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According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020.
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.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDAapproval to start clinical trials towards the end of 2022.
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.
Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use. The median durations of response were 10 months and seven months, respectively.
In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. Related: Vtama (tapinarof) Cream Gains FDAApproval for the Treatment of Plaque Psoriasis in Adults. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.
STS101 combines Satsuma’s nasal powder formulation and Shin Nippon Biomedical Laboratories’ (SNBL) delivery device technology, which was licensed by Satsuma. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA). in cash per share. in cash per share.
Amvuttra’s FDAapproval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. billion in global sales by 2026.
It will also receive an additional $15m in milestone payments, upon receipt of US FDAapproval for an additional indication. in sales-related milestone payments, along with tiered royalties on sales across all indications. The company will receive up to $245.5m Additionally, GSK will pay up to $242.5m
Ingrezza (valbenazine), first approved in 2017 for tardive dyskinesia, received a key label expansion in 2023 to include the treatment of chorea in patients with Huntingtons disease. Neurocrines hit drug generated $613 million in sales during the third quarter and is projected to reach $2.3 billion in revenue by 2024.
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. . TALi is also in line for royalties on sales.
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.
Q32 will also receive tiered royalty payments on net sales. In July, the US Food and Drug Administration (FDA) approved Horizon’s supplemental Biologics License Application for Krystexxa (pegloticase) plus methotrexate, to aid uncontrolled gout patients attain a complete response to treatment. A fully human anti-IL-7R?
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 FDAapproval and meet commercial objectives, plus royalties on net sales.
In June 2021, the FDAapproved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDAapproval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.
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. Linzagolix is not currently approved anywhere in the world.
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.
Takeda has scored the first-ever FDAapproval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Originally developed by GlaxoSmithKline, it was licensed to ViroPharma, which was subsequently bought put by Shire.
However, it is possible to target CD33 in the clinic, as evidenced by the FDAapproval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.
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. It’s also in line for up to $240 million in US sales-based milestones.
The US FDAapproved 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.
At its second attempt, Novartis has won FDAapproval 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.
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
FDAApproves 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 FDAapproved. Related Articles: Danyelza (naxitamab-gqgk) FDAApproval History. NEW YORK, Nov. Source link.
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.
Novartis has claimed FDAapproval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Tasigna made sales of $1.56 Scemblix could beef up Novartis’ CML portfolio, which remains a big earner for the company.
“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.
Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDAapproval in February 2020. A second liver biopsy will be performed after 18 months.
Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.
It’s a disappointing outcome for a programme that GSK said in 2021 could potentially generate £1 to £2 billion in peak sales because of the serious unmet need in RA patients. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront.
Rukobia works by targeting the first step of the HIV lifecycle and doesn’t have cross-resistance with other currently licensed antiretroviral classes, re-establishing virus control in patients who are at risk of disease progression and death.
FDAApproves 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. PALO ALTO, Calif., 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc.
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDAapproval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43
As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDAapproval of the drug. The agreement also includes sales target milestones which, if achieved, could total up to $225 million, Seres outlined in a news release from the company.
NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Company is currently seeking FDAapproval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia & ROCKVILLE, Md.–( based in Japan.
In May, the Delaware court sided with Hospira and ruled that three patents Astellas is relying on for Lexiscan market exclusivity in the US – 8,106,183; 8, 524,883; and RE47301 – are not infringed by Hospira’s generic, which was submitted for FDAapproval in 2018. It was first launched in the US in 2008.
Clovis Oncology has said it may not have enough cash to fund continuing operations beyond January next year, as it struggles to reverse a decline in sales of PARP inhibitor Rubraca. Sales were around $140 million in 2019, and climbed to $165 million the following year, despite the impact of the pandemic.
.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDAapproval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Life is on. Gifford, R.
Viatris (formerly Mylan) has become the first drugmaker to win full FDAapproval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1
Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. The recommended dosage of Qalsody is 100 mg (15 mL) per administration. What is SOD1 -ALS?
The jury in the US District Court for the Eastern District of Texas agreed with the biotech that the infringement was wilful, awarding it a sum based on past royalties that should have been paid on Enhertu sales in the US to date. billion licensing deal for the drug in 2019. That could be a sizeable sum.
Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06
The Japanese pharma and Gilead Sciences – which licensed US rights to Lexiscan to the Japanese company – won a temporary reprieve against the launch of the generic back in the autumn, winning a temporary stay on launch until 6 December. AmphaStar and Glenmark Pharma also claimed FDAapproval for versions of the drug earlier this year.
The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Products like electrophysiology devices, contact lenses and surgical products were major drivers of sales in this area. billion on R&D in 2023, representing almost 18 percent of the year’s sales.
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