Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex. All key questions to consider and address before the therapy even leaves the lab.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

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The Pharma Data

SEPTEMBER 6, 2021

In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. These results will guide us to advance our clinical development strategy of eliapixant.”.

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The Pharma Data

APRIL 28, 2022

Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from daily insulin. events per patient year exposed to once-weekly insulin icodec and 0.27

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Additional trials (e.g.,

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The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. In addition to the ongoing clinical studies, Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir. “We

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The Pharma Data

JANUARY 10, 2021

There were no serious adverse events related to treatment and no clinically significant injection site reactions. The approval was received following a review by the DMC of blinded safety data from all three dose cohorts of the MAD study. ASLAN004 was found to be well tolerated at all dose levels. Source link.

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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. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. President and CEO of Knopp. study centers.

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The Pharma Data

MARCH 23, 2021

Data presented at ENDO 2021 demonstrate clinically relevant weight loss, without weight regain, in people treated with semaglutide 2.4 Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinical trial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). asset has not been de-prioritized due to safety or efficacy)?

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DrugBank

SEPTEMBER 26, 2024

Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts. The primary advantage is cost-effectiveness.

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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. . “Results from this study, which we are calling SWARM- P.a. The SWARM- P.a. About Armata Pharmaceuticals, Inc.

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The Pharma Data

NOVEMBER 14, 2020

Nasdaq: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2 proof-of-concept trial. The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. The most common adverse events (AEs) were gastrointestinal.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare. MindMed Forward-Looking Statements.

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

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The Pharma Data

JUNE 7, 2023

Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 31% of patients receiving doublet therapy and 58% of patients receiving triplet therapy. Across treatment cohorts, there were 27 interstitial lung disease (ILD) or pneumonitis events adjudicated as drug-related by an independent committee.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec. Source link.

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The Pharma Data

OCTOBER 26, 2020

Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. The conference ID number for the call is 8557525.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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LifeSciVC

AUGUST 21, 2024

Clinical Trials Are your clinical trials on track? Companies fortunate enough to have reached the clinical stage are asking this question. What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Or maybe you are nearing the clinic.

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

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The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. nM and 13.81

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Advarra

APRIL 4, 2024

One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial.

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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.

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Conversations in Drug Development Trends

APRIL 5, 2024

Each day throughout the month of February, we heard what was on the minds and hearts of patients and patient advocacy organizations, clinical developers driving treatments, and family members supporting people with rare diseases. We were overwhelmed by how excited the community was to participate!

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The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

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The Pharma Data

DECEMBER 1, 2020

In addition, it should be noted that additional capital will be required to complete the planned URIROX-2 clinical trial, including the planned interim analysis at the first sample size reassessment, which capital may not be available to Allena on terms that are acceptable to it, if at all.

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