The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. It is based on DuoBody technology platform.

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Recombinant DNA Technology Production Antibody FDA Approval 100

XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. How does Evkeeza Lower Cholesterol Levels?

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XTalks

JUNE 20, 2023

Columvi is a bispecific antibody designed to bind to CD3 on the surface of T cells and CD20 on the surface of B cells in a novel 1:2 structural format where one region of the antibody binds to CD3 and two to CD20. Columvi’s approval was based on results from a pivotal Phase I/II NP30179 study of Columvi given as a fixed course for 8.5

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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pharmaphorum

DECEMBER 21, 2021

The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023. Anti-TIGIT antibodies are separated into groups, depending on the status of the Fc portion.

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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. ,

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XTalks

NOVEMBER 20, 2023

XTALKS WEBINAR: FDA Oncology Center of Excellence: Programs & Projects That Impact Drug Development Live and On-Demand: Thursday, December 7, 2023, at 9:30am EST (3:30pm CET/EU-Central) Register for this free webinar to learn about the FDA Oncology Center of Excellence’s special projects and programs. billion to $1.28

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The Pharma Data

NOVEMBER 18, 2021

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’santi-PD-1 remedy, for the adjuvant treatment of cases with renal cell melanoma (RCC) at intermediate-high or high threat of rush following nephrectomy, or following nephrectomy and resection of metastatic lesions. 0.87); p = 0.0010) compared to placebo. About Merck.

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FDA Approval HR Trials Drugs 52

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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Trials Clinical Trials Clinical Trials Immune Response 52

Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. Roche offloads clinical-phase cancer drug to Celleron. Roche has transferred its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics.

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Trials Research Drugs Protein 52

The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. About Lebrikizumab.

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Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. “We are pleased to work with U.S.

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Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

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

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. Breaking news: The FDA has approved Aducanumab, the first FDA-approved drug that delays decline due to Alzheimer’s.

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FDA Approval Drugs Trials Clinical Trials 89

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs Sales 52

Roots Analysis

DECEMBER 18, 2023

This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker.

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Drugs FDA Approval Antibody Development 40

The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020.

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Development Antibody Clinical Development FDA Approval 52

Roots Analysis

NOVEMBER 3, 2023

There are several types of NAMPT inhibitors, including small molecules, peptides, and antibodies. Despite their potential therapeutic benefits, NAMPT inhibitors have faced several challenges in clinical development. Several trials focused on evaluation of such drugs were discontinued in the past.

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Development Drugs Trials FDA Approval 40

The Pharma Data

MAY 31, 2022

The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis ( PRIME2 and PRIME ).

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Genetics Antibody Medicine Trials 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. and globally.”. About NVX-CoV2373. and Australia.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 30, 2022

The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug Eylea. It could also offer a cost advantage.

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Drugs Marketing Sales FDA Approval 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. 1. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. months, compared with 6.7 months in patients treated with chemotherapy.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The manuscript describing the detailed results will be accessible on an online preprint server shortly.

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Vaccination Vaccine Immune Response Protein 52

Delveinsight

AUGUST 2, 2020

Helsinn Group , a Swiss pharma player, is evaluating Anamorelin, an orally active selective ghrelin receptor agonist against Cancer cachexia, The company is conducting Phase III trial to test the efficacy and safety of anamorelin for the treatment of weight loss and anorexia in patients with advanced NSCLC with cachexia.

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Marketing Pharma Companies Development Hormones 94

Drug Discovery World

OCTOBER 4, 2022

Oligomerix’s portfolio of compounds is expected to provide a potentially lower-cost treatment alternative and/or complement to the newly emerging high-cost therapeutic options such as the monoclonal antibody products. But according to Erhardt, most are counting on antibody programs targeting beta amyloid or tau. William Erhardt, M.D.,

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Development In-Vivo Compound Screening Clinical Development 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98

XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Axovant Gene Therapies. After closing a $74.7

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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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Production Antibody Manufacturing Trials 52

Delveinsight

NOVEMBER 29, 2020

Brolucizumab is a humanized single-chain antibody fragment (scFv). Single-chain antibody fragments are highly regarded in the drug-development chain owing to their small size, enhanced tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics.

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Marketing Pharma Companies Drug Delivery Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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Vaccination Vaccine Trials Medicine 52

pharmaphorum

AUGUST 23, 2021

The drug’s US patent protection expires last year, but Samsung Bioepis and Biogen are still waiting for FDA approval, with a decision due in November. Lucentis was first approved in Europe in 2007 for wet AMD and grew quickly thereafter thanks to a string of additional indications. billion for Roche and $1.9

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