European Pharmaceutical Review

OCTOBER 31, 2022

Additionally, Danish biotech Genmab has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for epcoritamab for adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. ” Clinical trials for epcoritamab, a bsAb drug.

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European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

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European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

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European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed.

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European Pharmaceutical Review

NOVEMBER 22, 2022

The US Food and Drug Administration ( FDA ) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. What are risk minimisation methods? How is the efficacy of RMMs assessed?

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Food and Drug Administration Medicine Safety Food 96

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. percent of whooping cough cases in 2021 were those six months or younger.

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FDA Food and Drug Administration Side effects Food 105

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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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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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

AUGUST 28, 2023

Potential of inclisiran for lowering LDL-C These findings “reconfirm and extend prior observations about the safety profile and efficacy of inclisiran for people with ASCVD and those at risk of cardiovascular disease, in whom cholesterol levels are not adequately controlled,” Dr Ray explained.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.”

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Pharmaceutical Technology

MAY 9, 2023

The US Food and Drug Administration (FDA) has granted Vedanta Biosciences’ oral microbiome treatment VE303 a fast track designation for the treatment of recurrent Clostridioides difficile (C.diff) infection, as the company plans to start a Phase III trial later this year, based on a May 8 announcement.

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Food and Drug Administration FDA Food Safety 52

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

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.

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Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord US received exclusive rights for developing and marketing HLX02 in Canada and the US in 2021.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.

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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

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

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European Pharmaceutical Review

JULY 13, 2023

IL-2 therapy is associated with safety concerns, namely the adverse event capillary leak syndrome, which often leads to hospitalisations and thus limits its clinical use. Protein engineering comes with several challenges, including maintaining stability and immunogenicity of the novel protein and creating an inherently active drug.

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Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Panelists were asked to discuss the potential use of the drug during pregnancy.

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Medico Reach

OCTOBER 17, 2022

billion in 2021, with a compounded annual growth rate (CAGR) of 3.1% From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The article puts the global market size for the sector at $40.9 from 2022 to 2030.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication of AbbVie ’s Qulipta (atogepant) as a preventive treatment for chronic migraines in adult patients. Qulipta received the FDA’s approval to treat episodic migraine in adults in September 2021.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. 1,2 The second occurrence of NDMA arising from degradation was in metformin drug product.

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Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. In August 2021, the US FDA granted Fast Track designation to mRNA-1345. The findings showed 83.7%

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Food and Drug Administration Pharma Manufacturing Prescription 52

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Pharmaceutical Technology

APRIL 25, 2023

After missing the previous Q1 deadline, bluebird bio has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its sickle cell disease gene therapy lovo-cel, based on an April 24 company announcement. This hold was lifted a year later.

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Pharmaceutical Technology

APRIL 25, 2023

In October 2021, the World Health Organization recommended the use of GSK’s recombinant protein-based vaccine Mosquirix (RTS,S/AS01) for children at risk of contracting the infectious disease. Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy.

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Medico Reach

OCTOBER 17, 2022

billion in 2021, with a compounded annual growth rate (CAGR) of 3.1% From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The article puts the global market size for the sector at $40.9 from 2022 to 2030.

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Medical Food and Drug Administration Healthcare Healthcare 52