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.

Medicine 121

Medicine Marketing Pharmaceutical Leads 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.

Medicine 88

Medicine Safety Patients Pharmaceutical 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.”

Medicine 52

Medicine Safety Patients Leads 52

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.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Food 59

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.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105

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.

Manufacturing 105

Manufacturing Distribution Medicine Patients 105

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%.

Recruitment 78

Recruitment Pharma Education FDA 78

PM360

APRIL 22, 2024

Making the Case for Early Medical Affairs Involvement Early involvement of Medical Affairs in the product lifecycle is not just beneficial—it is mission critical. A clear understanding of the steps highlighted below will help the development of strong scientific partnership-based engagements with stakeholders.

Medical 52

Medical Healthcare Healthcare Education 52

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.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration FDA Food 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.

Manufacturing 52

Manufacturing Food and Drug Administration Prescription Distribution 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. .

Food and Drug Administration 59

Food and Drug Administration FDA Food Pharmaceutical 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.

Government 52

Government Safety Pharmaceutical Medicine 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.

Manufacturing 52

Manufacturing Networking Patients Leads 52

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.

Leads 52

Leads Patients Management Pharmaceutical 52

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.

Medicine 52

Medicine Marketing Pharma Management 52

Clarivate

MAY 26, 2022

Drug and device makers face daunting odds in seeking to bring a product from Phase I clinical trials through to market approval – according to the Massachusetts Institute of Technology’s Project Alpha, a mere 10.5% Engaging regulators early and often. Engaging regulators early and often. make it to market. [1]. References. [1]

Marketing 52

Marketing Patients Recruitment Management 52

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.

Pharmaceutical 127

Pharmaceutical Food and Drug Administration Manufacturing FDA 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.

Side effects 110

Side effects Pharmaceutical Patients Medicine 110

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.

Patients 96

Patients Pharmaceutical Medical Physicians 96

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.

Safety 98

Safety Patients Consulting Prospecting 98

Medico Reach

OCTOBER 17, 2022

Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Development Of New Biotech Coating In Orthopedic Medical Devices. One of the most exciting orthopedic medical device trends is the development of new bioactive coatings and composites for bone implants.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

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.

Pharma 75

Pharma Competition Healthcare Healthcare 75

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.

Side effects 52

Side effects Pharmaceutical Marketing Patients 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.

Food and Drug Administration 98

Food and Drug Administration Food Safety FDA 98

Celeritas

MARCH 3, 2023

Data Analytics is the next phase in the evolutionary data cycle. Getting quick, detailed, and accurate reports on animal health related topics a game-changer. Dr. Ed Tucker, VP of Janssen Research & Development put it best in an interview with MIT Sloan Management Review.

Food 98

Food Training Prescription Management 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.

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

Pharmaceutical Technology

FEBRUARY 28, 2023

Under the deal terms, Chipscreen NewWay will develop and commercialise YH008 in Greater China, including Macau, Mainland China, Taiwan, and Hong Kong. Eucure Biopharma will retain the global rights for the development and commercialisation of the antibody outside Greater China.

Biopharma 52

Biopharma Food and Drug Administration Pharmaceutical Sales 52

Medico Reach

OCTOBER 17, 2022

Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Development Of New Biotech Coating In Orthopedic Medical Devices. One of the most exciting orthopedic medical device trends is the development of new bioactive coatings and composites for bone implants.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Rep-Lite

JANUARY 25, 2024

The shift towards hospital-based treatments, as opposed to home care, gained traction in the late 1800s and early 1900s due to advancements in sanitation and the introduction of antiseptics. Early Days (Pre-1970s): Healthcare institutions traditionally handled recruitment internally, relying on personal networks and basic advertising methods.

Recruitment 52

Recruitment Specialization Healthcare Healthcare 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Under the licence deal, AstraZeneca will handle the research and activities related to the development, manufacturing, and commercialisation of CMG901 globally. It is being developed to treat solid tumours that express the Claudin 18.2 It is being developed to treat solid tumours that express the Claudin 18.2 expressing cancers.

Biopharma 52

Biopharma Engineering Pharmaceutical Safety 52

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.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

Impetus Digital

JANUARY 13, 2023

As a result, they will see higher-quality insights and be able to develop a clear plan for how to leverage these. In particular, AI-enabled sentiment analysis was a hot topic in 2022, but this will not replace manual analyses by medical writers and other human experts. Improved patient-centricity goes hand-in-hand with DEI initiatives.

Pharma 94

Pharma Medical Patients Healthcare 94

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.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

Integrity Solutions

MAY 13, 2021

Maximizing talent, developing a customer-centric culture and achieving aggressive sales goals are all made possible through ethical, values-driven behaviors. Let’s take a look at these selling principles and underlying beliefs that enable salespeople to build trust and develop valuable, lasting relationships with customers.

Ethics 86

Ethics Sales Sales process B2B Sales 86

pharmaphorum

JANUARY 23, 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. We have the most unbelievable, exponential developments taking place. It is about money.

Pharma 83

Pharma Food Pharmacology Patients 83

Pharmaceutical Technology

MARCH 9, 2023

The clinical development partnership will focus on the development of UCB6114 and UCB4594 investigational antibody candidates. It will combine Cancer Research UK’s oncology-focused translational research and clinical development capabilities and the antibody discovery expertise of UCB.

Leads 52

Leads Pharmaceutical Networking Manufacturing 52

Pharmaceutical Technology

APRIL 12, 2023

The partnership is seen as an important step in advancing Xenetic’s DNase-based oncology programme towards Phase I clinical development. We believe that the team at Scripps is well-equipped to provide valuable insight and generate meaningful data in our preclinical development programme as we work to advance. “We

Pharmaceutical 52

Pharmaceutical Marketing 52