Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

SEPTEMBER 28, 2022

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. Trial sponsors are still left with the challenge of including children in an ethical , safe, and secure way, and the new guidance is the FDA’s attempt to make that easier to achieve.

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FDA Ethics Prospecting Safety 57

Legacy MEDSearch

MAY 24, 2023

iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity and specificity. These prospective study results were initially presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and selected for Panel Discussion as outstanding work.

FDA 52

FDA Prospecting Recruitment Healthcare 52

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

FDA 71

FDA Side effects Biopharma Prospecting 71

pharmaphorum

OCTOBER 17, 2022

The FDA is planning to take an additional three months to review Biogen’s experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April. A few weeks ago the delay would have been a big deal for Biogen, as tofersen was among its most important near-term launch prospects.

FDA 52

FDA Prospecting Competition Safety 52

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The study, which enrolled 299 patients across 27 U.S. Empirical Spine, Inc., About LimiFlex.

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FDA Food and Drug Administration Recruitment Patients 94

pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The post FDA adcomm votes down Cytokinetics heart failure drug appeared first on. There was also no impact on quality-of-life measures.

FDA 52

FDA Side effects Prospecting Patients 52

Legacy MEDSearch

APRIL 5, 2023

announced today that the FDA has granted premarket approval (PMA) of the NeuRx ® Diaphragm Pacing System (NeuRx DPS ® ) for use in patients with spinal cord injuries who rely on mechanical ventilation. PMA is the most stringent type of device marketing application required by FDA. Synapse Biomedical, Inc.

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Patients Recruitment FDA Medical 52

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. This was a primary endpoint of the trial.

Food and Drug Administration 52

Food and Drug Administration FDA Prospecting Food 52

pharmaphorum

OCTOBER 7, 2022

The phase 3 LUCIDITY trial of tau aggregation inhibitor hydromethylthionine mesylate (HMTM, formerly known as LMTM or LMTX) showed improvements in cognition in patients compared to their performance and baseline, and also seemed to reduce brain atrophy to a rate similar to healthy individuals. ” Image by Colin Behrens from Pixabay

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FDA Transportation Patients Prospecting 85

pharmaphorum

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. Image by StockSnap from Pixabay .

FDA 52

FDA Side effects Prospecting Patients 52

Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. .

Food and Drug Administration 119

Food and Drug Administration Healthcare Provider FDA Prospecting 119

pharmaphorum

JULY 6, 2022

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. ” The post Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan appeared first on.

FDA 52

FDA Prospecting Marketing Patients 52

pharmaphorum

OCTOBER 12, 2022

Gilead Sciences will hear back from the FDA in February next year about its marketing application for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer, billed by the drugmaker as a key new indication for the drug. The post FDA sets Feb review date for Trodelvy in new breast cancer use appeared first on.

FDA 52

FDA Sales Prospecting Patients 52

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

Food and Drug Administration 52

Food and Drug Administration Side effects Prospecting FDA 52

pharmaphorum

SEPTEMBER 22, 2022

After a torrid couple of years, Biogen can be forgiven for making the most of new data on its tofersen drug for amyotrophic lateral sclerosis (ALS) – with an elevated status among its pipeline prospects largely as a result of failures in other programmes. The FDA granted the drug an accelerated review with a verdict expected by 25 January.

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FDA Sales Prospecting Patients 52

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Cimerli’s biosimilar status is appealing to providers and patients alike in the US.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Insurance 52

PM360

SEPTEMBER 21, 2023

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. When used in CMS-approved prospective comparative studies, the data for which may be collected in a registry.

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Manufacturing FDA Recruitment Prospecting 99

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process. “As a clinician, the prospect of accessing a more complete set of data intraoperatively is very exciting.”

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

APRIL 21, 2023

The therapy is intended for treating de-coppered adult patients who have stable disease and are tolerant to D-penicillamine. Cuvrior received approval from the US Food and Drug Administration (FDA) and orphan drug exclusivity for this patient group in April 2022. ”

Food and Drug Administration 52

Food and Drug Administration Transportation Distribution Prospecting 52

pharmaphorum

JANUARY 27, 2023

It refiled in the US, but got a complete response from the FDA in December with a request for more clinical information that has delayed the programme even further, and the CHMP’s decision will further undermine confidence in the drug’s prospects.

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FDA Marketing Medicine Prospecting 92

pharmaphorum

OCTOBER 27, 2022

The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

Side effects 81

Side effects FDA Patients Sales 81

pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

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FDA Safety Patients Doctors 102

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 116

Medicine Prospecting Networking Marketing 116

pharmaphorum

OCTOBER 26, 2022

Boehringer Ingelheim has moved one of its top pipeline prospects – oral phosphodiesterase 4B (PDE4B) inhibitor BI 1015550 – into late-stage clinical testing for idiopathic pulmonary fibrosis and other interstitial lung diseases (ILDs). IPF is more deadly than most cancers, with half of patients dying within two to three years of diagnosis.

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Recruitment Prospecting Marketing Patients 96

Pharmaceutical Technology

MAY 22, 2023

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour.

Medicine 59

Medicine FDA Prospecting Food 59

European Pharmaceutical Review

AUGUST 23, 2022

The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Patients’ symptoms were monitored for PTSD and hepatitis C virus between two clinical visits over eight to 12 weeks. MDMA-assisted therapy successful in PTSD patients.

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Food and Drug Administration Pharmacology Prospecting Medical 67

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. Following their introduction, these therapies have moved to early lines of treatment, but unfortunately, a significant number of patients are not cured with these approaches.

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Food and Drug Administration Patients Safety Medical science 84

Pharmaceutical Technology

JULY 1, 2022

The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

Medicine 59

Medicine Food and Drug Administration FDA Prospecting 59

pharmaphorum

OCTOBER 1, 2022

Shares in the company lost around 16% of their value after the top-line result of the REVERSE study in patients with compensated NASH-related cirrhosis were announced, as investors tried to work out what the failure will mean for the drug’s prospects. In REVERSE, 11.1%

Side effects 57

Side effects FDA Prospecting Pharma 57

pharmaphorum

DECEMBER 16, 2022

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 Claudin 18.2

Leads 57

Leads Biopharma Prospecting Patients 57

pharmaphorum

NOVEMBER 7, 2022

GSK has great expectations for its BCMA-directed cancer drug Blenrep, but a failed phase 3 trial in relapsed or refractory multiple myeloma has raised doubts about its prospects – and even the status of its regulatory approval. months and 21.1 months, respectively.

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Marketing FDA Prospecting Patients 52

pharmaphorum

NOVEMBER 21, 2022

With top-line results from the KALAHARI trial not due until the second half of 2023 – and cash reserves dwindling – the Belgian biotech hopes to look at the data after at least 25% of patients in the phase 2b portion of the study is completed. That dose – three monthly injections into the eye of 0.13 mg THR-149 – achieved a 6.1-point

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Prospecting Competition Patients FDA 57

pharmaphorum

SEPTEMBER 28, 2022

Clinical trial results reported at this year’s European Haematology Association (EHA) congress showed that a one-time treatment with exa-cel had a significant benefit in both SCD and thalassaemia patients. The post Vertex, CRISPR prep filing for gene-editing blood disorder therapy appeared first on.

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Side effects Prospecting Marketing Patients 57

pharmaphorum

NOVEMBER 16, 2022

Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the results were received, and what glimmer of hope this might hold for patients with GA. Bleak prospects, indeed.

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Safety Patients Consulting Prospecting 100

pharmaphorum

OCTOBER 24, 2022

Bristol-Myers Squibb is going after a second indication for its first-to-market cardiac myosin inhibitor Camzyos, a drug tipped to be a future blockbuster and the top prospect in the company’s growing cardiovascular pipeline. The FDA is due to decide on the new label by 16 June next year.

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FDA Prospecting Patients Physicians 40

European Pharmaceutical Review

JUNE 27, 2023

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines.

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Food and Drug Administration Manufacturing Medicine Pharma 95