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 Vaccination Vaccine 130

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. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

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).

Licensing 130

Licensing Licensing Manufacturing Antibody 130

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

Manufacturing Packaging Packaging Drugs 130

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.

Manufacturing 264

Manufacturing Gene Therapy Gene Genetics 264

Pharmaceutical Technology

FEBRUARY 27, 2023

Manufacturing a drug therapy usually involves several different stakeholders. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. Regulatory decisions by the EMA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

Manufacturing 130

Manufacturing Drugs Packaging Packaging 130

Pharmaceutical Technology

APRIL 18, 2023

Eli Lilly and Company (Lilly) has unveiled plans to invest $1.6bn in its two new manufacturing facilities located within the LEAP Innovation Park in Boone County, Indiana, US. The investment at the LEAP site marks the company’s biggest manufacturing investment at a single location to date.

Manufacturing 130

Manufacturing Medicine Genetics Production 130

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

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). Sharp Packaging Services is producing the solid dose of the drug and packaging it.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The funding is being provided under the agency’s Transforming Medicines Manufacturing programme.

Drug Delivery 242

Drug Delivery RNA Development Drugs 242

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 115

Contract Manufacturing Manufacturing Medicine Drugs 115

STAT News

MARCH 15, 2023

Pfizer had the most drugs on the list of any manufacturer, with five. Seagen’s bladder cancer drug Padcev, which also garnered penalties, will likely soon be in Pfizer’s portfolio, too, after the pharma giant completes its $43 billion acquisition of the Washington state company.

Manufacturing 105

Manufacturing Medicine Drugs 105

Fierce Pharma

NOVEMBER 29, 2023

Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon.

Manufacturing 126

Manufacturing Medicine Drugs Production 126

Bio Pharma Dive

FEBRUARY 6, 2024

The life sciences investor has backed a number of startups working on technologies for delivering and manufacturing cell and gene medicines.

Drug Delivery 200

Drug Delivery Life Science Gene Manufacturing 200

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.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production 138

Production Clinical Trials Clinical Trials Compliance 138

Pharmaceutical Technology

JUNE 26, 2022

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. Polymorphic form issues.

Manufacturing 130

Manufacturing Drugs Production Development 130

XTalks

MARCH 29, 2022

Jazz Pharmaceuticals has broken ground on a new $100 million manufacturing plant for cannabis-based medicines in the UK. The 60,000-square-foot facility was specially designed to support the company’s two regulatory-approved cannabis-based medicines and offer capacity for future drugs currently under development.

Medicine 111

Medicine Manufacturing Sales FDA Approval 111

Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This guidance was previously endorsed by the ICH Assembly in November 2022 and is regarded as an attempt to harmonise regulatory considerations surrounding continuous manufacturing.

Manufacturing 211

Manufacturing Production Drugs Protein 211

Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

Gene Therapy 130

Gene Therapy Gene Manufacturing Production 130

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

Manufacturing 130

Manufacturing Gene Therapy Production Clinical Trials 130

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development 316

Development Regulation Manufacturing Drugs 316

Fierce Pharma

SEPTEMBER 20, 2023

After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.

Manufacturing 97

Manufacturing Medicine Drugs 97

Bio Pharma Dive

JANUARY 31, 2024

The announcement ends a nine-month delay related to manufacturing snags that slowed Novo’s ability to meet demand for the fast-selling medicine.

Manufacturing 161

Manufacturing Medicine Drugs 161

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

Bio Pharma Dive

APRIL 14, 2023

The drugmaker said it is working with the FDA to resolve the issues so it can launch the medicine, an ulcerative colitis treatment known as mirikizumab, “as soon as possible.”

Manufacturing 154

Manufacturing Medicine Drugs 154

Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. Securing the supply chain.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

STAT News

APRIL 4, 2023

For the first time, Mark Cuban’s Cost Plus Drug Company is selling medicines made by a large drug manufacturer directly to consumers at a greatly reduced price, the latest sign that the billionaire is trying to make good on his vow to disrupt the opaque pharmaceutical supply chain.

Branding 140

Branding Medicine Manufacturing Drugs 140

STAT News

MARCH 7, 2023

After months of anticipation, the manufacturer of a controversial drug for premature births has agreed to withdraw its treatment, capping an unusual battle with the U.S. Food and Drug Administration over its authority to have medicines removed from the market. Continue to STAT+ to read the full story…

Manufacturing 98

Manufacturing Drugs Clinical Trials Clinical Trials 98

Pharmaceutical Technology

APRIL 24, 2023

Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture. These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. As a result, some pharmaceutical companies are turning to third parties.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024. This site will be used for Adstiladrin production.

Gene Therapy 246

Gene Therapy Manufacturing Gene FDA Approval 246

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

Drugs 298

Drugs Manufacturing Production Pharmacy 298

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

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. According to GlobalData, Phase III drugs for Prostate Cancer have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. Buy the report here.

Medicine 100

Medicine Hormones Production Clinical Trials 100

Medical Xpress

NOVEMBER 15, 2022

In a new 'Ideas and Opinions,' authors from Johns Hopkins Bloomberg School of Public Health analyze California's newly announced effort to manufacture insulin for its residents. The commentary is published in Annals of Internal Medicine.

Insulin 98

Insulin Manufacturing Medicine Drugs 98

Fierce Pharma

NOVEMBER 28, 2023

As drug shortages mount in the U.S. Among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains.

Manufacturing 91

Manufacturing Drugs Production Medicine 91

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 22, 2022

Drug manufacturers have hailed the Drugs (Eighth Amendment) Rules, 2022 mandating barcode or quick response (QR) code on the label of top 300 brands of formulations from August 1, 2023, saying that QR codes will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing.

Branding 160

Branding Drugs Manufacturing Medicine 160