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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Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Pharmaceutical Technology

OCTOBER 4, 2022

It will allow MPP to enable further manufacturing and supply of ensitrelvir following authorisation or approval from respective regulatory agencies. Under the deal, MPP granted sublicences to eligible generic manufacturers to produce and deliver ensitrelvir to 117 countries.

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Pharmaceutical Technology

JANUARY 25, 2023

The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). Previously, both companies signed license agreements for several biosimilars. The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab).

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Manufacturing Antibody Marketing Licensing 147

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

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Pharmaceutical Technology

OCTOBER 23, 2023

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

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Bio Pharma Dive

JANUARY 20, 2022

The licenses will help make molnupiravir available to people in more than 100 countries, giving public health authorities a needed tool despite the drug's limited effectiveness.

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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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Fossil Remedies

OCTOBER 16, 2022

The next important consideration is a proper distribution channel from the manufacturer to end customers. 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. Wholesale Drug License.

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Licensing Licensing Pharma Companies Cosmetics 52

STAT News

OCTOBER 20, 2022

Amid a push to widen access to medicines to poor countries, Novartis has reached an agreement to license one of its best-selling cancer treatments so that generic manufacturers can produce copies for distribution to 44 low- and middle-income nations.

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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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STAT News

JULY 28, 2022

In a much ballyhooed move, ViiV Healthcare finalized a deal to license its long-acting injectable HIV prevention shot to the Medicines Patent Pool so that generic companies can make and distribute lower-cost versions to low- and middle-income countries.

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BioSpace

OCTOBER 26, 2020

While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their.

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BioTech 365

FEBRUARY 15, 2021

Pure Extracts Agrees to Licensing deal with Taste-T, LLC the US manufacturer of Fireball Cannabis Gummies Pure Extracts Agrees to Licensing deal with Taste-T, LLC the US manufacturer of Fireball Cannabis Gummies VANCOUVER, British Columbia, Feb. 15, 2021 (GLOBE NEWSWIRE) … Continue reading →

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 16, 2023

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

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Bio Pharma Dive

AUGUST 6, 2020

The Serum Institute, one of the world's largest vaccine producers, licensed Novavax's experimental shot, while Wockhardt signed on with the U.K. to help make AstraZeneca's candidate.

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FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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BioTech 365

JULY 12, 2021

PRESS RELEASE Biotest receives manufacturing license for new production facility and plans to hire 150 additional employees – Final … Continue reading → DGAP-News: Biotest AG / Key word(s): Miscellaneous 13.07.2021 / 07:00 The issuer is solely responsible for the content of this announcement.

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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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BioTech 365

MARCH 18, 2021

ONK Therapeutics Strengthens its Cell Therapy Manufacturing Process with License for EBV-LCL Feeder Cell Line from NIH to Enhance NK Cell Expansion ONK Therapeutics Strengthens its Cell Therapy Manufacturing Process with License for EBV-LCL Feeder Cell Line from NIH to … Continue reading →

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BioTech 365

APRIL 26, 2021

OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, … Continue reading (..)

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Pharmaceutical Technology

APRIL 13, 2023

The initial agreement between Dyadic and Rubic involved discovery, development, manufacturing, and distribution of Covid-19 vaccines by transferring and licensing of C1 platform technology. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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Drug Discovery Today

JULY 7, 2022

Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess (..)

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pharmaphorum

MARCH 16, 2021

Indiana-based radiopharmaceutical Contract Development and Manufacturing Organization expands nuclear pharmacy capabilities with second location . SpectronRx , a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. To learn more, visit SpectronRx.com.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

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Fierce Pharma

APRIL 4, 2024

Teva has unveiled a fresh in-licensing accord with Spain’s mAbxience to chip in on an investigational biosimilar spanning multiple oncology indications. As Teva advances its Pivot to Growth strategy under CEO Richard Francis, the company is making good on its pledge to beef up its biosimilar pipeline through outside deals.

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BioTech 365

JANUARY 18, 2022

JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited IRVINE, Calif., JenaValve” or the “Company”), developer and manufacturer … Continue reading →

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BioTech 365

AUGUST 17, 2021

ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement License allows Cellular Engineering Technologies to develop, manufacture and commercialize next generation stem cell lines using CRISPR/Cas9 technology DUBLIN & … Continue (..)

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BioPharma Reporter

SEPTEMBER 2, 2021

Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.

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BioPharma Reporter

MAY 24, 2021

Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to âredefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectorsâ.

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BioTech 365

JULY 15, 2021

DEA Gives Colorado’s MedPharm the Green Light for Schedule 1 Research License DEA Gives Colorado’s MedPharm the Green Light for Schedule 1 Research License DENVER–(BUSINESS WIRE)–#cannabinoid–MedPharm Research, a wholly owned subsidiary of MedPharm Holdings, a leading medical cannabis manufacturer, R&D … Continue reading (..)

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BioPharma Reporter

DECEMBER 7, 2023

Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a Â1 million investment.

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BioPharma Reporter

APRIL 20, 2023

CDMO Sterling Pharma Solutions has been granted a Manufacturerâs Authorisation for Investigational Medicinal Products from the UKâs Medicines and Healthcare products Regulatory Agency (MHRA).

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Fierce Pharma

SEPTEMBER 14, 2023

Astellas will build its third Irish manufacturing facility. Astellas will build its third Irish manufacturing facility for $354 million. Insilico Medicine out-licensed an AI-discovered cancer drug candidate to Exelixis. Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5

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BioTech 365

JUNE 30, 2021

and Licensing Agreement for SPR206 Spero Therapeutics Announces $40 Million Equity Investment from Pfizer Inc. and Licensing Agreement for SPR206 Spero grants Pfizer rights to develop, manufacture, and commercialize SPR206 … Continue reading →

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XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.

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