Pharmaceutical Technology

MARCH 27, 2023

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. During 2013–2022, NME approvals were lower only in 2013 and 2016. Faced with such a disappointing approval number last year, manufacturers hope for more NMEs to enter the market in 2023.

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XTalks

DECEMBER 7, 2022

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). The median time to complete remission was 1.9

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XTalks

JULY 14, 2022

Rare and rheumatic disease-focused biotech Horizon Therapeutics has received expanded approval from the US Food and Drug Administration (FDA) for its gout injection Krystexxa (pegloticase) to include its co-administration with the immunomodulator methotrexate. It is the first and only biologic approved for the condition.

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pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

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XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

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FDA Approval Gene Expression Cosmetics Trials 97

XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia.

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Pharmaceutical Technology

APRIL 25, 2023

Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.

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Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. The drug is currently under review in Australia, the EU and Switzerland.

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XTalks

APRIL 23, 2021

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer. Dostarlimab and the GARNET Trial. percent after treatment with the monotherapy.

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. are expected to be approved by the U.S. . U.S.

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XTalks

FEBRUARY 29, 2024

Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab). After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. But Biogen couldn’t convince payers of its benefits.

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Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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pharmaphorum

NOVEMBER 10, 2021

Pfizer has bolstered its central nervous system (CNS) drugs portfolio with a $1.2 The drug was the first in the oral CGRP inhibitor class to get an prevention indication approved by the FDA in May, and that has helped accelerate its rollout, bringing in $336 million in US sales for Biohaven so far this year.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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Pharmaceutical Technology

MARCH 27, 2023

Iovance Bioterapeutics announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for Lifileucel. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

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pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients.

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Drug Discovery World

OCTOBER 11, 2023

Boehringer Ingelheim and CDR-Life entered a licensing agreement in May 2020 and announced the selection of an antibody fragment-based therapeutic candidate in September 2021.

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Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is claimed to be the only oral antifungal to receive approval from the US Food and Drug Administration (FDA) to treat VVC, as well as reducing RVVC incidence. Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection.

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XTalks

JUNE 20, 2022

Alnylam Pharmaceuticals, a leading RNA interference (RNAi) therapeutics biopharmaceutical company, announced it received approval from the US Food and Drug Administration (FDA) for its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults.

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore was granted the approval for Kimmtrak several weeks ahead of the scheduled PDUFA date of February 23. Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore.

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Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. It was also granted Orphan Drug Designation during the same time.

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pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. Spectrum licensed worldwide rights to poziotinib – excluding Korea and China – from Hanmi in back in 2015.

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XTalks

AUGUST 21, 2023

The US Food and Drug Administration (FDA) has approved Ipsen’s groundbreaking Sohonos (palovarotene) capsules for the treatment of fibrodysplasia ossificans progressive (FOP), an ultra-rare bone disease. Sohonos, the first and only approved drug, offers hope to those battling the disease.

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Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

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pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 With Jemperli , a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers.

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XTalks

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). The drug addresses a significant unmet need for patients, said Bausch + Lomb CEO Brent Saunders in a press release.

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pharmaphorum

NOVEMBER 21, 2022

The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D. . It also has an option on global marketing rights to the drug.

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pharmaphorum

NOVEMBER 24, 2021

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. It was one of the drugs acquired by Takeda when it merged with Shire in 2019.

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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Drugs FDA Approval Trials Licensing 115

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva. If approved, ObsEva’s drug will add another once-daily competitor to the ring.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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XTalks

JULY 6, 2021

to jointly commercialize the company’s investigational oral microbiome drug for recurrent Clostridioides difficile infection (CDI) in the US and Canada. The deal involved Nestlé gaining commercialization rights outside of the US and Canada for four experimental drugs: Seres’ SER-287 and SER-301 for irritable bowel disease and SER-262 for C.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S.

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XTalks

MARCH 21, 2023

The US Food and Drug Administration (FDA) has approved Acadia Pharmaceuticals’ Daybue (trofinetide) as the first and only treatment for Rett syndrome, a rare, complex neurodevelopmental disorder that mainly affects girls. Daybue is approved for adult and pediatric patients with Rett syndrome who are two years of age and older.

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FDA Approval Gene Therapy Gene Genetics 94

pharmaphorum

AUGUST 24, 2021

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. Cara and Vifor said they have identified a dose to take forward for that group, and will start recruiting patients into the phase 3 trial later this year.

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