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.

Contract Manufacturing 52

Contract Manufacturing Antibody Manufacturing Marketing 52

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.

Contract Manufacturing 100

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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

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.

Contract Manufacturing 52

Contract Manufacturing Gene Therapy Gene Manufacturing 52

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Roots Analysis

JANUARY 14, 2024

Like all drugs, biologics are regulated by the FDA. In fact, most developers tend to rely on biologics contract manufacturers / biologics contract manufacturing for the development and production of low value / opportunity products, such as drugs for rare indications and biosimilars.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

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.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Outsourcing Pharma

JANUARY 17, 2023

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

Regulation 96

Regulation Contract Manufacturing Manufacturing 96

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.

Medicine 65

Medicine Regulation Production Contract Manufacturing 65

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. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

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.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

pharmaphorum

AUGUST 10, 2020

The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.

Drugs 88

Drugs In-Vivo Contract Manufacturing In-Vitro 88

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.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

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.

Manufacturing 147

Manufacturing Production Contract Manufacturing Engineer 147

The Pharma Data

OCTOBER 22, 2021

Pfizer-BioNTech COVID-19 vaccine; or regarding implicit unborn earnings from the contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 vaccine. There can be no guarantee that our manufacturing of the the Pfizer-BioNTech COVID-19 vaccine will be successful.

Vaccination 52

Vaccination Vaccine Filler Contract Manufacturing 52

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.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

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.

FDA Approval 89

FDA Approval Contract Manufacturing Sales Trials 89

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.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Camargo

JANUARY 19, 2021

CMOs are subject to cGMP regulations, so they have standard operating procedures they must follow. They also have multiple clients, and thus by definition have many demands on their time and resources, particularly their manufacturing equipment and analytical capabilities. Having a quality agreement in place is critical.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

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

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

Gene Silencing 60

Gene Silencing Gene RNA Contract Manufacturing 60

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.

Drugs 52

Drugs Contract Manufacturing Marketing Clinical Trials 52

Roots Analysis

OCTOBER 24, 2023

Corticosteroids are produced by adrenal gland and play a role in controlling stress to decrease inflammation whereas, anabolic steroids regulate the manufacturing of testosterone in the testicles and the ovaries. This has led to an increased demand for contract manufacturing service providers in this field.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

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.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

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.

Vaccination 52

Vaccination Vaccine Manufacturing Contract Manufacturing 52

Roots Analysis

AUGUST 8, 2023

The feeding strategy can be modified accordingly, in order to regulate cell growth and fermentation. In this type of culture, a growth-limiting substrate is fed during the process which extends the duration and density of the culture. As a result, the products are also removed continuously.

Manufacturing 52

Manufacturing Production Marketing Gene Therapy 52

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.

Manufacturing 267

Manufacturing Contract Manufacturing Gene Therapy Gene 267

The Pharma Data

JANUARY 24, 2021

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.

Sales 52

Sales Manufacturing Contract Manufacturing Containment 52

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.,

Cosmetics 52

Cosmetics Contract Manufacturing Manufacturing Production 52

Pharmaceutical Technology

AUGUST 30, 2022

There are three US-based companies with a manufacturing presence in Brazil: Catalent (Somerset, New Jersey), Thermo Fisher Scientific’s (Waltham, Massachusetts) subsidiary Patheon (Durham, North Carolina), and Merieux NutriSciences (Chicago, Illinois), all contract manufacturing organisations (CMOs).

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

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.

Drugs 58

Drugs Dermatology Contract Manufacturing Manufacturing 58

Pharmaceutical Technology

JULY 4, 2022

Companies that own Russian pharma contract manufacturing or supply chain sites include Novo Nordisk (Bagsvaerd, Denmark); UPS (Atlanta, Georgia, US) subsidiary Marken (London, UK); Thermo Fisher Scientific (Waltham, Massachusetts) subsidiary Patheon (Durham, North Carolina); Servier (Paris, France); and Takeda (Tokyo, Japan).

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Manufacturing 40

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.

Vaccination 40

Vaccination Vaccine Production Manufacturing 40

Camargo

FEBRUARY 4, 2021

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. The Agency refers to such facility as a Monograph Drug Facility (MDF). The fee listed for MDFs was $14,060.

Development 131

Development Production Drugs Manufacturing 131

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.

Manufacturing 52

Manufacturing FDA Approval Trials Development 52

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