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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Pharma Mirror

APRIL 18, 2023

Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

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The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the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

NOVEMBER 15, 2024

MSD has secured an exclusive worldwide license from LaNova Medicines for developing, manufacturing, and commercialising the latter’s new investigational programmed cell death 1 (PD-1)/vascular endothelial growth factor (VEGF) bispecific antibody, LM-299.

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Pharmaceutical Technology

FEBRUARY 21, 2024

Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.

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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The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved,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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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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Licensing Licensing Manufacturing Medicine 147

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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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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Vaccination Vaccine Manufacturing Licensing 162

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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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

DECEMBER 4, 2024

Novo will pay $200 million to gain control of the protein manufacturing factory. Elsewhere, Roivant dropped a drug program and Takeda acquired a blood disease therapy.

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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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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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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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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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Drugs Licensing Licensing Manufacturing 188

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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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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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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Manufacturing Contract Manufacturing Licensing Licensing 91

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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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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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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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

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE). “We If proven and approved, the rapid introduction of AD04 into the U.K.

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Pharma Times

NOVEMBER 16, 2021

Voluntary license agreement will allow generic versions of pill to be manufactured

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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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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

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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Pharma Times

JULY 27, 2021

Organon will license the global development, manufacturing and commercial rights to investigational treatment ebopiprant

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Pharmaceutical Technology

DECEMBER 19, 2022

Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers. As per the deal, Sanofi will hold an option to include up to two further ANKET targets. On choosing the candidate, the company will oversee the complete development, production and marketing.

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pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

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Pharmaceutical Technology

MARCH 2, 2023

Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi. For fiscal 2022, Merck’s EBITDA increased by 9.4%

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Pharmaceutical Technology

DECEMBER 27, 2022

It intends to manufacture the drug at its facility in India. The company has signed a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) to produce and sell nirmatrelvir in LMICs. We are committed to making nirmacom available faster at affordable prices across 95 LMICs including India.”.

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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).

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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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Pharmaceutical Technology

AUGUST 1, 2022

In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide. In November last year, GreenLight and Samsung Biologics entered a collaboration agreement to manufacture mRNA Covid-19 vaccines.

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Pharmaceutical Technology

JANUARY 6, 2023

Dutch biotechnology company Synaffix and Amgen have entered a licensing agreement for the development of next-generation antibody-drug conjugates (ADCs). For four future programmes, Amgen will also have an option for exercising exclusive licenses for research and commercialisation. This is Synaffix’s 12th licensing agreement to date.

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