Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device.

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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Development Regulation Cosmetics Life Science 105

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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XTalks

MARCH 1, 2021

The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants. Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow.

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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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Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020. Within 30 calendar days.

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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

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 64

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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XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4

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XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. billion in revenue by 2024.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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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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Pharmaceutical Technology

MAY 24, 2023

It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.

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Gene Therapy Gene Licensing Licensing 130

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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Licensing Licensing Development Regulation 105

World of DTC Marketing

MAY 24, 2022

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. It means that mental help apps and services must be tightly regulated and reviewed. Here’s a great example.

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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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RNA Licensing Licensing Vaccination 52

XTalks

MARCH 19, 2025

XTALKS WEBINAR: Accelerating Drug Development by Operationalizing Patient Insights Live and On-Demand: Monday, June 9, 2025, at 12pm EDT (6pm CEST) Register for this free webinar to learn how patient-focused drug development can drive efficiency, minimize delays and support a successful commercialization strategy.

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Pharmaceutical Technology

JANUARY 19, 2023

It has been developed using the company’s recombinant nanoparticle technology. The regulator approved Nuvaxovid for use as a primary series in adolescents aged 12 to 17 years in August last year. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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Worldwide Clinical Trials

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Consistent training materials and programs should be developed to ensure uniform implementation of the trial protocol across all sites, regardless of location.

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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. Evolution of the Regulations Coming into force (1993–1997).

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pharmaphorum

JANUARY 11, 2023

AbbVie and Anima Biotech have announced that they are collaborating in a deal worth up to over $580 million to discover and develop drugs that modulate mRNA biology for three targets in cancer and immunology. before disease-related proteins are expressed). before disease-related proteins are expressed).

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pharmaphorum

DECEMBER 7, 2020

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.

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Pharmaceutical Technology

DECEMBER 9, 2022

Additionally, Brazil has been heading towards reforming its framework for drug pricing with new amendments currently under review with the Drug Market Regulation Chamber (CMED), as well as considering opportunities through telemedicine. These treatments may still be in development or already have approval somewhere in the world. </p>

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BioPharma Reporter

OCTOBER 18, 2022

Antibody-drug conjugate developer, Synaffix, has signed a licensing agreement with Cristal Therapeutics to gain access to its CliCr metal-free click chemistry.

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Development Licensing Licensing Antibody 52

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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BioPharma Reporter

JULY 25, 2023

ImmunoGen, a biotech company focused on the development of antibody-drug conjugate (ADC) technology to treat cancer, has announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem, a biopharma firm developing novel biological therapeutics.

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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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Licensing Licensing Drugs Development 52

pharmaphorum

JUNE 1, 2021

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. Working out which are more likely to benefit from stem cell therapy is likely to be a key challenge for developers. An interim look at the results is due later this month.

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Cloudbyz

NOVEMBER 22, 2024

Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks. Disclaimer  Licensed extracts taken from Everest Group’s PEAK Matrix® Reports, may be used by licensed third parties for use in their own marketing and promotional activities and collateral.

Life Science 52

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Danicamtiv overview Danicamtiv (MYK-491, DCM-1) is under development for the treatment of dilated cardiomyopathy (DCM), atrial fibrillation and systolic heart failure.

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Drugs Development Production Pharmacy 100

pharmaphorum

FEBRUARY 24, 2021

The main object of the deal is Merck’s MEK 1/2 inhibitor pimasertib, a drug it originally licensed from Santhera Pharmaceuticals more than a decade ago, bringing the drug to phase 2 in melanoma and ovarian cancer and running trials in various other solid tumours and blood cancers before shelving it in 2018.

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Pharmaceutical Technology

MARCH 9, 2023

T-cell activation can be measured by assessing proliferation, up-regulation of activation markers and production of effector cytokines (IFN-gamma and TNF-alpha). Immatics is a biopharmaceutical company focused on the development of T-cell immunotherapies to fight against cancer.

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pharmaphorum

DECEMBER 22, 2021

The Swiss pharma group has agreed to pay $800 million upfront for London, UK-based Gyroscope, with another $700 million to be paid if GT005 meets its objectives in terms of clinical development, regulatory approvals and reimbursement. CFI regulates the activity of the complement immune system which is over-activated in GA.

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Gene Therapy Gene Licensing Licensing 105

XTalks

MAY 11, 2021

RSE’s quality control manager, about the importance of manufacturing and regulating safe CBD and THC infusions. . Producers of cannabis-infused edibles and beverages haven’t always focused on taste during product development. When developing products, Mowbray said S?RSE RSE Regulated? Xtalks spoke to Loni Mowbray, S?RSE’s

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Camargo

JANUARY 12, 2022

For a standard new drug application (NDA) for a new molecular entity (NME) or original biologic license application (BLA) pre-approval, the FDA will communicate details on anticipated PMRs to the applicant no later than eight weeks prior to the PDUFA action date. prior to filing an Investigational New Drug [IND] application).

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