European Pharmaceutical Review

FEBRUARY 27, 2024

It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen.

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World of DTC Marketing

OCTOBER 21, 2021

More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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FDA Insurance Prescription Medicine 234

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government. Natalie Shure, The New Republic.

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FDA Side effects Physicians Patients 218

MedCity News

JUNE 20, 2023

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

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Patients FDA Manufacturing Biopharma 96

pharmaphorum

JANUARY 19, 2024

Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101.

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FDA Manufacturing Pharmaceutical Patients 88

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. We are working diligently with the FDA and hope to launch mirikizumab in the US as soon as possible.”

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Food and Drug Administration Manufacturing FDA Medicine 52

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).

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FDA Food and Drug Administration Manufacturing Medicine 73

Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). Anti-interleukin therapies are generally prescribed as second-line or third-line treatment in UC patients who have failed a biological drug.

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European Pharmaceutical Review

APRIL 27, 2023

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.

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Manufacturing Food and Drug Administration Pharmaceutical products Food 76

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.

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Manufacturing Food and Drug Administration Networking FDA 52

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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Food and Drug Administration Medical Patients FDA 73

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 108

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.

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Food and Drug Administration FDA Food Manufacturing 98

PharmExec

JANUARY 9, 2024

The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

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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

Pharmaceutical Technology

APRIL 4, 2023

The US Food and Drug Administration (FDA) has announced that opioid analgesics manufacturers are to be required to make pre-paid mail-back envelopes available to dispose of unused opioid analgesics. The envelopes will serve as an additional opioid analgesic disposal option for patients.

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Food and Drug Administration FDA Manufacturing Food 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

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PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. the patient population, product being studied, therapeutic area, and trial phase.

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Pharmacy Times

JANUARY 31, 2024

Less manufacturing time could be the difference between a patient receiving this life-saving therapy vs not.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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PharmExec

JUNE 7, 2024

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

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Prescription Manufacturing FDA Patients 52

Legacy MEDSearch

NOVEMBER 28, 2022

The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. NeuroLogica Corp., Are you hiring?

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FDA Food and Drug Administration Electronics Recruitment 92

Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there.

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Food and Drug Administration FDA Food Manufacturing 52

PharmExec

JANUARY 9, 2024

The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

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FDA Manufacturing Patients 40

Legacy MEDSearch

JULY 31, 2023

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Stratasys Ltd.

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European Pharmaceutical Review

FEBRUARY 19, 2024

Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER) stated that Amtagvi is a novel T cell immunotherapy for patients with limited treatment options. So far, we haven’t seen great success from CAR-T or other cell therapies in treating patients with solid tumours.

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Food and Drug Administration FDA Manufacturing Food 70

Pharma Leaders

MAY 15, 2023

Manufacturers of amphetamine and methylphenidate products, a class of stimulant medications used to treat ADHD and other disorders, must update their labeling and prescribing information to “clearly inform” patients, caregivers and healthcare professionals risks associated with these medications. Related Topics

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Medical FDA Prescription Manufacturing 52

Pharma Leaders

MAY 8, 2023

The FDA sent a complete response letter (CRL) to Novo Nordisk on April 24, requesting more information on the company’s hemophilia drug concizumab, the company announced in its first quarter earnings report. Novo Nordisk also said it is evaluating the content of the CRL and will work with the FDA to provide the requested data.

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Pharmaceutical Technology

JANUARY 20, 2023

The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”,

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Manufacturing Government Sales Pharmaceutical 98

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. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments. Are you hiring?

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FDA Patients Food and Drug Administration Recruitment 52

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). In other words, money over safety.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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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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Food and Drug Administration FDA Manufacturing Engineering 52

European Pharmaceutical Review

MARCH 7, 2024

Julien Dodet, CEO of Orano Med discusses the company’s approach to developing and manufacturing radioligand alpha therapies and predicts the key factors that could impact the field in the next five years. percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy).

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Manufacturing Food and Drug Administration Marketing Management 52

Pharma Leaders

MAY 1, 2023

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The FDA also did not request for new preclinical or Phase III clinical trials for assessing efficacy or safety.

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Food and Drug Administration FDA Safety Food 52

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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Food and Drug Administration FDA Food Safety 59

Legacy MEDSearch

JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

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