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. . Amarin said that Vazkepa is one of the first drugs filed and licensed through the MHRA’s new “Reliance” route following the end of the Brexit transition period.

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BioPharma Reporter

APRIL 2, 2024

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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 14, 2023

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

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Drug Discovery World

NOVEMBER 2, 2022

UK-based company Ubiquigent has signed an exclusive license with the University of Southern Denmark for its UbiSite technology. UbiSite will form a new component in Ubiquigent’s deubiquitylase (DUB) and ubiquitin-proteasome system (UPS) focused drug discovery platform.

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Drug Discovery World

MARCH 17, 2023

The drug has been accepted for the treatment of chronic HDV infection in adult patients with evidence of significant fibrosis, whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.

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Regulation Drugs Licensing Licensing 52

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.

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FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers.

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BioTech 365

JUNE 9, 2021

World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, (..)

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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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BioTech 365

JUNE 9, 2021

Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, (..)

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

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. […]

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Fossil Remedies

OCTOBER 16, 2022

To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. The next important thing is the license. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. Wholesale Drug License.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

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.

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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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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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Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. It was discovered in the labs of Craig Lindsley, Director of the Warren Center for Neuroscience Drug Discovery (WCNDD) and Director Emeritus Jeffrey Conn.

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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. Continued authorization for COVID-19 drugs.

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Drug Discovery World

SEPTEMBER 27, 2023

Seven years of trial data DLd is licensed and has been available for use in Europe since 2019. The post UK regulator gives green light to combination for multiple myeloma appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

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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. Food and Drug Administration (FDA). Dietary supplements are easily accessible on store shelves or online marketplaces.

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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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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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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.

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Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. It is developed based on MyoKardia's drug discovery platform.

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FDA Law Blog

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. 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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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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NY Times

AUGUST 20, 2021

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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Pharma in Brief

JANUARY 19, 2023

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments ). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1 , is open until March 27, 2023. We previously reported on the IO here.

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Pharmaceutical Technology

MAY 22, 2023

The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP). Eisai and Biogen recently announced that Health Canada has accepted a new drug submission for lecanemab to treat early AD. The Clarity AD trial showed significant results and met its primary and all key secondary endpoints.

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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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pharmaphorum

APRIL 28, 2022

billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. The post Pfizer/Biohaven migraine drug rimegepant gets EU green light appeared first on. Pfizer’s $1.2

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. Hope for drug that slows neurodegenerative disease . Scientists have found a new drug treatment that can slow the progression of neurodegenerative disease in mice.

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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 ).

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Drug Discovery World

AUGUST 1, 2023

Synthetic biology is increasingly important to drug discovery and development. Partnerships Earlier this year cell-engineering company MaxCyte signed a strategic platform license (SPL) with biotechnology company Catamaran Bio. In return MaxCyte will receive platform licensing fees and program-related revenue.

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