AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

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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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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

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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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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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

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.

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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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Fierce Pharma

OCTOBER 2, 2024

The company will allow six generic manufacturers to make and sell its long-acting PrEP drug, lenacapivir, in 120 resource-limited countries. Gilead Sciences is wasting no time in promoting worldwide access to its twice-yearly pre-exposure prophylaxis (PrEP) HIV candidate lenacapavir. |

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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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BioTech 365

FEBRUARY 3, 2022

Receives IMC-GMP License for its Manufacturing Plant in Israel MediCane Health Inc. Receives IMC-GMP License for its Manufacturing Plant in Israel KFAR SABA, Israel–(BUSINESS WIRE)–MediCane Health Inc. is pleased to announce the awarding of an IMC-GMP license … Continue reading →

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

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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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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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Pharmaceutical Commerce

OCTOBER 4, 2024

The goal is to provide greater access to HIV prevention drugs in low-income countries.

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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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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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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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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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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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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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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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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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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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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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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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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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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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pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. The post Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech appeared first on.

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