Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% 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.

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Food and Drug Administration FDA Food Safety 116

Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. It will focus on studying and developing new lipid nanoparticle (LNP) formulations for the delivery of RNA medicine.

Medicine 97

Medicine Side effects Manufacturing Leads 97

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. This will improve accessibility to services for AAV-mediated gene therapy programmes.

Manufacturing 102

Manufacturing Patients Medicine Leads 102

pharmaphorum

OCTOBER 26, 2022

Topicals — creams, ointments, foams, and lotions applied directly to the affected areas of the skin — don’t get nearly as much TV time as their systemic biologic counterparts, the self-injectables with catchy theme songs, where the smiley and sleeveless walk confidently down the street and/or swim. First in class. In May, the U.S.

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Side effects Food and Drug Administration Patients Management 94

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.

Food and Drug Administration 98

Food and Drug Administration FDA Medical science Food 98

European Pharmaceutical Review

OCTOBER 13, 2022

The research, published in the journal Science Robotics described how the new drug delivery system can transport large protein and small-molecule drugs, like vancomycin, an antibiotic peptide. Traditionally, delivering protein drugs orally has been challenging. The capsule is also coated with small studs that brush mucus away.

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Transportation Engineering Leads Medical 137

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). We look forward to the continued development of DTx-1252.” Topic sponsors are not involved in the creation of editorial content.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. in patients with seborrheic dermatitis.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

Pharma Leaders

APRIL 25, 2023

The drug candidate is an investigational radiopharmaceutical that targets prostate-specific membrane antigen, a protein found on normal prostate cells, but found in higher concentrations on prostate cancer cells. Related Topics

Biopharma 52

Biopharma FDA Medical 52

Pharmaceutical Technology

FEBRUARY 16, 2023

The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development. Under the deal, MD Anderson and Xilis aim to advance the development of drug and discovery projects using the MOS technology.

Pharmaceutical 96

Pharmaceutical Patients Medicine Leads 96

Pharmaceutical Technology

FEBRUARY 16, 2023

Ophthalmic technology firm Eyenovia and Formosa Pharmaceuticals have entered a collaboration agreement to develop new ophthalmic therapeutics. The collaboration will combine the Optejet dispensing technology of Eyenovia with the APNT nanoparticle formulation platform of Formosa to develop topical therapeutics.

Food and Drug Administration 59

Food and Drug Administration Food Pharmaceutical FDA 59

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte has signed a partnership and licence agreement with CMS subsidiary CMS Aesthetics to develop and market ruxolitinib cream to treat autoimmune and inflammatory dermatologic ailments in Greater China and some Southeast Asian countries. Ruxolitinib cream is the first topical inhibitor of JAK to obtain approval in the US.

Food and Drug Administration 52

Food and Drug Administration Healthcare Provider Food Patients 52

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government.

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Government FDA Pharmaceutical Pharma 105

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.

Biopharma 105

Biopharma Pharmaceutical Manufacturing Patients 105

Pharmaceutical Technology

APRIL 14, 2023

Twist Bioscience has introduced Twist T-cell receptor (TCR) and Twist chimeric antigen receptor (CAR) libraries to facilitate the development of cell therapies. Researchers will now be able to speed up the creation of tailor-made libraries that can help in identifying and developing new cell therapies.

Leads 98

Leads Pharmaceutical Patients 98

Pharmaceutical Technology

FEBRUARY 9, 2023

The collaboration is aimed at discovering and developing new advanced treatments for genitourinary (GU) tumours as well as other related serious diseases using ReviR’s RNA-targeted technologies. ReviR combines computational and high throughput drug discovery technologies to deliver advanced medicines to patients.

Biopharma 96

Biopharma Pharmaceutical Patients Marketing 96

Pharmaceutical Technology

MAY 23, 2023

Avrobio will retain complete rights to its HSC gene therapies portfolio developed to treat Pompe disease, Gaucher disease type 1 and type 3, and Hunter syndrome. In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration.

Food and Drug Administration 103

Food and Drug Administration Food Leads Pharmaceutical 103

European Pharmaceutical Review

NOVEMBER 11, 2022

A paper, published in the European Journal of Pharmaceutical Sciences identified the quality assurance (QA) challenges and trends of analytical techniques in ocular drug delivery and formulation, focusing on treatments for glaucoma. seven covered testing in combination drugs. Impurity profiling PGF2? for latanoprost.”

Pharmaceutical 95

Pharmaceutical Safety Medicine 95

European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). The gene therapy is a topical gel that restores functional copies of the COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.

Food and Drug Administration 101

Food and Drug Administration Medicine FDA Food 101

World of DTC Marketing

FEBRUARY 7, 2021

Drug Discovery and Manufacturing: It helps in the initial screening of drug compounds to the predicted success rate based on biological factors. Precision medicine or next-generation sequencing helps in the faster discovery of drugs and tailored medication for individual patients. . Measuring RNA, DNA quickly.

Pharma 164

Pharma Doctors Side effects Physicians 164

Pharmaceutical Technology

OCTOBER 19, 2022

Akouos focuses on developing adeno-associated viral gene therapies to treat inner ear conditions, including sensorineural hearing loss. It has combined expertise in otology, gene therapy and inner ear drug delivery to meet the requirements of individuals with disabling hearing loss globally.

Pharmaceutical 119

Pharmaceutical Medicine Leads Medical 119

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. The latest development comes after GreenLight signed a partnership with the US National Institutes of Health (NIH) to develop Covid-19 vaccines against new variants.

Engineering 104

Engineering Manufacturing Pharmaceutical 104

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. Topic sponsors are not involved in the creation of editorial content.

Food and Drug Administration 96

Food and Drug Administration Manufacturing FDA Food 96

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Drug pricing was a hot-button topic, and William Newton found that while e-commerce chains could cut insulin prices , any major change won’t happen overnight.

Healthcare 122

Healthcare Healthcare Pharma Medical 122

Clarivate

SEPTEMBER 19, 2023

Finally, we look at recent Nobel Prizes and judge whether the topics identified would likely receive attention within next few years. Although we do not forecast a topic or researchers for the Nobel Prize in the year we name them Citation Laureates, we do try to anticipate near-term awards.

Electronics 111

Electronics Medicine Government Patients 111

Clarivate

JANUARY 23, 2024

R&D productivity fell in 2022, but late-phase cancellations are also trending down The rise and fall of R&D productivity across the global biopharmaceutical industry is a well-documented and much discussed topic, with industry commentators quantifying productivity in many ways (e.g., Learn more about purchasing it here.

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Pharma Sales Consulting Pharmaceutical 52

Pharmaceutical Technology

JUNE 10, 2023

TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. The drug candidate acts as selective non-ATP competitive inhibitor of AKT.

Pharmaceutical 40

Pharmaceutical Pharmaceutical products Medicine Competition 40

Pharmaceutical Technology

JUNE 10, 2023

TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. The drug candidate acts as selective non-ATP competitive inhibitor of AKT.

Pharmaceutical 40

Pharmaceutical Pharmaceutical products Medicine Competition 40

Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. The company will help in managing the clinical trials of the products once the regulators provide approvals for the proposed research and development programmes.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 52

Pharma Leaders

APRIL 14, 2023

The FDA grants the Fast Track designation to facilitate development and expedite review of new therapeutics to treat serious or life-threatening conditions and to address unmet medical needs. The agency previously granted RGX-202 Orphan Drug and Rare Pediatric Disease designations. Related Topics

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FDA Medical Patients 52

PharmaTech

SEPTEMBER 19, 2022

fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Discovery the industry's best kept secret.a

Manufacturing 40

Manufacturing 40

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 103

Pharmaceutical Food and Drug Administration Medicine FDA 103

Pharmaceutical Technology

APRIL 21, 2023

Samyang has entered into a strategic partnership agreement with LG Chem to develop new cancer therapeutics using Samyang’s technology, NanoReady. LG Chem will use the technology for the development of innovative mRNA-based cancer therapeutics with maximised therapeutic efficacy.

Patients 52

Patients Leads Pharmaceutical 52

Pharmaceutical Technology

FEBRUARY 23, 2023

“This collaboration will enable us to utilise our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based Covid-19 vaccine and its therapeutic candidates.” With its technical strength and customer-centric approach, GenScript ProBio will help to accelerate the development of RVAC’s pipeline.”

Manufacturing 115

Manufacturing Medicine Consulting Pharmaceutical 115

pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Connected Drug Delivery Devices. Hear about new technological advances in the delivery of large volume drugs. Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives.

Engineering 52

Engineering Safety Consulting Medical 52

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Topic sponsors are not involved in the creation of editorial content.

Manufacturing 52

Manufacturing Government Safety Pharmaceutical 52