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

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 94

Licensing Licensing Regulation Marketing 94

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

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

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

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

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 94

Licensing Licensing Vaccination Vaccine 94

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. And the COVID-19 pandemic has likely given the market an added boost, Torous adds. Does this mean we should give up?

Licensing 252

Licensing Licensing Scientist Production 252

Camargo

NOVEMBER 11, 2020

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

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

Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. This trade has been able to continue for the most part, as the UK’s regulator (the MHRA) remains aligned in many areas with the EU’s regulator (the EMA).

Medicine 290

Medicine Production Generic Drugs Regulation 290

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

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

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.

Production 230

Production Packaging Packaging Development 230

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

MAY 20, 2024

CRISPR licensing company ERS Genomics and drug discovery firm IRBM have entered into a non-exclusive CRISPR/Cas9 license agreement.

Licensing 52

Licensing Licensing Genome Genomics 52

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

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

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

FEBRUARY 18, 2025

Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator

Licensing 59

Licensing Licensing Regulation Marketing 59

XTalks

FEBRUARY 12, 2025

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.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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

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

Camargo

DECEMBER 13, 2021

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.

Development 161

Development Production Immune Response Licensing 161

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

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).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

pharmaphorum

JANUARY 12, 2021

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. The promise of faster market access . More change at NICE.

Marketing 82

Marketing Medicine Branding Development 82

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 111

Regulation Marketing Licensing Licensing 111

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

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

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

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

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.

Regulation 52

Regulation Compliance Marketing Licensing 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

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. Qulipta hasn’t been approved in Europe yet but is following hard on Vydura’s heels, setting up what is expected to be a closely fought battle in the market.

Drugs 98

Drugs Marketing Compliance Licensing 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