Drug Discovery World

SEPTEMBER 7, 2022

According to MarketsandMarkets the global AI in drug discovery market is projected to reach $1,434 million by 2024 from $259 million in 2019. This comment followed the announcement by AI-driven pharma-tech company Exscientia that Bristol Myers Squibb had chosen to in-license its immune-modulating drug candidate. .

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

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The Pharma Data

AUGUST 17, 2020

DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About DF6002. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies.

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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.

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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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Drug Discovery World

FEBRUARY 12, 2024

It’s not even clear whether patients and their families will notice any benefit from the treatment, and there are serious questions about its value for women (women are twice as likely as men to develop Alzheimer’s). doi:10.1136/bmjos-2019-100039 Pound P. 1 Can this really be regarded as a success? doi:10.1001/jama.2023.14443

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New Drug Approvals

AUGUST 21, 2023

5] Medical uses Palovarotene is indicated for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. [4] 4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 22] Ipsen acquired Clementia in 2019. [23]

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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. Ricks , Lilly chairman and CEO.

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The Pharma Data

DECEMBER 16, 2020

(NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The agreement leverages Otsuka’s well-recognized expertise in rare kidney diseases to underscore Aurinia’s commitment to expanding global access to voclosporin for the treatment of LN.

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Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. She has managed multinational projects for charities and not-for-profits to find new treatments for Malaria and led Innovate UK grants through to successful completion.

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New Drug Approvals

SEPTEMBER 10, 2024

D8-ruxolitinib Ingredient UNII CAS InChI Key Deuruxolitinib phosphate 8VJ43S4LCM 2147706-60-1 JFMWPOCYMYGEDM-NTVOUFPTSA-N unii 0CA0VSF91Y Deuruxolitinib , sold under the brand name Leqselvi , is a medication used for the treatment of alopecia areata. [1] -(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-, (.beta.r)-D8-ruxolitinib

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The Pharma Data

NOVEMBER 2, 2020

(NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions.

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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

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment.

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. SEOUL, South Korea , Jan. U.S. .

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The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

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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 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.

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New Drug Approvals

DECEMBER 19, 2022

1] [2] [3] [4] Medical uses Olutasidenib is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. [1] World Health Organization (2019). Further reading Liu X, Gong Y (2019). Hz, 1 H), 4.62−4.75

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Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. The draft commission proposes to award medicines that meet “unmet medical needs” (UMN) an extra year of protection from generic competition.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Comenzo, M.D., Director, John C.

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New Drug Approvals

SEPTEMBER 20, 2023

To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma Motixafortide , sold under the brand name Aphexda , is a medication used for the treatment of multiple myeloma. [1] World Health Organization (2019).

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The Pharma Data

JANUARY 17, 2021

Launched in 2019, the company raised $700 million in June 2020 in its initial financing. Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. Loxo sold to Eli Lilly in 2019 for about $8 billion.

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The Pharma Data

MARCH 16, 2021

By combining our expertise, we hope to make significant steps forward to finding solutions for patients for which there currently is no treatment.”. In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders.

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda. – Ends-.

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The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M Ambulero holds an exclusive license from the University of Miami to develop and commercialize research from the laboratories of Drs. MIAMI, Jan. Velazquez and Jun Zhao-Liu.

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The Pharma Data

OCTOBER 26, 2020

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). Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located.

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. Founder and CEO of Asieris. ” About Photocure ASA.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Biosimilars play an important role in the treatment of autoimmune conditions. Pfizer Inc.

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Agency IQ

JANUARY 19, 2024

When compared to the year immediately prior to the pandemic, however, 2023 actually marks an increase in volume, with only 70 opinions issued in 2019. This approval type has always been uncommon – before the pandemic, this pathway was used just eight times between 2015 and 2019. [ for the years 2020 to 2022. Based on the E.U.

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The Premier Consulting Blog

AUGUST 8, 2024

As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024). October 2019. [iv] July 28, 2023. iii] US Food and Drug Administration. Guidance for Industry. Website: [link].

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The Pharma Data

FEBRUARY 22, 2021

Under the terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States and Nuceiva in all other territories in which Evolus has licensing rights.

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The Pharma Data

AUGUST 19, 2021

. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We

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The Pharma Data

OCTOBER 14, 2021

Novartis moment blazoned that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Operation (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation operation for Beovu ® (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).

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The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. De Backer said the past 10 months of the global pandemic has shown how important a cooperative landscape is to the development of promising new treatments. Photo courtesy of Bayer.

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