Pharmaceutical Technology

JULY 12, 2022

KOLs interviewed by GlobalData believe that the next iterations of the technology will be the most successful, having solved several current problems, namely long-term cell persistence, a need for inpatient admission for administration, and manufacturing/access challenges.

Clinical Development 130

Clinical Development Development Production Sales 130

Pharma Mirror

JULY 23, 2021

The initial phase of the expansion will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers. It will also. It will also.

Manufacturing 130

Manufacturing Gene Therapy Clinical Development Gene 130

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

Manufacturing 130

Manufacturing Gene Therapy Genetic Engineering Gene 130

Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

Manufacturing 130

Manufacturing Medicine Vaccination Vaccine 130

XTalks

JUNE 4, 2024

Oren Cohen, MD, FIDSA CMO & President of Clinical Pharmacology Fortrea Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, market access solutions and other enabling services.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.

Manufacturing 130

Manufacturing Production Packaging Packaging 130

Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. But the challenges for drug producers developing PDFs are numerous and varied. First and foremost, CDMOs must have expertise in formulation sciences and proven formulation success in clinical development and commercial approvals.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

Pharmaceutical Technology

JUNE 26, 2022

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development.

Manufacturing 130

Manufacturing Drugs Production Development 130

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases.

Gene Therapy 242

Gene Therapy Gene Development Manufacturing 242

XTalks

OCTOBER 22, 2020

To achieve transparency and actionability of data, pharmaceutical companies are evolving their manufacturing processes by digitalizing the data from all of their equipment. At Aizon , we provide solutions to speed up pharmaceutical manufacturing process development from the start in a GxP compliant platform.

Manufacturing 98

Manufacturing Development Production Gene Therapy 98

Pharmaceutical Technology

JUNE 12, 2023

In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.

Drugs 358

Drugs Development Clinical Development Sales 358

Outsourcing Pharma

DECEMBER 6, 2023

Varda, a company founded by former SpaceX employees, is taking pharmaceutical manufacturing all the way to space.

Manufacturing 100

Manufacturing Clinical Development Development 100

BioPharma Reporter

NOVEMBER 7, 2022

Charles River Laboratoriesâ growing gene therapy manufacturing capabilities have landed it a deal with the eye disease biotech Nanoscope Therapeutics.

Gene Therapy 98

Gene Therapy Manufacturing Gene Clinical Development 98

BioPharma Reporter

NOVEMBER 28, 2023

Hilleman Laboratories has opened a new 30,000 sq ft manufacturing facility in Singapore.

Manufacturing 91

Manufacturing Vaccination Vaccine Clinical Development 91

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

BioPharma Reporter

DECEMBER 5, 2022

Vaxxas has completed a financing round which raised US$23m (A$34m) in new funds: allowing the company to progress multiple vaccine programs in the clinic and ramp up manufacturing capabilities towards commercial scale.

Manufacturing 52

Manufacturing Clinical Development Vaccination Vaccine 52

Outsourcing Pharma

OCTOBER 30, 2023

Continuous flow manufacturing is taking off in the production of active pharmaceutical ingredients (APIs).

Manufacturing 84

Manufacturing Drugs Production Clinical Development 84

Outsourcing Pharma

APRIL 11, 2023

Operio has acquired a group of companies that provide both manufacturing equipment and services in the solid dose space.

Manufacturing 82

Manufacturing Clinical Development Development 82

pharmaphorum

APRIL 19, 2021

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . If you look at the development, we signed 15,000 people in six weeks in a trial set up by the NHS. Speed is everything in clinical development.

Vaccination 141

Vaccination Vaccine Manufacturing Clinical Development 141

Pharmaceutical Technology

APRIL 13, 2023

FPI-2068, which we believe will be the first TAT for two validated targets to enter the clinic, was designed to provide enhanced tumour specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets.”

Clinical Development 147

Clinical Development Antibody Development Trials 147

Pharmaceutical Technology

MAY 11, 2023

Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. Bicyclic peptides feature amino acids that can be manufactured synthetically.

Development 162

Development Manufacturing Protein Clinical Development 162

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development 59

Clinical Development Development Clinical Trials Clinical Trials 59

XTalks

JANUARY 7, 2025

Medtronics Acquisition of Covidien Deal value : $43 billion Announced : June 2014 Closed : January 2015 In January 2015, Medtronic, a leading medtech company, acquired Covidien , an Ireland-based medical device manufacturer, in a deal worth approximately $43 billion, one of the largest to date. billion in 2021. billion.

Life Science 105

Life Science Manufacturing Production Clinical Development 105

Pharmaceutical Technology

SEPTEMBER 13, 2022

The acquisition will expand the international solutions portfolio of AmerisourceBergen aiding in advancing its position as a preferred partner for biopharmaceutical manufacturers. This approach will support its manufacturer partners throughout the pharmaceutical development and marketing processes.

Manufacturing 130

Manufacturing Compliance Marketing Clinical Development 130

Pharmaceutical Technology

MAY 2, 2023

This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned. Our services allow us to deliver solutions that benefit our partners and ultimately patients.”

Production 130

Production Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JULY 7, 2022

But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

Pharmaceutical Technology

MAY 26, 2023

Looking at the targets, the majority of drugs in clinical development focus on CD19, said Chalk, noting that these are agents for blood malignancies. In China, immuno-oncology agents manufactured by Western companies are often only accessible with private insurance, based on a Chinese KOL.

Marketing 264

Marketing Vaccination Vaccine Development 264

Camargo

DECEMBER 20, 2021

Enhanced product quality reviews conducted under PDUFA VII will focus on innovative manufacturing technologies like those used to produce cell and gene therapies, particularly products with accelerated clinical development timelines. This is targeted for FY 2023.

Gene Therapy 184

Gene Therapy Gene Development Production 184

Outsourcing Pharma

MAY 9, 2023

Xequel Bio has selected Societal CDMO to support the ongoing clinical development of a patented new chemical entity based on its aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform.

Clinical Development 52

Clinical Development Development Contract Manufacturing Manufacturing 52

Roots Analysis

FEBRUARY 27, 2024

Over the last few decades, various viral vector manufacturing have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells.

Manufacturing 52

Manufacturing Gene Therapy Gene DNA 52

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. Novartis overview Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.

Generic Pharmaceutical 172

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials 172

Pharmaceutical Technology

FEBRUARY 24, 2023

(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. Novo Nordisk overview Novo Nordisk, a subsidiary of Novo Holdings AS, is a healthcare company focused on discovering, developing, and manufacturing of innovative biological medicines.

Insulin 182

Insulin Hormones Drugs Clinical Trials 182

Pharmaceutical Technology

MAY 31, 2023

Betta chairman and CEO Lieming Ding stated: “The collaboration will further expand Betta’s product pipeline and improve the productivity of the company’s research and development from discovery to clinical development and to commercialisation.”

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Pharmaceutical Technology

JUNE 13, 2023

Neobiosis chief scientific officer and CEO Dr Ian White stated: “This is an important milestone for Neobiosis and we are excited to be advancing ViXome, a refined product extracted from thoroughly screened and sterile amniotic fluid obtained at the time of C-section [Caesarean delivery] of full-term pregnancies, into clinical development. “We

FDA Approval 147

FDA Approval Production Clinical Development Manufacturing 147

Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences chief medical officer Syed Rizvi said: “Fast Track designation for CB-011 allows us instrumental interactions with the FDA as we progress our clinical development and regulatory plans for CB-011. This designation could not be more timely, as we recently dosed our first patient in the CaMMouflage Phase l trial.

Gene Therapy 147

Gene Therapy Gene Manufacturing Development 147

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.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264