Fierce Pharma

NOVEMBER 21, 2023

Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR.

Contract Manufacturing 113

Contract Manufacturing Manufacturing Medicine Drugs 113

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.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

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.

Manufacturing 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

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.

Manufacturing 130

Manufacturing Drugs Vaccine Vaccination 130

Pharmaceutical Technology

AUGUST 25, 2023

Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported.

Contract Manufacturing 130

Contract Manufacturing Drugs Manufacturing 130

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. In April 2023, Forge Biologics received a qualified person (QP) declaration for the manufacture of AAV gene therapies at its facility in Columbus, Ohio, US.

Gene Therapy 256

Gene Therapy Gene Development Manufacturing 256

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.

Manufacturing 130

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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.

Manufacturing 130

Manufacturing Generic Drugs Contract Manufacturing Production 130

Pharma Mirror

MARCH 31, 2022

Symbiosis Pharmaceutical Services Ltd (Symbiosis), a fast-growing contract manufacturing organisation (CMO) specialising in sterile global manufacture of pharmaceuticals, vaccines and biopharmaceuticals including Advanced Therapeutical Medicinal Products (ATMPs), has announced the completion of a £1.3

Manufacturing 130

Manufacturing Contract Manufacturing Gene Therapy Research 130

Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. The drug was approved to treat type 2 diabetes mellitus in May. The drug was approved to treat type 2 diabetes mellitus in May. million in Q3.

Drugs 264

Drugs Manufacturing Hormones Clinical Trials 264

Pharmaceutical Technology

MARCH 21, 2023

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). SK Biotek is contracted to manufacture the small molecule API.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. The drug was approved to treat type 2 diabetes mellitus in May. The drug was approved to treat type 2 diabetes mellitus in May. million in Q3.

Drugs 246

Drugs Manufacturing Hormones Clinical Trials 246

Roots Analysis

AUGUST 16, 2023

The success of COVID-19 vaccines paved the path for mRNA-based drug products. However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing RNA 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 Vaccine Vaccination Packaging 130

Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

Manufacturing 97

Manufacturing Drugs Production Contract Manufacturing 97

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations. Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups.

Manufacturing 100

Manufacturing Marketing Contract Manufacturing Containment 100

pharmaphorum

AUGUST 7, 2020

Pfizer has 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. Pfizer will provide contract manufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead.

Manufacturing 119

Manufacturing Contract Manufacturing Protein Allergies 119

Pharmaceutical Technology

JUNE 6, 2023

The global pharma industry experienced a 9% rise in social media posts on orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for Teva Pharmaceutical Industries, according to GlobalData’s analysis of social media posts.

Contract Manufacturing 100

Contract Manufacturing Drugs Manufacturing Vaccination 100

BioTech 365

JANUARY 5, 2021

ADC (Antibody Drug Conjugates) Contract Manufacturing Market, 2030 – ResearchAndMarkets.com ADC (Antibody Drug Conjugates) Contract Manufacturing Market, 2030 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “ADC Contract Manufacturing Market (4th Edition) by Phase of Development, Type of Component Manufacturing, Target (..)

Contract Manufacturing 40

Contract Manufacturing Antibody Manufacturing Marketing 40

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.

Manufacturing 130

Manufacturing Packaging Packaging Contract Manufacturing 130

Pharmaceutical Technology

MAY 29, 2023

The global pharmaceutical industry experienced an 18% drop in company filings mentions of orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for by Horizon Therapeutics with 50% year-on-year increase, according to GlobalData’s analysis of over 182 pharmaceutical company filings.

Contract Manufacturing 100

Contract Manufacturing Drugs Manufacturing Vaccination 100

Roots Analysis

AUGUST 29, 2023

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. What are the Benefits of Outsourcing Biopharmaceutical Manufacturing?

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Roots Analysis

AUGUST 29, 2023

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. What are the Benefits of Outsourcing Biopharmaceutical Manufacturing?

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Outsourcing Pharma

SEPTEMBER 10, 2021

A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come.

Manufacturing 105

Manufacturing Engineer Drugs Contract Manufacturing 105

BioTech 365

JANUARY 15, 2021

4th Edition Market Study into Small Molecule Drug Product Contract Manufacturer Quality – ResearchAndMarkets.com 4th Edition Market Study into Small Molecule Drug Product Contract Manufacturer Quality – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Small Molecule Drug Product Contract Manufacturer Quality Benchmarking (..)

Contract Manufacturing 40

Contract Manufacturing Manufacturing Production Marketing 40

Roots Analysis

JANUARY 15, 2024

Although biopharmaceuticals offer significant profit margins and have demonstrated the potential to treat a myriad of disease indications, they are generally associated with high costs of development and complex manufacturing protocols. Advanced and complex technologies are required for manufacturing, as well as testing of biopharmaceuticals.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Production Development 40

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). The most common marketed drugs in this space aim to address the hyperammonaemia caused by the defective genes in this disorder.

RNA 245

RNA Gene Expression Gene Gene Therapy 245

Roots Analysis

FEBRUARY 18, 2022

The current landscape consists of more than 95 players that claim to offer oligonucleotide contract manufacturing services for research, diagnostic and therapeutic applications. These contract service providers are actively entering into strategic collaborations to augment their existing portfolios. Our Social Media Platform.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Drug Delivery Systems RNA 52

Roots Analysis

FEBRUARY 24, 2022

The overall manufacturing of oligonucleotides involves the following steps. Owing to the incessant demand for oligonucleotide-based products, several small to mid-sized companies and certain pharma giants, have begun outsourcing their manufacturing operations to contract service providers. Accelerating Oligonucleotide Demand.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing Drug Delivery Systems 52

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. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Production Drugs 52

Fierce Pharma

NOVEMBER 17, 2023

Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing.

Contract Manufacturing 101

Contract Manufacturing Manufacturing Production Drugs 101

BioTech 365

DECEMBER 15, 2021

Global Pharmaceutical Contract Manufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com Global Pharmaceutical Contract Manufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com DUBLIN–(BUSINESS (..)

Contract Manufacturing 40

Contract Manufacturing Manufacturing Medicine Marketing 40

Fierce Pharma

SEPTEMBER 26, 2023

WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.

Contract Manufacturing 98

Contract Manufacturing Vaccine Vaccination Manufacturing 98

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Gene Therapy 162

Gene Therapy Packaging Packaging Contract Packaging 162

Roots Analysis

JANUARY 27, 2025

A radioactive tracer is a drug that is composed of a short-lived medical isotope tightly attached to a carrier molecule. Before being accessible for routine clinical use, the radioactive tracer must demonstrate its harmlessness in the patients body, along with its benefit for the treatment purpose (similar to any classical drug).

Manufacturing 40

Manufacturing Production Medicine Contract Manufacturing 40

Fierce Pharma

OCTOBER 2, 2023

After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag. | The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during the inspection of a third-party contract manufacturing organization.

Contract Manufacturing 87

Contract Manufacturing Manufacturing Drugs 87