Fierce BioTech

JULY 25, 2023

How combining datasets from multiple sources can inform and improve commercial strategies Hundreds of rare disease treatments have entered the market over the past decade—thanks largely to a combination of government incentives, strong urging from patient advocacy groups and advances in cell and gene therapies.

Pharma Companies 52

Pharma Companies Government Therapies Disease 52

The Pharma Data

OCTOBER 27, 2020

FDA Investigational New Drug application to test Ortho-R, our lead Chitosan-PRP hybrid drug/biologic implant combination product, for rotator cuff tear repair in patients” The OTCQB Venture Market is the premiere marketplace for early stage and developing U.S. View original content to download multimedia: [link]. Source link.

Marketing 40

Marketing Clinical Trials FDA International 40

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer. View original content to download multimedia: [link]. SAN CARLOS, Calif. , 15, 2020 /PRNewswire/ — Apexigen, Inc. ,

Treatment 40

Treatment Immune Response Clinical Trials Clinical Development 40

The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

Clinical Trials 52

Clinical Trials Treatment Trials Virus 52

The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. ,

FDA 40

FDA Marketing Therapies Treatment 40

DrugBank

AUGUST 20, 2024

We provide insights into how you can improve efficiency, success rates, and ultimately bring more effective therapies to market.   Download Unlocking Undruggable Targets: Biotechnology’s Role in Expanding Drug Discovery today. Despite significant investments, the path to approval is fraught with difficulties.

Therapies 72

Therapies Pharmaceuticals Disease Research 72

The Premier Consulting Blog

OCTOBER 24, 2022

The Marketing Authorization (MA) holder for a treatment for onychomycosis, having previously secured regulatory approval in several markets, sought to introduce the product to the European market. What regulatory considerations can come into play?

Production 40

Production Marketing Treatment Disease 40

The ChEMBL-og

MARCH 8, 2023

ChEMBL contains information on drugs that have been approved for treatment of a specific disease / diagnosis (an indication) within a region of the world (e.g. NEVANIMIBE HYDROCHLORIDE ( CHEMBL542103 ) is under clinical investigation for treatment of Cushing syndrome at Phase 2.

Clinical Trials 40

Clinical Trials FDA Approval Trials Treatment 40

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. About Pegunigalsidase Alfa.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

SEPTEMBER 15, 2020

Download Your Copy. We respect your privacy, by clicking “Download Your Copy” you will receive our e-newsletter, including information on Podcasts, Webinars, event discounts, online learning opportunities and agree to our User Agreement. Download Your Copy. Add bookmark.

Regulations 52

Regulations Production Therapies Treatment 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

PPD

OCTOBER 12, 2023

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

SEPTEMBER 11, 2020

In an effort to slow the spread of the disease and prevent a second wave, pharma companies around the world are continuously looking to advance new methods of treatment. DEP remdesivir enables subcutaneous or under the skin injections rather than intravenous infusion, allowing for outpatient treatments and reducing the burden on hospitals.

Clinical Trials 52

Clinical Trials Pharma Companies Trials Hospitals 52

The Pharma Data

AUGUST 19, 2020

Janssen expects nipocalimab to contribute to its goals of achieving above-market growth over the mid and long term. Autoantibody-driven diseases are often serious, and patients are underserved by current treatment options,” said Jennifer Taubert , Executive Vice President, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson.

Disease 40

Disease Pharmaceuticals Treatment Pharmaceutical Companies 40

The Pharma Data

NOVEMBER 1, 2020

Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. “Our novel approach allows us to bring potentially game-changing treatments to patients with neurological diseases.” PARIS , Nov.

Therapies 52

Therapies Science Treatment Disease 52

The Pharma Data

DECEMBER 14, 2020

The IND covers the development of Rabeximod in Covid-19 and other indications, such as rheumatoid arthritis, and is a prerequisite for a future validation of the company’s five recent patent applications in the US market. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. About Cyxone.

FDA 52

FDA Clinical Trials Clinical Development Treatment 52

The Pharma Data

DECEMBER 21, 2020

Extension eliminates out-of-pocket costs for treatment, allowing impacted members to focus on health and recovery for as long as the public health emergency lasts. View original content to download multimedia: [link]. OAKLAND, Calif. , 22, 2020 /PRNewswire/ — With new cases surging throughout the U.S, OAKLAND, Calif. ,

Virus 52

Virus Clinical Research Treatment Regulations 52

The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. STOCKHOLM , Jan.

Disease 40

Disease Pharmaceutical Companies Treatment Licensing 40

PPD

JULY 9, 2024

Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. However, completing this work is only half the challenge.

Compliance 52

Compliance Production Clinical Research Marketing 52

The Pharma Data

DECEMBER 9, 2020

10, 2020 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi ) (STO: SOBI) today announced that a Marketing Authorization Application for emapalumab has been accepted for review in China. The following files are available for download: View original content: [link]. STOCKHOLM , Dec. About emapalumab. Source link.

FDA Approval 40

FDA Approval Therapies FDA Treatment 40

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

Trials 40

Trials Marketing Clinical Trials Regulations 40

The Pharma Data

JANUARY 25, 2021

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. BioArctic focuses on innovative treatments in areas with high unmet medical needs.

Pharmaceutical Companies 40

Pharmaceutical Companies Disease Treatment Pharmaceuticals 40

The Pharma Data

NOVEMBER 23, 2020

CMTI has already been collecting anecdotal data from numerous study participants using prototype devices to evaluate the efficacy of RLT in the treatment of rheumatoid arthritis, chronic inflammation, and various degenerative neuropathies. . View original content to download multimedia: [link].

Therapies 52

Therapies Treatment Production Research 52

The Pharma Data

JANUARY 26, 2021

. Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. US market for overdose rescue medications. The following files are available for download: View original content: [link]. UPPSALA, Sweden , Jan. .

Drugs 52

Drugs Pharmacokinetics Production FDA 52

Perficient: Drug Development

NOVEMBER 15, 2023

Apps and reminders help users keep track of medication schedules, ensuring adherence to prescribed treatment plans and reducing the risk of missed doses. Medication Management Tools: Technology has simplified medication management for individuals with seizure disabilities.

Production 52

Production Treatment Marketing 52

The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

FDA 52

FDA Clinical Trials Drugs Pharmaceutical Companies 52

The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. SOURCE ImaginAb, Inc. Source link.

Licensing 52

Licensing Licensing Clinical Trials Pharmaceutical Companies 52

The Pharma Data

OCTOBER 27, 2020

The FDA’s Fast Track Designation Program aims to expedite the development and review of potential treatments for serious or potentially life-threatening illnesses with high unmet medical needs. Through this venture, Astellas aims to optimize treatment by improving diagnostic accuracy and surgical outcomes. Source link.

FDA 52

FDA Pharmaceuticals Production Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

An issue of SEK denominated senior unsecured callable floating rate bonds in the amount up to SEK 500 million , under a framework of SEK 1,000 million and with a tenor of four years (the “New Bonds”) may follow, subject to, inter alia, market conditions. CONTACT: This information was brought to you by Cision [link].

Production 40

Production Marketing Regulations Therapies 40

Perficient: Drug Development

JUNE 30, 2023

While this model has played a significant role in providing medical care and treatments, it has faced criticism for overlooking the social and environmental factors that contribute to disability and for pathologizing individuals with disabilities.

Treatment 52

Treatment Production Marketing 52

The Pharma Data

OCTOBER 19, 2020

Caris’ collaborative network focused on expanding the application of precision medicine in oncology supports Winship’s enterprising approach to research leading to transformative discoveries in cancer care and treatment. IRVING, Texas and ATLANTA , Oct. Winship is one of 32 U.S. Ramalingam , M.D.,

Clinical Trials 52

Clinical Trials RNA DNA Science 52

The Pharma Data

DECEMBER 8, 2020

The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

RNA 52

RNA Pharmaceuticals Disease Production 52

The Pharma Data

NOVEMBER 18, 2020

“These include high-quality images for treatment planning as well as low-dose images for guidance and quality assurance. . “These include high-quality images for treatment planning as well as low-dose images for guidance and quality assurance. VEENENDAAL, The Netherlands , Nov.

Hospitals 40

Hospitals Treatment Production Marketing 40

The Pharma Data

JANUARY 20, 2021

Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. It also showed that Nefecon was generally well-tolerated.

Trials 52

Trials Clinical Trials Pharmaceutical Companies Treatment 52

The Pharma Data

JANUARY 27, 2021

. “The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. CEO of BioInvent. Readout from two patients is still pending.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 14, 2020

The global GBM treatment market is projected to reach $3.3 representing the largest market. The ability of a drug candidate to cross the blood brain barrier is of critical importance in treatment outcomes for CNS and brain cancers. billion by 2024, according to GlobalData, with the U.S.

Clinical Trials 52

Clinical Trials DNA Drugs Therapies 52