FDA Law Blog

NOVEMBER 15, 2022

Industry agrees to fee collections in exchange for FDA commitments to meet certain performance goals, such as reaching a decision on a marketing application within a predictable timeline. The user fees, however, do not correlate to the review outcome for the application. First application submission fee waiver. Our Observations.

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Sciensano

FEBRUARY 9, 2024

Boulouffe, AVIQ 12:45-14:00 Lunch and poster session Session 3 | Chairs: Steven Van Gucht (Sciensano) & Rémy Demeester ( CHU Charleroi) 14:00 Best poster presentation 14:10 Clinical impact of a direct rapid antimicrobial susceptibility testing (dRAST) | C. Abstract rules Abstracts can only be submitted in English.

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The Pharma Data

JUNE 18, 2021

million people around the world, with children and adolescents representing at least 30,000 of those impacted. 3 The symptoms of MS can impact all aspects of a young person’s life from physical health to social development and self-esteem. MS affects an estimated 2.8 Therapeutic Area Head, Neurology Development at Sanofi Genzyme.

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The Pharma Data

JUNE 18, 2021

After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients in the induction-only control group (p<0.001). analysis plan), with 52 percent on risankizumab 360 mg achieving clinical remission versus 41 percent in the induction-only control group (p<0.01).

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pharmaphorum

JUNE 9, 2022

In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products. Herpers, P. Gjerdrum, P. About Micreos Pharmaceuticals. Eichenseher, B.

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The Pharma Data

MARCH 26, 2021

1 The Phase 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5% (p=0.0003) compared with teriflunomide. Ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56% (p<0.0001) at week 108 when compared to teriflunomide.

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The Pharma Data

JULY 25, 2021

GEMINI 1 data, in combination with data from the GEMINI 2 study, formed the basis of the AGN-190584 New Drug Application (NDA) currently under review with the U.S. Further details including additional efficacy and safety results are included in the “GEMINI 1 Study Results” section below. Robinson, M.D.,

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The Pharma Data

OCTOBER 29, 2021

mg/ day achieved bettered MADRS total score at week six compared to placebo (p- value = 0.0050). mg/ day demonstrated enhancement in MADRS total score at week six over placebo but didn’t meet statistical significance (p- value = 0.0727). Cases treated with cariprazine at1.5 Cases treated with cariprazine at3.0 mg/ day or3.0

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DECEMBER 15, 2020

The most common adverse events were application site pruritus and pain reported by 9% and 10% of treated patients, respectively. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. WARNINGS AND PRECAUTIONS. ADVERSE REACTIONS.

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The Pharma Data

AUGUST 30, 2021

0.98]; p=0.0264) over a median duration of follow-up of 3.4 0.95]; p=0.0018). 0.88]; p=0.0002). Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review. About Finerenone.

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The Pharma Data

SEPTEMBER 10, 2020

Grivas P. . Ascierto P. . . Avelumab First-line (1L) Maintenance + Best Supportive Care (BSC) vs BSC Alone with 1L Chemotherapy (CTx) for Advanced Urothelial Carcinoma (UC): Subgroup Analyses from JAVELIN Bladder 100. . Investigator-Sponsored Studies and Clinical Research Collaborations. . Proffered Paper (Presentation LBA12).

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Drug Discovery World

FEBRUARY 14, 2024

While a typical chemisty, manufacturing and controls (CMC) timeline from DNA to Investigational New Drug (IND) application in 2015 would have been approximately 24 months, by 2023 the same pathway was expected to take only 10 months. Thadani NN, Gurev S, Notin P, et al. DDW Volume 25 – Issue 1, Winter 2023/2024 References Tripathi T.

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Drug Discovery World

OCTOBER 31, 2023

Also, NfL measurements are impacted by how test samples are handled – especially blood samples. Impact on the investment landscape In neurodegeneration, we are looking for the ‘needle in a haystack’ drug. link] Koníčková D, Menšíková K, Tučková L, Hényková E, Strnad M, Friedecký D, Stejskal D, Matěj R, Kaňovský P.

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The Pharma Data

OCTOBER 28, 2020

log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003). placebo; p=0.024). There was a 1.08 combined dose groups; 6.5%

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The Pharma Data

FEBRUARY 22, 2021

1 In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001). All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo. ” U-ACCOMPLISH Efficacy Results at Week 8 *,1.

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The Pharma Data

MAY 12, 2021

1,2,3 CAD impacts the lives of an estimated 12,000 people in the U.S., Data o n the potential impact of sutimlimab on QOL and fatigue in people with CAD. Aiming to address unmet n eeds in i mmune t hrombocytopeni c p urpura. Bylsma, Anne Gulbech Ording, Adam Rosenthal, Buket Öztürk, Jon P. Europe, and Japan.

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The Pharma Data

MARCH 22, 2021

p<0.0001). p<0.0001). p<0.0001). All tested doses met the primary endpoint, rapidly and significantly reducing patients’ viral load (log10 copies/mL) compared to placebo (p<0.001), with all doses demonstrating similar efficacy. The impact of COVID-19 goes beyond those who contract it. Median (days).

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The Pharma Data

DECEMBER 13, 2020

In patients with T2DM (41-47% of each group), the results observed showed treatment with PXL770 resulted in a -27% mean relative reduction in liver fat content at 500 mg QD (p=0.004) versus baseline. statistically significant vs. placebo* or baseline** (p < 0.05) ^(p = 0.08; 0.052).

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XTalks

DECEMBER 12, 2023

Moreover, the adaptability of imaging extends to pediatric applications, a domain where non-intrusive procedures are paramount. Importantly, FDA-approved products are now available for these PET imaging applications. Monitoring treatment effects: They provide a means to evaluate the impact of treatments in real-time.

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Pfizer

FEBRUARY 9, 2023

0b013e3182a3516e 9 Piot P, Larson HJ, O'Brien KL, et al. Published 2022 Mar 21. doi:10.1177/25151355221084535 8 Yawn BP, Gilden D. The global epidemiology of herpes zoster. 2013;81(10):928-930. doi:10.1212/WNL.0b013e3182a3516e Immunization: vital progress, unfinished agenda. 2019;575(7781):119-129.

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ACRP blog

APRIL 13, 2023

Many attendees have a vision to learn and share, and a plan to advance the field of clinical research which will ultimately impact the treatment options to patients everywhere. Enjoy the unforgettable experience. You will depart with a plethora of ideas and feeling inspired…make sure to take action! And come back next year!

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Pharma in Brief

MARCH 18, 2021

The decision stands to impact numerous actions brought by generics on similar grounds against various innovator companies. Further, if Lilly was deemed never to have been granted the patent (and therefore no monopoly that could be considered unlawful), the prohibition has no application. Procedural Background . Apotex Inc. 24, Sched.

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The Pharma Data

JANUARY 13, 2021

“This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. ii She J, Yang P, Hong Q, et al. Chief Medical Officer, Immuno-Oncology at BeiGene. Global cancer statistics.

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The Pharma Data

DECEMBER 29, 2020

The results passed the futility analysis (p<0.3 log 10 copies/mL (nominal p=0.002 for combined doses). log 10 copies/mL (nominal p=0.002 for combined doses). The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

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The Pharma Data

APRIL 26, 2021

P aris and Amsterdam – April 26, 2021 – The Offeror, Sanofi (Euronext: SAN and NYSE: SNY) and Kiadis (Euronext Amsterdam and Brussels: KDS) today announce that the listing and trading of the Shares on Euronext will be terminated. Any material effect of COVID-19 on any of the foregoing could also adversely impact us.

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The Pharma Data

APRIL 28, 2021

The P hase 3 IKEMA trial’s finding that the addition of Sarclisa to this regimen reduce d the risk of progression or death by nearly half formed the basis for this important EC approval. ”. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. 1 Kazandjian. Semin Oncol. 2016;43(6):676-681.

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The Pharma Data

NOVEMBER 20, 2020

and plan to submit applications immediately to other regulatory agencies around the world. In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., by the middle to end of December 2020.

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The Pharma Data

DECEMBER 3, 2020

Any failure to comply with these restrictions may constitute a violation of applicable securities laws. 11 Martín-Gandul C, Pérez-Romero P, González-Roncero FM, et al. Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients.

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MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. All doses were well tolerated.

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APRIL 28, 2021

Subject to any applicable requirements of the applicable rules and without limiting the manner in which the Offeror may choose to make any public announcement, the Offeror will have no obligation to communicate any public announcement other than as described above.

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The Pharma Data

AUGUST 29, 2020

g/dL (p<0.001), and all but two patients (80%) achieved Hb levels >12 g/dL in the absence of red blood cell (RBC) transfusions. 2. Debureaux P, et al. Hematological Response to Eculizumab in Paroxysmal Nocturnal Hemoglobinuria: Application of a Novel Classification to Identify Unmet Clinical Needs and Future Clinical Goals.

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Clinical Trial Podcast

FEBRUARY 23, 2021

A great project manager is able to connect two seemingly unrelated issues and assess the impact on the project. The PM anticipates the negative impact of compliance issues on the overall trial. Life revolves around p-values, trial power and performance goals. Focused on clinical research software and applications.

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The Pharma Data

JUNE 18, 2021

All differences between the overall risankizumab dose groups and placebo are statistically significant, with p-values <0.001. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. NORTH CHICAGO, Ill. , Endoscopic Response c.

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The Pharma Data

DECEMBER 1, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. The companies have filed a request for Emergency Use Authorization with the U.S.

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The Pharma Data

DECEMBER 8, 2020

Delivering on these three priorities will have meaningful impact to patients, their families, and healthcare providers all while reducing the burden on healthcare systems and driving value for all Ionis’ stakeholders including patients and shareholders. Monia , Ph.D., It is available here for a limited time.

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The Pharma Data

DECEMBER 1, 2020

“Artificial intelligence holds immense promise to catalyze the development of the next generation of highly selective, orally bioavailable molecules, with reduced side effects, for the most impactful drug targets,” said Evan N. Feinberg, Ph.D., Genesis’ CEO and co-founder. “We

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NOVEMBER 4, 2020

Headquartered in Boston, Massachusetts , Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com. Forward-Looking Statement.

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