The Pharma Data

AUGUST 17, 2021

For more information, call 1-800-545-5979 or go to www.Lyumjev.com or www.humalog.com. This summary provides basic information about Lyumjev and Humalog. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled.

FDA Approval 52

FDA Approval FDA Doctors Production 52

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use.

FDA 40

FDA FDA Approval Production Regulations 40

The Pharma Data

DECEMBER 16, 2020

CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. For more information, please visit www.CNSPharma.com. Forward-Looking Statements .

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). For more information, please visit [link]. About Biohaven. About CGRP.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

Licensing 40

Licensing Licensing Therapies Laboratories 40

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

The Pharma Data

OCTOBER 26, 2020

News information is not all-inclusive and updates are published once a week on Tuesdays. . . FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Other Industry News.

Vaccine 52

Vaccine FDA Approval Clinical Trials FDA 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

FDA 52

FDA FDA Approval Treatment DNA 52

The Pharma Data

AUGUST 3, 2021

“In the interest of public health and safety, it remains a priority to provide healthcare professionals with as much information as possible about treatment options that may help improve outcomes for patients with severe disease,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

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. Food and Drug Administration (FDA).

FDA Approval 48

FDA Approval FDA International Clinical Trials 48

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)-,

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

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. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

JULY 12, 2021

While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome. For further information on the safety of authorized COVID-19 vaccines, please visit: [link].

Vaccine 52

Vaccine FDA Approval FDA Hospitals 52

New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 4 Similar in mechanism to the previously approved plerixafor , motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. 1] It is given by subcutaneous injection. [1]

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) on Nov. Please see below for important warnings and information about the authorized use of baricitinib in the U.S. Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. Serious Infections: ?Serious

Hospitals 52

Hospitals FDA Approval Laboratories Treatment 52

New Drug Approvals

DECEMBER 24, 2023

S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Retrieved 21 December 2023. ^ “Wainua (eplontersen) granted regulatory approval in the U.S. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. Retrieved 22 December 2023. hdl : 10665/340684.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

MAY 4, 2021

For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization , Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers ( English ; Spanish ). It is approved in the U.S.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

APRIL 26, 2022

Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

Treatment 52

Treatment Hospitals Science Licensing 52

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] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

Agency IQ

APRIL 26, 2024

For instance, it would be acceptable for a biosimilar’s labeling to differ from its reference product for the purpose of providing information necessary to inform its safe and effective use (e.g., In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. Yes, the guidance confirms.

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. Manufacturing and Supply Chain Information. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. There is no FDA-approved vaccine to prevent COVID-19. Important Safety Information.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 RYBREVANT™ IMPORTANT SAFETY INFORMATION 7.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. Data on these novel approvals is published throughout the year by both CDER and CBER.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS . USE IN SPECIFIC POPULATIONS.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. IMPORTANT SAFETY INFORMATION.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

The Pharma Data

AUGUST 19, 2021

The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. For further information, please see [link]. About Lenacapavir.

Marketing 52

Marketing Treatment FDA FDA Approval 52

The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL) in addition to Original Concentration Humira.”

FDA 59

FDA Biosimilars Production Regulations 59

The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. See the full Prescribing Information here.

Treatment 52

Treatment Clinical Trials Drugs Therapies 52

The Pharma Data

NOVEMBER 20, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

DECEMBER 31, 2020

–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced that the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review by the U.S. 1, 2021 11:59 UTC.

FDA 40

FDA FDA Approval Licensing Licensing 40

The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The target action date for the FDA decision is September 30, 2022. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

FDA 52

FDA Disease Trials FDA Approval 52

The Pharma Data

NOVEMBER 9, 2021

FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Malice, and Thrombosis. See the full Prescribing Information then. Marketing authorization for the treatment of rehabilitated cases with COVID-19 has been granted for OLUMIANT in multiple countries.

Treatment 52

Treatment FDA Approval Licensing Licensing 52

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

Agency IQ

MAY 31, 2024

The intended benefit for sponsors of this approach is that products making use of designated platforms would be eligible to receive expedited development benefits from the FDA, including access to early-stage development meetings with regulators. However, both deadlines came and went without any official action by the FDA.

Science 40

Science FDA Production Licensing 40