The Pharma Data

AUGUST 21, 2020

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. The “review phase” is the period between the initial submission and approval of the NADA.

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Drug Target Review

NOVEMBER 7, 2024

Agonist antibodies of immune checkpoint regulators These represent a groundbreaking class of immunotherapeutic agents that mimic the natural function of endogenous ligands by binding to specific cell-surface receptors. This approach augments the strength of achieving immune homeostasis.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. The regulation also obliges sharing information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.

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The Pharma Data

AUGUST 28, 2020

In addition, the consultation – which seeks to amend the Human Medicine Regulations 2012 – will look into ways to protect companies that manufacture and distribute the vaccine, should it cause any harm. Source link.

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Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. 2009 Mar 5;323(5922):1722–5. References Chen GY., Tang J, Zheng P, Liu Y.

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Drug Target Review

FEBRUARY 28, 2024

Previously, Mr Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co. Regulation of cutaneous malignancy by gammadelta T cells. from 2003 to 2006, covering the biotechnology and life-science tools sectors. J Hemotother 5(5):503-9 (1996).

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2009 Sep;14(17–18):876–84. Regul Toxicol Pharmacol RTP. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. 2018;53(4):519–25.

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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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The Pharma Data

APRIL 28, 2022

These proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products and build on the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes in 2009. Source link: [link].

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Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Drug Target Review

JUNE 29, 2023

It set a precedent with regulators as to what is expected in some instances. Prior to joining Adaptimmune in 2009, Jo held positions at Avidex, Medigene and Immunocore. Looking back, at the way we approach safety in preclinical testing and in IND (investigation new drug) submissions was really changed by those papers.

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Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Ecophyto II+ also incorporated European obligations under Directive (EC) 2009/128 on the sustainable use of pesticides (SUD) to adopt national action plans setting targets for pesticide reduction.

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Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. This regulation has since been repealed and replaced with Implementing Regulation (EU) 2020/1740 , though many of the provisions and their articles remain the same.

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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Eye on FDA

JULY 7, 2020

Then as part of the agency’s effort at putting together a regulatory stance regarding the unique questions posed by the huge migration into digital and social communications, FDA later that year posed a series of five questions to inform the regulation of this burgeoning environment during a public meeting held that same year.

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Advarra

FEBRUARY 22, 2024

regulations. In 2009, the Food and Drug Administration (FDA) released a  guidance document on AE reporting to IRBs. These responsibilities and reporting requirements are outlined in U.S.

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Broad Institute

AUGUST 2, 2023

Known to be a regulator of metabolism, we have found that in addition it has profound behavioral effects in animals and humans, even evident in population-level economic behavior. in Physics from Massachusetts Institute of Technology in 2009. With this proposal, we will add a measure of thyroid hormone, T3, to the assessment battery.

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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New Drug Approvals

DECEMBER 3, 2022

2] The Bcl-2 family is most notable for their regulation of apoptosis , a form of programmed cell death, at the mitochondrion ; Bcl-2 and Bcl-xL are anti-apoptotic proteins. Jump up to: a b Hauck P, Chao BH, Litz J, Krystal GW (April 2009). 68 (7): 2321–8. doi : 10.1158/0008-5472.can-07-5031. can-07-5031. PMC 3159963. PMID 18381439.

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New Drug Approvals

SEPTEMBER 29, 2024

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. 2009 Mar;77(3):1246-61. Known as gingipains, these proteases penetrate gingival tissue and cause inflammation at the site of periodontitis ( O’Brien-Simpson et al., All were deemed unrelated to drug. Infect Immun.

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Agency IQ

AUGUST 11, 2023

Given this significance, it’s worth analyzing its chaotic regulatory history, examining the implications of the risk assessment document itself, and projecting how this controversial active substance is likely to be treated by EU regulators going forward. The EU adopted an amendment allowing for this on the same day the AGG was formed.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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The Pharma Data

AUGUST 1, 2021

The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. 4 Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE. 17,18 At least five million people worldwide have a form of lupus.

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New Drug Approvals

JANUARY 9, 2024

Nature Cell Biology, 11, 1275 – 1276, 2009), whilst different tumors appear to require some, but they are independent of other interphase CDKs (CDK2, CDK4 , CDK6). In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. 27, 6012-6018, 2009; Christian et al., 3, S179-S185, 2009).

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Vial

MAY 1, 2024

It also maintains strict compliance with regulatory guidelines like the US Food and Drug Administration’s 21 CFR Part 11 , HIPAA (Health Insurance Portability and Accountability Act), and GDPR (General Data Protection Regulation). Read more here about how Vial’s EDC system compares with that of industry giants.

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Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

MARCH 7, 2024

Influenza strains are named according to the HA and NA subtypes (at least 18 HA and 11 NA subtypes have been identified), as with the H1N1 influenza strain that famously wreaked havoc in 2009. That influenza A virus strain is now termed A(H1N1)pdm09, to signify the pandemic of 2009.

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Codon

JULY 21, 2024

This is due, in part, to perceptions of public safety, and by extension, regulation. So, whereas a gene-edited feeder mouse or agricultural animal might take years to clear FDA regulations, an animal that has been bred for higher welfare would not. Another reason to favor breeding has to do with attitudes toward gene editing.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create PTEs for certain FDA-regulated products—and a recent spate of PTE-related items posted on regulations.gov, we thought we would peruse some decisions to see what’s up at (..)

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PLOS: DNA Science

SEPTEMBER 21, 2023

Biochemist Richard Lumb founded Front Line Genomics in 2009, when he lost his father to mesothelioma, a rare cancer associated with asbestos exposure. Their mission: “to deliver the benefits of genomics to patients faster,” through their website, publications, and events.

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Codon

APRIL 9, 2023

Read Probe-based bacterial single-cell RNA sequencing predicts toxin regulation. A programmable and red light-regulated CRISPR-dCas9 system for the activation of endogenous genes in Saccharomyces cerevisiae. Read DNA Sequencing & Synthesis *Quantitative analysis of tRNA abundance and modifications by nanopore RNA sequencing.

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. In 2009, the agency held a workshop to discuss the gaps in existing frameworks and present some new options for discussion, including four “prototypes” of potential PMIs.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

I joined the FARA staff in 2009, and our team built a nationwide series of bike rides called rideATAXIA to raise funds for research. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

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