BioTech 365

AUGUST 31, 2021

News, Trends, Challenges in Specialty Pharmacy: Rx Drug Manufacturers, Benefits Decision Makers Find Solutions in AscellaHealth Developments in Specialty Pharmacy Newsletter News, Trends, Challenges in Specialty Pharmacy: Rx Drug Manufacturers, Benefits Decision Makers Find Solutions in AscellaHealth Developments in Specialty … Continue reading (..)

Pharmacy 52

Pharmacy Manufacturing Development Drugs 52

BioTech 365

MARCH 12, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Chutes & Ladders—Lilly taps new manufacturing lead as longtime chief O’Neill tees up retirement.Chutes & Ladders—Lilly taps new manufacturing lead as longtime chief O’Neill tees up retirement … Continue (..)

Manufacturing 40

Manufacturing Research 40

Pharma Times

OCTOBER 27, 2023

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

Regulation 129

Regulation Development Manufacturing 129

Fierce Pharma

SEPTEMBER 7, 2023

University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing. Cell therapy manufacturer BlueWhale Bio uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by Danaher Corporation.

Gene Therapy 101

Gene Therapy Production Manufacturing Gene 101

Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Publishes ICH Guidelines on Continuous Manufacturing. FDA Guidance Addresses Real-World Evidence Data Standards.

Development 187

Development Manufacturing Production Packaging 187

Drug Channels

JANUARY 26, 2021

For my first Drug Channels news roundup of 2021, I focus on two remarkable, must-read reports that provide extraordinary details about the hidden economics of our drug channel: The Center for Medicare & Medicaid Services’ new transparency rule discloses how much major insurers overpay hospitals for outpatient drugs.

Insulin 52

Insulin Manufacturing Drugs 52

BioSpace

JANUARY 4, 2021

With COVID-19 still running rampant across the globe, Moderna announced it will rapidly expand its vaccine manufacturing operations in order to meet demand in the countries where the medication has received emergency authorization.

Manufacturing 77

Manufacturing Vaccination Vaccine 77

Pharma Times

AUGUST 30, 2023

Funding will progress the manufacture of oligonucleotide therapeutics alongside machine learning - News - PharmaTimes

Manufacturing 93

Manufacturing 93

BioSpace

JUNE 14, 2021

Please check out the biopharma industry's COVID-19 stories that are trending for June 15, 2021.

Manufacturing 101

Manufacturing 101

BioSpace

JULY 28, 2021

As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.

Manufacturing 73

Manufacturing Antibody Vaccination Vaccine 73

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. Regulatory decisions and clinical trial news.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Fierce Pharma

SEPTEMBER 8, 2023

Three Japanese pharma companies lead our news stories from Asia this week. And Takeda is ordered to pay AbbVie nearly $480 million because of a manufacturing hiccup. Astellas has abandoned its challenge against the Inflation Reduction Act. Astellas has abandoned its challenge against the Inflation Reduction Act. And more.

Pharma Companies 73

Pharma Companies Manufacturing 73

XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

Pharmaceutical Technology

MARCH 1, 2023

In the last few years, there have been growing calls to onshore the manufacturing of certain pharma products, including active pharmaceutical ingredients (API), to ensure a smooth supply and to minimise shortages in the European Union (EU). All this, and the latest pharma industry news, comment, and analysis from GlobalData.

Production 130

Production Insulin FDA Approval Pharma Production 130

XTalks

MAY 27, 2021

To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The vaccine doses are intended for countries outside the US, with manufacturing planned to commence in the third quarter of 2021.

Manufacturing 98

Manufacturing Production Vaccination Vaccine 98

STAT News

FEBRUARY 20, 2023

Dan Brickey was stunned when he learned the news. The dramatic change was due to a decision by the drug’s manufacturer, Vertex Pharmaceuticals, to slash the amount of financial assistance that it offers to patients this year.

Drugs 98

Drugs Manufacturing Medicine 98

Pharmaceutical Technology

MAY 16, 2023

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. This will include pairing up indications with manufacturers amongst the BGTC’s partners.

Gene Therapy 227

Gene Therapy Gene Research Clinical Trials 227

Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The skinny label approach has been used extensively by generic manufacturers since it was enacted via the Hatch-Waxman Act in 1984.

Development 186

Development Regulation Production Drugs 186

STAT News

MARCH 8, 2023

The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems. Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. Read the rest…

Manufacturing 105

Manufacturing Drugs 105

Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Manufacturing or salary discussions are also affected, notes Voigt. Foster also notes to Pharmaceutical Technology that clouds of a financial downturn became visible in August 2021.

Marketing 324

Marketing Gene Therapy Manufacturing Pharma Companies 324

Pharmaceutical Technology

DECEMBER 27, 2022

Tracking the news. Alzheimer’s disease drugs were constantly in the news, and not always for the right reasons. Patients with ultra-rare disorders face even more challenges in getting a new therapy investigated or approved. Newly authorised Covid-19 antivirals garnered interest for their potential to slow the spread.

Clinical Trials 306

Clinical Trials Clinical Trials Trials Vaccination 306

Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.

Development 189

Development Packaging Packaging Generic Drugs 189

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

Camargo

MARCH 9, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. In the News: March 2021 Regulatory and Development Updates. In the News: February 2021 Regulatory and Development Updates.

Development 146

Development Manufacturing Drugs Production 146

STAT News

DECEMBER 12, 2022

But while the study update presented Saturday at the annual meeting of the American Society of Hematology delivered encouraging news, the German biotech’s path forward remains murky due to changes to the treatment’s manufacturing process and the new restrictions enacted by the Food and Drug Administration on accelerated approvals of cancer (..)

Manufacturing 98

Manufacturing Drugs 98

Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Adding to this, other events like the worldwide energy crisis and the ongoing conflict in Ukraine have led to global uncertainty, Skillington tells this news service.

Marketing 162

Marketing Gene Therapy Manufacturing Pharma Companies 162

Pharmaceutical Technology

SEPTEMBER 1, 2022

While a significant proportion of this increase is due to the volume of lateral flow tests (LFTs) manufactured to perform mass screening of populations for Covid-19 over the last two years, this trend towards POC diagnostics is positive news. Manufacturing challenges. Customisable solutions.

Manufacturing 130

Manufacturing Bacterium Reagent Production 130

BioTech 365

JUNE 3, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: First cells reprogrammed to make synthetic polymers—and virus-resistant drug manufacturers.Scientists have developed the first cells that can construct artificial polymers from building blocks that are not found … Continue (..)

Manufacturing 40

Manufacturing Drugs Development Research 40

Outsourcing Pharma

MARCH 17, 2022

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

Manufacturing 52

Manufacturing Regulation Marketing 52

Drug Channels

DECEMBER 15, 2023

Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post. Another surprise: HRSA estimated that manufacturers' contract pharmacy restrictions reduced 340B purchases by only $470 million—or less than 1% of 2022's total purchases.

Pharmacy 82

Pharmacy Manufacturing Drugs 82

Pharmaceutical Technology

MAY 16, 2023

Emergent will also hand over San Diego, California-based research facilities (focused on the Chikungunya vaccine candidate), a Swiss-based biologics manufacturing facility, and the EU/US-based commercial operations. The news comes after a tricky opening quarter for Emergent.

Vaccination 130

Vaccination Vaccine Licensing Licensing 130

pharmaphorum

NOVEMBER 29, 2021

The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. It was billed at the time as a key tool to accelerate the development of new and innovative vaccines to combat some of the world’s most prevalent diseases, from discovery to licensed product.

Vaccination 105

Vaccination Vaccine Manufacturing Pharma Companies 105

Drug Discovery World

MARCH 1, 2024

News round-up for 26 Feb – 1 March by DDW Digital Content Editor Diana Spencer. The news highlights this week all focus on regulatory decisions, both positive and negative. The post This week in drug discovery (26 Feb – 1 March) appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Allergies FDA Approval Medicine 52

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. Lilly has disclosed only in-house manufacturing locations for the drug.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Outsourcing Pharma

JULY 22, 2021

This monthâs roundup of new excipients, manufacturing sites, partnerships, and other items includes news from DFE Pharma, Vetter, and other notable firms.

Manufacturing 52

Manufacturing Regulation Marketing 52

Drug Channels

SEPTEMBER 24, 2023

Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post. Another surprise: HRSA estimated that manufacturers' contract pharmacy restrictions reduced 340B purchases by only $470 million—or less than 1% of 2022's total purchases.

Pharmacy 71

Pharmacy Manufacturing Drugs 71

Scienmag

JUNE 13, 2022

COLUMBUS, Ohio – Scientists have reported good news on the pandemic preparedness front: A cocktail of four manufactured antibodies is effective at neutralizing a virus from the Henipavirus family, a group of pathogens considered to be a global biosecurity threat.

Antibody 61

Antibody Scientist Manufacturing 61