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The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.
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.
Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.
Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.
At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.
The startup, which aims to develop lower-cost alternatives to branded medicines, has licensed two drugs from CStone Pharmaceuticals in a deal that could signal a coming price war in cancer immunotherapy.
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).
The newly launched biotech is equipped with rights to a trio of weight loss medicineslicensed from China-based Sciwind Biosciences, led by an oral therapy ready for Phase 2 testing.
The Power of Patent Licensing: Unlocking Innovation and Access to Medicines Patent licensing agreements have become a crucial tool in the pharmaceutical industry, allowing companies to collaborate and…
The latest deal in AI drug discovery is a twist on the usual big pharma-startup collaboration model, with Insitro licensing technology and Lilly eligible for royalties.
The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]
Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.
The deal gives the company milestone payments and royalties to a medicine, frexalimab, that Sanofi licensed from biotech ImmuNext and expects to be a future blockbuster.
Last fall, Novartis agreed to license a best-selling cancer drug so that generic companies could make copies for distribution to 44 low- and middle-income nations, marking the first time a voluntary license was arranged for a cancer medicine. ANNECY, FRANCE — At first blush, the deal was hailed as a breakthrough.
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).
A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.
Shares of the biotech rose about 5% after a medicinelicensed from Takeda hit the main and key secondary goals of a mid-stage study focused on major depressive disorder.
The field of genomic medicine has reached a true turning point. As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. CEVEC became part of Cytiva in October 2022.
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). An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.
The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis. Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review. “By
Insilico Medicine is due to receive $80 million upfront plus potential milestone payments as Exelixis gains global rights to develop and commercialize the Hong Kong firmâs small molecule cancer treatment.
“We look forward to utilising our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China. “We We have a strong track record of working with companies that share our focus on bringing transformative medicines to patients around the globe who need them.”
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.
The company has secured Orphan Drug designations for Friedreich’s ataxia, offering benefits like market exclusivity and eligibility for Priority Review vouchers. These efforts aim to fast-track commercialization and out-licensing agreements in one of the world’s most promising pharmaceutical markets.
Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.
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…
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. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades.
Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor.
The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Outside of these steps, the reform targets drug shortages and pharma industry’s environmental impact.
The biotech, which went public in 2021 to develop a cancer druglicensed from Daiichi Sankyo, may try to acquire a different tumor-targeting medicine to grow its pipeline.
GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. The post GSK partners LifeMine on fungi-derived medicines appeared first on.
LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.
BioMarin chairman and CEO Jean-Jacques Bienaimé said: “Roctavian approval in Europe is a historic milestone in medicine and is built upon almost four decades of scientific discovery, innovation and perseverance. “We The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.
California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients. Continue to STAT+ to read the full story…
Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. The limits of animal models in drug discovery are well known. Beyond testing.
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. This includes Apretude and the two oral drugs— Descovy and Truvada.
AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.
Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. This paper was originally published by Md.
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