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.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

FEBRUARY 24, 2022

– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. vice president, Product Development, Lilly.

FDA Approval 52

FDA Approval FDA Hospitals Trials 52

The Pharma Data

JULY 12, 2021

Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia ®. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. Drug Enforcement Administration.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

AUGUST 24, 2020

It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

FDA Approval 52

FDA Approval Therapies FDA Trials 52

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

Drugs 69

Drugs FDA Approval Organic Chemistry Small Molecule 69

The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. TAIPEI, Taiwan , Nov. 1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S. SOURCE TaiGen.

FDA Approval 52

FDA Approval FDA Clinical Development Virus 52

The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM is indicated for the treatment of Alzheimer’s disease.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

JANUARY 6, 2021

As the compound was already approved by the FDA for its original indication, the companies are expecting significant savings in cost and time associated with its pre- or clinical development for the new indication. This patent is just the beginning of many results expected from our extended collaboration. Source link.

FDA Approval 52

FDA Approval FDA Drugs Science 52

The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. Roche’s Chief Medical Officer and Head of Global Product Development. with Xolair since its initial approval in 2003. today announced that the U.S. indications.

FDA Approval 52

FDA Approval Clinical Development FDA Treatment 52

The Pharma Data

JANUARY 17, 2021

a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma.

Treatment 52

Treatment Trials FDA Approval RNA 52

Drug Target Review

JANUARY 8, 2024

Following that work, it was discovered by Dr David Sinclair’s lab at Harvard that turning on only three of the four factors (OSK; Oct4, Sox2, Klf4) is the sweet spot for developing therapeutics where you can partially reprogram cells and restore cells to a more youthful state, while maintaining cell identity.

Science 145

Science Disease FDA Approval Clinical Trials 145

The Pharma Data

SEPTEMBER 29, 2020

Treatment becomes first and only biologic for HES in the US. GlaxoSmithKline’s Nucala has been approved by the US Food and Drug Administration (FDA) for the treatment of hypereosinophilic syndrome (HES), making it the first biologic approved in this indication. Source link.

FDA Approval 52

FDA Approval FDA Treatment Clinical Development 52

The Pharma Data

JUNE 30, 2021

The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

JUNE 26, 2021

Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populations Libtayo now approved by the European Commission for three advanced cancers. 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

Treatment 52

Treatment Trials Disease FDA Approval 52

The Pharma Data

AUGUST 17, 2021

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

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

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. The Company plans to initiate a Phase 2 trial within the next several months. “We

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

JANUARY 15, 2021

hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In the U.S.,

Treatment 52

Treatment Trials Disease Therapies 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

FDA 40

FDA Treatment Drugs FDA Approval 40

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. The FDA also granted a second meeting for review. Thus, the sponsor was able to satisfy regulatory requirements without conducting a Phase 3 trial.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

DECEMBER 9, 2020

Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. .

FDA Approval 52

FDA Approval Clinical Development Therapies Vaccine 52

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. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. president and chief executive officer of Passage Bio. “We About PBKR03.

Disease 40

Disease FDA Treatment Clinical Trials 40

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA 52

FDA Clinical Trials FDA Approval Small Molecule 52

The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. About DEXTENZA. Ocular Therapeutix, Inc.

Clinical Trials 52

Clinical Trials FDA Approval Treatment Production 52

The Connected Lab

APRIL 8, 2020

The cost to develop a new prescription medicine that gains market approval has gone up 145% to $2.6 billion and takes an average of 10 years to develop 1. For patients suffering from an illness with no approved treatment, the wait can be unnerving. A Tough Road: Cost To Develop One New Drug Is $2.6

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. His mother had a presentation of the disease that suggested her immune system was already on the job.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE.

FDA 52

FDA Treatment Disease FDA Approval 52

The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

Clinical Development 52

Clinical Development Disease Treatment FDA Approval 52