Bio Pharma Dive

JULY 5, 2023

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

Vaccine 189

Vaccine Vaccination Regulation Sales 189

Camargo

OCTOBER 15, 2020

If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same. To approve a product, the FDA requires substantial evidence of effectiveness, consisting of adequate and well-controlled (A&WC) trials. Simply, BIAS.

Production 190

Production Trials Development Clinical Trials 190

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials 147

Clinical Trials Clinical Trials Regulation Trials 147

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

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market.

Production 145

Production Marketing Regulation Drugs 145

STAT News

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. Read the rest…

Regulation 124

Regulation Pharmacy Production Drugs 124

Bio Pharma Dive

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

Drugs 204

Drugs Regulation Production Marketing 204

Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

Regulation 125

Regulation Production Clinical Trials Clinical Trials 125

XTalks

JULY 30, 2024

The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) declared Salmonella an adulterant in raw breaded stuffed chicken products when contamination levels exceed one colony-forming unit (CFU) per gram. This approach emphasizes stringent testing and preventive measures at earlier stages of the supply chain.

Regulation 98

Regulation Contamination Production Manufacturing 98

Camargo

OCTOBER 20, 2021

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Such products require more complex target profiling. Such products require more complex target profiling. Definition of Combination Products.

Production 206

Production Regulation Drugs Development 206

Pharmaceutical Technology

SEPTEMBER 8, 2022

Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

Regulation 278

Regulation Development Manufacturing Drugs 278

Pharmaceutical Technology

NOVEMBER 22, 2024

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

Production 130

Production Regulation Manufacturing 130

Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Last month, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorisation for SKYCovione to prevent Covid-19 resulting from SARS-CoV-2 infection in people aged 18 years and above.

Vaccine 363

Vaccine Vaccination Protein Clinical Trials 363

Bio Pharma Dive

DECEMBER 21, 2020

The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.

Regulation 195

Regulation Medicine Production 195

Pharma Mirror

FEBRUARY 6, 2024

In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle. In recent years, European regulators have supported the The post RWE’s Impact on Product Lifecycle for Biopharma Startups appeared first on Pharma Mirror Magazine.

Production 100

Production Packaging Packaging Clinical Research 100

FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

Regulation 114

Regulation Medicine Doctors Doctor 114

NPR Health - Shots

NOVEMBER 29, 2022

The FDA seems poised to at last yank some products aimed at teens from the market. The advent of vaping revived nicotine addiction among young people after a dramatic decline. Will it work? Image credit: Helen H. Richardson/Denver Post via Getty Images)

Regulation 134

Regulation Production Marketing 134

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

Regulation 145

Regulation Drugs Licensing Licensing 145

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production 69

Production Clinical Development Development Regulation 69

Camargo

SEPTEMBER 8, 2021

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device.

Development 186

Development Regulation Production Drugs 186

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. One consistent learning from ALL the research I have been involved in is that patients pick up when death is listed as a side effect and stay far away from the product.

Contamination 297

Contamination Production Marketing Drugs 297

Pharmaceutical Technology

NOVEMBER 28, 2022

on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product. A key natural regulator, NRF2 controls antioxidant genes’ expression. It is crucial in cellular defence against external insults and inflammatory response regulation. .

Development 264

Development Gene Expression Licensing Licensing 264

Bio Pharma Dive

OCTOBER 6, 2023

Regulators’ holdup of the deal had stoked investor fears of greater scrutiny on M&A. In the end, Amgen agreed to requirements meant to guard against product “bundling.”

Regulation 162

Regulation Production 162

Rethinking Clinical Trials

JANUARY 31, 2024

In this Friday's PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present "Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?" The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern.

Cosmetics 163

Cosmetics Clinical Trials Clinical Trials Production 163

NPR Health - Shots

NOVEMBER 28, 2022

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. Consumer Product Safety Commission) No injuries have been reported from such incidents. Image credit: U.S.

Containment 145

Containment Regulation Production 145

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The […].

Regulation 164

Regulation Manufacturing Production Marketing 164

Pharmaceutical Technology

SEPTEMBER 4, 2024

Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…

Regulation 130

Regulation Manufacturing Production Drugs 130

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Production 162

Production Regulation Clinical Trials Clinical Trials 162

STAT News

FEBRUARY 24, 2023

“With the reductions in [youth vaping rates] that we’ve seen, we’ve got an opportunity to ramp up our efforts related to the continuum of risk,” said Brian King, director of the FDA’s Center for Tobacco Products, at a Friday event. ” Continue to STAT+ to read the full story…

Regulation 111

Regulation Production 111

Pharma Mirror

NOVEMBER 7, 2023

Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products.

Compliance 130

Compliance Regulation Production Manufacturing 130

Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

Medicine 262

Medicine Drugs Production Research 262

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. It can be used as a monotherapy or along with cholesterol-lowering medicines. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

Pharmaceutical Technology

JULY 25, 2022

But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds. Supply chain issues also come into play, meaning that owning proprietary API production is an advantage, he says. The only way forward for generics producers.

Drugs 298

Drugs Manufacturing Production Marketing 298

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials 149

Trials Clinical Trials Clinical Trials Drugs 149

World of DTC Marketing

MARCH 6, 2022

The excitement about these technologies partially stems from their potential to address health care system challenges that have slightly improved with traditional health care processes, payment models, regulations, guidelines, and innovations such as drugs and devices. Heath Affairs. What about patients?

Production 244

Production Doctor Doctors Branding 244

Camargo

AUGUST 5, 2021

The product was later approved to prevent organ rejection for heart ( 2006 ) and kidney ( 2009 ) transplants, the latter based on a single prospective clinical trial. A number of Camargo clients are stuck in situations similar to this, with such inspections being the only remaining hurdle before their products are approved. Stay tuned.

Development 232

Development Production Regulation Clinical Trials 232