The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 will also receive from Merck an equity investment and reimbursement of certain expenses. Merck has the option to designate a new Tmod program with increased economic terms.

Development 52

Development Engineer Manufacturing In-Vitro 52

The Pharma Data

JANUARY 6, 2021

SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. Further research on and development of the compound is ongoing with the objective of completing preclinical studies. About Standigm. Standigm is an AI-driven drug discovery company.

FDA Approval 52

FDA Approval Life Science Drugs In-Vivo 52

pharmaphorum

NOVEMBER 9, 2022

A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed. Inhibition of the mPTP has been shown, however, to protect neurons, reduce neuroinflammation, and extend survival in pre-clinical disease models.

In-Vitro 52

In-Vitro Bioavailability Medicine Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

The proceeds will be used to fund its ongoing clinical and preclinical programs. The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. Ortho Clinical Diagnostics is a leader in in vitro diagnostics. TCR2 Therapeutics – The Cambridge, Mass.

In-Vitro 52

In-Vitro Production Trials Manufacturing 52

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Dr. Graham earned an M.D.,

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.” before expanding it into Europe.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

The Pharma Data

APRIL 4, 2022

Chief Medical Officer and Head of Global Product Development, Roche. About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19. A decision on U.S. Actemra/RoActemra is not U.S.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

The Pharma Data

APRIL 29, 2022

Among the infants with an available assessment (n=48) treated with Evrysdi, 32 infants maintained and four gained the ability to sit without support for at least five seconds since month 24, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III).

Protein 52

Protein In-Vitro Medicine Development 52

The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Jude Children’s Research Hospital.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

The Pharma Data

MAY 27, 2022

Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics.

Antibody 52

Antibody In-Vitro Medicine Engineer 52

The Pharma Data

JANUARY 31, 2021

As a first step, Sosei Heptares and Metrion will combine their respective capabilities in a drug discovery program to identify novel, highly specific drug leads for further development against a single ion channel associated with neurological diseases. ” About Sosei Heptares.

Drugs 52

Drugs Protein In-Vitro Development 52

The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

In-Vitro 40

In-Vitro Clinical Trials Clinical Trials Clinical Development 40

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

MAY 15, 2023

Roche’s Chief Medical Officer and Head of Global Product Development. The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

Antibody 40

Antibody In-Vitro Clinical Development Medicine 40

FDA Law Blog

OCTOBER 2, 2023

The Act defines substantial evidence as that consisting of “adequate and well-controlled [clinical] investigations” upon which qualified scientific experts could conclude that a drug will have its purported effect.

Drugs 64

Drugs Development Trials In-Vitro 64

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.

HR 52

HR Medicine In-Vitro Development 52

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

APRIL 12, 2023

Chief Medical Officer and Head of Global Product Development. Chief Medical Officer and Head of Global Product Development. Chief Medical Officer and Head of Global Product Development. Chief Medical Officer and Head of Global Product Development. “We

Antibody 40

Antibody In-Vitro Development Trials 40

The Pharma Data

DECEMBER 13, 2020

Selected Clinical Parameters in Patients with Type 2 Diabetes at 12 Weeks. Selected Clinical Parameters in Patients with Type 2 Diabetes at 12 Weeks. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator.

Trials 40

Trials In-Vitro Insulin Protein 40

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

pharmaphorum

JULY 6, 2022

The JV has been formed German pharma companies Boehringer Ingelheim and Evotec with in vitro diagnostics specialist bioMérieux, with the objective of developing new antimicrobial drugs backed by diagnostics to quickly identify pathogens and their resistance patterns and guide treatment.

In-Vitro 59

In-Vitro Development Pharma Companies Drugs 59

Pharmaceutical Technology

MAY 26, 2023

Doggybone DNA is named for its bone-shaped schematic structure and produced using an in vitro enzymatic process over 50 days, which is more than five times quicker than the 270 days taken for plasmid DNA E.Coli fermentation process. One big pharma company has already given the seal of approval with a successful customer quality audit.

DNA 130

DNA Manufacturing Gene Gene Therapy 130

XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. Fever and joint pain are the most common symptoms of chikungunya.

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

The Pharma Data

SEPTEMBER 9, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies support continued effect of ENSPRYNG reducing risk of relapse in the longer term. ENSPRYNG was recently approved by the U.S.

Antibody 52

Antibody Medicine In-Vitro HR 52

The Pharma Data

AUGUST 16, 2020

“Today’s FDA approval of ENSPRYNG, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with OCREVUS to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., with placebo.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 9, 2020

Uniquely positioned in the rapidly evolving local biotech ecosystem in China in addition to an expansive global presence, Overland will strategically partner to jointly develop innovative, novel therapeutics. We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

NOVEMBER 12, 2021

COMET-TAIL Phase III data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations The trial enrolled participants during the Delta variant wave of the pandemic in the US. GlaxoSmithKline plc (LSE/ NYSE GSK) and Vir Biotechnology,Inc.

Trials 40

Trials In-Vitro Antibody Clinical Development 40

The Pharma Data

APRIL 22, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vitro 40

The Pharma Data

MAY 18, 2021

Chief Medical Officer and Head of Global Product Development. If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. Preventing these relapses is the primary goal for disease management.

Antibody 40

Antibody Medicine In-Vitro Development 40

The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”.

In-Vivo 40

In-Vivo In-Vitro Bioavailability Clinical Trials 40

The Pharma Data

MARCH 17, 2021

This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference. Overall, patient compliance for PROs was greater than 90 percent.

HR 52

HR Trials In-Vitro Manufacturing 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial. Christoph D.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

Pharmaceutical Technology

AUGUST 26, 2008

It was once derided as the stuff of science fiction, but in recent years, biotechnology has emerged as an important growth area in pharmaceuticals. As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines.

Antibody 100

Antibody Licensing Licensing Production 100

The Pharma Data

JUNE 26, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients.

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

The Pharma Data

SEPTEMBER 27, 2020

In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support for at least 5 seconds, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development – Third Edition (BSID-III). Roche’s Chief Medical Officer and Head of Global Product Development.

Protein 52

Protein In-Vitro Medicine FDA Approval 52