The Pharma Data

NOVEMBER 15, 2020

As its name aptly suggests, Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions such as overactive bladder (OAB) and maladies involving adjacent areas of the human anatomy. .

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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] Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017).

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The Pharma Data

NOVEMBER 15, 2020

” The study looked at more than 301,000 antipsychotic prescriptions filled between 2007 and 2017 for children ages 2 to 7 who were covered by private insurance. . “However, fewer than half of the children receiving antipsychotic treatment in our study had a visit with a psychiatrist or a psychotherapy claim.”

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The Pharma Data

DECEMBER 18, 2020

AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. .

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The Pharma Data

AUGUST 25, 2020

In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients.

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The Pharma Data

SEPTEMBER 28, 2021

The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to 6 weeks aged and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne dystrophy (DMD).

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Eye on FDA

JANUARY 16, 2023

By contrast in 2021 there were only 10 (see blue bars below in the chart tracking meetings from 2017 – 2022). Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased.

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The Pharma Data

APRIL 4, 2022

FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. The most common adverse event observed with Dupixent, in Part A and Part B, was injection site reactions.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017.

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RNA Therapies Disease Protein Expression 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 [] for [PTE] request under 35 U.S.C. §

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FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C. Jazz also asserts that FDA failed to disclose or explain three prior memos in the Lumryz administrative record that found that Lumryz does not provide a MC-to-PC.

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The Pharma Data

JANUARY 31, 2021

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. For more information, please visit our website: www.cloverbiopharma.com. About CEPI.

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Clinical Trials Vaccine Trials Virus 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Furthermore, the next-gen, combo therapies were generally well tolerated and served to improve sweat chloride levels.

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The Pharma Data

AUGUST 27, 2020

Roche is committed to improve patient outcomes by providing multiple testing options that support decision-making during all lines of therapy. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes.

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The Pharma Data

DECEMBER 3, 2020

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. For more information, please visit our website: www.cloverbiopharma.com. About CEPI.

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Vaccine Immune Response Virus RNA 52

The Pharma Data

FEBRUARY 8, 2021

In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. The recruitment period for the study spanned from December 2015 to July 2017. Safety and tolerability of ERLEADA ® was consistent with previously reported studies.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: [link].

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The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA was approved in the U.S. for the treatment of adults with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA. TREMFYA q4w is not currently FDA-approved. TREMFYA is approved in the U.S.,

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Agency IQ

JANUARY 19, 2024

Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. However, BeiGene announced that it is seeking approval in the U.S. Inaqovi (cedazuridine/decitabine; Otsuka Pharmaceuticals) is approved in the E.U.

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The Pharma Data

SEPTEMBER 10, 2021

Registry Analysis (In Progress) to Evaluate Clinical Outcomes and Disease Burden of Advanced PD in Patients with Motor Fluctuations and Dyskinesia Managed with Oral Dopaminergic Therapies Versus Device-Aided Therapies. Polyneuropathy has been reported; evaluate for history/signs of and known risk factors before starting therapy.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection.

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Broad Institute

OCTOBER 11, 2023

But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way. His mother had a presentation of the disease that suggested her immune system was already on the job.

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The Pharma Data

SEPTEMBER 10, 2020

Today’s approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once a day.”. Trelegy is a combination of three molecules in a single inhaler that needs to be taken once per day.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The meeting’s outcome did not receive a rave review from former FDA Commissioner Scott Gottlieb, who led the agency between 2017 and 2019.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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Agency IQ

MAY 17, 2024

The bill is effectively a successor to the RACE for Children Act of 2017, which became law as part of the FDA Reauthorization Act of 2017 (FDARA). The Give Kids a Chance Act extends the RACE for Children Act’s requirements one major step farther , applying them to combination therapies in addition to single-drug therapies.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. There are currently no approved therapies to treat this disorder’s hyperphagia, anxiety, or metabolic aspects.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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Clinical Trials Disease Treatment Therapies 52

Drug Target Review

AUGUST 3, 2023

How does your team navigate these challenges to help ensure the successful implementation and advancement of personalised treatments and therapies? He launched Sano Genetics in 2017, along with fellow postgraduate genomics students Charlotte Guzzo and Will Jones. To date, the company has raised $14.9

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The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Following U.S. Roche’s Chief Medical Officer and Head of Global Product Development.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.” suppositories).

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The Pharma Data

NOVEMBER 4, 2020

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. 500 mg/dL) hypertriglyceridemia.

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The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. percent of patients in the combination arm versus 56.2 10 months. [iv]

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The Pharma Data

JUNE 18, 2021

. “These data add to the overall body of evidence that patients treated with ibrutinib can achieve extended progression-free survival and overall survival when used as a first-line therapy,” said Paul M. Single-agent ibrutinib was the most common treatment across line of therapy at enrollment. Barr , M.D., IMBRUVICA ®.

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