European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

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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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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. About NeuroLogica. NeuroLogica Corp., NeuroLogica Corp., Are you hiring?

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FDA Food and Drug Administration Electronics Recruitment 92

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

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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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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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. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.

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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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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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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.

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European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. In parallel, European Medicines Agency (EMA) has issued an update on its guidance.

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Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. Lisa Anderson, CEO and President of Paragonix. For more information, visit www.paragonix.com. Are you hiring?

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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FDA Food and Drug Administration Recruitment Medical 95

European Pharmaceutical Review

SEPTEMBER 8, 2023

Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. Upon publication, tirzepatide will be made available in the NHS within 90 days, although this is dependent on manufacturing supply. Final guidance is scheduled to be published on 11 October 2023.

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Food and Drug Administration Medicine Food Manufacturing 93

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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European Pharmaceutical Review

JANUARY 23, 2023

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

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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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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Food and Drug Administration Manufacturing Engineering Food 97

Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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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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Pharmaceutical Technology

MAY 16, 2023

Emergent will also hand over San Diego, California-based research facilities (focused on the Chikungunya vaccine candidate), a Swiss-based biologics manufacturing facility, and the EU/US-based commercial operations. Emergent says most employees working at these facilities will join Bavarian Nordic.

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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.

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Pharmaceutical Technology

JUNE 5, 2023

The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities. The US Food and Drug Administration (FDA) granted ITM-11 a fast track designation in October 2022.

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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. The FDA’s target action date is the second half of 2024.

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Food and Drug Administration Manufacturing Safety Medicine 86

Pharmaceutical Technology

MAY 10, 2023

Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. Roche will handle the global development, manufacturing and commercialisation activities of ZN-A-1041, after an initial transition period.

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Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx. Are you hiring?

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FDA Food and Drug Administration Recruitment Manufacturing 52

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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Pharmaceutical Technology

MAY 1, 2023

The grant will help in expediting pre-clinical and manufacturing activities of the product. In March this year, the US Food and Drug Administration (FDA) accepted Ossium Health’s Investigational New Drug (IND) application for OSSM-001 to treat refractory perianal fistulas in Crohn’s disease patients.

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PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. From the manufacturer perspective, payer policies and legislation on combination therapy pricing are impacting global development, pricing, access, and commercialization strategies.

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Pharmaceutical Technology

DECEMBER 14, 2022

These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA). On concluding the NDA transfer period, Harrow will take over the complete US market operations and commence works to manufacture the products through third parties.

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Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024.

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Legacy MEDSearch

MAY 18, 2023

the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. “This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability. Paradromics Inc.,

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Food and Drug Administration Manufacturing Engineering Pharmacology 75

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. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al.

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