Advarra

APRIL 30, 2024

For example, non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. In some countries, local regulations may indicate the sub-investigators need to sign as well.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Perficient: Drug Development

MARCH 5, 2024

Assigning the Right License Access to objects is determined based on the license type, such as High-Volume Customer Community, Customer Community Plus, and Partner Community. Therefore, profiles can be employed to regulate access to objects, fields, and other elements. Monitoring unauthenticated user behavior can be complex.

Licensing 59

Licensing Licensing International Regulations 59

The Pharma Data

DECEMBER 13, 2020

In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, Relay Therapeutics is eligible to receive additional royalties. Relay Therapeutics retains the right to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3K? About RLY-1971.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

Production 114

Production Small Molecule Regulations Trials 114

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. SUZHOU, China and ROCKVILLE, Md. ,

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

Vaccine 52

Vaccine Virus Licensing Licensing 52

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA 40

FDA Science Regulations Production 40

Perficient: Drug Development

SEPTEMBER 19, 2023

Last week, Perficient attended the largest AI event in the world, Dreamforce, in San Francisco. jobs by 2028.

Licensing 59

Licensing Licensing Production Marketing 59

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The remaining 19% would be furloughed.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Drug Target Review

OCTOBER 10, 2024

Diseased cells can respond differently to treatment, leading to unforeseen adverse events, including severe toxicity and even death. Therapies that showed promise in healthy cell models may fail to achieve desired clinical outcomes in patients. Furthermore, fostering cross-industry collaboration is essential.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

SugarCone Biotech

JUNE 10, 2024

This is where things get interesting due to the complexity of the immune system and its regulation. Orchestration of immune responses therein is highly complex and fiercely regulated. These adverse events suggest widespread, uncoordinated and nonspecific immune activation. Let’s back up a bit. One more question.

Immune Response 88

Immune Response Production Regulations Clinical Trials 88

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies.

Therapies 119

Therapies FDA FDA Approval Treatment 119

The Pharma Data

DECEMBER 23, 2020

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.

Pharmaceuticals 52

Pharmaceuticals Regulations Compliance Licensing 52

The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

Compliance 52

Compliance Licensing Licensing Virus 52

The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

Pharmacy 40

Pharmacy Regulations Treatment Compliance 40

The Pharma Data

JANUARY 10, 2021

Sébastien Peltier, CEO of VALBIOTIS, and Jocelyn Pineau, CFO, are taking part in this key event for biotechnology and pharmaceutical companies. Founded in 1983, this annual event has become the most important international conference in the sector. VALBIOTIS is one of the French companies invited to this major event.

International 40

International Pharmaceutical Companies Disease Licensing 40

Advarra

JUNE 14, 2024

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

New Drug Approvals

SEPTEMBER 29, 2024

The most common treatment-related adverse events were gastrointestinal, occurring in 12 to 15 percent of treated participants. At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. Improvements in ADAS-Cog and other cognitive endpoints correlated with reductions in saliva P.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Agency IQ

SEPTEMBER 1, 2023

For example, in September 2022 the FDA finalized a guidance document on how sponsors of drug product submissions could effectively flag RWE for regulators. As the guidance notes, sponsors are already tasked with reporting safety events to the FDA in a post-market setting. BIO called this a “very common” issue for sponsors.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. Danyelza appears to be well tolerated with few discontinuations of treatment in the clinical trials and adverse events were clinically manageable. The FDA granted approval under the accelerated approval regulation.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives. Contact: Tauriga Sciences, Inc.

Science 52

Science Pharmaceuticals Clinical Development Production 52

The Pharma Data

NOVEMBER 26, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives. Contact: . Tauriga Sciences, Inc.

Science 52

Science Production Licensing Licensing 52

Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

AUGUST 31, 2021

Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a 6-monthly maintenance dose ‡ , in the community setting. Coronary or other arterial revascularisation procedures. Coronary heart disease.

Therapies 52

Therapies Disease RNA Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). in July 2019, who have recently initiated a Phase 1 study with their formulation. Source link.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

JANUARY 27, 2021

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

FDA 52

FDA Synthetic Chemistry Assay Development Treatment 52

The Pharma Data

DECEMBER 20, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

Production 52

Production Clinical Trials Compliance Licensing 52

The Pharma Data

JANUARY 25, 2021

Further to the update outlined in the Company’s results for the year ended 31 December 2019, Secura Bio, Inc. (“Secura Bio”), the licensor of panobinostat, the API component of MTX110, has twice declined an invitation to withdraw its purported termination of the license. We are well positioned for a productive 2021.”

Licensing 52

Licensing Licensing Production Regulations 52

The Pharma Data

JANUARY 26, 2021

is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027. About Q BioMed Inc.

FDA 40

FDA Treatment Small Molecule Drugs 40

The Pharma Data

AUGUST 30, 2021

We know that long-term exposure to persistently elevated LDL-C increases the risk of ASCVD, which may lead to cardiovascular events such as heart attack or stroke. Treatment-emergent serious adverse events (TESAEs) were reported more frequently in patients with PVD, which was likely due to their more advanced disease 2.

RNA 52

RNA Disease Trials Therapies 52