Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. According to GlobalData, Phase I drugs for Gastric Cancer have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is being developed based on XmAb technology.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. According to GlobalData, Phase I drugs for Adenocarcinoma Of The Gastroesophageal Junction have an 88% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. The past few weeks have seen a flurry of companies in this space announce that they intend to go public. .

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Pharmaceutical Technology

NOVEMBER 25, 2022

The demand for PDFs of drugs spanning a broad range of therapeutic areas will likely continue to grow. But the challenges for drug producers developing PDFs are numerous and varied. But the challenges for drug producers developing PDFs are numerous and varied. PDF scale and reformulation challenge manufacturers.

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The Pharma Data

JANUARY 13, 2021

(NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. President and Chief Executive of Harpoon Therapeutics. “I

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XTalks

JUNE 14, 2023

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Attendees will understand best practices for novel drug delivery design and development. Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “The executive vice president of research and development. “We THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc.

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The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Previously, KEYTRUDA was indicated for the treatment of patients with locally advanced or mUC who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ?10),

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pharmaphorum

AUGUST 31, 2022

The treatment also has a 10-minute onset of action that, according to Future, is “demonstrably faster” than the orally-dosed active comparator (tadalafil) used in the study, and also avoids the potential side effects of oral drugs for ED, which can take 30-60 minutes to take effect.

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XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

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Delveinsight

JULY 27, 2021

Various Active Pharmaceuticals & Biotechnological Companies including Cassava Sciences, INmune Bio, Cognito Therapeutics, Cortexyme among others presented their new and upcoming drugs, therapies, shared their research studies and clinical data. An Awaited Ulcerative Colitis Phase 2 Seres Therapeutics Trial Drug Crashed Down.

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The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In July 2020, the U.S.

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The Pharma Data

JANUARY 31, 2021

Ion channels represent a large but under-exploited class of drug targets beyond G protein-coupled proteins (GPCRs). Collaboration combines Sosei Heptares’ leading structure-based drug design platform with Metrion Biosciences’ ion channel expertise. TOKYO and CAMBRIDGE, England , Feb.

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pharmaphorum

OCTOBER 30, 2019

Overview Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies). Pathways have not held up to their promise for containing cost.

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The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna. Moderna has been named a top biopharmaceutical employer by Science for the past five years.

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The Pharma Data

JANUARY 3, 2021

The strategic move to partition lung disease programs from TLC will allow TLC to maintain focus on its current pipeline of liposomal injectable formulation programs, such as TLC599 for osteoarthritis pain and TLC590 for postsurgical pain, while instilling to InspirMed funding designated for use in the development of inhalable drugs.

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FDA Law Blog

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

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Pharmaceutical Technology

JUNE 5, 2023

In results presented at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting , Summit reported an overall response rate (ORR) of 67% in NSCLC patients with squamous histology treated with its lead drug ivonescimab plus chemotherapy. The ASCO conference is being held 2–6 June in Chicago. months for the overall cohort.

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The Pharma Data

MARCH 28, 2022

Based on these results, the BIIB078 clinical development program will be discontinued, including its ongoing open-label extension study. “We Vice President and Head of the Neuromuscular Development Unit at Biogen.

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pharmaphorum

MARCH 29, 2022

Late last year, the duo revealed similarly disappointing results for the antisense ALS drug, tofersen, which failed to meet its primary objective in the Phase 3 VALOR trial. Based on the results from this study, Biogen and Ionis have confirmed that the BIIB078 clinical development programme will be discontinued.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration cleared Investigational New Drug Application. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency.

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The Pharma Data

JANUARY 27, 2021

(Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S. We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

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The Pharma Data

DECEMBER 9, 2020

Each study is designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). “As The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. About Fast Track Designation.

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The Pharma Data

DECEMBER 21, 2020

. Unique combination of novel technologies to enhance GPCR drug discovery and expand capabilities into wider drug target universe. Targeted protein degradation (TPD) is an approach whereby the body’s natural process for degrading proteins is diverted using small molecule drugs to eliminate disease-causing proteins.

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The Pharma Data

JANUARY 10, 2021

(Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S.

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Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

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The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

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The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. Knopp’s pipeline consists of investigational drug products that have not been approved by the U.S.

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Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted The information contained in this release is as of September 28, 2022.

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The Pharma Data

OCTOBER 14, 2020

is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis.

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The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. About LogicBio Therapeutics.

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