The Pharma Data

AUGUST 21, 2020

Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments. The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider.

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The Pharma Data

NOVEMBER 9, 2020

Image: Copyright © 2009-2020 Merck Sharp & Dohme Corp., The product is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight off tumor cells. a subsidiary of Merck & Co., Kenilworth, N.J., All rights reserved. Merck , also known as MSD outside of the U.S. Source link.

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Drug Target Review

APRIL 8, 2024

How have recent advancements in immune checkpoint blockade therapy affected outcomes for primary NSCLC? Dr Govindan : Even though immunotherapy and chemotherapy given after surgery improve the overall survival, as Dr Cote said, many may not need those therapies and a good number of them recur despite post operative systemic therapies.

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The Pharma Data

NOVEMBER 10, 2020

SAMI is a renal replacement therapy (RRT) machine manufactured and commercialized by Spectral’s wholly-owned subsidiary, Dialco Medical Inc. ( “Dialco” ). The paper describes the first month of using SAMI as part of UMMC’s PIRRT (Prolonged Intermittent Renal Replacement Therapy) program throughout April 2020.

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The Pharma Data

JANUARY 20, 2021

Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, today announced the pricing of an underwritten public offering of 14,285,714 shares of its common stock at a price to the public of $7.00 SOUTH SAN FRANCISCO, Calif.,

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Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 2009 Sep;14(17–18):876–84. Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling.

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New Drug Approvals

SEPTEMBER 13, 2024

16] [17] The compound was first patented in 2009. [18] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 16] [17] The compound was first patented in 2009. [18] 16] [17] The compound was first patented in 2009. [18]

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s In September 2014—nearly ten years ago!

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The Pharma Data

NOVEMBER 25, 2020

It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. 2009 Oct 7; 15(37): 4638-4643. Vifor Pharma Group is a global pharmaceuticals company. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Qual Life Res. 2000;9:491-497. Favrat, B.,

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International Pharmaceuticals Disease Pharmaceutical Companies 52

The Pharma Data

MARCH 27, 2022

and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis and is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. It is approved in the U.S.

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Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. The first project, REMIND, began in 2009. View our database of DARPA neurotechnology projects online. “I am a brain, Watson.

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Engineering Research Science FDA Approval 52

The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs.

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Trials FDA Clinical Trials Disease 52

DrugBank

JUNE 27, 2023

Their use, as well as their integration into other types of data, has enabled the development of more precise therapies. 5 , e1000433 (2009). Out of the millions of genetic variants present in human populations, GWAS are designed to uncover those associated with specific traits or diseases. PLoS Genet.  Kennedy, A. Ozbek, U. &

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The Pharma Data

NOVEMBER 11, 2020

KSI-301 is an investigational anti-VEGF therapy built on the Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. About KSI-301.

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The Pharma Data

NOVEMBER 17, 2020

In 2009 Tony took on the challenge of a new start up in San Antonio at RMATX that has grown to 2 IVF centers and 2 satellite centers. She speaks nationally and internationally on how cancer and autoimmune disease therapies affect reproductive health and fertility, ovarian aging, primary ovarian insufficiency and genetics.

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New Drug Approvals

SEPTEMBER 7, 2024

Although compounds have been reported to inhibit 3CLpro activity, they have not been approved as coronavirus therapies. As there is no human homolog of 3CLpro, it is an ideal antiviral target.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

I joined the FARA staff in 2009, and our team built a nationwide series of bike rides called rideATAXIA to raise funds for research. I completed a few long-distance rides and raised some funds for research, and in the process, I realized this is what I wanted to do with the rest of my life.

Disease 52

Disease Clinical Trials Trials Treatment 52

Agency IQ

JUNE 7, 2024

The Notified Body Operations Group (NBOG) published a best practice guide in 2009 that defined the scope of designation for a Notified Body under all three medical product directives. The competent authorities devised a coding system to describe the depth and breadth of the designation scope.

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Agency IQ

APRIL 12, 2024

Member State, with orphan drugs or advanced therapy products’ requirements limited to the applicable patient population. The new compromise Article 58a requires marketing authorization holders to submit an application for pricing and reimbursement negotiation in response to the request by an E.U.

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Drug Target Review

JUNE 29, 2023

I think the cell-therapy field has evolved a lot – and is continuing to do so – in the time I’ve been working with this. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. I mean, I think cell-therapy is an great place to be.

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Therapies Science Production Cell Biology 116

Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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Disease Clinical Trials Therapies Science 112

The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. 7,8,9,10,11.

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Trials Therapies Disease Treatment 52

Codon

APRIL 9, 2023

” — Harold Morowitz 🔥 Ten Amazing Things (that happened this week…) A CAR-T therapy was tested in 27 children with neuroblastomas. Read Ocular stress enhances contralateral transfer of lenadogene nolparvovec gene therapy through astrocyte networks. Molecular Therapy. Gene Therapy. McGrady N.R.

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The Pharma Data

MARCH 9, 2021

ViiV Healthcare has begun the phase IIb study of GSK’254, to evaluate the efficacy, safety, and tolerability of this maturation inhibitor as part of a combination therapy for treatment naïve adults living with HIV. About ViiV Healthcare.

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The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

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Clinical Trials DNA Trials Treatment 52

The Pharma Data

OCTOBER 14, 2020

is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. About ImmunityBio ImmunityBio, Inc.

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Vaccine Trials FDA Clinical Trials 40

The Pharma Data

MARCH 2, 2021

The findings that will be presented at CROI 2021 reflect this goal, with new data that further establish our leadership in long-acting therapies for HIV treatment and prevention, as well as proof-of-concept data from our early pipeline that explore a new mechanism of action maturation inhibitor. Kimberly Smith, M.D., About ViiV Healthcare.

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Treatment Pharmacokinetics Licensing Licensing 52

LifeSciVC

APRIL 14, 2023

Fundamentally, we continue to believe this is great time for skilled venture creation strategies to take cutting-edge science and back seasoned management teams to advance it into innovative new therapies for patients!

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Marketing Science Therapies Drugs 52

PLOS: DNA Science

OCTOBER 17, 2024

The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. Until today, there were no approved therapies in the US. The original approved was in 2003 to treat a type of Gaucher disease. FDA approval of Miplyffa marks a significant moment for those living with NPC and the global NPC community.

Disease 52

Disease FDA Approval Drugs Treatment 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Clin Infect Dis.

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New Drug Approvals

DECEMBER 3, 2022

“Bcl-2 inhibitors: small molecules with a big impact on cancer therapy.” Jump up to: a b Hauck P, Chao BH, Litz J, Krystal GW (April 2009). Bibcode : 2016NatCo…711190Y. doi : 10.1038/ncomms11190. PMC 4823827. PMID 27048913. Vogler, Meike, et al. ” Cell Death & Differentiation 16.3 2008): 360–367.

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Small Molecule Clinical Trials Laboratories Regulations 52

The Pharma Data

OCTOBER 9, 2021

STELARA is the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, both of which play an important role in inflammation associated with immune-mediated diseases like PsA.

Treatment 52

Treatment FDA Approval FDA Pharmaceutical Companies 52

The Pharma Data

APRIL 24, 2021

In 1999, Novartis launched the first fixed-dose Artemisinin-based Combination Therapy (ACT) and in 2009, the first dispersible pediatric ACT developed in partnership with Medicines for Malaria Venture (MMV). Follow us on social media at #MalariaFuture.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

APRIL 8, 2021

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19.

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Hospitals FDA Approval Laboratories Treatment 52

The Pharma Data

MAY 4, 2021

ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1] ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1]

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The Pharma Data

NOVEMBER 8, 2020

The HPTN 084 study, with 3,223 participants in 20 sites across seven countries in sub-Saharan Africa (Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe), is the first study of long-acting injectable therapy for HIV prevention among women. For more information, visit hptn.org.

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Trials Treatment Science Research 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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