The Pharma Data

OCTOBER 18, 2020

BOSTON–( BUSINESS WIRE )– AVEO Oncology (Nasdaq: AVEO) today announced the appointment of David Crist as Vice President of Sales. Mr. Crist brings more than twenty years of oncology sales experience in both launch-stage and late-stage companies, building commercial organizations and developing high performing sales force teams.

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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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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. 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.

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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). That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients.

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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

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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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). Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. (Nasdaq: CASI), a U.S. CEO of BioInvent.

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XTalks

MAY 1, 2023

XTALKS WEBINAR: Patient-Centricity in Clinical Trials Sites — The Trinity of Patient, Sites and Sponsors Live and On-Demand: Monday, June 12, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how the Patient Concierge program increases study participants’ engagement and decreases dropout. How Does Qalsody Work?

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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. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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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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The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

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The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Novartis is committed to bringing ofatumumab to patients worldwide and additional regulatory filings are currently underway. 10% of patients 1.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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The Pharma Data

DECEMBER 27, 2020

Novel tumor-specific antigens can also provide targets for bispecific antibody (BiSAb) therapeutics for solid tumors, and Gritstone’s BiSAb program is currently in lead optimization. Gross proceeds from the two PIPE financings total $125 million, before deducting placement agent fees and offering expenses.

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The Pharma Data

JANUARY 7, 2021

The Company also has granted to the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the Public Offering Price to cover over-allotments in the sales of the securities, if any. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. About Cerecor Inc.

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The Pharma Data

DECEMBER 14, 2020

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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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). billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone. The drug was added to Novartis’ portfolio through a $2.1

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The Pharma Data

NOVEMBER 5, 2020

net sales increased 11% to $1.32 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Third quarter 2020 EYLEA ® U.S.

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. The company recognized worldwide revenue of $148.9

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The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus.

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The Pharma Data

OCTOBER 15, 2020

In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start. Y-mAbs is a development-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. NEW YORK, Oct.

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Drug Discovery World

OCTOBER 20, 2022

According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan. While the number of antibody drugs sold in Japan is on the rise, approximately 90% of the products are manufactured overseas, indicating a high degree of dependence on overseas manufacturing bases.” .

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The Pharma Data

NOVEMBER 27, 2020

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. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. Contraindications.

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pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Aduhelm’s Q3/2021 sales were $300k; investors will expect strong ramp-up in H1/2022. Despite an estimated 9.25 CNS’s moment of truth.

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The Pharma Data

JANUARY 12, 2021

Select pipeline updates, since third quarter results were reported in October 2020 , regarding promising individual programs and broader platform opportunities include: Completion of enrollment in the Phase 3 trial of ULTOMIRIS in gMG, with top-line data expected in the second half of 2021.

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pharmaphorum

SEPTEMBER 18, 2020

AstraZeneca also wanted to endure shareholder value through global power and reach in sales and marketing, greater financial strategic flexibility and the creation of a stronger R&D platform for innovation-led growth. The merger of Astra and Zeneca aimed to improve the combined companies’ ability to deliver long term growth.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival. receptors.

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The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. It contains the antiviral medications nirmatrelvir and ritonavir. billion in pharmaceutical sales from 2021. RELATED: Top 10 Medical Device Companies in 2023: Statistics and Trends 1) Pfizer By: Nadia Stec, M.Sc. billion, a 42.74

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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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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Outside the U.S.,

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. Amgen will record sales in the U.S.

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The Pharma Data

AUGUST 13, 2020

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Forward-Looking Statements. No forward-looking statement can be guaranteed and actual results may differ materially from those we project.

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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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The Pharma Data

JANUARY 6, 2021

In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. billion euros. Capital expenditures amounted to 2.9

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