Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

Diabetes 98

Diabetes 98

RX Note

JULY 15, 2023

Infantile haemangiomas can be Superficial (50-60%) - Typically has a sharp border, and is a round or oval with a smooth or slightly bump surface Deep (15%) - Develops under the skin and may appear as a slow-glowing skin-coloured or slightly blue lump. Treatment If treatment warranted, Topical timolol For smaller flat lesions.

Hospitals 52

Hospitals 52

Pharmaceutical Technology

APRIL 6, 2023

The PRIME scheme designation was granted by the EMA based on positive results obtained from the ongoing Phase IIb randomised, open-label KEYNOTE-942/mRNA-4157-P201 trial that enrolled 157 patients with stage III/IV melanoma. Topic sponsors are not involved in the creation of editorial content.

Vaccines 98

Vaccines Labelling Immunity Immunization 98

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.

Communication 59

Communication 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.

Vaccines 121

Vaccines Communication 121

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.

88

88

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.”

Labelling 52

Labelling 52

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.

Documentation 105

Documentation Drug Development Communication 105

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.

52

52

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.

Communication 105

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

95

95

PharmaShots

APRIL 18, 2023

Following the success of our Phase I intravenous (I.V.) Following the success of our Phase I intravenous (I.V.) The Phase Ib/IIa intravenous multiple-dose safety and tolerability study is expected to see first patient dosing in the early part of next year. What are your expectations from the Phase 2 results?

Diabetes 53

Diabetes Hospitals 53

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%.

86

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.

52

52

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up. Physicochemical properties.

Dosage 52

Dosage Packaging Communication 52

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.

Vaccines 52

Vaccines 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.

52

52

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. .

59

59

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.

Immunity 52

Immunity Immunization Vaccines 52

FDA Law Blog: Biosimilars

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.

Drug Development 98

Drug Development Immunity Immunization 98

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.

92

92

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.

Diabetes 52

Diabetes 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.

Immunity 52

Immunity Immunization 52

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

52

52

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.

Vaccines 105

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 105

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Another major topic covered by the experts was technological advances. Miriam Guest, Principal Microbiologist at AstraZeneca.

Vaccines 127

Vaccines Research Laboratories Documentation Compounding 127

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.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Labelling 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.

Immunity 104

Immunity Immunization Hospitals Drug Development 104

The Thyroid Pharmacist

SEPTEMBER 15, 2023

Female hormones are thought to play a role in the development of autoimmune thyroid conditions. I also developed skin issues, anxiety, irritability, weight gain, and insomnia, and had super heavy periods twice per month. Sex hormones have an important role in modulating the immune system and may impact autoimmune disease.

Health and Personal Care Stores 57

Health and Personal Care Stores Dosage Compounding Diabetes 57

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.

Hospitals 83

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.

Labelling 62

Labelling Communication Pharmaceutical Manufacturing Pharmaceutical Companies 62

ID Stewardship

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.

Communication 52

Communication Documentation Vaccines 52

Pharmaceutical Technology

MARCH 3, 2023

It is currently being evaluated in a Phase I first-in-human trial and represents a non-opioid approach for treating neuropathic pain, a devastating condition caused by damage to the nerves outside the brain and spinal cord. Under the deal, Lilly will be responsible for continuing the clinical development of CFTX-1554 beyond the Phase I trial.

Communication 52

Communication 52

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.

Hospitals 92

Hospitals Diabetes 92

pharmaphorum

APRIL 20, 2022

The potential of CRISPR technology has been a hot topic in the industry ever since it was first developed, but as trials progress further into the clinic, what therapeutic areas could be set to benefit? Once developed, potential therapies for cancer also hold some crucial advantages over existing treatments. The final hurdles.

Chemotherapy 52

Chemotherapy Immunity Immunization Drug Development 52

Pharmaceutical Technology

MARCH 20, 2023

BioNTech has signed an exclusive worldwide licence and collaboration agreement with OncoC4 to co-develop and commercialise a new checkpoint antibody in multiple solid tumour indications. BioNTech will solely develop all the combinations other than the PD-1 inhibition. These are mainly all those with a compound in BioNTech’s pipeline.

Compounding 98

Compounding Communication 98

Pharmaceutical Technology

APRIL 12, 2023

Pharmaceutical research has long relied on non-human primate models for early-stage discoveries, but their use continues to cause controversy. The topic of animal testing remains a fiercely contentious topic in the public eye.

Vaccines 98

Vaccines Biosimilars Communication Pharmaceutical Companies 98