pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year.

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FDA Side effects Competition Patients 52

European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

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Food and Drug Administration Side effects Safety Food 96

European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

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Food and Drug Administration Side effects Medicine Food 89

pharmaphorum

JANUARY 13, 2023

And as I look out the window at that snow, my travel-addled brain can’t help but see it as a metaphor for pharma in 2023: a crisp white, wide canvas laden with possibilities, but also one that’s going to require a lot of immediate, hard work from me if I want to be a responsible homeowner. Ups and downs of government – FDA.

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FDA Side effects Pharma Manufacturing 98

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.

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Pharmaceutical Technology

NOVEMBER 14, 2022

Several other investigational therapies are expected to have material updates in 2023. The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson.

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Side effects Patients Manufacturing Safety 144

pharmaphorum

SEPTEMBER 16, 2022

Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen. Regarding both common cold and headache, they are as well among the side effects reported for similar drugs.

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Management Side effects Patients Safety 86

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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Food and Drug Administration Side effects Pharmaceutical Leads 108

European Pharmaceutical Review

OCTOBER 21, 2022

The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. The clinical trial is estimated to be completed in March 2023. Eight weeks after the second dose, 94.4

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Patients Food and Drug Administration Side effects Food 77

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. months longer on the treatment.

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Manufacturing FDA Side effects Marketing 52

pharmaphorum

SEPTEMBER 12, 2022

CodeBreak-200 will nevertheless likely serve as a confirmatory study for the approval of Lumakras (sotorasib) in this heavily pretreated patient population, which was granted by the FDA in May 2021. Overall, almost 83% of patients taking Amgen’s drug saw their tumours shrink or stabilise, versus 60% of those on chemo.

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Side effects FDA Patients Safety 52

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

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Consulting Side effects Manufacturing Safety 61

Pharmaceutical Technology

JUNE 16, 2023

But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects. ANeuroTech CEO Erik Buntinx ANeuroTech will enrol the first patient in its Phase IIIb trial of ANT01 in MDD in Q4 2023, said Buntinx.

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Food and Drug Administration Side effects Safety Recruitment 52

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

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Food and Drug Administration Side effects Sales Food 52

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].

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Food and Drug Administration Side effects Leads Patients 96

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].

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Food and Drug Administration Side effects Leads Patients 95

Pharmaceutical Technology

JULY 28, 2022

The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023. Citing feedback from the US Food and Drug Administration (FDA) regarding labelling and device design for the SC formulation of Entyvio, it is not yet approved in the US.

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Food and Drug Administration Safety Side effects Marketing 98

PM360

AUGUST 9, 2022

This allows patients to complete the whole treatment process, from drug preparation and drug administration to treatment monitoring, side effect reporting, and communication, with one click on their device and smartphone. The FDA 510(k) submission is expected to take place in Quarter 3 2023. Orbita Outreach.

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Prescription Medical Side effects Patients 105

Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. with placebo.

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European Pharmaceutical Review

OCTOBER 19, 2023

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. Like other cancer treatments, we must prove the effectiveness of radiopharmaceuticals through clinical trials, so they are more available and eventually implemented as a common standard of treatment to control tumours.

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Food and Drug Administration Side effects Manufacturing Doctors 92

PM360

JULY 13, 2023

The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023. Preliminary data are expected in 2023. What Other Developments Within Oncology Excite You?

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Patients Engineering Side effects Leads 98

pharmaphorum

AUGUST 5, 2022

The latest milestone payment has been triggered by FDA approval to start a phase 2 trial of the drug in schizophrenia, said Sosei Heptares this morning. Also covered by the pact is a dual M1/M4 agonist and a selective M1 agonist, which are scheduled to start clinical trials in 2023 and would trigger additional payments.

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Side effects Safety FDA 52

European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

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Patients Food and Drug Administration Side effects Food 52

PM360

NOVEMBER 29, 2022

The patient populations of these diseases have long been without options, these advancements have inspired hope and the possibility of receiving an effective treatment. However, these immense efforts are in vain if they come with detrimental or life-threatening side effects or are simply unaffordable for the patients they intend to treat.

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Patients Safety Marketing Side effects 111

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. 2023 AD/PD Conference. References Hendrix S.

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Food and Drug Administration Safety Patients Leads 81

Medgadget

FEBRUARY 17, 2023

Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. ” An attractive proposition in a world in which technology has contributed significantly to the distancing of physicians from their patients, usually leading to negative side effects.

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Physicians Engineering Side effects Leads 80

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

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Pharmacology Side effects FDA Safety 59

European Pharmaceutical Review

DECEMBER 27, 2023

Lessons learned The process of establishing point-of-care CAR T manufacturing was a learning curve, not just in managing the toxicities and side effects, but also in understanding the important difference between emerging CAR T-cell adoptive immunotherapy and traditional stem cell transplantation. FDA; 2022 [cited 2023 Mar].

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Manufacturing Food and Drug Administration Patients Pharma 87

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. GlobalData is the parent company of Pharmaceutical Technology.

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