The Pharma Data

MARCH 5, 2021

” “While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives,” said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. chief medical officer of Loxo Oncology at Lilly. About Loxo Oncology at Lilly.

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The Pharma Data

SEPTEMBER 26, 2021

VUMERITY may be a next-generation oral fumarate for the treatment of adults with relapsing-remitting MS (RRMS). With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D.,

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The Pharma Data

APRIL 27, 2021

Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We In 2019, the U.S. and around the globe.”. About the Phase 1/2 Trial. 81 (0) 3-3278-3414.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis DNA was detected in postmortem cortices from people with AD and healthy controls, and in CSF of AD patients ( Jan 2019 news on Dominy et al., Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. All volunteers with AD had P.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. On October 28, 2019 , Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK. SUZHOU, China and ROCKVILLE, Md. ,

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PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. As expected, epinephrine treatment led to an increase in cardiomyocyte beating rate. Sci Rep 9, 18911 (2019). References Hingorani, A.D., 2021 [cited 16 December 2021].

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Source link.

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The Pharma Data

FEBRUARY 25, 2022

“Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”. Biosimilars play an important role in the treatment of autoimmune conditions.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. Hepion intends to use AI-POWR to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. ” About SPR206.

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The Pharma Data

DECEMBER 13, 2020

We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. The companies filed in December 2019, and included analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data from two clinical trials.

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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] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

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The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., October 2019. [iv] patients with renal, hepatic, or cardiovascular concerns). July 28, 2023. iii] US Food and Drug Administration. Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.

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The Pharma Data

AUGUST 22, 2021

12)AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. Ongoing trials include TACKLE COVID-19(13), a Phase III treatment trial in an outpatient setting and collaborator treatment trials in outpatient and hospitalised settings.

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The Pharma Data

JULY 11, 2021

years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH. SEFA-1024 is one of NST’s three SEFA programs. Notes to Editors.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] June 2019). 1] It is taken by mouth. [1] 11] SYN ACS Med. 11] SYN ACS Med. .

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The Pharma Data

SEPTEMBER 19, 2020

Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . There was no significant difference in OS between the treatment groups in the ITT population.

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The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. chief medical officer, oncology at Lilly.

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The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercialize its lead product ZUBSOLV® for treatment of opioid use disorder. UPPSALA, Sweden , Jan.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

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The Pharma Data

JANUARY 4, 2021

Cell 2019 ). NKCEs may show improved therapeutic window for cancer treatment as compared to bispecific T lymphocyte-engaging formats. IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. About Innate Pharma: Innate Pharma S.A.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

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Molecular Design

MARCH 26, 2024

With apologies to Manfred Eigen (1927 - 2019) I've just returned to Cheshire from the Caribbean and, to kick off blogging from 2024 I'll share a photo of the orchids at Berwick-on-Sea on the north coast of Trinidad. A theory has only the alternative of being true or false. A model has a third possibility: it may be true, but irrelevant.

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Metabolite Tales Blog

APRIL 4, 2023

3 Metabolism differences at steady state Adagrasib, Mirati’s irreversible KRASG12C inhibitor for treatment of non-small cell lung cancer is mainly metabolised by CYP3A4. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Dermavant’s tapinarof is one such friend.

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The Pharma Data

OCTOBER 27, 2020

2019. 2019. million for the three months ended September 30, 2020 , compared to the same period in 2019. In addition, as previously disclosed, our 2019 revenues were impacted by a mistake by one of our U.S. million in total, during the third quarter of 2019. 2019.

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The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

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Agency IQ

JULY 28, 2023

During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.”

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The Pharma Data

SEPTEMBER 15, 2020

The prophylactic steroid treatment was also changed from 1 mg/kg to an intermediate dose of 2mg/kg. Given the encouraging safety and efficacy profile, the Company initiated a Phase 3 study in 2019 and the prospective lead-in study with 40 patients has now been fully enrolled.

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Agency IQ

FEBRUARY 2, 2024

In 2019 more than one in four (28%) of deaths in the E.U. EMA floated these updates through a Concept Paper in 2019 and subsequently issued a draft updated guideline for public consultation in late 2020. Prognostic biomarkers enable patient selection that would have a better clinical outcome irrespective of treatment.

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The Pharma Data

DECEMBER 5, 2020

Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 “As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.” TARRYTOWN, N.Y. ,

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Metabolite Tales Blog

MARCH 1, 2023

9 The evidence here is that treatment with P450 inhibitors removed the toxic effects seen in the compounds of interest. 2019, 14, 2, 142–16 [link] 10 Chem. 2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. 11 Figure 11 Pyrazoles – more stable to oxidative cleavage? 2000, 2, 195-201 [link] 6 Biochem. link] 12 Biochim.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S., Read full announcement here: [link].

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The Pharma Data

JULY 6, 2021

At ISTH, we are sharing data across all our innovative approaches and collectively, the data reinforce how our pipeline and portfolio may unlock new possibilities in the treatment of rare blood disorders.”. Breaking barriers in hemophilia: helping to evolv e the treatment paradigm. ePoster Abstract # OC48.2 ePoster Abstract # OC48.2

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The Pharma Data

DECEMBER 3, 2020

Safety and Pharmacokinetics of Antisense Oligonucleotide STK-001 in Children and Adolescents with Dravet Syndrome: Single and Multiple Ascending Dose Design for the Open-Label Phase 1/2a MONARCH Study. The primary endpoints are safety, tolerability and pharmacokinetic (PK) profile of STK-001 in Dravet syndrome patients. About STK-001.

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The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Alzheimer’s Disease (AD). P6: Neuromuscular Disorders and Clinical Trials.

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