NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2016 March 4.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

AUGUST 30, 2021

Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. Parents and caregivers are challenged to find safe and effective treatment options,” said John Reed, M.D., Global Head of Research and Development at Sanofi.

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Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

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The Pharma Data

DECEMBER 21, 2020

21 December 2020 — AstraZeneca’s Tagrisso ( osimertinib ) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. 0.23; p<0.0001). 0.27; p<0.0001).

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The Pharma Data

SEPTEMBER 15, 2020

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S.,

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023.

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Drug Discovery World

APRIL 17, 2023

DDW’s Megan Thomas rounds up highlights from Monday 16 April at AACR 2023, from promising trial results for colorectal cancer patients to updates on Biden’s Cancer Moonshot initiative. She said it is not always feasible to offer treatment that will permit the mother to live long enough for the pregnancy to reach viability.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. EINSTEIN-Jr. About the EINSTEIN-Jr.

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients. Learn more: [link].

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The Pharma Data

JUNE 18, 2021

Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17 , including findings from the informCLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN ® )-recommended regimens for CLL/SLL.

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Codon

JUNE 18, 2024

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

In their trial run of PRISM, the researchers uniquely barcoded more than 100 cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved. 2016 Feb 29. Nat Biotechnol.

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The Pharma Data

SEPTEMBER 10, 2021

If approved for this indication, we believe MYFEMBREE has the potential to redefine care for women with endometriosis as an effective, one pill, once-a-day treatment option.”. We look forward to potentially bringing this important new treatment option to women with endometriosis.”. In the U.S., About MYFEMBREE®.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children. It has also been approved for newborns of mothers who have tested positive for Ebola. during the 2014 to 2016 epidemic. In 2019, the FDA approved an Ebola vaccine, Merck’s Ervebo. “We

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. , 4th 1261 (11th Cir. Ethicon, Inc. ,

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. Danco Labs., See 21 U.S.C.§

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Drug & Device Law

MAY 26, 2022

When the court denied a plaintiff motion for a new trial after a defense verdict, we found the reasoning a bit shaky and the leeway plaintiff had received along the way excessive. About three and a half years after that, she complained of new pain in her left hip, was worked up, and had a left hip revision surgery in December 2016.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

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