Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

Food and Drug Administration 65

Food and Drug Administration Safety Medicine Food 65

European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

Food and Drug Administration 73

Food and Drug Administration FDA Food Marketing 73

European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Medicine FDA 94

European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. per share in cash.

Food and Drug Administration 92

Food and Drug Administration Side effects Safety Food 92

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Management 52

European Pharmaceutical Review

MARCH 18, 2024

He added that the trial results could lead to this specific infusion pump delivery system to be approved by regulatory bodies such as the US Food and Drug Administration (FDA). Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

Food and Drug Administration 87

Food and Drug Administration Medicine Physicians Food 87

Pharmaceutical Technology

OCTOBER 12, 2022

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.

Food and Drug Administration 72

Food and Drug Administration FDA Marketing Patients 72

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.

Food and Drug Administration 80

Food and Drug Administration Medicine FDA Food 80

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

AUGUST 21, 2023

Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We Global expansion will begin in 2024. This new generation polyethylene is the latest, first-of-a-kind innovation by Orhun Muratoglu, Ph.D., Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma. DEB patients are also at risk of developing an aggressive form of skin cancer.

Food and Drug Administration 93

Food and Drug Administration Medicine FDA Food 93

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

Distribution 52

Distribution FDA Specialization Sales 52

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

PM360

MARCH 22, 2024

and is one of the leading causes of kidney failure. As of January 10, 2024, four PKD-free babies have been born as part of our 100 PKD-Free Babies initiative and more than 50 families are now part of our program,” said Richard Kellner founder of the PKD Outreach Foundation. was approved by the U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Healthcare Healthcare 52

pharmaphorum

SEPTEMBER 6, 2022

Pleco Therapeutics has closed a first-round financing, raising just over €17 million that it says will fund the development of its lead therapy for acute myeloid leukaemia (AML) through to regulatory filings in the US and EU. The Series A round includes €3.6

Leads 81

Leads Biopharma Government Patients 81

pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

FDA 95

FDA Marketing Safety Patients 95

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 91

Food and Drug Administration Side effects Leads Patients 91

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 91

Food and Drug Administration Side effects Leads Patients 91

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. The Phase II clinical trial for Orano Med’s candidate AlphaMedix ( 212 Pb-DOTAMTATE) is still ongoing and top-line data are expected in mid-2024.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

Pharmaceutical Technology

MAY 16, 2023

In the next 12 months, the organisation will conduct the work leading up to investigational new drug (IND) submissions for new gene therapies. Silverthorn said, “We hope to have those INDs submitted in the first half of next year, and hopefully, enrol patients in mid to late 2024”.

Manufacturing 90

Manufacturing Medicine Patients FDA 90

pharmaphorum

JANUARY 9, 2023

Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. in an all-cash transaction at $14.50

Pharma 85

Pharma Biopharma Management Medicine 85

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.

Food and Drug Administration 86

Food and Drug Administration Manufacturing Safety Medicine 86

PM360

DECEMBER 20, 2023

Learn more about why each company went with its respective strategy and the current outlook for each company in 2024 and beyond. The deal is expected to close in 2024. What is your outlook for 2024 and how do you believe companies can effectively differentiate themselves? and 10X Capital Venture Acquisition Corp.

Management 109

Management Marketing Healthcare Healthcare 109

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. It can lead to progressive paralysis and death.

Insurance 52

Insurance Prescription FDA Patients 52

pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

Patients 52

Patients Management Consulting FDA 52

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

Pharmaceutical Technology

JANUARY 8, 2023

Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Tezspire is being studied in a Phase II COPD study (NCT04039113) that is expected to complete in March 2024. Still, patients require an individual-led approach.

Patients 119

Patients FDA Pharmaceutical Pharma 119

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.

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Pharmaceutical 52

pharmaphorum

JANUARY 9, 2023

Meanwhile, Bylvay is also in late-stage development for rare paediatric liver disorder biliary atresia (BA), with the phase 3 BOLD study recently completing enrolment and due to generate data by the end of 2024. FDA approval in this indication would unlock the additional $10 CVR payment, providing it takes place before the end of 2027.

Transportation 52

Transportation Sales Leads FDA 52

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. Additionally, the attempt to borrow outcome measures from other diseases, which can lead to a lack of sensitivity in the measure.

Food and Drug Administration 52

Food and Drug Administration FDA Patients Insurance 52

Clarivate

OCTOBER 30, 2022

Of surveyed MCOs that cover or plan to cover DTx apps for the three conditions, more than 80% of respondents reported reimbursing DTx for at least one of the conditions in their fully insured commercial plans as of March 2022, with the remainder expecting to do so by 2024. As a result, few products have FDA clearance. What’s next?

Insurance 52

Insurance FDA Prescription Marketing 52

Pharmaceutical Technology

MAY 30, 2023

Maselli also cited non-manufacturing factors in Catalent’s poor performance and incorrect forecasting, especially a revenue cliff as the pandemic recedes: Catalent’s Covid-related sales will decline by more than 50% compared with last year, he said, and will be even lower in 2024. The CEO, who took over in July 2022, will remain in place.

Manufacturing 52

Manufacturing FDA Sales Leads 52

Nixon Gwilt Law

APRIL 22, 2024

HHS DSI Presentation (1/18/2024) Specifically, the HTI-1 Final Rule establishes algorithm transparency and risk management requirements and introduces the agency’s “FAVES” principles. In a recent blog post, the FTC illustrated how an AI company’s TOUs and PPs might lead to enforcement action. Pro Tip: We are in a moment of transition.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). The company aims to run an interim analysis of the trial by mid-2024 at the very latest.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

OCTOBER 10, 2022

Immutep claimed fast-track status from the FDA for efti last week as a combination therapy alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) for previously-untreated non-small cell lung cancer (NSCLC), based on the results of the phase 2 TACTI-002 study. Also in its favour is that LAG-3 is now a tried and tested target.

Side effects 57

Side effects Sales Marketing FDA 57