Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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The Pharma Data

DECEMBER 15, 2020

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. ” “We look forward to working side by side with Lipidor to be able to offer manufacturing to their future licensees. .”

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BioPharma Reporter

NOVEMBER 30, 2021

As capital project delivery ramps back up to pre-pandemic levels over the coming months and years, the smaller biopharma players are looking outside their own resources for strategic manufacturing and research support, confirms a new market outlook from CRB.

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Roots Analysis

AUGUST 8, 2023

Presently, a number of single use bioreactor systems are available that can be used for culturing variety of cells for manufacturing numerous biotherapeutics. A single-use bioreactor, also known as disposable bioreactor, employs single use bioreactor bags instead of stainless-steel culture vessel for the manufacturing of various biologics.

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BioPharma Reporter

FEBRUARY 9, 2023

The South Korean player plans to expand its recently acquired US facility, provide contract manufacturing services for Antibody Drug Conjugates (ADC), and to add drug product fill & finish facilities to establish a foothold in the North American CDMO market.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. The company offers consumer, prescription and automation products.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. The company offers consumer, prescription and automation products.

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Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

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BioPharma Reporter

DECEMBER 9, 2021

Taiwan based contract manufacturer, Bora Pharmaceuticals, in partnership with Taishin Healthcare Limited, is ready to spend millions to expand its footprint in the CDMO sector.

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Pharmaceutical Technology

JULY 29, 2022

However, while there appears to be a collegiate spirit among these companies, barriers remain in partnering with other entities, with 75% of executives identifying partnering with private companies as a challenge and 86% stating the same about contract research organizations. Manufacturing agility: Index score 6.5/10.

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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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The Pharma Data

OCTOBER 22, 2021

Novartis blazoned moment that it has inked an original agreement to work its manufacturing capacity and capabilities to address the COVID-19 epidemic by expanding its support of the filler and finish of the Pfizer-BioNTech COVID-19 vaccine. The specifics will be bared when we conclude specific agreements.

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pharmaphorum

AUGUST 10, 2020

The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan. Last week Pfizer signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic.

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Outsourcing Pharma

JANUARY 17, 2023

Celadon Pharmaceuticals Plc has become the first to clear the regulations to make medical cannabis in the UK.

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Outsourcing Pharma

JANUARY 31, 2023

Amid incidents of toxic cough syrups, the organization has called on countries and regulators to strengthen action against the threat of substandard and falsified medical products.

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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pharmaphorum

JULY 7, 2021

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

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pharmaphorum

MARCH 21, 2022

Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status. Teplizumab is thought to work by binding to CD3, preventing the activation of T cells that attack and kill insulin-producing pancreatic beta cells in the autoimmune disease.

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Camargo

JANUARY 19, 2021

On the other hand, an NDA for a drug improvement product utilizing the 505(b)(2) pathway typically has a Phase 1 bridging study, for which the drug product and API generally need to be at the to-be-manufactured stage. CMOs are subject to cGMP regulations, so they have standard operating procedures they must follow.

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pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines. “The

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Pharmaceutical Technology

OCTOBER 27, 2022

The increasing regulation of biotech and manufacturing deals in the US could prompt foreign companies such as Chinese contract development and manufacturing organisations (CDMOs) to seek alternative targets in Europe or elsewhere. There are already nine Chinese-based companies with 14 US contract manufacturing facilities.

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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually.

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pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

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pharmaphorum

JUNE 14, 2021

The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string of violations including that the building was “not maintained in a clean and sanitary condition.” rather than three months if kept at 2-8 degrees Celsius.

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pharmaphorum

JANUARY 6, 2021

RNAi uses small RNA molecules to bind to messenger RNA, which is responsible for synthesising proteins, and either destroy it or recruit other cellular factors that regulate its activity. The nomination of a first candidate in the collaboration that will advance into development triggers a $2.5

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pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. It is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19.

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pharmaphorum

AUGUST 11, 2021

On Axsome’s second-quarter results call, chief executive Herriot Tabuteau said that the FDA letter received on 30 July indicated that the problems with the filing “preclude discussion of labelling and post-marketing requirements,” adding that the company has been in communication with the regulator to try to learn more.

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The Pharma Data

JANUARY 24, 2021

(TSXV: THRM) (“Therma Bright” or the “Company”), a progressive medical device technology company announces that it has taken 100% control of the research and development, regulatory, manufacturing and commercialization of its saliva-based rapid antigen test.

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FDA Law Blog

AUGUST 13, 2023

Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,

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Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Roots Analysis

FEBRUARY 28, 2024

With the growing stem cell therapy pipeline, do we have enough manufacturing capacity: Given complex manufacturing protocols, and high development costs, stem cell therapy developers are increasingly becoming dependent on contract service providers to leverage long term expertise and optimize operating expenses.

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pharmaphorum

MAY 25, 2022

The problems outlined in the US regulator’s complete response letter (CRL) for VP-102 centre around contract manufacturing organisation (CMO) Sterling Pharmaceuticals Services, which is producing VP-102 for Verrica. Sterling was classified by the FDA as voluntary action indicated (VAI) last November.

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Camargo

FEBRUARY 4, 2021

Among the revisions was the creation of annual facility fees for manufacturing sites producing OTC products. The notice specified the two facility types: An OTC monograph drug facility is a foreign or domestic entity engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

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The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Development of oral biosensor and contract development & manufacturing. Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

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Roots Analysis

OCTOBER 3, 2023

The feeding strategy can be modified accordingly, in order to regulate cell growth and fermentation. For instance, In March 2022, Mabion ordered four Kuhner Orbital Shaken Bioreactors (OSB) for contract manufacturing of the first protein-based COVID 19 vaccine developed by Novavax.

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. and agonism of 5HT-1A, which regulate food intake, metabolism, weight control, and anxiety. About Radius.

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