Agency IQ

JUNE 26, 2023

Because these diseases affect so few people, it can be difficult to characterize and track disease progression – and develop drugs for treatment. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S. regulators. In the U.S., Recently, U.S. In particular, Sec.

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The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., vice president and head, global oncology development, AbbVie.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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The Pharma Data

JANUARY 6, 2021

We would like to thank the regulators for their swift and decisive actions and our partner, Serum Institute of India, for its substantial contribution to this global effort.”. The Lancet publication confirmed that AZD1222 was well tolerated and that there were no serious safety events confirmed related to the vaccine.

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Agency IQ

NOVEMBER 3, 2023

Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. wide level.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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The Pharma Data

JUNE 18, 2021

In the ADVANCE study, risankizumab showed efficacy regardless of prior treatment status by subgroup analysis in patients with moderate to severe Crohn’s disease, and non-bio-IR patients had numerically higher rates of efficacy compared to bio-IR patients. In ADVANCE, serious adverse events (SAEs) occurred in 7.2

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Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.”

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The Pharma Data

JUNE 18, 2021

In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group). 1-7 Serious adverse events (SAEs) occurred in 12.3

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What does a shutdown mean for the FDA?

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The Pharma Data

FEBRUARY 22, 2021

“We remain steadfast in our pursuit of transforming the treatment landscape for people living with ulcerative colitis,” said Tom Hudson , senior vice president of research and development, AbbVie. 1 Serious adverse events occurred in 3.2 percent) were observed in the two treatment groups.

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The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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The Pharma Data

APRIL 28, 2021

Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. “We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.” NORTH CHICAGO, Ill.

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The Pharma Data

AUGUST 3, 2021

“As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” Bradway, chairman and chief executive officer. With Parsabiv’s inclusion in the U.S.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U.-level, level, including the development of lists of critical medicines during major events that affect public health.

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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. For instance, though psilocybin remains illegal in Maryland, The Johns Hopkins Center for Psychedelic and Consciousness Research continues to explore innovative treatments using psilocybin and its potential for mental illnesses 3.

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The Pharma Data

AUGUST 3, 2021

– Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). . Key Events Over the Last Three Months Regulatory. 23% Net Income – Reported 1,390.2 2)% EPS – Reported 1.53

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S., Read full announcement here: [link].

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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.

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The Pharma Data

NOVEMBER 2, 2020

In the event the price of Oncopeptides’ share has thereby increased by more than 60 per cent, 100 per cent of the Share Awards shall vest, and should the share price have increased by 20 per cent, 33 per cent of such Share Awards shall vest. The Share Awards are non-transferable and may not be pledged.

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The Pharma Data

JUNE 18, 2021

. “We are encouraged by these promising results, which indicate ibrutinib and venetoclax combined has the potential to serve as an important chemotherapy-free, fixed-duration treatment option for people living with CLL,” said Dr. Paolo Ghia , M.D., 95% irrespective of subsequent randomized treatment ( Wierda, ASH 2020 ).

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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.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: 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

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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Agency IQ

DECEMBER 1, 2023

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

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Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

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The Pharma Data

AUGUST 3, 2021

2 years and <5 years old OAV-101 IT under investigation as a one-time, single-dose, treatment option for older patients with SMA. Novartis today announced that the U.S. While disease progression is slower in patients with later-onset SMA, there are significant unmet needs. “We SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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Drug Discovery World

DECEMBER 15, 2022

Complicating matters even more, researchers currently lack effective and reliable methods for detecting and measuring off-target genomic events. While LV can create sustained expression of the genome editing tool, the randomness of integration could lead to activation of oncogenes and poor regulation of the genome editing tool expression.

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The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Oncology and Hematology. Regulatory. Regulatory.

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The Pharma Data

JUNE 18, 2021

The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Three months after the completion of treatment uMRD was observed in 51.9% and 17.1%, respectively. vs. 11.4%) (p < 0.0001). .

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The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. New GSK positioned to maximise opportunities across prevention and treatment. Forward-looking statements give the Group’s current expectations or forecasts of future events.

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Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Nature Biotechnology.

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The Pharma Data

OCTOBER 14, 2020

solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.

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Agency IQ

FEBRUARY 23, 2024

As the name implies, the MTD seeks to find the highest dose of a treatment that can both be tolerated and treat the cancer. Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies.

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