FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Drug Target Review

APRIL 14, 2025

With many healthcare systems prioritising cost-effectiveness, there is limited demand for novel treatments, even though they are crucial to combatting antibiotic resistance. Spirulina-based production scales in straightforward cultivation systems, which keeps costs under control.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA Koblitz & Jeffrey N. FDA once estimated that OTC hearing aids would save patients over $3000.)

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. ImaginAb’s products have the potential to improve patient care and lower healthcare costs.

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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. About MODAG.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Drug Target Review

FEBRUARY 9, 2024

What are the current challenges and limitations surrounding stem cell therapy in preclinical studies, and how are these issues addressed to ensure the safety and efficacy of potential treatments before advancing to clinical trials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.

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The Pharma Data

NOVEMBER 11, 2020

Lung Tx”) announced today an exclusive license agreement of LTI-01 , a recombinant human single-chain urokinase plasminogen activator, currently under development by Lung Tx for loculated pleural effusions , for the territory of Japan. Lung Tx will receive an upfront payment, milestone, and royalty payments based on product sales.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

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The Pharma Data

DECEMBER 15, 2020

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This will enable Lipidor to offer potential licensees the opportunity for large-scale commercial production.

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The Pharma Data

AUGUST 17, 2020

. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. About DF6002.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Omidubicel is the first bone marrow transplant cell therapy product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S.

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The Pharma Data

DECEMBER 20, 2020

Under the Agreement, Peijia is entitled to, among other things, manufacture, develop, and commercialize the products in the greater China region, and HighLife is in return entitled to receive an upfront fee and subsequent milestone payments. “We always strive to provide more innovative products and solutions for patients.

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The Pharma Data

JULY 12, 2021

(Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) today announced that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS). Head of Research and Development at Biogen.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. The drug product is packaged and shipped as a solid powder. Is this a drug product or drug-device combination product?

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Drug Hunter

APRIL 20, 2023

The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade. We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). chief medical officer of Passage Bio. About PBGM01.

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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. Vlad Coric , M.D.,

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The Pharma Data

NOVEMBER 26, 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.,

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The Pharma Data

MARCH 2, 2021

Bayer will introduce Vynyty Citrus ® , its latest biological and pheromone-based crop protection product to control pests on citrus farms during the International Symposium on Horticulture in Europe – SHE2021 , March 8-11. Promising results were achieved in tomato production in Spain. More than 500 are expected to attend.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

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New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride.

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The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche. today announced that the U.S.

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The Pharma Data

DECEMBER 30, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

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The Pharma Data

MAY 5, 2022

Novartis today announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them.

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New Drug Approvals

APRIL 2, 2025

2] Medical uses Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults. [1] The FDA has long supported development of non-opioid pain treatment. Suzetrigine is taken by mouth. [1] 1] The most common adverse reactions include itching, muscle spasms, increased blood level of creatine kinase, and rash. [1]

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The Pharma Data

MARCH 25, 2021

mg administered subcutaneously (SC) every eight weeks is being evaluated for the treatment of moderate-to-severe osteoarthritis (OA) pain in adult patients for whom use of other analgesics is ineffective or not appropriate. Tanezumab 2.5 We will continue to work with the FDA as the agency continues its review of our application.”. “We

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. Subjects will participate in a pre-dosing screening period followed by a four-week treatment period in which subjects will receive INZ-701 subcutaneously twice weekly. BOSTON, Jan. About Inozyme Pharma.

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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.,

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Drug Target Review

DECEMBER 11, 2024

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. However, this method isn’t universally applicable, as some matrices may not be compatible with charcoal treatment due to their specific composition or the nature of the analytes involved.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche’s Chief Medical Officer and Head of Global Product Development. “If

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.

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The Pharma Data

SEPTEMBER 10, 2021

– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. Source link: [link].

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The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure . generic version of the product. These are challenges not only for ViiV Healthcare but also for any future generic licensees. About ViiV Healthcare. Source link: www.viivhealthcare.com. .

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