Legacy MEDSearch

OCTOBER 2, 2023

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

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Food and Drug Administration Food FDA Recruitment 52

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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FDA Food and Drug Administration Patients Biopharma 207

European Pharmaceutical Review

NOVEMBER 19, 2024

.” Ratio is honoured and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic” Novartis will be responsible for all remaining development, manufacturing, and commercialisation. For example, targeted radioligand therapy has shown promise for eligible patients with prostate cancer.

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food Safety 52

European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

Food and Drug Administration 105

Food and Drug Administration Manufacturing Pharmaceutical FDA 105

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand. This is variable and to some extent unpredictable.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Food and Drug Administration Side effects FDA Medicine 111

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously.

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Food and Drug Administration FDA Food Manufacturing 98

Infuse Medical

JULY 4, 2024

Or else looking to manufacture medical equipment in the United States? Do you know the FDA is the Food and Drug Administration? Brief Introduction to Key FDA Regulatory Requirements The Food and Drug Administration plays an important role in ensuring the safety of medical devices in the United States.

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Training Medical FDA Food and Drug Administration 130

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. The history of PIE.

Food and Drug Administration 95

Food and Drug Administration Medical Patients FDA 95

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel.

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Manufacturing FDA Food and Drug Administration Medical 98

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Food and Drug Administration Manufacturing Management Safety 98

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? What are the trends affecting drug development today?

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Food and Drug Administration Manufacturing Pharma Patients 98

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. It dissolves rapidly releasing the active ingredient in the mouth, meaning there is no requirement for the patient to swallow a pill.

Food and Drug Administration 98

Food and Drug Administration FDA Food Marketing 98

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.

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Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

AUGUST 16, 2022

Despite improvements in screening, surveillance rules, and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosis, BeiGene said. Currently there are few treatment options if patients cannot tolerate [tyrosine kinase inhibitor] TKI therapy or if their condition progresses,” he added.

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Food and Drug Administration Patients Safety Food 98

European Pharmaceutical Review

DECEMBER 30, 2024

Numerous groundbreaking advances have shown these therapies hold potential to revolutionise how we treat, and potentially cure, many conditions, including for patients with underlying genetic or cellular causes of disease that have been difficult to treat with conventionalapproaches.

Manufacturing 52

Manufacturing Food and Drug Administration Medicine Training 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 97

European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

FDA 96

FDA Food and Drug Administration Manufacturing Medicine 96

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.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Food Medicine 98

European Pharmaceutical Review

APRIL 19, 2023

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study.

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FDA Food and Drug Administration Food Patients 116

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. However, each regulator will have specific national guidance which manufacturers must follow.

Medical 105

Medical Food and Drug Administration Manufacturing Safety 105

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. This opinion is intended for use of the drug as a first-in-class treatment for adults with moderately to severely active UC.

Food and Drug Administration 52

Food and Drug Administration Manufacturing FDA Medicine 52

PM360

AUGUST 29, 2022

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute. There are no shortcuts in drug development, and nor should there be.

Marketing 105

Marketing Food and Drug Administration Pharma Manufacturing 105

European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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Food and Drug Administration Medicine Marketing Food 98

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

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Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

JANUARY 25, 2023

The edited cells, exa-cel, are then infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT). The elevation of HbF by exa-cel has the potential to reduce or eliminate painful and debilitating vaso-occlusive crises for patients with SCD and alleviate transfusion requirements for patients with TDT.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease.

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Food and Drug Administration FDA Manufacturing Food 105

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Additionally, AI can improve patient wellbeing by automating health records, predicting illness, and enhancing treatment efficiency. 3D bioprinting offers an alternative to animal testing in drug development.

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Food and Drug Administration Government Pharma Healthcare 98

Pharmaceutical Technology

NOVEMBER 7, 2022

Leveraging its cell expansion and activation technology as well as cell manufacturing capabilities, the company can extend NK cells while substantially boosting cytotoxicity across peripheral blood-derived products. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. Wyost Similarly, Wyost 120 mg/1.7 mL (70 mg/mL) injection is a human monoclonal antibody designed to bind to the RANKL protein.

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Food and Drug Administration Medicine FDA Food 98

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.

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Food and Drug Administration Manufacturing FDA Food 96

Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic.

Manufacturing 52

Manufacturing Food and Drug Administration Networking FDA 52

European Pharmaceutical Review

OCTOBER 19, 2023

In this exclusive discussion with EPR , Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape, including the challenges of manufacturing these cancer treatments and why radiopharmaceutical therapeutics are so promising for this widespread disease.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Side effects Doctors 105

European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

Medicine 105

Medicine Food and Drug Administration Ethics Government 105

Pharmaceutical Technology

MAY 26, 2023

Chronic disease tech company Convatec Group has partnered with Beta Bionics to manufacture the insulin delivery system iLet Bionic Pancrease. The device received US Food and Drug Administration 510(k) clearance last week for those ages six years and above living with type 1 diabetes.

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Manufacturing Food and Drug Administration Management Government 59

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

JUNE 29, 2023

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. In some Type 1 diabetes patients, these infused cells can produce enough insulin. An extra infusion may be needed, depending on the patient response.

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Food and Drug Administration FDA Food Education 98