New Drug Approvals

SEPTEMBER 13, 2024

2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7] 16] [17] The compound was first patented in 2009. [18] 2] Aticaprant is taken by mouth. [1]

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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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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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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. This will be achieved by inducing a seizurogenic phenotype using a known seizurogenic compound, and then determining if these changes are reduced by application epilepsy treatments. Neurotoxicology.

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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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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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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

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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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The Pharma Data

NOVEMBER 25, 2020

A new website takeironseriously.com has been launched to educate individuals and healthcare professionals on the symptoms of iron deficiency, demonstrate the ease of diagnosis and encourage people to seek treatment to protect their health. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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The Pharma Data

NOVEMBER 11, 2020

The presentation also refreshes the durability proportions of Phase 1b wet AMD and DME patients who achieved a 6 months or longer treatment-free interval during follow-up and RVO patients who achieved a 4 months or longer treatment-free interval during follow-up.” Chief Executive Officer. About the BEACON Study.

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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. The present invention provides the process of novel compounds which act in inhibiting or preventing SARS-CoV-2 viral replication and thus are used in the treatment of COVID-19 (see PCT/US21/60247).

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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. MEPS welcomed the modulated orphan drug incentives to steer research to rare diseases that don’t have treatments. Wölken cited the figure that 95% of rare diseases still don’t have any treatments.

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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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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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The Pharma Data

MARCH 9, 2021

Because maturation inhibitors use a unique mechanism of action that targets HIV differently than other antiretrovirals currently available, they have the potential to offer new treatment options for individuals who may have experienced resistance to other classes of HIV treatment. Kimberly Smith, M.D., Kimberly Smith, M.D.,

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The Pharma Data

MARCH 2, 2021

and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March. Kimberly Smith, M.D.,

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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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The Pharma Data

OCTOBER 9, 2021

With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. A decision from the U.S. FDA is anticipated in late 2022. “As

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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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PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. “Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. Bluebird Bio developed the new drug.

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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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The Pharma Data

APRIL 8, 2021

“There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients,” said co-primary investigator E. These important findings advance our pursuit of treatment options to save lives in hospitalized COVID-19 patients.” Baricitinib-treated patients were 2.7

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Codon

APRIL 9, 2023

.” — Harold Morowitz 🔥 Ten Amazing Things (that happened this week…) A CAR-T therapy was tested in 27 children with neuroblastomas. Of those, 17 children responded to the treatment, and the 3-year overall survival rate was 60 percent. Molecular Therapy. Gene Therapy. McGrady N.R. Shenderov E.

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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). Novartis is advancing Research & Development of next-generation treatments to combat emerging drug resistance.

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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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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. Shionogi joined in October 2012.

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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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Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” Another part of providing research animals with a good life is granting them a good death.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. Ricks , Lilly chairman and CEO.

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The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). “We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.”

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The Pharma Data

MAY 4, 2021

Baricitinib is an oral medication currently registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Ricks , Lilly chairman and CEO.

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The Pharma Data

OCTOBER 29, 2020

Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1. .”

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The Pharma Data

MARCH 17, 2022

Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. About EORTC. About ETOP.

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