Fierce Pharma

AUGUST 3, 2023

In a high-stakes race of their eye disease drugs, Roche has sprinted to a significant lead over Regeneron. Playing catch-up with Roche in a war of eye disease treatments, Regeneron hopes to gain an FDA decision for its recently rejected high-dose Eylea in this quarter.

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FDA Leads 222

MedCity News

JANUARY 16, 2024

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

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FDA Pharmaceutical Leads Biopharma 125

MedCity News

MARCH 7, 2023

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

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FDA Leads Pharmaceutical Patients 94

Pharmaceutical Technology

JULY 31, 2023

US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.

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Leads FDA 52

MedCity News

APRIL 24, 2023

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

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FDA Leads Patients Biopharma 89

MedCity News

JULY 27, 2022

ObsEva’s uterine fibroids drug linzagolix has hit a snag at the FDA, portending a likely delayed regulatory decision. Rather than stick it out and see if its small molecule can match up against commercialized products from AbbVie and Myovant, ObsEva plans to give up rights to the drug as part of a corporate restructuring.

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FDA Leads Biopharma Pharma 119

World of DTC Marketing

OCTOBER 21, 2021

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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FDA Insurance Prescription Medicine 234

MedCity News

SEPTEMBER 30, 2022

An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”.

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FDA Leads Pharmaceutical Marketing 79

Pharmaceutical Technology

SEPTEMBER 20, 2023

The FDA wanted changes to the Phase I/II study designs investigating TSHA-120 in the rare neurological disorder, giant axonal neuropathy.

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FDA Leads 52

MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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Safety Leads FDA Biopharma 99

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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FDA Leads Safety Patients 97

MedCity News

MAY 19, 2023

Bausch + Lomb drug Miebo is now FDA approved as a new treatment for dry eye disease. Unlike many products that rewet the eye, Miebo is designed to address one of the factors that leads to dry eyes.

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FDA Leads Biopharma Pharma 111

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

Fierce Pharma

AUGUST 8, 2023

After closing shop in Europe two years ago, bluebird bio still aims to become an industry-leading gene therapy maker in the U.S. Bluebird aims to become an industry-leading gene therapy maker. First, it’s hoping new launches will help keep its doors open over the next 12 months.

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Leads FDA 215

MedCity News

FEBRUARY 21, 2023

Travere Therapeutics drug Filspari won accelerated FDA approval to treat a rare disorder that can lead to kidney failure. The small molecule is also in late-stage testing for another rare kidney disease; analysts say each indication represents a blockbuster opportunity.

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FDA Leads Biopharma Pharma 95

Pharmaceutical Technology

FEBRUARY 22, 2024

United has commenced litigation with the FDA to combat Liquidia’s Yutrepia encroaching on the market for its leading drug Tyvaso.

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FDA Leads Marketing 52

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

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FDA Competition Leads Marketing 105

Pharmaceutical Technology

FEBRUARY 14, 2023

Biogen is the leading patent filer in neuro-degenerative receptor binding drug compositions and has more than 15 neurodegenerative drugs in development. It has recently received new drug approval from the US FDA for an anti-beta-amyloid monoclonal antibody (Aduhelm) for the treatment of AD.

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Leads Pharmaceutical FDA 98

pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster. The post PARP rivals close in on AZ and Merck’s market leading Lynparza appeared first on.

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Leads Marketing FDA Patients 52

Pharmaceutical Technology

DECEMBER 21, 2023

The US FDA has granted orphan drug designation for Ocelot Bio’s lead candidate OCE-205 to treat ascites, excluding cancer-associated cases.

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FDA Leads 52

MedCity News

JUNE 14, 2023

The FDA has been notified and an investigation is underway. 2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study.

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Leads Patients FDA Biopharma 89

pharmaphorum

NOVEMBER 23, 2022

The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60. Dengue fever is unusual in that a first infection is rarely serious, but a second can lead to much more serious disease. billion in peak sales.

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FDA Marketing Leads Safety 118

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The post FDA approves new cell therapy manufacturing plant appeared first on European Pharmaceutical Review.

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Manufacturing Food and Drug Administration FDA Engineering 102

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021. ©GlobalData.

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FDA Specialization Leads Marketing 98

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). Click here to read EPR’s previous ‘ Women Inspiring Pharma’ series.

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Leads Pharma Food and Drug Administration Medicine 52

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The drug constricts blood vessels leading to a reduction in swelling and inflammation of blood vessels associated with migraine.

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Food and Drug Administration FDA Food Manufacturing 98

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The post FDA approves first treatment for geographic atrophy appeared first on European Pharmaceutical Review.

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FDA Food and Drug Administration Food Leads 95

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

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Food and Drug Administration FDA Food Safety 98

Pharmaceutical Technology

FEBRUARY 14, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Key innovation: Leading companies in nanoparticles for drug delivery. Bristol-Myers Squibb is the leading patent filer in nanoparticles for drug delivery.

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Leads Pharmaceutical Transportation FDA 59

pharmaphorum

JANUARY 9, 2024

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted targeted drug candidates for cancer.

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Manufacturing FDA Leads 94

Pharmacy Times

SEPTEMBER 29, 2023

Mesa, MD, FACP, discusses the results of the SIMPLIFY-1 and MOMENTUM trials and how the data led to the approval of momelotinib to treat intermediate or high-risk myelofibrosis in adult patients with anemia.

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Leads FDA Patients 58

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

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Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). CMT1A is a progressive neuromuscular autosomal-dominant disease that leads to life-long loss of muscle function, as well as disability.

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Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year.

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Leads Food and Drug Administration Food Medicine 59

pharmaphorum

JULY 1, 2022

Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to encroach on its territory. The post AZ takes aim at BMS’ lead in neoadjuvant NSCLC appeared first on.

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Leads FDA Patients 52

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

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Food and Drug Administration FDA Safety Food 98