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.

Cardiology 98

Cardiology Regulation Drugs Medicine 98

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.

Licensing 52

Licensing Licensing Pharma Companies Manufacturing 52

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.

Licensing 52

Licensing Licensing Antibody Drugs 52

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.

Licensing 59

Licensing Licensing Antibody Drugs 59

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.

Licensing 59

Licensing Licensing Drug Delivery Drugs 59

BioPharma Reporter

SEPTEMBER 25, 2023

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

Licensing 52

Licensing Licensing Drugs Regulation 52

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.

Licensing 52

Licensing Licensing Antibody Development 52

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).

Marketing 97

Marketing Research Trials Clinical Trials 97

pharmaphorum

OCTOBER 18, 2021

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.

Marketing 52

Marketing Licensing Licensing 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.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

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).

Licensing 52

Licensing Licensing Manufacturing Regulation 52

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.

Licensing 98

Licensing Licensing Regulation Marketing 98

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.

Marketing 109

Marketing Regulation Production Medicine 109

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.

Licensing 92

Licensing Licensing Regulation Marketing 92

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.

Licensing 52

Licensing Licensing Sales Regulation 52

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.

Licensing 64

Licensing Licensing Sales FDA Approval 64

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.

Licensing 64

Licensing Licensing Immune Response Antibody 64

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).

Regulation 52

Regulation Research Production Compliance 52

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.

Licensing 93

Licensing Licensing Vaccination Vaccine 93

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.

Licensing 98

Licensing Licensing Regulation Marketing 98

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.

RNA 52

RNA Licensing Licensing Vaccination 52

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

DNA Licensing Licensing Production 52

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.

Marketing 52

Marketing Research Trials Clinical Trials 52

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.

Licensing 64

Licensing Licensing Genome Genomics 64

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).

Licensing 52

Licensing Licensing Antibody Research 52

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.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

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).

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharma Packaging Solutions

JULY 17, 2023

The biopharmaceutical market is ever growing, thanks to constant scientific advancements in the field. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. General Regulations (From Section 112.1)

Packaging 52

Packaging Packaging Containment Regulation 52

FDA Law Blog

JUNE 12, 2024

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.

Regulation 109

Regulation Marketing Licensing Licensing 109

Roots Analysis

FEBRUARY 21, 2024

Broadly, wearable exoskeleton market can be classified into two major categories, namely medical and non-medical exoskeletons. The exoskeleton market is witnessing substantial growth, propelled by technological advancements in both medical and non-medical domains.

Marketing 40

Marketing Regulation Production Development 40

Cloudbyz

NOVEMBER 22, 2024

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.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

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.

Marketing 75

Marketing Production Drugs Licensing 75

XTalks

JULY 19, 2024

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.

Pharmacy 95

Pharmacy Drugs Production Sales 95

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.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

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).

Licensing 105

Licensing Licensing Development Regulation 105

Pharmaceutical Technology

JANUARY 19, 2023

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.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

In-Vitro 80

In-Vitro Regulation Manufacturing Licensing 80