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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.
Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
MSD has secured an exclusive worldwide license from LaNova Medicines for developing, manufacturing, and commercialising the latter’s new investigational programmed cell death 1 (PD-1)/vascular endothelial growth factor (VEGF) bispecific antibody, LM-299.
The field of genomic medicine has reached a true turning point. In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1]
Shionogi & Co and the United Nations (UN)-backed public health organisation Medicines Patent Pool (MPP) have entered a voluntary licence agreement for the former’s oral Covid-19 antiviral candidate ensitrelvir fumaric acid (S-217622).
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. If proven and approved, the rapid introduction of AD04 into the U.K.
Amid a push to widen access to medicines to poor countries, Novartis has reached an agreement to license one of its best-selling cancer treatments so that generic manufacturers can produce copies for distribution to 44 low- and middle-income nations. Continue to STAT+ to read the full story…
In a much ballyhooed move, ViiV Healthcare finalized a deal to license its long-acting injectable HIV prevention shot to the Medicines Patent Pool so that generic companies can make and distribute lower-cost versions to low- and middle-income countries.
On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV.
Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). It intends to manufacture the drug at its facility in India.
Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%. The increase in sales was due to new medicines. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi. in organic sales.
Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction. Following the introduction of customs controls in January 2021, medicine imports from the EU fell to their lowest levels in years. Industry figures have spoken out against this prospect.
Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a Â1 million investment.
The next important consideration is a proper distribution channel from the manufacturer to end customers. In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. Wholesale Drug License.
The Medicines Patent Pool (MPP) and Novartis have unveiled a new voluntary licensing agreement to allow generic drugmakers in seven middle income nations to develop, manufacture, and supply generic versions of the leukaemia treatment nilotinib. Patents on the product are pending or in force in these seven chosen nations.
National Institutes of Health rejected a petition urging the agency to use a controversial provision of federal law to widen access to a cancer drug by forcing the manufacturers to license their patents. The medicine was developed at the University of California, Los Angeles, with help from U.S.
The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.
… Merck plans to take legal action against several pharmaceutical companies in China after noticing that some manufacturers were supplying Covid-19 drugs to some provinces and cities saying the medicines were authorized by Merck , Reuters reports. Have a wonderful day, and please do stay in touch.
Astellas will build its third Irish manufacturing facility. Astellas will build its third Irish manufacturing facility for $354 million. Insilico Medicine out-licensed an AI-discovered cancer drug candidate to Exelixis. Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5
By remaining compliant, medicines are manufactured in line with their pre-defined and approved specifications, in order to ensure the delivery of safe and effective products to consumers. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data. About the author.
Under the deal, Karuna will have an exclusive worldwide licence for the development, manufacturing, and commercialisation of multiple Goldfinch Bio’s TRPC4/5 candidates, including GFB-887, the lead clinical-stage candidate. Additionally, the company will receive a royalty on net sales of each licensed product.
Indiana-based radiopharmaceutical Contract Development and Manufacturing Organization expands nuclear pharmacy capabilities with second location . SpectronRx , a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. To learn more, visit SpectronRx.com.
Several of the top pharmaceutical companies have joined a new coalition that aims to improve access to cancer medicines in low- and lower-middle-income countries (LLMICs). It is taking a broader approach, making sure patients living with cancer “receive the medicines they need at the right time,” he said.
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 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. has a fever.
Adalvo has entered a strategic licensing agreement with Swiss pharmaceutical company EQL Pharma for Mellozzan (melatonin) outside Europe and the US. With a network of more than 134 local pharmaceutical companies, Adalvo supplies more than 110 different medicines in over 100 countries across the world.
VA seeking companies to license, manufacture Credit: Dr. Scott Fuller/VA SACRAMENTO, Calif. – An ear, nose, and throat doctor has invented a simple mask design that significantly improves safety during aerosol-generating procedures of the head and neck.
CSL Behring has a commercialisation and license agreement to develop EtranaDez. On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application.
The European Medicines Agency has also approved Efmody for the treatment of congenital adrenal hyperplasia medicine in patients ages 12 years and above in the European Union. Separate from drug development, the Italian company also offers contract manufacturing and clinical supply services.
Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted
CDMO Sterling Pharma Solutions has been granted a Manufacturerâs Authorisation for Investigational Medicinal Products from the UKâs Medicines and Healthcare products Regulatory Agency (MHRA).
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. It was billed at the time as a key tool to accelerate the development of new and innovative vaccines to combat some of the world’s most prevalent diseases, from discovery to licensed product.
The agreement will enable MPP to grease fresh product and distribution of the investigational antiviral, pending nonsupervisory authorization or blessing, by grantingsub-licenses to good general drug manufacturers, with the thing of easing lesser access to the global population. This press release features multimedia.
The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 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 1-adapted vaccine. 5-adapted bivalent vaccine.
Seagen and Lava Therapeutics have entered an exclusive licence agreement for the development, manufacturing and commercialisation of the latter’s LAVA-1223 for solid tumours. An advanced preclinical asset, LAVA-1223 is a bispecific T cell engager. It can act on and activate V?9V?2
Twenty-seven drug makers have signed onto a deal to manufacture a generic version of molnupiravir , Merck’s oral antiviral for the treatment of COVID-19. We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”.
Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. “We expect to manufacture our COVID-19 vaccine as well as additional products within our mRNA vaccine portfolio at this facility.”
Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.
A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! that online retail giants Alibaba and JD were selling medicines in a gray area of law.
ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure . Widening access for an injectable such as this is complex and will take all stakeholders playing their part. Shionogi B.V. joined in October 2012. Source link: www.viivhealthcare.com. .
The combined company will cover a broad swathe of the digital health landscape, bringing together population health software, telehealth services, digital pharmacy delivering compounded and manufacturedmedicines, and tech enabled behavioural health services for people with mental health and substance abuse issues.
RNA has the potential to underpin breakthrough treatments for a wide variety of diseases, including many cancers, and transform medicine as we know it. But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. Polydispersity is the range of particle sizes produced during manufacturing.
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