XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody DNA 105

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 received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

FDA Approval 98

FDA Approval Development Containment Licensing 98

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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Licensing 130

XTalks

FEBRUARY 4, 2025

The company plans to use these funds to advance its groundbreaking research in small molecule precision medicines, targeting renal, cardiovascular and metabolic diseases, including obesity. To further expand its research, Maze has entered several strategic partnerships and licensing agreements. The offering, which includes 8.75

Clinical Trials 66

Clinical Trials Clinical Trials Trials Genetics 66

Scienmag

AUGUST 5, 2020

Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink.

FDA Approval 55

FDA Approval Licensing Licensing Engineer 55

Pharmaceutical Technology

NOVEMBER 1, 2022

The European Commission (EC) has granted orphan medicinal product designation for Karyopharm Therapeutics and the Menarini Group’s Nexpovio (selinexor) to treat myelofibrosis (MF). The companies signed an exclusive licensing agreement in December 2021. The therapy is commercialised in the US as Xpovio.

Protein 130

Protein FDA Approval Production Licensing 130

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

Development 242

Development Bioequivalency Generic Drugs Production 242

Scienmag

MARCH 28, 2021

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. March 29, 2021) – The U.S.

Production 76

Production FDA Approval Licensing Licensing 76

XTalks

DECEMBER 18, 2024

Trial data for both the pediatric and adult trials were published in The New England Journal of Medicine. Crenessity marks the third approved drug for Neurocrine. In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis.

Genetics 116

Genetics Hormones Trials Drugs 116

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.

FDA Approval 130

FDA Approval Licensing Licensing Trials 130

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. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

FEBRUARY 12, 2025

Nerandomilast is Boehringers next candidate for PPF and IPF following their FDA-approved treatment, Ofev (nintedanib) one of only two approved therapies for IPF, alongside pirfenidone.

Clinical Trials 66

Clinical Trials Clinical Trials Trials FDA Approval 66

Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. While Rebyota was the first to be approved, more could be coming up soon, says Gilbert.

Bacteria 278

Bacteria Trials Research Medicine 278

Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is a novel, approved anti-fungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. It will also receive an additional $15m in milestone payments, upon receipt of US FDA approval for an additional indication. The company will receive up to $245.5m

Sales 130

Sales FDA Approval Clinical Trials Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez. After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8 million at the time). million price tag.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Pharmaceutical Technology

JUNE 9, 2023

Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding. The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. Still, Jackson added she felt comfortable about available safety and pharmacokinetic information.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

pharmaphorum

NOVEMBER 24, 2020

Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year. Alnylam licensed inclisiran to The Medicines Company, which was bought last year by Novartis for $9.7

FDA Approval 52

FDA Approval Gene Silencing Drugs RNA 52

Pharmaceutical Technology

AUGUST 23, 2022

The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine.

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.

FDA Approval 52

FDA Approval Licensing Licensing Vaccination 52

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 29, 2021

Amazon is advancing into healthcare on multiple fronts, launching its own pharmacy business for medicines delivery in the US last year, whilst also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.

FDA Approval 138

FDA Approval Pharmacy Development Containment 138

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average.

Drugs 130

Drugs Pharma Companies Medicine Production 130

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.

Hormones 98

Hormones Drugs FDA Approval Sales 98

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

pharmaphorum

JANUARY 11, 2023

The partnership will build on Anima’s previous discovery and development collaborations with Eli Lilly in July 2018 and with Takeda in 2021, giving AbbVie exclusive rights to license and further develop and commercialise the programmes. Anima’s wholly owned pipeline programmes, meanwhile, are in fibrosis, oncology, and neuroscience.

Protein 105

Protein Regulation FDA Approval Licensing 105

pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

Marketing 98

Marketing Antibody Medicine FDA Approval 98

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 98

pharmaphorum

OCTOBER 3, 2022

Translarna was the first licensed treatment for DMD which addresses the loss of dystrophin. Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021. The post Translarna not approved by NICE for DMD on NHS appeared first on.

Gene Therapy 98

Gene Therapy Gene FDA Approval DNA 98

pharmaphorum

NOVEMBER 17, 2021

The filing is seeking FDA approval of the drug for adults who are newly diagnosed with COVID-19 and are at risk of developing severe disease. Rolling marketing applications are also underway in other countries including in the UK, Australia, New Zealand and South Korea, said Pfizer.

Licensing 98

Licensing Licensing FDA Approval Drugs 98

XTalks

JANUARY 4, 2024

Pfizer licensed Beqvez from Spark Therapeutics nine years ago. Related: Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease While the Health Canada approval is a significant inaugural win, Pfizer is looking to discontinue development of viral vector-based gene therapies. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Related Articles: Zokinvy (lonafarnib) FDA Approval History.

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). Additional data from the CAPELLA study will be presented at a future scientific conference.

Medicine 52

Medicine Marketing Drugs FDA Approval 52

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.

Drugs 98

Drugs FDA Approval Genetics Clinical Trials 98

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]

FDA Approval 52

FDA Approval Production Research Development 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

Drugs 105

Drugs Sales Antibody FDA Approval 105