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. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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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

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). INDIANAPOLIS, Nov.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. government allocation program. Regeneron Pharmaceuticals, Inc.

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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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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 Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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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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pharmaphorum

NOVEMBER 28, 2021

The drug is – an oral spray containing cannabinoids THC and CBD which is already licensed and sold by other companies in some markets for neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis. Jazz acquired rights to Sativex when it completed its $7.2

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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 1, 2020

is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.

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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

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

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

DECEMBER 2, 2020

Twist may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products. This press release contains forward-looking statements. Morgan Securities LLC, Goldman Sachs & Co. LLC, Cowen and Company, LLC and Evercore Group L.L.C. are acting as joint book-running managers.

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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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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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Roots Analysis

FEBRUARY 15, 2022

ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Over time, the intellectual property related to ADC payloads / warheads has grown at a significant rate, primarily for ADCs containing auristatin, calicheamicin and maytansinoids as payloads.

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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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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. BA HCP ISI 09JUL2020.

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The Pharma Data

DECEMBER 20, 2020

platform and its patented large-capacity VV cop TK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR ® /F.I.R.S.T LUND, Sweden and STRASBOURG, France , Dec. It has been generated using Transgene’s Invir.IO

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pharmaphorum

FEBRUARY 2, 2022

Along with the one-off settlement, Gilead has agreed to pay ViiV a 3% royalty rate on Biktarvy sales and any other bictegravir-containing product in the US until 5 October 2027, when ViiV’s US patent on dolutegravir expires. Biktarvy is Gilead’s top-selling drug with bringing in $8.6

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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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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

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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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The Pharma Data

AUGUST 15, 2021

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. About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S.,

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The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. Horizon Discovery Group – U.K.-based for its cGMP-compliant CHOSOURCE platform.

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Drugs Gene Editing Genome Genomics 52

XTalks

AUGUST 15, 2023

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Niraparib is also sold by GSK under the name Zejula in other indications. In April 2016, Janssen Biotech, Inc.

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XTalks

APRIL 23, 2021

Dostarlimab is a programmed death receptor-1 (PD-1) blocking antibody that targets the PD-1/PD-L1 pathway to block its inhibition of T cell function, allowing the immune cells to seek out and destroy cancer cells. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

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Delveinsight

AUGUST 17, 2021

The vaccine induces neutralizing antibodies as a response against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature. “We Seagen and RemeGen comes under an agreement to add an experimental antibody drug – disitamab vedotin, to the pipeline of cancer medicines.

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XTalks

APRIL 26, 2021

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. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial.

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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 copper pairing provides significant supply and manufacturing advantages.

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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

OCTOBER 22, 2020

Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies (André et al, Cell 2018). About Cetuximab: Cetuximab is an anti-EGFR monoclonal antibody. overall response rate, a median time to progression of 2.3

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