XTalks

NOVEMBER 20, 2023

PI3K/AKT is a key intracellular signaling pathway that regulates cell survival and proliferation. 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. It was also given FDA priority review. billion to $1.28

HR 98

HR FDA Approval Gene Trials 98

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). percent and the risk of developing severe RSV-associated LRTD by 94.1

Vaccination 105

Vaccination Vaccine FDA Approval Development 105

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. 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.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

Pharmaceutical Technology

APRIL 5, 2023

It will be six years since the US FDA approval of Kymriah in August this year. Bruce Levine [BL]: We now have six approved CAR-T therapies. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. . CARMIEL, Israel and BOSTON , Dec. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. About Fabry Disease.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 52

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group.

Drugs 94

Drugs Medicine Regulation Licensing 94

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.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

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.

FDA Approval 87

FDA Approval Drugs Trials Clinical Trials 87

pharmaphorum

DECEMBER 21, 2021

BeiGene was also the developer of Novartis’ PD-1 inhibitor tislelizumab , which was filed for FDA approval in September as a second-line treatment for oesophageal cancer. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

Drugs 88

Drugs Antibody Pharma Companies Development 88

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. The regulator had already approved the combination treatment in advanced cancers the previous year.

Protein 52

Protein Trials Clinical Trials Clinical Trials 52

The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. There are multiple heritable forms of FTD.

Genetics 52

Genetics Gene Antibody Development 52

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. At present, Diet-regulation is one of the mainstays of gastroparesis treatment.

Marketing 54

Marketing FDA Approval Trials Clinical Development 54

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

Production 52

Production Medicine Containment Development 52

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The human monoclonal antibody targets specific immune plasma cells.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

AUGUST 17, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. CTLA-4 is a negative regulator of T-cell activity. About Yervoy.

Immune Response 52

Immune Response Trials Medicine FDA Approval 52

XTalks

APRIL 12, 2021

Currently being tested in the Phase 1/II PROPEL trial — announced in June 2019 — PR001 is the company’s first compound and is being developed to treat patients with Parkinson’s disease with confirmed mutations in the GBA1 gene (PD-GBA). Cellular accumulation of ?-synuclein

Gene Therapy 96

Gene Therapy Gene Trials Development 96

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 is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

Trials 52

Trials Production FDA Approval Development 52

XTalks

DECEMBER 24, 2020

As of November, the WHO has discouraged the use of the drug as the agency’s review of data from four different clinical trials yielded no worthy effect on mortality, need for mechanical ventilation, time to clinical improvement or any other important patient outcomes. Vaccine Considerations.

Life Science 111

Life Science Vaccination Vaccine Gene 111

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

Drugs 52

Drugs Containment Development Sales 52

The Pharma Data

SEPTEMBER 8, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. CTLA-4 is a negative regulator of T-cell activity. About Yervoy.

Research 52

Research Immune Response Antibody Trials 52

The Pharma Data

OCTOBER 28, 2020

“Takeda continues to focus on developing potential therapies to treat COVID-19 with, for example, the enrollment of the first patients in the CoVIg-19 Plasma Alliance Phase 3 clinical trial — an outstanding achievement in such a short time. “We Press release ). Press release ). Press release ).

Sales 40

Sales Production Engineer Development 40