pharmaphorum

NOVEMBER 24, 2020

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

FDA Approval 105

FDA Approval Medicine Licensing Licensing 105

XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Competitors in the PNH market include Novartis, which won approval for its factor B inhibitor Fabhalta (iptacopan), the first oral pill for PNH treatment, late last year.

FDA Approval 102

FDA Approval Sales Trials Development 102

Pharmaceutical Technology

SEPTEMBER 13, 2022

Trodelvy has already received regulatory approval for previously treated triple-negative breast cancer (TNBC) across the eight major markets (8MM – US, France, Germany, Italy, Spain, UK, Japan and China). The post ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition appeared first on Pharmaceutical Technology.

HR 162

HR Marketing Hormones FDA Approval 162

XTalks

OCTOBER 22, 2024

The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. At the end of May, the FDA accepted the Japanese company’s resubmission of its biologics license application (BLA) for the drug.

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

Marketing 130

Marketing Gene Editing Production Sales 130

Fierce Pharma

OCTOBER 24, 2023

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

FDA Approval 93

FDA Approval Vaccine Vaccination Licensing 93

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). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Drugs 93

Pharmaceutical Technology

MAY 30, 2023

Medsenic reached licensing, marketing and supply agreements with Phebra for OATO in May 2021. Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of arsenic trioxide (OATO).

Clinical Supply 130

Clinical Supply FDA Approval Licensing Licensing 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. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.

FDA Approval 102

FDA Approval Vaccine Vaccination Clinical Trials 102

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

XTalks

SEPTEMBER 13, 2024

This blog explores the top 10 largest publicly traded healthcare companies by market capitalization , making strides in healthcare delivery and innovation. UnitedHealth Group (UNH) Market Capitalization : $738.67 Elevance Health (ELV) Market Capitalization : $170.91 HCA Healthcare (HCA) Market Capitalization : $136.05

Marketing 98

Marketing Pharmacy Gene Therapy Hormones 98

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

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

XTalks

JULY 6, 2021

As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug. SER-109 “repopulates” the microbiome to induce compositional and functional changes that are critical to a sustained clinical response.

Marketing 105

Marketing Drugs Bacteria FDA Approval 105

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

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). Last year, the FDA approved the first generic version of Restasis. The global dry eye disease market was valued at $5.53

FDA Approval 98

FDA Approval Gene Therapy Gene Marketing 98

pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. .

Licensing 64

Licensing Licensing Sales FDA Approval 64

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.

Licensing 52

Licensing Licensing FDA Approval Trials 52

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Drugs 289

pharmaphorum

NOVEMBER 24, 2020

Oxlumo (lumasiran) was also approved in the European Union last week, making it the third from Alnylam’s pipeline of RNA interference therapeutics to make it to market. 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

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. In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. million ($1.5

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Pharmaceutical Technology

MARCH 6, 2023

Tuoyi received marketing authorisation in China for six oncology indications, including NPC, in December 2018. Coherus Biosciences subsequently acquired the rights to commercialise Tuoyi in the US and Canada, and a revised biologics license application (BLA) was submitted to the FDA in July 2022 under priority review.

HR 130

HR FDA Approval Licensing Licensing 130

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. Coupled with this, the harsh conditions of the biotech market affected some companies.

Bacteria 278

Bacteria Trials Research Medicine 278

The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

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.

FDA Approval 52

FDA Approval Drugs Marketing Licensing 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 “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 5-adapted bivalent vaccine.

Vaccine 130

Vaccine Vaccination Gene Therapy Protein 130

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs Sales 52

Fierce Pharma

NOVEMBER 30, 2023

22, 2025, pending an FDA approval. J&J has reached similar deals with other companies seeking to market their own Stelara biosimilars. As Johnson & Johnson’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med.

Licensing 52

Licensing Licensing FDA Approval Marketing 52

XTalks

JANUARY 16, 2025

It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDA approval in 2020. Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

Trials 59

Trials Clinical Trials Clinical Trials Insulin 59

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. About High-Risk Neuroblastoma.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

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. The post CHMP clears way for EU approval of Novartis’ MS drug appeared first on.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 98

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

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

pharmaphorum

NOVEMBER 21, 2022

The US FDA approved the anti-CD3 antibody to delay the onset of stage 3 T1D in patients aged eight years and older who are currently diagnosed with stage 2 disease – a population estimated by Provention to be around 30,000 in the US. It also has an option on global marketing rights to the drug.

Drugs 116

Drugs Insulin FDA Approval Sales 116

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.

Drugs 105

Drugs Sales FDA Approval Licensing 105

Pharmaceutical Technology

JANUARY 6, 2023

This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. These actions allegedly led to the extension of Novartis’ patents.

Doctor 242

Doctor Doctors Drugs Sales 242

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