield. ” Emma Marris. (h/t

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

NOVEMBER 8, 2020

Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL.”. “We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

APRIL 14, 2021

There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Government 52

Government Hospitals Long-Term Care Facilities Treatment 52

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife.

Licensing 52

Licensing Licensing Vaccine Trials 52

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. Basis at 18; NPRM at 44,605. Basis at 24. Basis at 63-64.

Regulations 69

Regulations FDA Drugs Treatment 69

The Pharma Data

APRIL 16, 2021

For media resources, including product images and fact sheets, please click here. There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Important Information about bamlanivimab and etesevimab together. Breastfeeding.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. “Today’s approval brings hope to patients in Japan who can now access this important treatment option.”

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Breastfeeding There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. It is approved in the U.S.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MARCH 5, 2021

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. Breastfeeding. About bamlanivimab.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). For media resources, including product images and fact sheets, please click here. Breastfeeding. About bamlanivimab.

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40