The Premier Consulting Blog

MARCH 7, 2024

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

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The Pharma Data

SEPTEMBER 29, 2021

Patients are going to be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy like an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). billion euros. billion euros.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.

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The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020. executive vice president of Research and Development at Amgen. 20, 2020, at?11:00

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The Pharma Data

JANUARY 17, 2021

“We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma” said Jeffrey H. These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J. and SINGAPORE , Jan. Buchalter , President and CEO of Tessa Therapeutics.

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The Pharma Data

OCTOBER 27, 2020

27, 2020 /PRNewswire/ — Mirati Therapeutics, Inc. The offering is expected to close on or about October 30, 2020 , subject to customary closing conditions. Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. SAN DIEGO , Oct.

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The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. 22, 2021 12:00 UTC.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S.

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The Pharma Data

DECEMBER 21, 2020

22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. , SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

DECEMBER 13, 2020

NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1].

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LifeSciVC

JANUARY 16, 2024

In lean times such as 2023, we saw a shift towards several “hot” areas driven by massive commercial potential, clinically (± commercially) validated mechanisms, and exits that encouraged further investing, even at the early stage.

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Creative Biolabs

MAY 25, 2022

Cancer has become the second largest health threat in the world, with about 10 million people dying of cancer in 2020. Fu, 2022) Clinical research progress of ADC After decades of efforts, more than 100 ADCs are currently under clinical development.

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Drug Target Review

OCTOBER 1, 2024

At the beginning of my career, during my scholarship, I worked for two years at a research institute where I set up a research project focused on the study of metronomic oral therapies for patients with metastatic breast cancer (BC). That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. vice president of immunology development at Lilly.

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The Pharma Data

DECEMBER 14, 2020

14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec.

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The Pharma Data

DECEMBER 2, 2020

NEW YORK–(BUSINESS WIRE) November 23, 2020 — Pfizer Inc. It is a lifelong disease that requires constant monitoring and therapy. treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot). Approximately 20% of participants will be adolescents (ages between 12 to <18 years old).

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The Pharma Data

JANUARY 17, 2021

LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.

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The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

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The Pharma Data

DECEMBER 15, 2020

16, 2020 02:47 UTC. Nasdaq: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50

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The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Roche highlights featured at ESMO Virtual Congress 2020. Overview of key presentations featuring Roche medicines at ESMO 2020. Join this event on Roche’s LinkedIn page here. Abstract title. Abstract number.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

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Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.

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The Pharma Data

JANUARY 4, 2021

The most recent data from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) estimated 19,940 new cases of AML and 11,180 deaths from this disease in the United States in 2020. . SUZHOU, China and ROCKVILLE, Md. , 4, 2021 /PRNewswire/ — Ascentage Pharma (6855.HK),

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The Pharma Data

NOVEMBER 11, 2020

12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Separately, Fast Track Designation facilitates the potential expedited development and review of a drug for the treatment of a serious or life-threatening disease and that has demonstrated the potential to address unmet medical needs. Third Quarter 2020 Financial Results.

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The Pharma Data

DECEMBER 10, 2020

GREEN BROOK, NJ, December 10, 2020 /24-7PressRelease/ — Gianluca Pirozzi, MD, PhD, has been included in Marquis Who’s Who. He became Head of Development for Rare Diseases and Gene Therapy in Sanofi-Genzyme’s office in Cambridge, Massachusetts. positions he assumed in 2020.

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The Pharma Data

JULY 28, 2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for avalglucosidase alfa, a long-term enzyme replacement therapy for the treatment of people with Pompe disease. Avalglucosidase alfa is also currently undergoing review in other countries including the U.S.,

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The Pharma Data

APRIL 27, 2022

“We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”.

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The Pharma Data

DECEMBER 29, 2020

30, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 30, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), This was officially announced by the Shenzhen Stock Exchange (“SZSE”) on December 25, 2020 , which has been effective since December 28, 2020. SUZHOU, China and ROCKVILLE, Md.,

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The NDA was resubmitted on May 2020. Carlo, president and chief executive officer of Adamis, in May 2020. Supernus Pharmaceuticals’ SPN-812 for ADHD.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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The Pharma Data

JANUARY 21, 2021

Precigen is focused on next-generation gene and cell therapy using precision technology. In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development. Precigen – Germantown, Md.-based

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The Pharma Data

DECEMBER 21, 2020

22, 2020 07:13 UTC. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D.,

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JUNE 25, 2021

CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).

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The Pharma Data

DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov.

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