2015, Pharmacy and Trials - Drug Discovery Digest

Decoding Clinical Trial Costs and Efficiency Roadblocks

Vial

MAY 13, 2024

However, progress from molecule to approved drug is hampered by extremely high costs and lengthy clinical trials , and approximately 90% of drugs that reach clinical trials fail. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 An estimated 80% of clinical trials do not finish on time.

Clinical Trials

Clinical Trials Trials Drug Development Production

Massive Bio Launches Industry’s First NASA-Style, Oncology Clinical Trial Command Center to Disrupt and Accelerate Trial Enrollment, Featuring 72-Hour Instant Enrollment from Time of Patient Identification

The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

Clinical Trials

Clinical Trials Trials Clinical Research Pharmaceutical Companies

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Four comments were submitted to the docket established for the 2015 Petition.

Science

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Bridging Innovation & Patient Care: The Growing Role of AI

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WCLC: Lilly, Innovent tout Tyvyt front-line lung cancer win. Can it challenge Merck’s Keytruda?

The Pharma Data

AUGUST 8, 2020

With its latest trial win, Eli Lilly and its Chinese partner Innovent Biologics are eyeing an all-important front-line non-small cell lung cancer approval in China for their PD-1 checkpoint inhibitor, Tyvyt. In November, Keytruda nabbed its chemo combo squamous go-ahead in China based on data from the phase 3 Keynote-407 trial.

Trials

Trials Pharmacy Hospitals International

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. What’s ahead? Putting policy into practice.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. And it is generally understood that, as soon as the drug is removed from the pharmacy, its storage in ideal conditions cannot be guaranteed. Every facility (i.e.,

Science

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA

FDA Science Regulations Production

The rising demand for lentiviral vectors for in vivo gene therapy

Drug Target Review

SEPTEMBER 6, 2024

VIVEbiotech is involved in the manufacture of more than 50 different LVVs since 2015, eight of these programmes being for in vivo applications. Finally, the market demand has increased as clinical trials are advancing towards more advanced phases and more vectors are being approved for commercial use.

Therapies

Therapies Vaccine Marketing Disease

Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

The Pharma Data

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P, BARCELONA, Spain , Jan.

Clinical Trials

Clinical Trials Treatment Trials Virus

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA

FDA Science Regulations Production

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

FDA and other global organizations to offer Inmazeb under a compassionate use protocol and include it in the four-arm PALM (PAmoja TuLinde Maisha) Trial. “Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire.

FDA Approval

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Using clinical genomics and AI in drug development to elevate success

Drug Target Review

FEBRUARY 11, 2025

The typical drug development journey spans a decade or more, encompassing distinct phases: discovery, preclinical research, clinical trials and regulatory approval. As recently as 2015, the likelihood of a drug in early clinical development achieving regulatory approval was around 25 percent.In

Drug Development

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Our best expert admissibility/Rule 702 (and best trial court) decision of 2023 was issued earlier this month, shortly after the Rule 702 amendments went into effect. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

Testimonials

Testimonials Drugs FDA Vaccine

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In at least the short term, a popular pain reliever would have to be removed from pharmacies. 0295, 2015 WL 5022618, at *12 (N.J. Lack of FDA approval was “dispositive”: The consequences of imposing on defendants a duty to develop a safer [OTC] product. . . This would run counter to. . . See In re Alloderm Litigation , No.

FDA

FDA FDA Approval Testimonials Vaccine

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong. 3d 27 (Okla.

FDA Approval

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Drug Discovery Digest

Decoding Clinical Trial Costs and Efficiency Roadblocks

Massive Bio Launches Industry’s First NASA-Style, Oncology Clinical Trial Command Center to Disrupt and Accelerate Trial Enrollment, Featuring 72-Hour Instant Enrollment from Time of Patient Identification

Webinars

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Webinars

WCLC: Lilly, Innovent tout Tyvyt front-line lung cancer win. Can it challenge Merck’s Keytruda?

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

The rising demand for lentiviral vectors for in vivo gene therapy

Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

Using clinical genomics and AI in drug development to elevate success

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

The FDA and Feasible Alternative Designs

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

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