The FDA Law Blog

NOVEMBER 17, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 69

The FDA Law Blog

NOVEMBER 21, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 59

Pharmaceutical Technology

DECEMBER 18, 2022

Additionally, the application included findings from a Phase II/III clinical trial of mRNA-1273.214. At present, a Phase II/III trial of mRNA-1273.214 for usage as a booster and initial regimen in children aged six months to five years is progressing. Preliminary data from this trial is anticipated early next year.

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Vaccines Communication 121

Pharmaceutical Technology

APRIL 5, 2023

The therapy is currently under development for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM). Caribou is presently conducting its Phase l CaMMouflage trial to assess CB-011 in r/r MM patients. The newly granted designation helps the firm accelerate the development and evaluation of CB-011.

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FDA Communication 59

European Pharmaceutical Review

JANUARY 31, 2023

It is the “… first and only targeted treatment option clinically proven to reduce both oesophageal inflammation and damage,” explained Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi. Improvements were observed as early as four weeks.

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Pharmaceutical Technology

APRIL 27, 2023

The European Commission is expected to make an early decision on Columvi’s authorisation. The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration therapy for people with diffuse large B-cell lymphoma that induces early and long-lasting responses.”

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Labelling 52

IDStewardship

MAY 12, 2023

BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. As residents review the topics they need to cover during their residency, it can be helpful to also include the Board of Pharmacy Specialties examination content outline for the specialty area in addition to ASHP requirements.

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Communication Documentation Vaccines 130

The FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Common CMC Issues for Phase 1 IND Study. The workshop is also discussed in Cell & Gene here and here.

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FDA Labelling 59

The FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” avoid CMC bottleneck prior to initiating pivotal study).

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pharmaphorum

NOVEMBER 19, 2021

Domvanalimab is the furthest along in development of the partnered drugs, as it is currently in phase 2 and 3 studies in non-small cell lung cancer (NSCLC), while AB308 is in phase 1 testing. Learn more about AB308 in our @sitcancer (SITC) poster presentation here: [link] pic.twitter.com/N9i2HImkWg.

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ISPE

JUNE 23, 2023

This comprehensive education program provides attendees with technical sessions on the latest developments in supply chain, production and quality systems, sustainability, and cutting-edge industry innovations. This can increase the chances of changing attributes for API or DS during development.

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Pharmaceutical Companies Pharmaceutical Companies 94

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. Personalised medicines will also be developed at the centre. Personalised medicines will also be developed at the centre.

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Communication 105

pharmaphorum

NOVEMBER 2, 2021

The approach has become a hot topic in biopharma with a string of big ticket partnerships over the last couple of years, including a $2.4 billion alliance between Pfizer and Arvinas for a breast cancer candidate in phase 2 that included a whopping $1 billion upfront payment. Others include a $1.6 Others include a $1.6

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pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. While the data for 2021 isn’t complete, early signs are that it has fallen further to 6%.

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FDA 86

Pharmaceutical Technology

MAY 24, 2023

The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. It also provides the ability for early FDA interactions, support accelerated approvals and priority review of biologics licensing applications.

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FDA 52

Pharmaceutical Technology

MAY 17, 2023

Both platforms use the company’s development, manufacturing and analytical capabilities in lentiviral vector (LVV) and adeno-associated viral vector (AAV). AGC Biologics’ proprietary procedure and capsid-based platform methods can speed up development timelines, thereby enabling the delivery of GMP products in nine months.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

According to initial findings from the Phase I/II clinical trial, which is underway at the University of California San Diego, the therapy was found to be well tolerated. The FDA's rare pediatric disease designation and Voucher Program aid the development of new drugs and biologics to prevent and treat rare paediatric ailments. .

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FDA 59

Pharmaceutical Technology

AUGUST 30, 2022

The approval is based on findings from the Phase II/III clinical trial of the mRNA-1273.214 vaccine. The company is collaborating with Swissmedic and the Government of Switzerland to supply the mRNA-1273.214 vaccine to people in the country by early September this year. According to the study data, the trial met all primary endpoints.

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Vaccines 52

The FDA Law Blog

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). There have been challenges in gene therapy development. Early attempts at gene therapy had unseen issues.

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Pharmaceutical Technology

MAY 24, 2023

Our board and management team believe that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need.” Topic sponsors are not involved in the creation of editorial content.

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pharmaphorum

MARCH 19, 2021

The company has developed a toolkit called Site-Directed Enzyme Enhancement Therapy or SEE-Tx, which uses computational techniques to find small-molecule drugs that are able to bind to sites on misfolded proteins, restore their shape and function and in some cases prevent them clumping together.

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pharmaphorum

NOVEMBER 25, 2022

German pharma Grünenthal has started the process of taking ownership of 13 ageing medicines developed by Japan’s Kyowa Kirin, which are currently sold by affiliate companies across Europe.

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 105

pharmaphorum

AUGUST 16, 2021

Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. Lilly is also running the Adhere trial of lebrikizumab in combination with topical corticosteroids, which should generate results in the coming months. Lilly shelled out $1.1

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FDA 52

pharmaphorum

AUGUST 28, 2020

Italian biotech Cassiopea has won US approval for Winlevi, a topical therapy it says is the first new approach to treating acne in nearly 40 years. Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged.

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Pharmaceutical Technology

NOVEMBER 29, 2022

On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease. The company now plans to move this approach into a Phase III trial. In 1970, the FDA approved ketamine as an anesthetic.

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Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 110

pharmaphorum

NOVEMBER 16, 2022

Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the results were received, and what glimmer of hope this might hold for patients with GA. “As That’s the efficacy data.

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pharmaphorum

JANUARY 19, 2023

It was a unique event, at which leaders from across the pharmaceutical pipeline addressed the needs of the industry, shared their own insights, and tackled debates on the crucial topics that influence the future of patient outcomes. Pretty much every system in the developed world is a late-stage sick system and failing. he exclaimed.

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Hospitals Vaccines 83

pharmaphorum

APRIL 15, 2021

When it comes to developing cutting-edge innovations, Astellas aims to be at the forefront. We work to build positive and effective relationships by having open and early engagement and dialogue. We work to build positive and effective relationships by having open and early engagement and dialogue.

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Labelling Communication FDA Pharmaceutical Companies 62

pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. How they could facilitate clinical engagement with late-phase research.

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Hospitals 92

ISPE

FEBRUARY 7, 2023

The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, ™, emerging technologies, and facility design and construction. She said that 10 people have been dosed and they do have 14-day resonance.

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Pharmaceutical Technology

JUNE 15, 2023

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. Once the target is identified, researchers work to develop a compound that can interact with it.

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Compounding Adverse Reactions Dosage Documentation 52

pharmaphorum

OCTOBER 2, 2020

The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. How they could facilitate clinical engagement with late-phase research. How they can serve as a test bed for pharmaceutical innovation.

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Hospitals 52

European Pharmaceutical Review

JANUARY 29, 2024

17 Accelerating drug development The first issue of 2023 , 18 dealt with accelerating drug development. Repurposing of currently marketed products, eg, methotrexate, 20 was an important and effective strategy in combatting COVID-19, particularly in the early stages prior to effective vaccines being developed.

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Viseven

NOVEMBER 9, 2022

However, given the current regulatory approval challenges, many pharma companies seek to collaborate with KOLs medical throughout the entire drug development cycle. KOLs can also offer their unique insights as early adopters of new therapies, which can help create brand acceptance in the healthcare. How to identify KOLs in pharma?

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Pharmaceutical Companies Pharmaceutical Companies Communication Hospitals 52

pharmaphorum

MARCH 30, 2021

These include perceptions of transformational therapies as ‘unaffordable’ and the often-limited evidence available when ground-breaking treatments come to market sometimes on the basis of phase 2 data alone. “If He frequently presents on the topic at conferences and symposia and has authored numerous peer reviewed publications.

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Communication Labelling 62

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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