The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. We at the LRA are thrilled to share this news about belimumab and look forward to future approvals of other lupus nephritis treatment options.”.

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The Pharma Data

JANUARY 18, 2021

“It’s important that Impulse Dynamics acted quickly in a joint effort with the FDA to remove this potential barrier standing in the way of critical diagnostic procedures for a subset of patients with HF. CCM therapy is the first approach designed to optimize heart contraction, allowing more oxygen-rich blood to reach the body.

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The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. in the coming weeks. Source link: [link].

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Comenzo, M.D., Director, John C. Approximately 4,500 people in the U.S.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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The Pharma Data

JANUARY 22, 2021

22, 2021 — The first monthly shots to treat adults with HIV were approved by the U.S. “Having this treatment available for some patients provides an alternative for managing this chronic condition,” he added in an agency news release. . FRIDAY, Jan. Food and Drug Administration on Thursday.

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The Pharma Data

SEPTEMBER 6, 2020

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. 2 In the 27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%), with an 11% CR rate.

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. 20 August 2024.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

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The Pharma Data

NOVEMBER 29, 2021

The American Cancer Society estimates there will be more than 21,000 new cases of ovarian cancer and more than 13,000 deaths from this disease in 2021, making it the deadliest of all female reproductive system cancers. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. Related Information.

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

MAY 5, 2021

Farxiga received fast track, breakthrough therapy and priority review designations for the current indication. . The SGLT2 inhibitor was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise. . © 2021 Regulatory Affairs Professionals Society. blind, placebo?controlled

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The Pharma Data

JULY 12, 2021

The approval of finerenone offers a new path to protect patients from further kidney damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies.”. There are more than 160 million patients living with CKD and T2D worldwide. The study met its primary endpoint.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec.

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The Pharma Data

MAY 18, 2021

VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI ( dostarlimab-gxly ). Basel, 23 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Endometrial cancer is the most common gynecologic cancer in the U.S.

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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.,

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The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Title: Targeted Therapy and Ovarian Cancer Trials.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

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The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Abstract Title. Presentation Details.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. 1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. Efficacy data reported based on randomized treatment. RINVOQ 15 mg. (n=211).

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The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Key results include: Total revenues increased 5% to $6.5 on a non-GAAP basis.

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Drug Discovery World

JULY 2, 2024

OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2. A study conducted by IQVIA and published in the 2023 Swiss Biotech Report recently showed that 20% of European biotech companies are now headquartered in Switzerland 3.

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The Pharma Data

NOVEMBER 18, 2021

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions. KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC. In theU.S.,

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

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The Pharma Data

FEBRUARY 1, 2021

01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). CAMBRIDGE, Mass., Nasdaq: BIIB) today announced that the U.S.

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The Pharma Data

MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001). of women who continued relugolix combination therapy remained responders through Week 104. Eastern Time / 5:30 a.m.

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The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 14 August 2024. 14 August 2024.

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The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®.

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The Pharma Data

SEPTEMBER 28, 2021

Roche today announced data from across its growing neuromuscular portfolio at the planet Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. We are grateful for the partnerships that are helping us to develop new therapies for people impacted by these devastating rare diseases.”. About SRP-9001 SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin)

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.

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