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According to the revised deal, Daiichi Sankyo and Kite will transfer the Marketing Authorization for Yescarta to Gilead’s Japan subsidiary, Gilead Sciences K.K., The therapy’s sales and promotion works in Japan following the transfer of marketing authorisation will be carried out by the Kite Cell Therapy Business Unit at Gilead Sciences K.K.
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 regulator has also cleared the investigational new drug (IND) application for APB-102.
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.
There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).
Premarketing drug studies vs Post- Marketing research. Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA).
The next step will be to start a rolling submission for a Biologics License Application (BLA) for its COVID-19 vaccine with the FDA this month. Moderna has reported the first profitable quarter in the companyâs history: after 10 years of research and several billion dollars of investment in its mRNA platform.
DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. And the COVID-19 pandemic has likely given the market an added boost, Torous adds. Does this mean we should give up?
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.
Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The post physIQ licenses virtual trial tech to Janssen in multi-year deal appeared first on. No financial details were disclosed.
The Everest Group PEAK Matrix® is an industry-standard evaluation that ranks service providers on two essential dimensions: market impact and vision & capability. Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks. To learn more, visit www.cloudbyz.com.
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. . It takes around 20 minutes of game play to provide a reading.
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. To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. Wholesale Drug License.
billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.
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). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.
Companies looking to replicate a drug’s EU market success in the US will face significant hurdles unless they are fully aware of the ever-changing national and state requirements and regulations, says Two Labs’ Howard Miller. These are counterparts to the different regulations and requirements found across Europe.
LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. This gives lerodalcibep an edge to approved PCSK9 inhibitors.
ERS Genomics, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by the one of the joint 2020 Nobel Prize winners for Chemistry, Dr Emmanuelle Charpentier, has granted a non-exclusive license agreement to German startup, Vivlion.
The biopharmaceutical industry witnessed a 400% growth in total deal value of antibody-drug conjugate (ADC) licensing agreements from 2017-2022 and reached a peak of $16.6 billion in 2022, reveals data and analytics company GlobalData.
A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. The regulator approved Nuvaxovid for use as a primary series in adolescents aged 12 to 17 years in August last year.
While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.
The French biotech company Vect-Horus has licensed its technology to the Danish big pharma Novo Nordisk to deliver drug cargoes to undisclosed disease targets in three programs.
Ipsen is expanding its oncology pipeline by securing the global licensing rights to an antibody-drug conjugate (ADC) for solid tumors from Sutro Biopharma, its first drug in the category.
Synaffix, a Netherlands based company providing clinical-stage platform technology for the development of antibody-drug conjugates (ADCs), has signed off on two new licensing deals this week.
Emergence Therapeutics has become the tenth company to license ADC technology from Synaffix. The deal has a total potential value of up to US$360m, plus royalties on commercial sales.
The company said that Microtox BT already satisfies many of the criteria set out in a document published by the UK regulator, setting out standards for COVID-19 breath tests. It has licensed in a patented breathalyser, the analysts noted.
Australiaâs Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharmâs subsidiary Pharmorage.
Pennsylvania-based Levolta Pharmaceuticals has entered into an exclusive licensing and distribution agreement with Saudi Arabia company, Tabuk Pharmaceutical Manufacturing Company to start commercializing a therapy for osteoarthritis (OA).
Corbus Pharmaceuticals announced the expansion of its portfolio into immuno-oncology through licensing deals with the University of California San Francisco and Panorama Research Inc for two new monoclonal antibodies (mAbs).
Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target for regulators. When companies target new markets, most will ensure their distribution partners sign legal agreements stating they won’t engage in corrupt practices. . No excuses. Get control back.
AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale. Companies must comply with the regulations, but how compliance is achieved can be somewhat different. Looking beyond balance sheets. Post-acquisition compliance.
These advertisements, often found on social media platforms, search engines and various websites, frequently violate advertising guidelines and regulations. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.
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