Pharmaceutical Technology

MAY 3, 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has also awarded a BTD to spesolimab. In April 2023, Boehringer Ingelheim and Swiss company RetinAI Medical colla borated to leverage artificial intelligence to advance novel treatments for geographic atrophy patients.

Antibody 130

Antibody Clinical Trials Clinical Trials Trials 130

Pharmaceutical Technology

FEBRUARY 17, 2023

It will use the machine learning platform from Zephyr AI and a real-world data set (RWD) from M2GEN for creating an oncology discovery product. Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services.

Bioinformatics 147

Bioinformatics Production Clinical Trials Clinical Trials 147

Pharmaceutical Technology

MARCH 22, 2023

A recent study in the Journal of the American Medical Association found that between 2015 and 2019 as high as one in eight deaths in the US could be attributable to excessive alcohol consumption. For example, Continuous Precision Medicine’s CPMRx is a mobile app used to monitor the use of pain medication by women following caesarean surgery.

FDA Approval 130

FDA Approval Production Compliance Clinical Trials 130

Pharmaceutical Technology

MAY 31, 2023

Bridge Biotherapeutics overview Bridge Biotherapeutics is a biotechnology company that develops novel therapeutics and unmet medical needs in conditions such as ulcerative colitis, fibrotic diseases and cancers. The company product pipeline incudes BBT-401, BBT-877 and BBT-176.

Clinical Trials 130

Clinical Trials Clinical Trials Drugs Clinical Development 130

Rethinking Clinical Trials

OCTOBER 4, 2022

Medical Director. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints. Decentralized trials require novel technology and digital endpoints. CTTI wants to increase meaningful novel digital endpoints that are clinically relevant and fit-for-purpose.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

Pharmaceutical Technology

MARCH 1, 2023

Bristol-Myers Squibb overview Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. BMS provides its products in the US, Europe, and Japan.

Pharmacy 100

Pharmacy Production Clinical Trials Clinical Trials 100

Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

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Pharmaceutical Technology

MAY 10, 2023

The acquisition will strengthen Sobi’s haematology medicines portfolio with the addition of CTI’s lead product Vonjo (pacritinib), a novel oral kinase inhibitor of JAK2, IRAK1 and ACRV1. Sobi will start a tender offer through its wholly owned indirect subsidiary to buy all outstanding CTI shares for $9.10

Medicine 147

Medicine Development Production Drugs 147

Pharmaceutical Technology

JANUARY 2, 2023

Bristol-Myers Squibb overview Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. BMS provides its products in the US, Europe, and Japan.

Drugs 100

Drugs Pharmacy Production Development 100

XTalks

DECEMBER 11, 2023

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Let’s examine the list of the top ten fastest growing medical device companies in 2023, ranked by their compound annual growth rate (CAGR). 3) Inari Medical Headquartered in California, Inari Medical, Inc.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

AceLink Therapeutics chief medical officer Marvin Garovoy said: “Receiving an FDA Orphan Drug Designation further validates AL01211 as a novel, once-daily orally administered GCS inhibitor as a potential treatment to improve the quality of life of patients suffering from Fabry disease.

Drugs 130

Drugs Clinical Trials Clinical Trials Genetics 130

Drug Discovery World

SEPTEMBER 12, 2023

Twist Bioscience and Ono Pharmaceutical will combine their efforts to discover and develop novel antibodies for the treatment of autoimmune diseases. Under the terms of the agreement, Twist will use its ‘Library of Libraries’ to conduct research activities to discover novel antibodies against targets identified by Ono.

Antibody 72

Antibody Sales Production Development 72

Pharmaceutical Technology

APRIL 17, 2023

Nine universities and research institutes, along with seven medical and industry partners, will work on the IN-ARMOR project across nine EU countries. The therapy will undergo pre-clinical validation for safety and efficacy, to ensure that it meets all investigational medicinal product requirements.

Drug Delivery Systems 147

Drug Delivery Systems Drug Delivery Bacteria Drugs 147

Camargo

OCTOBER 14, 2021

None of the presentations revealed anything new outside of the commitment letter, but some may have indicated areas which the FDA intends to focus on and/or emphasize: The Split Time Application Review (STAR) pilot that seeks to expedite patient access to novel uses for existing therapies to treat serious conditions with unmet medical needs.

Development 189

Development Packaging Packaging Generic Drugs 189

Worldwide Clinical Trials

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Gene Editing 184

Gene Editing Gene Gene Therapy In-Vivo 184

Pharmaceutical Technology

FEBRUARY 3, 2023

The company plans to assess these product candidates as potential treatments for many psychiatric and neurological conditions. Additionally, the company will receive a royalty on net sales of each licensed product. In preclinical models of mood and anxiety disorders, GFB-887 showed compelling benefits.

Licensing 130

Licensing Licensing Sales Development 130

XTalks

JUNE 14, 2023

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 Attendees will understand best practices for novel drug delivery design and development. As a water-free product, it does not have an associated pH value or osmolarity.

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

Pharmaceutical Technology

SEPTEMBER 28, 2022

Seagen also will make potential development, regulatory and commercial milestone payments of up to nearly $650m, as well as royalty payments on the sales of the product in the future. The therapy uses the Gammabody technology of Lava to act on EGFR-expressing solid tumours.

Licensing 130

Licensing Licensing Development Sales 130

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

FDA Approval 130

FDA Approval Pharmacy Marketing Branding 130

Drug Discovery World

FEBRUARY 20, 2024

The contract was awarded by the Defense Threat Reduction Agency’s (DTRA) Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense (CBD) Program, through the Medical Chemical, Biological, Radiological, and Nuclear (CBRN) Defense Consortium (MCDC) requirement 22-05, ‘Adjuvant Activity to Vaccines Prototype’.

Vaccination 52

Vaccination Vaccine Development Immune Response 52

Pharmaceutical Technology

JULY 7, 2022

In December last year, China’s National Medical Products Administration (NMPA) granted approval for amubarvimab/romlusevimab combination to treat mild and normal Covid-19 in adults and paediatric patients aged 12 to 17 years. “Our The initial commercial batch of the antibody therapy was released on 7 July this year.

Antibody 264

Antibody Clinical Trials Clinical Trials Production 264

Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases. Under CDER’s eligibility criteria, the product must be intended to treat rare neurodegenerative conditions, including those of rare genetic metabolic type.

Clinical Trials 52

Clinical Trials Clinical Trials Production Regulation 52

BioTech 365

APRIL 26, 2021

Novel Foods CBD Products Validation from the Foods Standards Agency Novel Foods CBD Products Validation from the Foods Standards Agency UK Regulator decision cements EMMAC’s position as a leader in the medical cannabis and CBD wellness market across the UK … Continue reading →

Production 52

Production Regulation Marketing 52

Pharmaceutical Technology

DECEMBER 6, 2022

Evaxion CEO Per Norlén said: “We believe that ExpreS 2 ion´s superb platforms for the production of complex proteins are a great match with our AI platform for target discovery and our novel technologies for inducing strong immune responses.

Vaccination 130

Vaccination Vaccine Development Immune Response 130

Worldwide Clinical Trials

FEBRUARY 21, 2024

Using both traditional and novel approaches, we ensure recruitment and retention of optimal study participants by thoroughly screening our subjects. This process involves a careful assessment of medical history and daily bowel habits.

Clinical Trials 196

Clinical Trials Clinical Trials Pharmacy Trials 196

Roots Analysis

AUGUST 7, 2023

Over the past 50 years, the medical device industry has seen several notable developments. In fact, the use of biomedical devices, such as medical implants, surgical instruments, and prostheses has increased substantially over the time. Every year, millions of individuals undergo surgeries and implantations.

Marketing 52

Marketing Engineer Production Development 52

Pharmaceutical Technology

OCTOBER 17, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended granting conditional marketing authorization (CMA) for Boehringer Ingelheim’s spesolimab as a therapy option in adults with generalised pustular psoriasis (GPP) flares.

Antibody 130

Antibody Clinical Trials Clinical Trials Medicine 130

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. The meeting has several goals: Discuss issues critical to early product development.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

pharmaphorum

OCTOBER 12, 2022

Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives. Understand the latest regulatory requirements from regulatory experts surrounding medical devices and digital health. Claus Geiger, Global Medical Device Leader, Sanofi.

Drugs 52

Drugs Packaging Packaging Drug Delivery 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

Helping to make drug launch possible for these innovators is a growing number of commercialisation vendors offering services for market access, product distribution, sales, and commercial support. We’re doing this all the time – constantly taking new products into the markets that we’re familiar with.

Drugs 130

Drugs Pharma Companies Sales Production 130

XTalks

NOVEMBER 28, 2023

An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence. Kesin Pharma is headquartered in New York and focuses on the development, manufacturing and commercialization of generic and innovative products in liquid and semi-solid dosage forms.

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FDA Approval Bacteria DNA Drugs 103

Drug Discovery World

FEBRUARY 1, 2024

“We were able to achieve a process minimisation without compromising the quality of the operations or the characteristics of the resulting product.” The post Novel CAR T-cell vein-to-vein process could reduce time and cost appeared first on Drug Discovery World (DDW).

Protein 59

Protein Production Development Gene Therapy 59

pharmaphorum

OCTOBER 25, 2022

Healthware, as the key R&D partner, has been supporting Orion Corporation to design and develop a novel treatment, a Digital Therapeutics software solution “ Rohkea ” to treat Chronic Pain ( DTxP ) using Virtual Reality ( VR ). The attendance is free but requires registration here.

Clinical Trials 91

Clinical Trials Clinical Trials Trials Medicine 91

XTalks

MARCH 13, 2024

This year’s week-long campaign is a platform for eye care professionals, health organizations and the medical device and healthcare industry to share the latest knowledge and innovations being explored and tested in the fight against glaucoma. The theme for World Glaucoma Week 2024 is “Uniting for a Glaucoma-Free World.”

Gene Therapy 111

Gene Therapy Gene Life Science DNA 111

Pharmaceutical Technology

DECEMBER 22, 2022

This consists of any projects that have expanded the company’s footprint in the sector, including: contract wins; launching in new territories; launching new product lines; the acquisition and expansion of facilities and real estate; acquisition of new machinery or other assets; improved logistics; partnerships; and significant staff increases.

Insulin 130

Insulin Production Development Genetics 130

Pharmaceutical Technology

MAY 9, 2023

Zibbell says that similar to how fentanyl was first used to turbocharge a weakened heroin product, people may be using xylazine to extend fentanyl’s extremely short high. There will undoubtedly be other novel and similar substances coming down the pike.”

Drugs 278

Drugs Regulation Containment Scientist 278

FDA Law Blog

APRIL 8, 2024

That sterile injectables may be more vulnerable to supply change disruptions is not a novel concept. In the White Paper, HHS recognizes that “these challenges affect other products, and therefore, the solutions described here may be applicable in other markets.” In Section I.A, surgical robots, MRIs)?

Drugs 59

Drugs Manufacturing Generic Drugs Production 59