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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Manufacturing Contract Manufacturing Gene Therapy Gene 267

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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Contract Manufacturing Antibody Manufacturing Marketing 52

BioPharma Reporter

SEPTEMBER 19, 2023

The big pharma company Bristol Myers Squibb (BMS) has recruited contract manufacturing and development organization (CDMO) Samsung Biologics to manufacture a commercial antibody cancer treatment until 2030.

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Manufacturing Contract Manufacturing Pharma Companies Antibody 59

Pharmaceutical Technology

JULY 29, 2022

Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is still a considerable need for variant-specific boosters. Regulators are well-disposed to these boosters. Commercial dose manufacturing.

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Manufacturing Vaccination Vaccine Packaging 130

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others. The company also offers contract manufacturing and laboratory services.

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Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others. The company also offers contract manufacturing and laboratory services.

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Contract Manufacturing Dermatology Hormones Production 100

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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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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Contract Manufacturing Gene Therapy Gene Manufacturing 52

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.

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Roots Analysis

JANUARY 14, 2024

Like all drugs, biologics are regulated by the FDA. In this competitive global market, outsourcing has evolved into a viable and profitable business model. They are different from small molecules in terms of their size and complexity. This has led the biologics to be on the verge of surpassing small molecules in terms of revenues.

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Contract Manufacturing Manufacturing Protein Bacteria 40

Pharmaceutical Technology

NOVEMBER 30, 2022

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. The EMA had provided a positive opinion for this marketing authorization back in July.

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Manufacturing Packaging Packaging Drugs 130

Roots Analysis

FEBRUARY 28, 2024

Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies.

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Clinical Trials Clinical Trials Trials Manufacturing 40

FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Manufacturing Production Drugs FDA Compliance 59

Pharmaceutical Technology

JULY 29, 2022

From automotive engineering firms retooling their operations to produce key components for ventilators to pharmaceutical manufacturers drastically ramping up production to meet unprecedented levels of demand, the agility of supply chains was key to overcoming the crisis. Government policy and regulation: Index score 6.96/10.

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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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Drugs Dermatology Contract Manufacturing Manufacturing 57

pharmaphorum

MARCH 21, 2022

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status.

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Drugs Insulin Contract Manufacturing Clinical Trials 52

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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Drugs Insulin Contract Manufacturing Antibody 98

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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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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Vaccination Vaccine Production Manufacturing 40

pharmaphorum

AUGUST 11, 2021

The FDA was supposed to be delivering its verdict on Axsome Therapeutics’ depression therapy AXS-05 in less than a fortnight – but instead has delivered the company a letter outlining deficiencies in its marketing application.

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Drugs Contract Manufacturing Marketing Clinical Trials 52

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis.

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FDA Approval Contract Manufacturing Sales Trials 74

Roots Analysis

AUGUST 8, 2023

The feeding strategy can be modified accordingly, in order to regulate cell growth and fermentation. Key Trends that are Shaping up the Global Single-use Bioreactors Market Technological innovations related to single use bioreactors have enabled the development of advanced systems.

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Manufacturing Production Marketing Gene Therapy 52

The Pharma Data

OCTOBER 22, 2021

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of Emergency Use Authorizations or coequals in the United States ( concertedly with Pfizer) and other countries. The specifics will be bared when we conclude specific agreements.

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Vaccination Vaccine Filler Contract Manufacturing 52

Camargo

JANUARY 19, 2021

However – particularly in rare disease programs with only one Phase 3 trial, often of short duration – sponsors many times find themselves ready to file clinical data before completing the minimum 12 months of stability testing on the to-be-marketed finished product and API. Having a quality agreement in place is critical.

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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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Gene Silencing Gene RNA Contract Manufacturing 58

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. US marketing application. It is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19.

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Vaccination Vaccine Contract Manufacturing Production 52

Roots Analysis

OCTOBER 24, 2023

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

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Manufacturing Hormones Contamination Containment 40

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.”

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

APRIL 6, 2021

The mix-up at the facility operated by contract manufacturer Emergent BioSolutions resulted in ingredients destined for AZ’s AZD1222 jab being mixed into vials of the J&J product , rendering them unusable, according to media reports.

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Vaccination Vaccine Contamination Contract Manufacturing 53

pharmaphorum

APRIL 22, 2021

The EU regulator said this week that the benefits of the vaccine outweigh a very small risk of clots, clearing the way for the rollout of the one-shot vaccine to resume. AZ’s vaccine meanwhile has yet to be approved in the US. An FDA decision is expected tomorrow.

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Vaccination Vaccine Contamination Contract Manufacturing 52

Camargo

FEBRUARY 4, 2021

Our structured and systematic approach to decision-making incorporates market-based insights into the development program well before the designs of pivotal studies are finalized. However, the committee was split on whether to withdraw the product (nine votes) or keep it on the market pending additional studies (seven votes).

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The Pharma Data

JANUARY 27, 2021

For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

The Pharma Data

JANUARY 24, 2021

Such regulatory approvals will allow for the roll out of the commercial test for multiple markets in the future. Therma Bright is also in the process of identifying component suppliers to be used in the large-scale manufacturing of the SCV2 test and is identifying contract manufacturers to manufacture and assemble the final product.

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Sales Manufacturing Contract Manufacturing Containment 52

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.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and.

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Vaccination Vaccine Production Sales 40