The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Food and Drug Administration or any other health authority. About GDA-201. About Gamida Cell.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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Drug Discovery World

AUGUST 9, 2023

The company’s collaboration partner, Cancer Research UK’s Centre for Drug Development, has sponsored and will conduct the Phase I/II clinical trial. ” CD19-directed CAR T therapies Aleta’s lead development programme, ALETA-001, contains the CD19 target protein which is further linked to an CD20 antibody domain.

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XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 4, 2021

IPH6101/SAR443579 is an NKp46-based NK cell engager (NKCE) that uses Innate’s proprietary multispecific antibody format. IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. MARSEILLE, France, Jan. MARSEILLE, France, Jan. Cell 2019 ).

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pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The median durations of response were 10 months and seven months, respectively.

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Pharmaceutical Technology

MAY 15, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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pharmaphorum

FEBRUARY 2, 2022

The dispute centred around Gilead’s triple-drug regimen Biktarvy , which is based on emtricitabine, tenofovir alafenamide and integrase inhibitor bictegravir. ViiV claimed the latter compound infringes its patents for dolutegravir and other compounds based on the drug’s chemical scaffold.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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The Pharma Data

OCTOBER 28, 2020

(NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron has shared these results with the U.S. combined dose groups; 6.5% placebo; p=0.024). .”

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pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

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The Pharma Data

JANUARY 19, 2021

RIIB antibody, BI-1206, a novel monoclonal antibody that specifically targets the antibody “brakes” to help overcome resistance to rituximab. The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. LUND, Sweden , Jan. About BioInvent.

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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The Pharma Data

JANUARY 27, 2021

RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). (Nasdaq: CASI), a U.S. Wei-Wu He , Ph.D., About BioInvent. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., In July 2020, the U.S.

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Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

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pharmaphorum

SEPTEMBER 8, 2022

It is a similar approach to that of another form of oncology treatment that is also experiencing a surge of interest, antibody-drug conjugates (ADCs). Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 The drug was added to Novartis’ portfolio through a $2.1

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The Pharma Data

JANUARY 12, 2021

where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. Dr. Graham stated: “I am excited to join Tiziana to help develop its unique monoclonal antibody platform for autoimmune diseases.

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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.

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The Pharma Data

DECEMBER 9, 2020

Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. and TOKYO, Dec.

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XTalks

APRIL 23, 2021

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

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The Pharma Data

DECEMBER 22, 2020

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye.

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The Pharma Data

AUGUST 17, 2021

Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell [i]. About JEMPERLI (dostarlimab-gxly) JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 7 It is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Currently, the only other viable malaria vaccine, known as RTS,S/AS01 (Mosquirix), has a demonstrated efficacy of 55.8

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The Pharma Data

JANUARY 13, 2021

We are humbled by the expeditious review of our supplemental new drug application and hope our broad development program for tislelizumab will continue its momentum and benefit additional patients,” said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene. R on macrophages. In pre-clinical studies, binding to Fc?R

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The Pharma Data

JULY 27, 2021

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

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The Pharma Data

JANUARY 7, 2021

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye.

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The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics Inc. About Y-mAbs.

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The Pharma Data

JANUARY 18, 2021

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. About Sorrento Therapeutics, Inc.

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