pharmaphorum

APRIL 27, 2021

Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis.

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Doctors Doctor FDA Approval Trials 104

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial.

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Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas.

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Gene Therapy Gene Clinical Trials Clinical Trials 64

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX ® compared to 2 of the 542 treated with placebo.

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Botox FDA Approval Doctors Doctor 52

Pharmaceutical Technology

AUGUST 12, 2022

Dr Merit Cudkowicz, a co-principal investigator in Amylyx’s clinical trials, says patients and investigators are pushing for an approval given the unmet need for therapies. “By Another objective deals with improving trial infrastructure and encouraging enrolment on decentralised clinical trials (DCT).

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Pharmaceutical Technology

JULY 28, 2022

Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year.

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Marketing Gene Therapy FDA Approval Doctors 130

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

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pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. This leads back to the barriers in developing successful treatments.

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The Pharma Data

DECEMBER 12, 2020

. “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Dr. Stephen Hahn said in a statement released Friday.

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pharmaphorum

FEBRUARY 21, 2022

One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Clinical trial diversity improved during COVID-19 (but not enough) .

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The Pharma Data

NOVEMBER 23, 2020

Drug giant AstraZeneca announcing that late-stage clinical trials of its coronavirus shot showed it to be 70.4% The trials were conducted in the United Kingdom and Brazil in collaboration with the University of Oxford. Doctors say this reflects India’s younger and leaner population. effective, The New York Times reported.

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FDA Approval Vaccination Vaccine Antibody 52

The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes. .”

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FDA Approval Vaccination Vaccine Genetics 52

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year. pic.twitter.com/Kck0tp1nSJ.

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Drugs Doctors Doctor FDA Approval 96

The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

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Hormones FDA Approval Containment Medicine 52

XTalks

DECEMBER 20, 2023

These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices. Novo and Lilly are hard at work to expand their manufacturing capacities to meet the skyrocketing demand for their GLP-1 blockbusters.

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Life Science Clinical Trials Clinical Trials FDA Approval 59

XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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Drugs FDA Approval Genetics Clinical Trials 98

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Gene Therapy Gene FDA Approval Production 119

Triage Cancer

AUGUST 18, 2020

Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDA approved 99% of all expanded access requests for almost 9,000 investigational drugs. The manufacturer agrees, and together with the patient’s doctor, develops a treatment protocol specific to patient.

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Clinical Trials Clinical Trials FDA Approval Manufacturing 59

STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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pharmaphorum

SEPTEMBER 12, 2022

Across LabCorp , we innovate through science and technology, with access to approximately 2,500 [doctors] and PhDs and over 700 patients. This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states. Tailored oncology.

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Find Me Cure

SEPTEMBER 2, 2020

This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. . Today let’s take a look at some of the barriers to trial participation and the issues that break the trust patients have in research. .

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Clinical Research Research Clinical Trials Clinical Trials 97

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year. SVB has forecasted around $2.2

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Gene Therapy Gene FDA Approval Antibody 98

pharmaphorum

NOVEMBER 11, 2022

Last year, Biogen won controversial FDA approval of Aduhelm, billed as the first drug to treat Alzheimer’s underlying cause. However, Viehbacher comes on board following a surprising clinical trial success for lecanemab , another Alzheimer’s drug Biogen is developing, in partnership with Eisai.

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pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster. Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects.

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Pharmaceutical Technology

OCTOBER 5, 2022

It is also important to ask whether doctors are being paid fair market value and if they are providing the services for which they’re being compensated, he adds. In 2005, Biogen withdrew Tysabri from the market following a clinical trial that resulted in two participants contracting progressive multifocal leukoencephalopathy (PML).

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Pfizer

SEPTEMBER 27, 2022

That’s why Pfizer invests in research and development: to produce groundbreaking treatments, like the COVID-19 vaccine, that improve people’s lives. Support the development of more treatment options by increasing access to biosimilars. on the policies of foreign governments — and could alter how doctors and patients access drugs.

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The Pharma Data

OCTOBER 27, 2020

National Institute of Allergy and Infectious Diseases, which sponsored the Lilly study, pulled the plug on the trial Monday — not because of any safety problem, but because there was only a slight chance that the drug would be effective, the AP said. Remdesivir gets full FDA approval to treat COVID-19. But the U.S.

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pharmaphorum

SEPTEMBER 15, 2022

Pfizer’s close-fought contest with GSK to bring a next-generation meningitis vaccine to market has entered the final rounds, with the former ahead on points following the readout of a pivotal phase 3 clinical trial.

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Vaccination Vaccine Sales FDA Approval 52

The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. “The

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Doctors Doctor Medicine Clinical Trials 52

pharmaphorum

FEBRUARY 2, 2021

However, as the pandemic took hold BMS opted to delay its launch, mindful that prescribing rates could be held back by the lack of patient contact with doctors. Novartis isn’t developing either Gilenya or Mayzent for UC, so the indication would give BMS a chance to grow Zeposia in a category without S1P competition for the time being.

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XTalks

JUNE 8, 2021

In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease. It was first approved in the US in 2019 to treat children below the age of two with SMA. Related: Is $2 Million Too Much For FDA-Approved SMA Gene Therapy? With a price tag of over $2.5

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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Vaccination Vaccine FDA Approval Regulation 52

The Pharma Data

APRIL 6, 2022

Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. . Robinson, M.D., ” About Presbyopia.

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Trials Production FDA Approval Doctors 52

XTalks

MARCH 16, 2022

Although colonoscopy remains the gold standard test for colon cancer, doctors deem stool DNA tests as an acceptable alternative for people at average risk who may be hesitant to get the more invasive procedure. Exact Sciences is eyeing an FDA approval for a newer version of its test, Cologuard 2.0,

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DNA FDA Approval Doctors Doctor 98

XTalks

JANUARY 12, 2023

With data recently published from a large global confirmatory Phase III clinical trial (Clarity AD) , Eisai will also file a supplemental Biologics License Application (sBLA) to the FDA to have Leqembi approved under the traditional pathway, too. What We Know About Leqembi and Clinical Trial Results.

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