The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. and 2 trials planned by our sublicensee WPD in Poland. and 2 trials planned by our sublicensee WPD in Poland.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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Drug Target Review

JANUARY 8, 2024

With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK. We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation.

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Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. What specific patient populations are benefiting the most from these developments?

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The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. Actemra/RoActemra is not U.S. Both studies were published in the New England Journal of Medicine.

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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

MARCH 28, 2022

The FDA approval is based on the results from the SUSTAIN FORTE trial. In the trial, people treated with semaglutide 2.0 We are pleased with the FDA approval for a higher 2.0 mg is now approved in the US, the EU, Canada and Switzerland. The most common adverse events were gastrointestinal.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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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.”. For further information about our oncology clinical trials, visitwww.merck.com/clinicaltrials. About Merck.

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The Pharma Data

JULY 12, 2021

“The Phase III FIDELIO-DKD trial is the first large contemporary positive outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) with a primary composite endpoint consisting exclusively of kidney-specific outcomes.

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The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. About DEXTENZA. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

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The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. About the Phase 1/2 Trial for HPN217. HPN217 is covered by a global development and option agreement with AbbVie Inc. NYSE: ABBV).

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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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. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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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

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 Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

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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

DECEMBER 10, 2020

Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities and clinical trials.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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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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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. Dupilumab Development Program. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

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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

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7].

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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

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

NOVEMBER 30, 2020

HTL0022562 has already advanced successfully through a rigorous preclinical program and we are confident that the CGRP expertise and resources Biohaven brings will enable the further development of this and other promising CGRP antagonist candidates into human clinical trials. GPCR – G protein-coupled receptors.

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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

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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