Pharmaceutical Technology

APRIL 13, 2023

Takeda’s announcement underlines the risk associated with gene therapy R&D at the preclinical stage and the fact that many current AAV programs are unlikely to reach late-stage trials. Takeda’s pivot away from AAV gene therapy follows a similar action taken by Pfizer in January 2023 to externalise its gene therapy R&D.

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Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 The post Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

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Pharmaceutical Technology

MAY 26, 2023

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. There are currently over 700 immuno-oncology products in Phase I-III of development in the eight major markets, said Chalk.

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Marketing Vaccination Vaccine Development 264

XTalks

JANUARY 29, 2021

Oncology products monopolise the list of best-selling drugs. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products.

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Clinical Trials Clinical Trials Production Trials 104

ProRelix Research

NOVEMBER 2, 2023

Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […] The post Post-Marketing Surveillance Strategies appeared first on ProRelix Research.

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Pharmaceutical Technology

JUNE 7, 2023

The European Commission (EC) has granted marketing authorisation for Fennec Pharmaceuticals’ Pedmarqsi (sodium thiosulfate) to reduce the risk of hearing loss in paediatric oncology patients.

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Marketing Medicine Trials Production 130

World of DTC Marketing

AUGUST 11, 2021

SUMMARY: DTC metrics change by product life cycle and DTC managers usually have to justify their budgets. You should tell a story on the value of your marketing using metrics that senior managers understand. That’s what most DTC marketers believe because management wants concrete results. Never report just raw numbers.

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ProRelix Research

JULY 6, 2023

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases.

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Clinical Trials Clinical Trials Trials Production 105

Pharmaceutical Technology

DECEMBER 9, 2022

The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. The approval in the European Union (EU) was backed by data from 19 Phase I, II, and III clinical trials in over 28,000 children and adults.

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Pharmaceutical Technology

MAY 5, 2023

The European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended full marketing authorisation (MA) for Gilead Sciences ’ Hepcludex (bulevirtide) to treat chronic hepatitis delta virus (HDV) and compensated liver disease in adult patients.

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Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. GlobalData’s Pharma Intelligence Center shows 19 autologous CAR-T cell products in Phase I, and nine products in Phase II, globally.

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Pharmaceutical Technology

FEBRUARY 23, 2023

The market for UC is filled with various treatment options, and the pipeline is relatively strong. These novel agents are expected to strengthen the market by bringing more innovation to the space. Pivotal data is expected around May next year with the maintenance trial expected to read out in June 2025.

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Pharmaceutical Technology

DECEMBER 15, 2022

The congenital fibrinogen deficiency (CFD) market is expected to grow at a compound annual growth rate (CAGR) of 1.7% through 2031, reaching over $800m across the three major markets (3MM: US, Germany, and Japan), according to GlobalData’s recent report: Congenital Fibrinogen Deficiency: Opportunity Assessment and Forecast.

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Pharmaceutical Technology

NOVEMBER 14, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Oncopeptides’ Pepaxti (melphalan flufenamide; melflufen) along with dexamethasone to treat multiple myeloma patients. Currently, the company is analysing Pepaxti’s market access options in the country.

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Pharmaceutical Technology

MAY 23, 2023

The UK’s medicines and healthcare products regulatory agency (MHRA) has granted marketing authorisation for Akebia Therapeutics’ Vafseo (vadadustat) to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients on chronic maintenance dialysis.

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Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The EC approval follows a positive opinion from the European Medicines Agency’s committee on medicinal products for human use (CHMP) in April 2023.

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Pharmaceutical Technology

JANUARY 20, 2023

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

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Marketing Bioavailability Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

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Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The submission of MAA is based on the findings from the Phase III Clarity AD trial and Phase IIb clinical study (Study 201).

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Marketing Antibody Licensing Licensing 130

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The vaccine works by inducing the body's immune response.

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Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The vaccine works by inducing the body's immune response.

Production 100

Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

MAY 3, 2023

Aurinia Pharmaceuticals has received marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) for Lupkynis (voclosporin), along with a background immunosuppressive therapy. The regulatory authorisation is based on the Phase III AURORA 1 study and the AURORA 2 continuation trial.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

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Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

OCTOBER 31, 2022

The osteoarthritis (OA) market was valued at $2.5 billion in the 7MM (seven major markets) in 2021, and is expected to increase to $3.8 Two categories of novel therapies stand out: cell therapies and therapies with novel MOAs, with new products in each category being forecast to launch between 2023 and 2025. in the US).

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Pharmaceutical Technology

MARCH 28, 2023

The obesity market is expected to grow at a compound annual growth rate (CAGR) of 31.3% over the course of the forecast period, reaching $37.1bn across the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK and Japan) according to GlobalData’s recent report, Obesity: Seven-Market Drug Forecast and Market Analysis.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.

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Marketing Sales Vaccination Vaccine 195

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 7, 2022

The Ayush cluster in Kerala, Care-Keralam Ayurvedic Resource Centre at Koratty in Thrissur, is planning to adopt a multi-pronged strategy to support the small and medium ayurvedic drug manufacturing enterprises (SMEs) by focusing on their production growth and marketing of products.

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Marketing Manufacturing Production Drugs 151

Outsourcing Pharma

JANUARY 25, 2024

Meghan Harrington recently joined Medidata as vice president of product, clinical trial financial management and is responsible for driving the strategic direction of the grants manager and payments products.

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Trials Clinical Trials Clinical Trials Production 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Contract marketing companies offer various marketing services that connect suitable strategies with customers at different points in the product lifecycle, helping to increase the customer base and thus revenue. Finding the top API chemical companies in contract marketing.

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Marketing Manufacturing Generic Drugs Containment 130

Pharmaceutical Technology

NOVEMBER 2, 2022

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU).

Vaccination 147

Vaccination Vaccine Marketing Clinical Trials 147

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. Find the leading clinical dose companies in contract marketing. Prospects of clinical dose companies in contract marketing.

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Marketing Contract Manufacturing Sales Clinical Trials 100

XTalks

JULY 18, 2023

Nestlé’s ongoing R&D has led to a groundbreaking sugar reduction technology that not only significantly diminishes sugar content, but also brings additional benefits to a wide array of products. The sugar-reduced ingredients are then incorporated into the recipes for a variety of products.

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Production Bacteria Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MARCH 16, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for argenx’s Vyvgart (efgartigimod alfa-fcab) to treat generalised myasthenia gravis (gMG). The regulatory approval was based on the data obtained from the international Phase III ADAPT trial.

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Marketing Antibody Trials Medicine 130

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.

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