Pharmaceutical Technology

APRIL 4, 2023

The firm, which is a partner of PharmaJet, has submitted interim safety and immunogenicity endpoints data from the Phase II/III trial to the Indian regulator to secure the EUA. Topic sponsors are not involved in the creation of editorial content. The move follows a rise in the incidence of Covid-19 in India.

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Pharmaceutical Technology

MAY 24, 2023

The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

MAY 3, 2023

The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL). Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JUNE 8, 2023

Based on past data announcements, all three participants maintained consistent cystic fibrosis transmembrane conductance regulator (CFTR) expression. Topic sponsors are not involved in the creation of editorial content. Both the aerosol delivery and the therapy itself were well tolerated, with no related adverse events.

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Patients Food and Drug Administration Food Safety 98

pharmaphorum

AUGUST 18, 2022

Megan Coder is chief policy officer at DTA and a member of the Frontiers Health steering committee. Now the conversation has moved on in [recent] years more to how could these get reimbursed and how are they regulated and how do we get them to market? Far from it.

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Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. Topic sponsors are not involved in the creation of editorial content.

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Clarivate

APRIL 3, 2024

We explored these timely topics with a panel of experts, capturing their insights in a new white paper entitled “The future of the IP legal profession: Balancing the rise of artificial intelligence with human expertise.” How will corporate and law firm intellectual property (IP) professionals navigate this shifting landscape successfully?

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Clarivate

NOVEMBER 2, 2021

Our team is looking forward to working diligently with our clients and other industry players on a variety of hot topic issues that are important to both Clarivate and INTA.

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Government Marketing Sales Management 52

pharmaphorum

OCTOBER 12, 2022

The group will be leading a workshop on the topic at Frontiers Health next week. In one exercise Albani does with his students, they actually map these different stakeholder priorities in a graph, to help lay out what sorts of things patients value versus regulators versus researchers. Unifying varied stakeholders. Planting seeds.

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Clarivate

NOVEMBER 17, 2021

The pharmaceutical industry is among the most regulated of all commercial sectors. To be able to discover, develop, manufacture and sell medicines, pharmaceutical companies have to comply with masses of regulations, which despite efforts to find global standards, can still differ significantly between different markets.

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Clarivate

SEPTEMBER 27, 2022

Our analysis of papers related to SDG6: Clean Water and Sanitation produced a list of nearly 400 Highly Cited Researchers working in this area, and 1,800 Highly Cited Papers published on this topic. We are very proud that the Chinese government has made many policies that are closely relevant to the recommendations in our review paper.

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Nixon Gwilt Law

DECEMBER 16, 2021

In addition to this daily immersion in the waters of innovation, we also advocate for change in the industry with regulatory agencies , policy makers , and thought leaders. Reema Taneja, our resident telepharmacy expert, says she’s expecting “increased expansion of telepharmacy adoption, as well as increased state regulation of telepharmacy.

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Pharmaceutical Technology

APRIL 5, 2023

AZ: How can regulators ensure that they nurture future innovations in the field? Across the world, to varying degrees, the regulations were written in an era of small molecules and biologics. Topic sponsors are not involved in the creation of editorial content. But we need to recognize the challenge of solid tumours.

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Food and Drug Administration Engineering Patients Education 59

European Pharmaceutical Review

AUGUST 17, 2022

This is why we developed a manufacturing standard ; to minimise the contribution antibiotics manufacturers are making to AMR, even in the absence of any other type of control (eg, government regulation). Overall, our goal with the Alliance is to align this cross-sector life sciences group on the important topic of combatting AMR.

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Manufacturing Food and Drug Administration Management Pharmaceutical manufacturing 92

Impetus Digital

APRIL 24, 2023

Reviewing the recent literature on the topic, it is interesting to note how many predictions are already coming true but also where more work is needed to bring the visions to life. Evolving abilities to share content on-demand with HCPs and re-examined policies for communicating with HCPs virtually. Changes to medical education.

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Pharma Marketing Network

JUNE 8, 2020

Thanks for joining us today, we’re excited to talk about CCPA, the timing seems perfect, maybe 7 days too late but the topic for today is on everyone’s mind right now for sure. So, in some ways it’s ironic that it’s January 7th and we’re talking about it and yet the topic is still so highly relevant.

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Pharmaceutical Technology

JANUARY 31, 2023

The regulator has also cleared the investigational new drug (IND) application for APB-102. Topic sponsors are not involved in the creation of editorial content. The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA).

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Pharma Leaders

JUNE 27, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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Pharma Leaders

JUNE 22, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 19, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 17, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 12, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 11, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 9, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 8, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 5, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 3, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MAY 1, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 20, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 18, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 14, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 7, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 4, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

APRIL 3, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharma Leaders

MARCH 27, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

FDA 52

FDA Manufacturing Pharmaceutical Pharma 52

Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

FEBRUARY 8, 2023

Dr. Lei Xu, chief of the General Medicine Branch 2 in the FDA’s DCEPT, said this is a dilemma as more permanent treatments like gene therapies come to the regulator that often “require substantial evidence of effectiveness from adequate and well controlled clinical studies”.

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