Bio Pharma Dive

NOVEMBER 2, 2022

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

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Bio Pharma Dive

SEPTEMBER 12, 2022

The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline.

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Bio Pharma Dive

APRIL 22, 2024

The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. GlobalData is the parent company of Pharmaceutical Technology. Regulatory decisions come in.

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Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

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Bio Pharma Dive

MARCH 11, 2024

Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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Pharmaceutical Technology

MARCH 6, 2024

To protect patient safety and reduce recall risks, drug manufacturers must reduce particle contamination sources wherever possible.

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BioSpace

MAY 19, 2024

To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.

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pharmaphorum

JANUARY 9, 2024

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted targeted drug candidates for cancer.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)

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Outsourcing Pharma

JANUARY 16, 2024

and Argonaut Manufacturing Services Inc., has been formed so biopharma clients can receive end-to-end drug substance and drug product manufacturing solutions. An alliance between KBI Biopharma Inc.,

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Bio Pharma Dive

SEPTEMBER 8, 2023

Roche says it won’t be able to launch the subcutaneous version of the drug until 2024 as it works with the FDA on manufacturing “updates.”

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Bio Pharma Dive

OCTOBER 2, 2023

The rejection of lebrikizumab is Lilly’s second for an immunology drug this year, following a complete response letter for mirikizumab in April.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. This opinion is intended for use of the drug as a first-in-class treatment for adults with moderately to severely active UC.

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pharmaphorum

MARCH 7, 2024

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development Mike.Hammerton Thu, 07/03/2024 - 09:43 Bookmark this

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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

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.

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Bio Pharma Dive

APRIL 30, 2024

Increasing the production capacity for Zepbound and Mounjaro is “the most ambitious expansion plan in our company’s history,” said CEO David Ricks.

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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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Bio Pharma Dive

MAY 17, 2022

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

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Bio Pharma Dive

OCTOBER 22, 2020

The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Pharmaceutical Technology

SEPTEMBER 20, 2023

The biologics manufacturing company’s CEO said robotics and AI adoption in biopharma needs to catch up to other industries.

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Pharmaceutical Technology

DECEMBER 8, 2023

The newly announced plans would allow third parties to manufacture such drugs if manufacturers make them unaffordable.

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Pharmaceutical Technology

SEPTEMBER 27, 2023

MilliporeSigma has opened two new messenger ribonucleic acid (mRNA) drug substance manufacturing facilities in Germany.

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Pharmaceutical Technology

JUNE 23, 2022

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.

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Fierce Pharma

MAY 20, 2024

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a b | Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan (..)

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Pharmaceutical Technology

JANUARY 12, 2024

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

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Pharma Mirror

DECEMBER 9, 2021

Combatting the pandemic has highlighted the importance of the partnership between biopharma organizations and the contract manufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up.

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Bio Pharma Dive

NOVEMBER 10, 2023

The maker of Wegovy and Ozempic plans to expand production in its home country of Denmark to help meet surging demand for the GLP-1 drugs.

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Pharmaceutical Technology

NOVEMBER 14, 2022

BioNTech’s Singapore affiliate BioNTech Pharmaceuticals Asia Pacific has signed an agreement with Novartis Singapore Pharmaceutical Manufacturing to acquire a GMP-certified manufacturing site in the country. . It also has the potential for extension into the manufacturing of other drug classes such as cell therapies. .

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Bio Pharma Dive

AUGUST 24, 2023

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

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Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic.

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