Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. 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.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

Fierce Pharma

SEPTEMBER 14, 2023

Efforts from regulators and manufacturers have brought the U.S. While there's certainly more work to do, the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

Manufacturing 105

Manufacturing Regulation Drugs 105

BioPharma Reporter

APRIL 22, 2024

SK pharmteco has signed an agreement with Ferring Pharmaceuticals, to scale up commercial manufacturing capacity for the drug substance of Ferringâs intravesical gene therapy Adstiladrin.

Gene Therapy 59

Gene Therapy Manufacturing Gene Drugs 59

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Manufacturing Controls. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282. Risk Management Plan (RMP).

Regulation 98

Regulation Drugs Manufacturing Production 98

BioPharma Reporter

MARCH 11, 2024

million grant to help the company develop a âminiaturized and autonomousâ cell therapy manufacturing platform using deep tech. Austian start-up Sarcura has secured a â1.7

Manufacturing 97

Manufacturing Development Regulation Marketing 97

FDA Law Blog

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

Regulation 64

Regulation In-Vitro Development Gene Therapy 64

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Pharmacy 59

Pharmacy Manufacturing Drugs Regulation 59

Pharma Times

OCTOBER 27, 2023

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

Regulation 125

Regulation Development Manufacturing 125

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

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

Fierce Pharma

AUGUST 2, 2023

FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | Intas Pharmaceuticals’ new warning letter from the U.S. The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022.

Manufacturing 97

Manufacturing Regulation Production 97

STAT News

JANUARY 9, 2023

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

Manufacturing 122

Manufacturing Containment Regulation Medicine 122

Fierce Pharma

JULY 12, 2023

drug regulator certainly could have been worse for the company. Following an inspection of Lupin’s Pithampur Unit-2 manufacturing facility in Madhya Pradesh, India, from March 21 to March 29, the FDA handed the company an inspection with a classification of Voluntary Action Indicated. .

Manufacturing 79

Manufacturing Regulation Drugs 79

BioPharma Reporter

APRIL 18, 2024

When imagining a pharmaceutical manufacturing facility, many picture it in a vast rural setting, offering ample space for large-scale operations.

Manufacturing 52

Manufacturing Regulation Marketing 52

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

Regulation 133

Regulation Production Life Science Drugs 133

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

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

BioPharma Reporter

MARCH 20, 2024

Lonza is set to acquire a large-scale manufacturing site from Roche-owned U.S. giant Genentech for $1.2 billion.

Manufacturing 98

Manufacturing Regulation Marketing 98

STAT News

OCTOBER 25, 2022

The antitrust regulator in Spain has fined Merck approximately $39 million for preventing a competitor from marketing a generic version of a hormonal contraceptive, the latest effort by a European government to crack down on anti-competitive practices in the pharmaceutical industry. Continue to STAT+ to read the full story…

Regulation 98

Regulation Hormones Manufacturing Production 98

Drug Discovery World

SEPTEMBER 5, 2023

In the eleventh eBook of the Hamilton series ‘Analytical Methods for Viral Vector Development and Manufacturing in Gene Therapy’, we learn about: Gene therapy: history, viral vectors and the role of CDMOs Automation of analytical assays during viral vector development and manufacturing The solutions that Hamilton offers to customers working (..)

Gene Therapy 52

Gene Therapy Manufacturing Gene Development 52

BioPharma Reporter

SEPTEMBER 19, 2023

The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.

Manufacturing 98

Manufacturing Gene Therapy Clinical Trials Clinical Trials 98

Pharmaceutical Technology

OCTOBER 26, 2022

Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination.

Manufacturing 130

Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

FDA Law Blog

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. (HP&M), the largest dedicated food and drug law firm in the U.S.,

In-Vitro 59

In-Vitro Manufacturing Regulation Development 59

Bio Pharma Dive

SEPTEMBER 20, 2023

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

Regulation 161

Regulation Manufacturing Drugs 161

BioSpace

FEBRUARY 7, 2023

regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice. Following reports of destroyed and discarded data, the U.S.

Manufacturing 52

Manufacturing Regulation Drugs 52

pharmaphorum

MARCH 22, 2022

In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. The importance of manufacturing. the streamlining of pharma manufacturing in the 21st century. Taking manufacturing to the next level.

Manufacturing 137

Manufacturing Production Contamination Gene Therapy 137

BioPharma Reporter

AUGUST 31, 2023

Lonza and Vertex Pharmaceuticals have revealed plans to open a dedicated manufacturing facility in Portsmouth, New Hampshire.

Manufacturing 105

Manufacturing Regulation Marketing 105

BioPharma Reporter

MARCH 19, 2024

Food and Drug Administration has cleared AGC Biologicsâ Milan site to begin manufacturing of Orchard Therapeuticsâ Lenmeldy (atidarsagene autotemcel), a gene therapy for early-onset metachromatic leukodystrophy (MLD).

Gene Therapy 59

Gene Therapy Manufacturing Gene FDA Approval 59

Outsourcing Pharma

MAY 25, 2021

The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week.

Regulation 52

Regulation Manufacturing Marketing 52

XTalks

SEPTEMBER 12, 2022

New regulations are often reflective of the supply chain, food safety and consumer trends. Here are some of the top food industry regulations food and beverage companies should watch out for in 2022. Regulating Heavy Metals in Baby Food. Cannabinoid Regulations.

Regulation 52

Regulation Production Contamination Marketing 52

BioSpace

OCTOBER 12, 2023

The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.

Manufacturing 87

Manufacturing Regulation 87

Pharma Mirror

NOVEMBER 7, 2023

The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products. In the United States, for example, the Food and Drug Administration (FDA) plays a central role, while the European Medicines Agency (EMA) oversees regulations in the European Union.

Compliance 130

Compliance Regulation Manufacturing Production 130

FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

Manufacturing 59

Manufacturing Production Drugs Marketing 59

BioSpace

APRIL 22, 2024

The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.

Regulation 69

Regulation Manufacturing 69

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. The post Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show appeared first on.

Regulation 138

Regulation Vaccination Vaccine RNA 138

FDA Law Blog

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. Thus ends a saga that began with a proposal in 2015 to amend the “intended use” regulation.

Regulation 93

Regulation Manufacturing Drugs Marketing 93