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Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA).
Merck has reported an increase in group net sales by 12.9% The growth in sales was driven by all regions and business sectors, particularly Life Science. in group sales in fiscal 2022. Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity. In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).
Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. billion in global sales in 2029, while Truvada estimates amount to $30 million.
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Stealth’s elamipretide tetrapeptide drug is an investigational mitochondrial protective agent that binds to cardiolipin in dysfunctional mitochondria.
Shionogi will waive royalty payments on product sales in all countries under this deal as long as Covid-19 is listed by the World Health Organization as a Public Health Emergency of International Concern. An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.
Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Denali is also expected to receive potential development and commercial milestone payments upon achieving certain milestones, along with royalties based on the future net sales of the drug.
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]
Antares Pharma's auto-injector technology is of particular interest to Halozyme, which believes that the various markets to which it could be applied represent billions of dollars in potential sales.
As per the terms of the agreement, HUTCHMED will receive an upfront payment of $400m on the closing of the deal, along with additional potential payments of up to $730m in regulatory, development and commercial sales milestones and royalties on net sales. The submission is planned to be completed in the first half of this year.
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The company stated that the collaboration will use the local presence, sales and marketing capabilities of Biomm in Brazil.
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 post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.
US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).
LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). The company will also be eligible for tiered royalties as a percentage of global commercial sales of the products.
Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). sales milestones along with royalties ranging between 5% and 9% of net sales of the solution by Ocumension.
On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021. targeting ADC.
On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .
Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. According to the agreement, CSPC will receive a $7.5m
The company has just claimed its first approval for the drug in Canada – under the Sohonos brand name – as a treatment for the ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP), but was forced to withdraw its marketing application for the drug in the US last summer after a request for more data.
Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio. BRII-877 (VIR-3434) will be integrated into our innovative drug combination strategies that may lead to a higher functional cure rate across all patient groups.”.
Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4
exclusivity period on its immunology blockbuster Stelara ticks away, another biosimilar player has lined up for the piece of the drug's sales pie. | exclusivity period on Stelara ticks away, another biosimilar player has lined up for the piece of the blockbuster's sales pie. As Johnson & Johnson's U.S.
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. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.
The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . The drug targets CCR8, a chemokine receptor enriched on TITR cells. The results spooked investors and caused shares in Jounce to fall, but the drug is continuing through phase 2 trials.
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.
Neurocrine Biosciences Crenessity (crinecerfont) has been given the green light by the US Food and Drug Administration (FDA) as a new treatment for congenital adrenal hyperplasia (CAH). Crenessity marks the third approved drug for Neurocrine. billion in revenue by 2024. billion in revenue by 2024.
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.
Dutch biotechnology company Synaffix and Amgen have entered a licensing agreement for the development of next-generation antibody-drug conjugates (ADCs). For four future programmes, Amgen will also have an option for exercising exclusive licenses for research and commercialisation.
Pharmaceutical sales in Brazil reached $17bn in 2021, according to GlobalData figures. Brazilian public spending on healthcare, drug pricing reforms and remote medicine. of the total value of pharmaceutical market sales, with the value of generics sales forecast to grow to $5.7bn in 2022.
In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Haemophilia B is a rare condition.
Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. The drug is also approved for other CD30-expressing T-cell lymphomas, such as anaplastic large cell lymphoma, in both frontline and refractory settings.
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.
Sosei Heptares , a corporate brand of Sosei Group Corporation, has signed a new drug discovery partnership and option-to-license agreement with AbbVie for discovering, developing and marketing new therapies for neurological ailments. Additionally, AbbVie will make tiered royalty payments based on global product sales to Sosei Heptares.
Grünenthal is paying up to €500 million ($501 million) for rights to Nebido (testosterone undecanoate), which is sold in around 80 countries worldwide for testosterone deficiency and made sales of €117 million last year. The post Bayer sells testosterone drug rights to Grünenthal for €500m appeared first on.
Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. We also offer licenses to our secure hosted learning environmentno internal setup required! Visit our eLearning page to get started.
The green light prompts a $50 million payment to Cara from Vifor Pharma , which has licensed US and European commercialisation rights to the drug under a profit-sharing agreement. It’s also in line for up to $240 million in US sales-based milestones.
Goldfinch Bio’s assignment estate will receive an upfront payment of $15m and is eligible for milestone payments of up to $520m for each licensed TRPC4/5 candidate, from which $410m relates to regulatory approval and commercial sales milestones. Additionally, the company will receive a royalty on net sales of each licensed product.
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). Tasigna made sales of $1.56 The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.
AstraZeneca has snapped up another Ionis-discovered drug for its pipeline, this time phase 3 candidate eplontersen for the disease transthyretin amyloidosis (ATTR). billion in milestones depending on sales levels if the antisense-based drug reaches the market.
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