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. , Yancopoulos , M.D.,

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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

MAY 7, 2021

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. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

NOVEMBER 18, 2021

With this FDA blessing, pembrolizumab may address a critical unmet treatment need and has the implicit to come a new standard of care in the adjuvant setting for meetly named cases.”. Merck has the assiduity’s largest immuno-oncology clinical exploration program. About Merck.

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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. Senior Vice President and Head of Global Clinical Development at Regeneron.

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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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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

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.

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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.”. and Australia.

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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

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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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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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. However, despite initial optimism, the development of these inhibitors has faced significant challenges.

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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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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. . Almirall S.A.’s

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The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

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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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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History.

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The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

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Delveinsight

AUGUST 2, 2020

The company has also signed a licensing agreement with Ono Pharmaceutical , a Japanese pharma company, transferring exclusive rights to develop and commercialise anamorelin in Japan, South Korea, and Taiwan. Apart from the products as mentioned earlier, Tetra Bio?

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Nuance Pharma .

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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 10, 2020

The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. ImmunityBio’s hAd5 vaccine generated robust neutralizing antibody activity that was present 14 days post-final vaccination. This press release features multimedia. Graphic: Business Wire).

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XTalks

MAY 31, 2023

The success of Acelyrin can be attributed to its industry-leading immunology portfolio and a robust pipeline of clinical and preclinical programs. Izokibep has progressed to Phase II/III clinical trials for multiple indications, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and uveitis.

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pharmaphorum

DECEMBER 23, 2020

In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1 There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. months, compared with 6.7 Neurology on the march.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

APRIL 4, 2022

The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

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Delveinsight

AUGUST 17, 2020

million in 2019 and is anticipated to increase at a CAGR for the study period 2017-2030 owing to dynamic pipeline therapies in the mid-/ late-stage clinical development and rising gastroparesis prevalence. However, the drug is not FDA-approved but is available in some European countries. Another U.S.

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The Pharma Data

NOVEMBER 20, 2020

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. as well as Europe, Latin America, and South Africa. About the Study.

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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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Drug Discovery World

DECEMBER 13, 2023

In the ever-evolving landscape of therapeutic development, the role of antibodies has become increasingly apparent. Antibodies are used as therapeutics, components of therapeutics such as antibody-drug conjugates (ADC) and CAR-T cells, and as companion diagnostic tools.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.

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The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). Presentation Topic: Clinical Trials.

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XTalks

NOVEMBER 20, 2023

The FDA has also been placing greater emphasis on overall survival, longer follow-up of studies and life expectancy in their review of oncology drugs. The clinical development of PI3K and AKT inhibitors has proven to be more challenging than expected. It was also given FDA priority review. billion to $1.28

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The Pharma Data

NOVEMBER 5, 2020

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Evinacumab , an antibody to ANGPTL3.

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