The Pharma Data

OCTOBER 14, 2021

For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy (DMT). Cleveland Clinic, and a paid consultant for Biogen. Source link: [link].

Vaccine 52

Vaccine Therapies Immune Response Disease 52

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. UNITY is a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. SUZHOU, China and ROCKVILLE, Md. , Ascentage Pharma (6855.HK)

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Clinical Development Disease Treatment Licensing 40

New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., Cortexyme’s approach is based on the theory that P.

Small Molecule 62

Small Molecule DNA Disease Trials 62

The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease. Pfizer Inc.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

Disease 40

Disease FDA Clinical Trials Licensing 40

The Pharma Data

JANUARY 31, 2021

.–( BUSINESS WIRE )– Pinteon Therapeutics, a biotechnology company focused on protecting neuronal health by targeting neurotoxic forms of tau, today announced results from its Phase 1 study of PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease.

Pharmacokinetics 52

Pharmacokinetics Disease Treatment Therapies 52

LifeSciVC

APRIL 24, 2024

Target validation : Do we believe the target(s) plays a central role in disease biology and that modulation will modify disease? There is nothing more exciting than digging into a new target and trying to develop a thesis on whether modulation may be impactful in disease. Is the functionality of mutations known?

Production 114

Production Small Molecule Regulations Trials 114

Drug Target Review

JULY 1, 2024

As a non-NSAID, it reduces adverse effects associated with these pain relief drugs, including kidney injury, GI gastritis/ulceration and blood pressure elevation, which can affect patients with cardiovascular disease and the elderly. We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

AUGUST 22, 2021

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

Drug Target Review

SEPTEMBER 25, 2024

At TOLREMO, we have developed a proprietary modular phenotypic screening platform that leverages transcriptional reprogramming events associated with non-genetic resistance to deliver new chemical scaffolds and identify novel resistance regulators. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].

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Small Molecule Therapies Regulations Treatment 105

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

The Pharma Data

MARCH 13, 2021

HAE is unpredictable, debilitating and potentially life-threatening, and recognition of the disease remains low in Japan, meaning there are significant challenges relating to diagnosis and access to effective therapies,” said Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. Takeda in Hereditary Angioedema. Interactions.

Treatment 52

Treatment Pharmacokinetics Drugs Production 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. . BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

Treatment 52

Treatment Pharmacokinetics Therapies FDA 52

The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Dr. Kimble Matos, the lead coordinating physician of the study, commented: “The observations made during the Clinical study did not show any adverse events.”.

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Clinical Trials Science Treatment Trials 40

The Pharma Data

SEPTEMBER 26, 2021

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., In clinical trials, the foremost common adverse events related to TECFIDERA were flushing, abdominal pain, diarrhea and nausea.

Treatment 40

Treatment Clinical Trials Virus Pharmacokinetics 40

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec. Source link.

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Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

AUGUST 19, 2021

1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) 1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) Interstitial Lung Disease/Pneumonitis 7.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

APRIL 7, 2021

The subcutaneous administration of TYSABRI expands choices when it comes to controlling MS disease activity,” said Sven G. Nearly 15 years of real-world experience helps reinforce its effectiveness in reducing MS disease activity, showing that early treatment leads to better clinical outcomes,” said Maha Radhakrishnan, M.D.,

Clinical Trials 52

Clinical Trials Treatment Virus Pharmacokinetics 52

The Pharma Data

AUGUST 29, 2020

Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis . Peffault de Latour. The most common AEs reported were headache, insomnia, rhinitis, and rhinorrhea.

Treatment 52

Treatment Disease Small Molecule Production 52

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.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 28, 2020

NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. and is a leading cause of liver transplantation.

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Clinical Trials Trials Pharmaceuticals Treatment 40

The Pharma Data

JULY 22, 2021

The prospective, phase 3, open-label, international multicenter study included 23 patients with severe von Willebrand disease (VWD). No new risks were identified, with no serious adverse events related to rVWF reported. About von Willebrand Disease (VWD). The sABR was reduced by 91.5% population. population. About Hemophilia.

Treatment 52

Treatment Laboratories Production Disease 52

The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Government 52

Government Hospitals Long-Term Care Facilities Treatment 52

The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

AUGUST 30, 2021

Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%. A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D.,

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

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. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. 3 hemorrhagic events occurred in 2.3%

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. INDIANAPOLIS, Jan. See Limitations of Authorized Use. patients who recovered from COVID-19. .

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

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

Treatment 52

Treatment Pharmacokinetics Production Disease 52

The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.

Trials 52

Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

NOVEMBER 11, 2020

The Dorothy Crowfoot Hodgkin Campus will boast the co-location of in vitro pharmacology and protein sciences, structural biology, drug metabolism and pharmacokinetics, computational, synthetic, and medicinal chemistry, formulation sciences, development chemistry and API manufacture. 0)40.56081-255, gabriele.hansen@evotec.com.

Small Molecule 40

Small Molecule Science Pharmacokinetics Disease 40

The Pharma Data

SEPTEMBER 19, 2020

While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., 2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), pCR was observed in 57.6% (95% CI: 49.7–65.2)

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

APRIL 16, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 42% (n=8) had a CR or sCR.

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