FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Drug Target Review

AUGUST 9, 2023

14 TDP-43 is a DNA and RNA binding protein that regulates the expression and splicing of several target transcripts. Stathmin-2 is one of many proteins that appear critical for the growth and stabilisation of axons, most likely by regulating the dynamics of axonal microtubules.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Drug Target Review

NOVEMBER 27, 2023

Because these proteins have such a profound effect on cells, there is typically a second hurdle of regulation that needs to be overcome to make the proteins. eFFECTOR Therapeutics has developed a novel class of cancer drugs known as Selective Translation Regulator Inhibitors (STRIs), which directly target the eIF4F complex.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10

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FDA Law Blog: Biosimilars

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”

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The Pharma Data

NOVEMBER 23, 2020

Zhang, who founded Legend Biotech in 2015 as a subsidiary of parent company GenScript, a company he also co-founded, had been under residential surveillance in connection with an investigation by the Customs Anti-Smuggling Department of Zhenjiang in China since Sept. Human genetic goods are tightly regulated by the Chinese government.

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Elrig

APRIL 11, 2024

From 2015 to 2019, he was a postdoctoral researcher in Juergen Knoblich’s lab at the Institute of Molecular Biotechnology (IMBA), Vienna, Austria where he designed advanced human brain organoids aiming to recapitulate the architecture and function of the developing brain. He is an outdoor aficionado and loves to climb the highest summits.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2015 ), with raw powders imported from ‘producer’ countries like China, Egypt, Greece, Thailand, Turkey, and India (Antonopoulos and Hall 2016 ; Brennan et al. 2015 : 241) suggest that some suppliers are subject to a process of normalisation due to their IPED-using peers, and thus do not view themselves as ‘real dealers’.

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Broad Institute

AUGUST 31, 2023

Through the imposition of a user-defined GRN in its architecture, GRouNdGAN simulates steady-state and transient-state single-cell datasets where genes are causally expressed under the control of their regulating transcription factors (TFs).

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NIH Director's Blog: Drug Discovery

MAY 26, 2016

To help him shrink the size barrier in cryo-EM, Lyumkis received a 2015 NIH Director’s Early Independence Award. One of his test cases involves the multi-protein IKK complex, the master regulator of the NF-kB cellular pathway that is dysregulated in many cancers and a range of inflammatory conditions. And the good news keeps coming.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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DrugBaron

NOVEMBER 22, 2022

But data is accumulating to suggest it matters a lot: resolving one variant from another – and understanding what drives their relative concentrations – may be just as important in biology as regulation of gene expression. We are about to find out.

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The Pharma Data

NOVEMBER 17, 2020

In 2015, Lead Pharma partnered with Sanofi to develop and commercialize small-molecule therapies against ROR?t While the antibody responsible for immune-mediated diseases is yet to be identified, they are thought to be regulated by an aberrant immune response. Humans as well as cats and dogs can be affected. .

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The Pharma Data

AUGUST 8, 2020

Lilly earned Chinese rights to Tyvyt through a pact the two signed in 2015, and the drug was first approved in December 2018 in third-line classic Hodgkin lymphoma. BeiGene’s application for that indication was accepted by Chinese regulators in June. The three meds were also up for a fight in first-line squamous NSCLC.

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Drug Target Review

SEPTEMBER 4, 2023

2018): Silent Information Regulator 2 from Trypanosoma cruzi is a potential target to infection control, IntechOpen. 2015): A new approach to chemotherapy: drug-induced differentiation kills African trypanosomes, Scientific Report. (6):22451. 12(11): e0006980. Nilmar, S. and Anabela, C. doi.org/10.5772/intechopen.770301 Michael, A.

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The Pharma Data

OCTOBER 25, 2020

Vatiquinone, developed from PTC’s Bio-e platform, is an investigational oral small molecule that inhibits 15-Lipoxygenase, a key enzyme that regulates oxidative stress and inflammation response pathways underpinning many neurological disease pathologies, including epilepsy. 2015; Chevallier et al. 1 Gorman et al.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. FDA can continue to work within this framework to appropriately regulate these products.”

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DrugBank

AUGUST 15, 2024

This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. RE 44,599 and U.S. RE 44,638 and with respect to each NDA approval, See FDA Docket Nos. Earlier this month, the PTO issued a REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. 1.750 with respect to the multiple PTE applications for each of U.S.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2015 ) not only access to their client base, but also a periscope into the language, self-presentation, and culture of prospective consumers. This has potentially negative consequences for the safety of users and the regulation of the market." dwf_admin Thu, 06/06/2024 - 23:27 Source Gibbs N. Trends Organ Crime.

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Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

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Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. When it became clear this target was not going to be met, Ecophyto II was released in 2015. Several iterations of the French Ecophyto Plan have been observed over the years.

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. Trends in Cannabis Use Among Older Adults in the United States, 2015-2018. Journal of Adolescent Health. 2020; 66(2):247-254.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Additional information about this stay can be found in the Notice of Stay published in the Federal Register, October 30, 2015 (80 FR 66907). Q: What is your advice for approaching the regulatory strategy?

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The Pharma Data

JULY 28, 2021

She will serve as Chair of the Board of Directors upon transformation of EUROAPI into a société anonyme , in compliance with applicable corporate governance regulations. Together, these appointments underscore the company’s strategy to further increase the diversity and cultural backgrounds of the executives leading Sanofi’s modernization.

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The Pharma Data

DECEMBER 4, 2020

Between 1989 and 2015, nearly 4,800 were diagnosed with endometriosis. But in theory, there’s an explanation, she said: Sunlight — and specifically the ultraviolet B radiation it emits — spurs the body to produce vitamin D, which is anti-inflammatory and helps regulate immune function.

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Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Clinical Trials Small Molecule Therapies Disease 52

Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. 2015 Sep;26 Suppl 5:v139-51. Epub 2015 Jul 4. link] Peterson DE, Boers-Doets CB, Bensadoun RJ, Herrstedt J; ESMO Guidelines Committee. doi: 10.1093/annonc/mdv202. PMID: 26142468.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

MARCH 15, 2022

In June 2015, FDA published a PSG for budesonide and formoterol fumarate dihydrate inhalation aerosol. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Source link: [link] ov/.

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The Pharma Data

MARCH 27, 2021

11 Like human GLP-1, Saxenda ® is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus. Since launch in 2015, more than 1.5 Saxenda ® (liraglutide 3.0 million patients have been treated with Saxenda ® globally.

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Drug Target Review

JANUARY 5, 2024

and the work reported in: Bosch DE, Jeck WR, and Siderovski DP ‘Self-activating G protein alpha subunits engage seven-transmembrane regulator of G protein signaling (RGS) proteins and a Rho guanine nucleotide exchange factor effector in the amoeba Naegleria fowleri.’ NIH R01 DA048153 (to D.P.S.), T he Journal of biological chemistry.

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Drug Target Review

OCTOBER 17, 2024

By definition, the do-not-eat-me signal refers to phagocytosis of tumour cells by macrophages, although we and others have shown that the CD24/Siglec-10 pathway also regulates the function of T cells and NK cells.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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