FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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BioSpace

JULY 13, 2023

This week: Cancer license deals from J&J and BeiGene, a potential $7B acquisition by Roche and confirmed $1.9B Lilly buy, EU fine for Illumina, and more legal challenges to the Inflation Reduction Act.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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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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Fierce Pharma

APRIL 26, 2024

Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. | Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an FDA approval for the acquired treatment.

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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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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. We are pleased to be licensing our UbiSite technology to Ubiquigent, a company that is strongly positioned to facilitate DUB focused drug discovery programmes and power advances in this largely unexploited field.”.

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Bio Pharma Dive

JANUARY 23, 2023

The deal is the second big licensing deal Takeda has signed in as many months and gives the company rights to a drug Hutchmed began submitting to U.S. regulators in December.

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JAMA Internal Medicine

JANUARY 12, 2021

This Viewpoint discusses ways in which state medical licensing regulations can be modified to allow wider adoption of telemedicine by practitioners and to increase access for 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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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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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. License required to start a Pharmaceutical Business in India.

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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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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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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

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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BioSpace

OCTOBER 1, 2023

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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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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FDA Law Blog

JUNE 30, 2022

The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. We have all long grappled with the multitude of state licensing obligations. 6,708 (Feb. 1) In general.

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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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BioSpace

SEPTEMBER 28, 2023

Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.

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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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Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. A key natural regulator, NRF2 controls antioxidant genes’ expression.

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BioSpace

SEPTEMBER 11, 2023

The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.

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BioSpace

SEPTEMBER 28, 2020

The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.

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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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Drug Discovery World

MARCH 17, 2023

Dr Véronique Walsh, Vice President and General Manager, Gilead Sciences UK & Ireland said: “For years, chronic hepatitis delta virus infection has proven to be a notoriously difficult challenge to treat, with no licensed therapy options in the UK.

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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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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

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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BioTech 365

APRIL 12, 2021

Eckert & Ziegler Strahlen- und Medizintechnik AG / Key word(s): Strategic Company Decision/Miscellaneous Eckert & Ziegler Receives Technetium Generator Licenses for Brazil 12-Apr-2021 / 21:12 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) … Continue reading →

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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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Scienmag

JANUARY 12, 2022

E-cigarettes are currently regulated as consumer products so cannot be promoted as smoking cessation aids, he explains. Nicholas Hopkinson at Imperial College London welcomes the move, saying this will give doctors another means to help smokers quit.

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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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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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