Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019. By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy.

Communication 119

Communication FDA 119

The FDA Law Blog

DECEMBER 12, 2022

Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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Documentation FDA Communication 23

Pharmaceutical Technology

JANUARY 31, 2023

The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA). It includes a recombinant AAVrh10 vector that expresses a micro ribonucleic acid (miRNA) which reduces the expression of SOD1 to slow down or reverse ALS progression in SOD1 mutation patients.

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Communication FDA 111

ISPE

MAY 1, 2023

Any violations concerning data integrity would lead to several regulatory actions like warning letters and alerts that are issued by the FDA. Since many international regulatory agencies are focusing on data integrity, FDA auditors are being trained to recognize data integrity issues in a more effective way.

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FDA Communication 98

Pharmaceutical Technology

MARCH 8, 2023

Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

Communication 97

Communication FDA 97

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

Vaccines 64

Vaccines FDA Communication Immunization 64

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.”

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FDA Generic Medicine Communication 98

ISPE

DECEMBER 14, 2022

Indeed, the narrative within Annex 1 has already been adopted by PIC/s, and with the close links to WHO and FDA, it will undoubtedly soon have a global reach. Download White Paper. To download this white paper, complete the form below. You may unsubscribe from these ISPE communications at any time. Company Name.

Communication 98

Communication FDA 98

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046). Please check your email to download the Report.

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FDA Communication Hospitals 52

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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FDA Communication Labelling 59

Pharmaceutical Technology

JUNE 20, 2023

UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA). F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period. Please check your email to download the Report.

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FDA Packaging Communication Labelling 52

Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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Mayo Clinic FDA Communication Labelling 97

Pharmaceutical Technology

APRIL 18, 2023

This news follows the treatment’s FDA approval on 10 March, making it the first-approved Rett Syndrome treatment in the US. The FDA approved the drug based on positive Phase III data from the Lavender trial. We have worked hard to make Daybue available as quickly as possible following FDA approval.”

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FDA Communication 102

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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FDA Documentation Communication 52

ISPE

MARCH 6, 2023

Secured by default When the FDA determines a manufacturer violated manufacturing practices, including ALCOA, they issue a Warning Letter. Systems should auto update features to assure that whole systems, whether remotely connecting or otherwise, have the latest version of the client software or patches without manual downloads.

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Communication FDA Pharmaceutical Companies Pharmaceutical Companies 97

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Download the full report to understand what to expect and how to align your strategies for success.

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Documentation FDA Hospitals Dosage 97

Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. It is also expected to help Caribou receive early and continual communication from the FDA during the regulatory review procedures. The trial includes patients at dose level one.

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FDA Communication 59

Pharmaceutical Technology

MARCH 21, 2023

So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i]. For further information on how Frewitt can help with your project, download the paper below. [i] Please check your email to download the Whitepaper.

Communication 97

Communication FDA 97

Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. Download the full report to understand what to expect and how to align your strategies for success.

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FDA Hospitals Communication 52

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval. Please check your email to download the Report.

Chemotherapy 98

Chemotherapy FDA Communication Immunization 98

Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

FDA 52

FDA Communication 52

Pharmaceutical Technology

APRIL 6, 2023

Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. Verismo Therapeutics CEO, DMD and co-founder Dr Bryan Kim said: “We are thrilled to receive Fast Track designation from the FDA. Please check your email to download the Whitepaper.

FDA 52

FDA Communication 52

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

Labelling 105

Labelling Insurance Communication FDA 105

The People's Pharmacy

APRIL 13, 2023

FDA Considers New Warnings on LASIK Eye Surgery: The FDA first approved the laser devices for this procedure in 1999. Consequently, he petitioned the FDA to issue a Public Health Advisory regarding LASIK-related injuries. The FDA understands LASIK is safe and effective for those who are good candidates.

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FDA Communication 81

Pharmaceutical Technology

MARCH 20, 2023

The US Food and Drug Administration (FDA) granted Fast Track designation to ONC-392 as a monotherapy to treat immunotherapy-resistant non-small cell lung cancer (NSCLC). Please check your email to download the Whitepaper. A randomised Phase III trial of ONC-392 as monotherapy is planned to commence this year.

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Compounding Communication FDA 98

Pharma Marketing Network

FEBRUARY 19, 2025

Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging. Ideal: 2-5% CTR ).

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HIPAA FDA Communication Labelling 72

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Please check your email to download the Report.

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FDA Chemotherapy Labelling Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 16, 2022

The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE). In the registrational trial, the therapy showed a complete success rate of drug production in r/r B-ALL patients. By Cytiva Thematic.

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Communication Labelling FDA 59

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector. By GlobalData. United Kingdom.

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Communication Labelling Hospitals FDA 104

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

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Labelling Insurance Communication FDA 98

Pharmaceutical Technology

DECEMBER 14, 2022

In October, the US Food and Drug Administration (FDA) granted approval for the company’s Boostrix for use in pregnant women during their third trimester to prevent pertussis in newborn infants. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. By Cytiva Thematic.

Communication 64

Communication FDA 64

Pharmaceutical Technology

APRIL 11, 2023

The FDA initially granted Orkambi approval in 2015 as the first medicine to treat the underlying cause of CF for individuals aged 12 or older with two copies of the F508del mutation. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Labelling 98

Labelling Communication FDA 98

The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. It must first be downloaded, revised, and uploaded back to the system. It is unclear how FDA will handle changes to the template. Lack of compatibility with cloud-based document sharing.

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Documentation FDA Communication 59

The FDA Law Blog

NOVEMBER 15, 2022

User fees are fees that FDA collects from “companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.” These fees supplement the annual funding Congress provides for FDA. These fees are negotiated by FDA and industry every five years.

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FDA Documentation Communication 59

Pharmaceutical Technology

JANUARY 15, 2023

FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Regulatory decisions by the US FDA from late November to mid-December for select therapies, and the CMOs contracted to manufacture them. Please check your email to download the Report. By GlobalData.

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Labelling Packaging FDA Communication 52

Pharmaceutical Technology

MARCH 1, 2023

Recently, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Paxlovid, an inhibitor for the first protease of SARS-CoV-2 (Mpro). Please check your email to download the Whitepaper. The licensed technology specifically includes small molecules found to be efficient PLpro inhibitors.

Communication 59

Communication Immunization FDA 59

ISPE

OCTOBER 1, 2023

With regard to equipment design and use, leading authorities such as the FDA or the Global Food Safety Initiative (GFSI) are very consistent in their Good Manufacturing Practice (GMP) guidance. Download White Paper To download this white paper, complete the form below.

Communication 52

Communication FDA 52