pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Pharmaceutical Technology

MARCH 1, 2023

While the pandemic dramatically increased public awareness of mRNA therapeutics, lesser-known categories of RNA-based therapies have been established and approved for use by the FDA for almost a decade. RNA-based drug development warrants close monitoring as more RNA drug assets enter late-stage clinical trials.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. About the long-acting regimen of cabotegravir and rilpivirine. Shionogi joined in October 2012.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Food and Drug Administration in 2017.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., Outside the U.S.,

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. KENILWORTH, N.J.–(BUSINESS

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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Trials Clinical Trials Clinical Trials FDA Approval 52

XTalks

JANUARY 6, 2021

In the past 10 years, the US has seen a surge in research into the beneficial effects of psychedelic drugs as medicines. However, there was a pause in developments in this field after psychedelic research was banned in the late 1960s. Some include Mind Medicine, Compass Pathways and Champignon Brands. Mind Medicine.

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XTalks

AUGUST 9, 2023

According to information shared by brain health disorders-focused biotech Sage in a press release announcing Zurzuvae’s FDA approval, approximately half of all PPD cases may go undiagnosed without appropriate screening. Maternal mental health has been sidelined for far too long, but today’s approval of Zurzuvae helps to change that.

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pharmaphorum

MAY 13, 2021

The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries. The trial is expected to enrol 99 ambulatory male patients, aged four to seven.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. “The Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. Actemra/RoActemra is not U.S.

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The Pharma Data

JULY 12, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. There are more than 160 million patients living with CKD and T2D worldwide.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

MARCH 28, 2022

The FDA approval is based on the results from the SUSTAIN FORTE trial. In the trial, people treated with semaglutide 2.0 We are pleased with the FDA approval for a higher 2.0 mg is now approved in the US, the EU, Canada and Switzerland. The most common adverse events were gastrointestinal.

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pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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pharmaphorum

FEBRUARY 21, 2022

Oral, non-steroidal mineralocorticoid receptor (MR) antagonist Kerendia claimed its first regulatory approval in the US last summer, the culmination of several years of clinical development and a hefty investment in three large-scale clinical trials.

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Drugs Trials Insulin FDA Approval 122

Pharmaceutical Technology

APRIL 5, 2023

It will be six years since the US FDA approval of Kymriah in August this year. Bruce Levine [BL]: We now have six approved CAR-T therapies. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. About the Phase 2/3 Study.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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Roots Analysis

DECEMBER 18, 2023

Various types of next generation drug conjugates, such as peptide receptor radionuclide therapy (PRRT), GalNac conjugates, peptide drug conjugates, peptide oligomer conjugate, ligand conjugated anti sense medicine (LICA) and peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) have emerged as the direct competitors to the ADCs.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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The Pharma Data

NOVEMBER 12, 2020

José Baselga, Executive Vice President, Oncology R&D, said: “Since the beginning of the year, AstraZeneca has been committed to doing everything we can to respond to COVID-19, including investigating existing medicines as potential treatments. Related Articles: Calquence (acalabrutinib) FDA Approval History. J Hematol Oncol.

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Pfizer

AUGUST 3, 2022

The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac, renal and inherited metabolic disorders. COVID-19, Vaccines. 07.13.2022.

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XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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Delveinsight

AUGUST 13, 2020

Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

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Genetics Antibody Medicine Trials 52

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab Development Program. About Eosinophilic Esophagitis (EoE).

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Medicine Trials Allergies FDA Approval 52

XTalks

MAY 31, 2023

Headquartered in California, Acelyrin is a late-stage clinical biopharmaceutical company dedicated to expediting the development and delivery of groundbreaking medicines in the field of immunology. On May 4, 2023, Acelyrin announced its IPO of 30,000,000 shares of common stock at a price of $18.00

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Delveinsight

MARCH 1, 2021

The US FDA is working with stakeholders, including patients, patient advocates, product developers, and researchers, to fulfill its multiple, complex responsibilities towards improving rare disease clinical development. The passage of the Orphan drug act brought a wave of orphan drug approvals and launches.

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Marketing Clinical Trials Clinical Trials Drugs 52

The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. INTERCHANGEABILITY.

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Delveinsight

AUGUST 2, 2020

The company has also signed a licensing agreement with Ono Pharmaceutical , a Japanese pharma company, transferring exclusive rights to develop and commercialise anamorelin in Japan, South Korea, and Taiwan.

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The Pharma Data

OCTOBER 27, 2020

NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. PHILADELPHIA, Oct. 28, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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