Pharmaceutical Technology

APRIL 24, 2023

Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. Such activation may lead to the onset and progression of many serious diseases.

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Marketing Food and Drug Administration Food Safety 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

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Food and Drug Administration FDA Food Marketing 97

PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. Marketing to rare disease patient populations is equal parts opportunity and responsibility. Food & Drug Administration (FDA).

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Marketing Patients Food and Drug Administration Education 52

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. The market for biologics The growing interest in biologics resonates with their impressive expansion on the global market. percent through 2027.

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World of DTC Marketing

NOVEMBER 1, 2020

Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday. Fauci, a leading member of the government’s coronavirus response, said the United States needed to make an “abrupt change” in public health practices and behaviors. We’re in for a whole lot of hurt.

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European Pharmaceutical Review

OCTOBER 2, 2023

has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). difficile infection, delivered high rates of clinical cure without any emerging safety concerns. Due to observed clinical success, Acurx Pharmaceuticals, Inc. Developing a front-line C.

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Food and Drug Administration Pharmaceutical Food Safety 111

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components. and projected to impact 70 million Americans by 2040.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Food and Drug Administration Side effects Recruitment Safety 52

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections.

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World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. A new approach to market was needed. But it’s a bet that seems to have paid off.

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Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

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European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful.

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Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). While the drug is marketed in other countries, it is not registered in the US.

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Food and Drug Administration Side effects Safety Recruitment 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. “We months for TEVIMBRA versus 6.3 months for chemotherapy.

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Pharmaceutical Technology

SEPTEMBER 12, 2022

This dosage was chosen as the preferred dose in children aged under five years based on safety, tolerability and immunogenicity findings. BioNTech is the Marketing Authorization Holder for the vaccine in the US, Canada, the European Union and the UK. g initial regimen for usage in children aged six months to under five years.

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Food and Drug Administration Government Food Safety 52

Pharmaceutical Representative Training

JUNE 22, 2024

Technological advancements, shifting market dynamics, and updated regulations are leading to significant changes within the pharmaceutical industry. The pharmaceutical industry is one of the most heavily regulated sectors due to the direct impact of its products on public health and safety.

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Sales Pharmaceutical Ethics Pharmaceutical Sales 52

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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Food and Drug Administration Safety Recruitment Medical 98

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Food and Drug Administration Patients Leads Side effects 98

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. ETDRS letters.

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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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Legacy MEDSearch

MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., Are you hiring?

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Food and Drug Administration FDA Recruitment Medical 52

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Moving towards continuous processing of nanomedicines Many biotech nanomedicines recently reached the market due to the drive of the COVID-19 pandemic, according to the authors.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

Carisma develops chimeric antigen receptor macrophage (CAR-M) therapies and is said to be the only firm developing such therapies with proof of mechanism and safety findings shown in clinical trials. . Carisma president and CEO Steven Kelly will lead the combined business.

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Food and Drug Administration Engineering Food Leads 52

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Food and Drug Administration Recruitment Medical Management 98

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.

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Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

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Medical Food and Drug Administration Recruitment Manufacturing 40

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

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Patients Food and Drug Administration FDA Safety 52

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

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Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data. What is an effective solution?

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Government Pharma Ethics Training 98

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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