Pharmaceutical Technology

JULY 19, 2022

as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor. In non-segmental vitiligo patients, it is indicated for continuous topical use twice a day to affected regions of up to 10% body surface area.

Food and Drug Administration 116

Food and Drug Administration FDA Food Safety 116

Pharmaceutical Technology

JUNE 9, 2023

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.

Food and Drug Administration 98

Food and Drug Administration FDA Medical science Food 98

Pharmaceutical Technology

APRIL 20, 2023

Situated at the hub of the country’s northeastern pharmaceutical corridor, the new facility is staffed by research, application and formulation specialists. The centre will also organise manufacturing-based seminars on topics such as improving wet/dry granulation procedures and approaches for continuous manufacturing.

Pharmaceutical 52

Pharmaceutical Training Manufacturing Pharma 52

Pharmaceutical Technology

MAY 12, 2023

The in vivo study, conducted in mice, involved a phosphatidylserine-containing nano-formulation of mRNA supplied by BioNTech, distinct from traditional lipid nanocrystals (LNCs). Matinas said it developed this unique formulation to “handle the physical complexity and biological fragility of mRNA”.

Leads 52

Leads Pharmaceutical Patients 52

PM360

OCTOBER 27, 2022

a clinical-stage biopharmaceutical company focused on gene therapies for dermatological diseases, recently announced positive results from a Phase 3 clinical trial on its investigational compound Beremagene Geperpavec (B-VEC), a topical gene therapy designed to treat the debilitating skin condition dystrophic epidermolysis bullosa (DEB).

Safety 104

Safety Patients FDA Medical 104

pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

FDA 52

FDA Side effects Prescription Medical 52

Pharmaceutical Technology

APRIL 19, 2023

Arcutis Biotherapeutics president and CEO Frank Watanabe stated: “The acceptance of the NDA for roflumilast foam marks a major milestone toward our goal of bringing a steroid-free, topical foam treatment option to market, addressing a significant unmet need for individuals living with seborrheic dermatitis. “If

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte could also grant a potential licence to CMS for other topical formulations of ruxolitinib to treat ailments, such as vitiligo and atopic dermatitis, in the future, for patients in mainland China, Hong Kong, Macau, Taiwan and some Southeast Asia nations.

Food and Drug Administration 52

Food and Drug Administration Healthcare Provider Food Patients 52

Pharmaceutical Technology

APRIL 17, 2023

CannQuit-Nicotine combines nicotine and cannabidiol (CBD) in a controlled-release, pharmaceutical-grade medicated chewing gum formulation. ReneCann is Incannex’s topical cannabinoid formulation and is being developed to treat dermatological conditions caused by immune system disorders, including atopic dermatitis, psoriasis and vitiligo.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 52

European Pharmaceutical Review

AUGUST 22, 2023

Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing. Theragenix aims to develop the world’s first dry powder gene therapy formulation for bone graft augmentation. The investment aims to improve vaccines and shorten the time it takes to produce medicines.

Medicine 92

Medicine Manufacturing Biopharma Competition 92

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. million people in the US.

FDA 92

FDA Side effects Sales Safety 92

European Pharmaceutical Review

FEBRUARY 24, 2023

About ruxolitinib cream Ruxolitinib cream is a novel cream formulation of Incyte’s selective Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib, approved by the US Food & Drug Administration (FDA) for topical treatment of nonsegmental vitiligo in patients 12 years of age and older.

Food and Drug Administration 102

Food and Drug Administration Medicine Medical Food 102

Pharmaceutical Technology

JULY 12, 2022

The Roflumilast cream is a once-a-day topical formulation of the selective phosphodiesterase type 4 (PDE4) inhibitor, roflumilast. Health Canada has accepted to review Arcutis Biotherapeutics’ New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adult and adolescent patients.

Food and Drug Administration 64

Food and Drug Administration Safety Food Pharmaceutical 64

Pharmaceutical Technology

AUGUST 2, 2022

GreenLight’s process from formulation of the drug substance and lipid nanoparticle to bulk drug product can be carried out in this facility. Topic sponsors are not involved in the creation of editorial content. Furthermore, the mRNA synthesis reaction of GreenLight had a titer of 12g/L at a commercial scale and yielded 650g mRNA.

Engineering 104

Engineering Manufacturing Pharmaceutical 104

Pharmaceutical Technology

JUNE 10, 2023

It is investigating its lead candidate, daxibotulinumtoxinA, a topical gel formulation as a needle-free approach for a wide range of therapeutic and aesthetic indications, such as chronic migraine, facial wrinkles and muscle disorders.

Manufacturing 52

Manufacturing Leads Marketing Patients 52

Pharmaceutical Technology

JUNE 10, 2023

It is investigating its lead candidate, daxibotulinumtoxinA, a topical gel formulation as a needle-free approach for a wide range of therapeutic and aesthetic indications, such as chronic migraine, facial wrinkles and muscle disorders.

Manufacturing 52

Manufacturing Leads Marketing Patients 52

European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

Manufacturing 97

Manufacturing Government Safety Medicine 97

Pharmaceutical Technology

OCTOBER 31, 2022

As such, analgesics with innovative MOAs—including anti-nerve growth factors (anti-NGFs; fasinumab), an IA formulation of capsaicin (CNTX-4975), and novel improved formulations of marketed therapies (X-0002)—continue to be studied in clinical trials. in the US) and opioids (CAGR 1.0% in the US).

Marketing 59

Marketing Sales Patients Competition 59

pharmaphorum

OCTOBER 18, 2022

It combines dexamethasone, an approved active ingredient proven as effective and safe in the treatment of DME, with Oculis’ novel formulation Optireach technology, which facilitates active ingredient access to the back of the eye. glaucoma), the OCS-05 proof-of-concept trial in acute optic neuritis.

Biopharma 59

Biopharma Management Specialization Physicians 59

Pharmaceutical Technology

APRIL 21, 2023

The company stated that bringing together advanced formulation discovery and generative AI will help in designing new mRNA medicines with optimal safety and performance. Topic sponsors are not involved in the creation of editorial content. Moderna aims to leverage MoLFormer to optimise lipid nanoparticles and mRNA.

Medicine 98

Medicine Networking Safety Leads 98

Pharmaceutical Technology

JULY 6, 2022

These involve mRNA molecule engineering, including sequence modifications to enhance stability and boost protein expression, and mRNA vaccine formulations appropriate for SARS CoV-2 vaccines. Topic sponsors are not involved in the creation of editorial content.

Distribution 72

Distribution Engineering Pharmaceutical Sales 72

European Pharmaceutical Review

JULY 13, 2023

6 There is vast heterogeneity of products available to study owing to there being over 140 cannabinoids identified from the cannabis plant to date Medical cannabis can be manufactured into several formulations, including oils, dried flowers, capsules, suppositories and topical ointments. This could lead to significant research waste.

Medical 90

Medical Food and Drug Administration Pharmacology Medicine 90

Pharmaceutical Technology

JUNE 1, 2023

It will focus on studying and developing new lipid nanoparticle (LNP) formulations for the delivery of RNA medicine. Topic sponsors are not involved in the creation of editorial content. The centre will provide innovators in the area of drug discovery and development access to new capabilities in intracellular drug delivery.

Medicine 97

Medicine Side effects Manufacturing Leads 97

European Pharmaceutical Review

MARCH 10, 2023

Currently, effective topical administration is challenging as the industry aims to prolong drug residence time and guarantee appropriate ocular permeation. How to enhance ocular drug bioavailability One approach to enhance drug bioavailability after topical administration is increasing corneal permeability.

Side effects 80

Side effects Management Leads Safety 80

pharmaphorum

AUGUST 19, 2022

The drug works via the same target as capsaicin, a compound found in chilli peppers that is used in some topical formulations for pain relief in arthritis and other conditions, but is much more potent.

Side effects 52

Side effects Recruitment Safety Patients 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

This has led to applications with biopharmaceutical formulations and protein investigations. Analysis of biopharmaceutical formulations by Time Domain Nuclear Magnetic Resonance (TD-NMR) spectroscopy: A potential method for detection of counterfeit biologic pharmaceuticals. IPQ International Pharmaceutical Quality. Cited 2023Feb].

Pharmaceutical 97

Pharmaceutical Manufacturing Food Electronics 97

Pharmaceutical Technology

APRIL 21, 2023

When combined with mRNA therapeutic molecules developed by LG Chem, the pre-made drug delivery formulation helps to simplify and improve the combination process. Topic sponsors are not involved in the creation of editorial content. The company stated that NanoReady provides high versatility to different mRNA molecules.

Patients 52

Patients Leads Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 22, 2022

In addition, the storage of mRNA therapeutics is important as this can affect the long-term stability of carrier-mRNA formulations. While mRNA technologies still face long-term safety and efficacy evaluations, recent developments in new materials and delivery formulations are becoming effective solutions to enhancing therapeutic efficacy.

Medicine 110

Medicine Food and Drug Administration Transportation Distribution 110

Pharmaceutical Technology

OCTOBER 5, 2022

Under the partnership, the anti-DUX4 RNA therapy of miRecule will be merged with the muscle-targeted NANOBODY technology of Sanofi to fuse the two molecules into an ARC using the NAVIgGator conjugation and formulation chemistry of the former. Topic sponsors are not involved in the creation of editorial content.

Pharmaceutical 52

Pharmaceutical Sales Leads Patients 52

Pharmaceutical Technology

AUGUST 17, 2022

Other capabilities include upstream processing in 2D flask and 3D bioreactor systems, downstream purification for attaining preferred purity and potency, as well as complete analytical characterisation of the resultant cell or exosome therapy that is formulated. . Topic sponsors are not involved in the creation of editorial content.

Manufacturing 52

Manufacturing Networking Media Engineering 52

pharmaphorum

OCTOBER 12, 2022

Sustainability for Injectable Delivery Devices. Primary Packaging Development. Connected Drug Delivery Devices. This event will not only bring you key insights you need to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. find out more at [link].

Engineering 52

Engineering Safety Consulting Medical 52

pharmaphorum

SEPTEMBER 28, 2022

The US Paediatric Research Equity Act authorises the FDA to require studies for new drugs and biologics, as well as new indications and formulations of already-approved products, in children, and there are also financial incentives to do so in the form of an additional six months of market exclusivity.

FDA 59

FDA Ethics Prospecting Safety 59

European Pharmaceutical Review

OCTOBER 5, 2023

What are the key topics you plan to cover during your session at CPHI Barcelona? I firmly believe that manufacturing plays a pivotal role in this endeavour, and I will delve into topics such as production system optimisation and the standardisation of chemistry, manufacturing, and control (CMC) processes.”

Manufacturing 90

Manufacturing Consulting Patients Marketing 90

pharmaphorum

NOVEMBER 28, 2022

Action is now being taken across many industries to face down this threat, with the report compiling the lessons learnt across industries to formulate a pathway for companies to make the transition to being more sustainable.

Pharma 97

Pharma Consulting Education Management 97

European Pharmaceutical Review

JANUARY 29, 2024

LBDDS formulations enhance the bioavailability of poorly soluble drugs and “have a proven track record of innovative and commercial success”. LBDDS formulations enhance the bioavailability of poorly soluble drugs and “have a proven track record of innovative and commercial success”. 25 Sun et al. Eur Pharm Rev. 2023; 28(6): 5.

Pharmaceutical 102

Pharmaceutical Food and Drug Administration Medicine FDA 102

PM360

OCTOBER 13, 2023

FDA Update Drug Approvals The FDA approved Biogen’s Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Genentech’s Actemra. for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

Pharmaceutical Technology

SEPTEMBER 7, 2022

This includes Kodiak Sciences’ KSI-301 and Roche’s Susvimo (ranibizumab sustained release formulation), the latter of which is already approved for wet age-related macular degeneration (AMD) and has a significantly reduced frequency of administration of two days a year.

Food and Drug Administration 52

Food and Drug Administration Marketing Food Patients 52