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

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The Pharma Data

MAY 13, 2021

. Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef ( Endpoints ). Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review ( Endpoints ). In Focus: International. Coronavirus Pandemic.

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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]

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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). . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

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New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). 88 (12): 5389–5398.

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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] 1] [9] [10] Names Etrasimod is the international nonproprietary name. [11]

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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.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. deletion syndrome. 15 References [link] [link] [link].

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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. 7 Implementing an international differentiated pricing strategy specifically designed to address needs during this pandemic and improve affordability.7 today announced that the U.S. A decision on U.S.

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The Pharma Data

NOVEMBER 2, 2020

This announcement comes while the company continues its testing efforts with a Pennsylvania-based FDA and CLIA certified testing lab as it moves forward with another FDA submission. The company continues to recruit and accept applications from prospective domestic and international distributors. Two of the company’s.

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The Pharma Data

JUNE 28, 2021

The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

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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. 8] , [9] , [10] , [11] , [12]. **In

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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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. Additional data from the CAPELLA study will be presented at a future scientific conference.

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The Pharma Data

DECEMBER 8, 2020

RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. SciNeuro Pharmaceuticals . Headquartered in Shanghai, the company will also have a hub in Philadelphia.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Now, a large international study, partly funded by NIH, offers some good news: proof-of-principle that “Big Data” tools can help to identify a drug’s potential side effects much earlier in the drug development process [2].

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Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. Some probiotics are also sold as plain old conventional foods.

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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

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc. Eastern Time.

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The Pharma Data

AUGUST 17, 2021

Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Be sure to talk to your doctor or other healthcare provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). R&D: Up-front payments related to license and collaboration agreements. (85). Regeneron Pharmaceuticals, Inc. Oncology Program.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA has not approved an NDA for a drug containing botanical marijuana but notes that two drug products containing delta-9-tetrahydrocannabinol (“delta-9-THC”) (as dronabinol), the primary compound in marijuana have received FDA approval: Marinol and Syndros. to comply with its international treaty obligations.

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The Pharma Data

JANUARY 21, 2021

. “This is an exciting new option for patients and providers, as it provides an alternative strategy for effective HIV treatment,” said Susan Swindells , MBBS, Professor, Department of Internal Medicine, University of Nebraska Medical Center. Global Head, Janssen Research & Development, Johnson & Johnson.

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The Pharma Data

MARCH 31, 2023

NASDAQ: SCYX), today announced they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). GSK will pay up to $245.5

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The Pharma Data

AUGUST 6, 2020

International revenues increased 40% to $3.6 When adjusted for foreign exchange impact, international revenues increased 43%. billion in the quarter primarily due to tax charges resulting from an internal transfer of certain intangible assets and the Otezla® Divestiture and purchase price adjustments. billion in the quarter.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tezepelumab.

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Drug Discovery World

JUNE 14, 2023

One example we are following with anticipation are the two FDA approvals for the first gene therapies for sickle cell disease. Without it, this work stops. We read every day about biotech’s and their work to develop new treatment options. A spokesperson from NHSBT said: “In 1937, the UK created the world’s first blood bank.

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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. Canada) or (346) 406-0961 (international); conference ID: 9156145. We look forward to supporting Radius through our U.S.

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The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Licensing and royalty revenue. The increase was also driven by VASCEPA sales outside of the United States of approximately $0.5 million and $8.9 million and $5.7 million and $1.1

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Agency IQ

JUNE 16, 2023

0910-AI78 June 2023 May 2023 Final Rule Stage Sunlamp Products; Amendment to the Performance Standard FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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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.

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Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

NOVEMBER 26, 2020

an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix has licensed to Pfizer Inc. About Chiesi Group.

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Agency IQ

JUNE 2, 2023

Also in 2010, the agency held a two-day public hearing on the subject; following the feedback and lessons from the Brookings Institute and the FDA’s own work, the agency then “narrowed down” the four PMI prototypes to two options, which were further studied by RTI International under a contract with FDA.

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The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. A global Phase 3 study of ULTOMIRIS in children and adolescents with aHUS is underway. Eastern Time.

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