pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA 94

FDA Side effects Biopharma Marketing 94

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects. Washington Post.

Side effects 187

Side effects FDA Patients Doctors 187

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A breakdown of the data showed: HbsAb levels were greater than 1000mIU/ml in 88 percent of patients.

Patients 81

Patients Food and Drug Administration Side effects Food 81

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Pharmacology Side effects 98

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. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

FDA 52

FDA Side effects Competition Patients 52

European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

Food and Drug Administration 97

Food and Drug Administration Side effects Safety Food 97

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. But two new non-steroidal topicals were introduced this year — Dermavant Science’s Vtama and Arcutis Biotherapeutics’ Zoryve — and each one solves a long-time problem plaguing millions of psoriasis patients.

Side effects 98

Side effects Food and Drug Administration Patients Management 98

Legacy MEDSearch

DECEMBER 12, 2022

Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine.

Side effects 98

Side effects Insurance FDA Pharmacology 98

World of DTC Marketing

FEBRUARY 22, 2021

Jazz Pharmaceuticals has introduced a new prescription medication for patients with sleep apnea/narcolepsy that “helped adults get up to 9 hours of improved wakefulness in clinical studies at 12 weeks” and they’re using a flying pig on their DTC. First, the problem of sleep apnea. This DTC is an embaressment.

Pharma 181

Pharma Doctors Side effects Prescription 181

European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor.

Food and Drug Administration 92

Food and Drug Administration Side effects Medicine Food 92

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

Side effects 92

Side effects Safety Biopharma Recruitment 92

Legacy MEDSearch

JUNE 28, 2023

1 Early treatment of PWS during childhood leads to the best clinical response. 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 1 Early treatment of PWS during childhood leads to the best clinical response. Geronemus, M.D.,

Medical 52

Medical FDA Recruitment Side effects 52

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

Side effects 144

Side effects Patients Manufacturing Safety 144

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

Management 84

Management Side effects Patients Safety 84

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

Food and Drug Administration 110

Food and Drug Administration Side effects Pharmaceutical Leads 110

Pharmaceutical Technology

MARCH 7, 2023

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy.

Side effects 100

Side effects Patients Leads Safety 100

pharmaphorum

AUGUST 8, 2022

Karuna Therapeutics has unveiled positive topline results from its phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia. The post Karuna Therapeutics scores phase 3 win for schizophrenia therapy KarXT appeared first on.

Side effects 52

Side effects Leads Safety Medical 52

pharmaphorum

AUGUST 11, 2022

The system did not only spend money and resources trying to address issues caused by those treatments, but patients also wasted time looking for answers; precious time that could have been spent receiving proper and effective treatment. billion in the United States alone.

Side effects 94

Side effects Medical Prescription Patients 94

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).

Food and Drug Administration 97

Food and Drug Administration Side effects Leads Patients 97

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).

Food and Drug Administration 96

Food and Drug Administration Side effects Leads Patients 96

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). Due to this, adjunctive treatments are used as part of a patient’s treatment regimen.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

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

JULY 7, 2022

Updated results from several trials of SRP-9001 (delandistrogene moxeparvovec) revealed a wealth of positives, including functional benefits in patients with the muscle-wasting disease after one to fours years of follow-up, pointing to a durable effect of the gene therapy. Roche has exclusive rights to the therapy outside the US.

Safety 57

Safety Side effects FDA Patients 57

Legacy MEDSearch

OCTOBER 25, 2023

Andrea Synowiec, a neurologist and headache specialist who serves as System Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania is the lead author of the study. As for clinical efficacy, 74.1% of the participants reported consistent 2-hour pain relief, and 26% reported consistent pain freedom.

Side effects 52

Side effects Recruitment Networking Management 52

pharmaphorum

AUGUST 5, 2022

Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as possible to patients in the world’s second-largest pharma market. It is being tested in a wide range of solid tumours and lymphoma, alone and in combination with other drugs.

Side effects 94

Side effects Marketing Pharma Medicine 94

pharmaphorum

OCTOBER 13, 2022

BeiGene is looking increasingly like it will become the leading challenger to AbbVie and Johnson & Johnson’s market-leading BTK inhibitor Imbruvica for cancer, after besting its rival in a clinical trial showdown.

Side effects 52

Side effects Sales Marketing Competition 52

pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder. After 24 weeks, 21.8%

Side effects 52

Side effects Sales Competition Patients 52

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

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

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. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

Manufacturing 52

Manufacturing FDA Side effects Marketing 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. month mPFS with Keytruda plus chemo, with fewer side effects.

Side effects 57

Side effects Sales Marketing FDA 57

European Pharmaceutical Review

NOVEMBER 4, 2022

tumour effects. Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. The importance of taxanes in oncology.

Food and Drug Administration 88

Food and Drug Administration FDA Pharmaceutical Patients 88

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Electronics Patients Healthcare 105

pharmaphorum

DECEMBER 15, 2022

Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved. Despite the slap on the wrist, the campaign was highly effective and there is no sign of this approach going away.

Media 91

Media Healthcare Healthcare Education 91

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.

Consulting 64

Consulting Side effects Manufacturing Safety 64