European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

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Food and Drug Administration Medicine Food Government 108

European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . In addition, the safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported.

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Food and Drug Administration Patients Safety Food 97

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.

Medical 91

Medical Food and Drug Administration Manufacturing Safety 91

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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Food and Drug Administration FDA Prescription Food 59

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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Food and Drug Administration FDA Safety Biopharma 52

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

DECEMBER 7, 2022

The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years.

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Food and Drug Administration Patients Side effects Medicine 84

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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Food and Drug Administration Medicine Food Safety 86

Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). In response to the approval news, some pointed concerns about long-term safety.

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Food and Drug Administration FDA Side effects Safety 59

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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

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

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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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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Food and Drug Administration FDA Food Safety 52

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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Food and Drug Administration Manufacturing Food Medicine 86

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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Food and Drug Administration Physicians Competition FDA 59

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 79

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 75

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

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

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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Medical Food and Drug Administration Pharmacology Medicine 85

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 Prescription Manufacturing 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 Medicine Patients 91

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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Food and Drug Administration Manufacturing Medicine Pharma 98

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

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Patients Food and Drug Administration Side effects Safety 84

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

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Yet in 2021, 100 nanomedicines had been marketed. Another 563 new nanomedicines were under clinical trial or in other stages of drug development.

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Food and Drug Administration Manufacturing Pharma Pharmaceutical 72

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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Food and Drug Administration Patients Pharmaceutical Food 52

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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Food and Drug Administration Pharmaceutical FDA Medicine 88

Pharmaceutical Technology

APRIL 13, 2023

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

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Legacy MEDSearch

MAY 23, 2022

Developed by Cleveland-based Lazurite Holdings LLC, ArthroFree recently became the first wireless camera for arthroscopy and general endoscopy to receive market clearance from the Food and Drug Administration. He joined the company in early 2021 and is an investor. He received his M.D. The Cleveland-based company (est.

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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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Food and Drug Administration Safety FDA Ethics 10

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.

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Food and Drug Administration Safety Recruitment FDA 91

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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European Pharmaceutical Review

OCTOBER 25, 2022

Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. No new safety precautions were identified.

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Food and Drug Administration Patients Safety Physicians 97

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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Medicine Food and Drug Administration FDA Pharmaceutical 103

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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