Fossil Remedies

OCTOBER 16, 2022

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.

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pharmaphorum

APRIL 23, 2021

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.

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BioPharma Reporter

OCTOBER 26, 2023

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.

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BioPharma Reporter

OCTOBER 31, 2023

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.

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Drug Discovery World

MARCH 17, 2023

The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203. The post Scottish regulator approves first chronic hepatitis delta virus drug appeared first on Drug Discovery World (DDW).

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BioPharma Reporter

SEPTEMBER 25, 2023

MC2 Therapeutics has acquired the exclusive licensing rights for Regranionâs RGRN-305, a new treatment for hidradenitis suppurativa (HS).

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BioPharma Reporter

JANUARY 6, 2023

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.

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WCG Clinical

DECEMBER 13, 2023

These supplements are not classified as drugs under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, as such, do not require pre-marketing approval from the U.S. This is true regardless of whether the product is legally marketed as a food or a dietary supplement. Food and Drug Administration (FDA).

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Outsourcing Pharma

JUNE 5, 2023

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).

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Licensing Licensing Manufacturing Regulation 52

pharmaphorum

APRIL 22, 2021

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.

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Cloudbyz

AUGUST 2, 2022

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).

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BioPharma Reporter

NOVEMBER 9, 2021

Birmingham Biotech and the University of Birmingham have signed a licensing agreement for an anti-viral nasal spray against COVID-19.

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BioPharma Reporter

SEPTEMBER 6, 2022

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.

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pharmaphorum

AUGUST 18, 2021

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.

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Licensing Licensing Sales FDA Approval 63

pharmaphorum

APRIL 14, 2022

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.

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BioPharma Reporter

NOVEMBER 9, 2021

Birmingham Biotech and the University of Birmingham have signed a licensing agreement for an anti-viral nasal spray against COVID-19.

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BioPharma Reporter

MAY 6, 2021

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.

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BioPharma Reporter

DECEMBER 6, 2021

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.

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BioPharma Reporter

NOVEMBER 26, 2020

The European Federation of Pharmaceutical Industries and Associations (EFPIA) gave a cautious welcome to the EU action plan on intellectual property (IP), published yesterday, expressing alarm, though, over proposals within it on compulsory licensing.

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BioPharma Reporter

JULY 6, 2022

Touchlight has agreed to a non-exclusive patent license for Pfizer to utilize its enzymatic doggybone DNA (dbDNA).

DNA 52

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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Pharma in Brief

NOVEMBER 16, 2020

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance ( NOC ) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. Fresenius Kabi Canada Ltd.

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Pharmaceutical Technology

OCTOBER 25, 2022

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).

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BioPharma Reporter

JUNE 1, 2021

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).

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BioPharma Reporter

DECEMBER 3, 2020

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.

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BioPharma Reporter

MAY 7, 2021

Pfizer and BioNTech have started a rolling submission for a Biologics License Application (BLA) in the US for their COVID-19 vaccine.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Drug establishment licensing.

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BioPharma Reporter

JANUARY 8, 2024

Merck has announced a new licensing agreement with Inspirna for ompenaclid, a first-in-class treatment currently in phase 2 development for RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

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Pfizer

JANUARY 27, 2023

telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function.

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Pharmaceutical Technology

OCTOBER 31, 2022

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.

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Outsourcing Pharma

JANUARY 29, 2024

under an open-source license. The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0

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Life Science Licensing Licensing Medicine 88

BioPharma Reporter

APRIL 13, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford, has received its first regulatory clearance.

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Vaccination Vaccine Licensing Licensing 52

FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 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. In 2023, its second year on the market, the drug earned $91 million in sales.

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Outsourcing Pharma

DECEMBER 5, 2023

Merck has entered into a $70 million licensing agreement with Abbisko Therapeutics for pimicotinib, which is currently being evaluated in a phase 3 study for the treatment of tenosynovial giant cell tumor (TGCT).

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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pharmaphorum

MAY 30, 2022

It has been eight years since Sanofi licensed rights to an over-the-counter version of erectile dysfunction (ED) drug Cialis from Eli Lilly, and the FDA has just thrown a spanner into its plans to bring it to market in the US. Terms of that license deal have not been disclosed.

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