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.”. Posted: January 2021. Related Articles: Verquvo (vericiguat) FDA Approval History.

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. P15: MS Clinical Trials and Therapeutics. Spinal Muscular Atrophy (SMA). Abstract Title.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research 52

Research Immune Response Treatment Trials 52

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. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

JULY 12, 2021

The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information. INDICATION.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

DECEMBER 9, 2020

Initial results for the open-label study are expected in 2021. It has shown remarkably high safety and tolerability measure during non-clinical development. . The total transaction value for the acquisition also includes contingent clinical and regulatory milestones and is set to close in early 2021. .

FDA Approval 52

FDA Approval Clinical Development Therapies Vaccine 52

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.”. it’s estimated there will be further than new cases of order cancer diagnosed and nearly deaths from the complaint in 2021. In theU.S.,

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

The Pharma Data

MAY 7, 2021

The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Broad Institute

OCTOBER 11, 2023

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014. Along the way, TIDE is showing how careful, systematic science at scale can quickly home in on promising drug targets.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

Research 52

Research Treatment Therapies Trials 52

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. 7 Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), Actemra/RoActemra is not U.S.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

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. 2021 [cited 16 December 2021]. Sci Rep 9, 18911 (2019).

Drugs 52

Drugs FDA Approval Pharmacokinetics Drug Development 52

The Pharma Data

JANUARY 13, 2021

13, 2021 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma.

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

OCTOBER 25, 2020

FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

FDA 52

FDA Hospitals Clinical Development FDA Approval 52

The Pharma Data

APRIL 10, 2022

” “Since the FDA approval almost a year ago, LUMAKRAS has changed the treatment paradigm for patients with advanced non-small cell lung cancer who harbor the KRAS G12C mutation,” said Grace Dy, M.D., In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval with its approval in the U.S.,

FDA Approval 52

FDA Approval Therapies Treatment FDA 52

The Pharma Data

JANUARY 7, 2021

07, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. The offering is expected to close on or about January 12, 2021, subject to customary closing conditions. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. ROCKVILLE, Md. and CHESTERBROOK, Pa., per share (the “Public Offering Price”).

Clinical Development 52

Clinical Development Disease Treatment FDA Approval 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Disease 52

Disease Immune Response Vaccine FDA Approval 52

The Pharma Data

JANUARY 17, 2021

Company Expects to Report Initial Clinical Data in 2021. 17, 2021 /PRNewswire/ — Sirnaomics, Inc. , ” The Company expects to report initial clinical data from the trial in 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.

Treatment 52

Treatment Trials FDA Approval RNA 52

The Pharma Data

JULY 6, 2021

AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. billion in clinical development, regulatory and commercial launch-related milestone payments.

Disease 52

Disease Science Treatment Clinical Development 52

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

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA 52

FDA Clinical Trials FDA Approval Treatment 52

The Pharma Data

JANUARY 31, 2021

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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

DECEMBER 18, 2020

(FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions. The NDA remains under regulatory review, with the FDA having set a new action date of 20 March 2021. The Lancet 2020; 395(10225):709–33.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

JANUARY 24, 2021

– January 25, 2021) – PharmaDrug Inc. Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. About PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Disease 52

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).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

Treatment 52

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

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

AUGUST 17, 2021

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program. To date, the Opdivo clinical development program has treated more than 35,000 patients. On March 25, 2011, the U.S.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021.

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

APRIL 11, 2021

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials 52

Trials Treatment Clinical Trials Immune Response 52

The Pharma Data

SEPTEMBER 8, 2021

Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRAS G12C inhibitor. In May 2021, LUMAKRAS was the first KRAS G12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. In the U.S.,

Trials 52

Trials Clinical Trials Therapies Treatment 52

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. WAKEFIELD, Mass., Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

Disease 111

Disease Clinical Trials Therapies Science 111