Bio Pharma Dive

MAY 21, 2021

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.

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XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success.

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NPR Health - Shots

JULY 30, 2022

Delta-8 is a hemp product designed to get users high, but misleading labels or added chemicals have caused people to get sick. And a lack of federal regulation or guidance has states stepping in.

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Medical Xpress

JANUARY 27, 2023

Food and Drug Administration said Thursday it can't regulate CBD supplements because there isn't enough evidence on their safety. The agency also called on Congress to create new rules for what has become a burgeoning industry.

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World of DTC Marketing

FEBRUARY 21, 2022

Reportedly, the cost of production for molnupiravir stands at about $17.74. The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. Merck’s molnupiravir, now approved for use in the U.K.,

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FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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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.

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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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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.

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Scienmag

JANUARY 22, 2021

coli enzyme synthesizing ribosomal RNA that shift it between turbo- and slow-modes depending on the bacteria’s growth rate Credit: Murakami Laboratory, Penn State The enzyme that makes RNA from a DNA template is altered to slow the production of ribosomal RNA (rRNA), the […].

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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…

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FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

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FDA Law Blog

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. The conference, held in Washington, D.C., April 4th and 5th, is an in-person and virtual event.

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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.

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Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The post Biggest overhaul of UK clinical trial regulation for 20 years appeared first on Drug Discovery World (DDW).

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Fierce Pharma

JANUARY 26, 2024

Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will (..)

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Pharma Mirror

MARCH 29, 2022

This newly launched liquid filling machine is the pharmaceutical machinery manufacturer’s answer to the growing demand for ophthalmic products with no added preservatives. Much stricter GMP regulations apply when these modern pharmaceutical formulations have to be filled under sterile conditions, and the Oftalmica.

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pharmaphorum

SEPTEMBER 2, 2020

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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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. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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Pharma in Brief

NOVEMBER 20, 2023

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.

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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…

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Scienmag

JUNE 25, 2021

New study identifies possible therapeutic target to suppress cancer cell growth Credit: UCI School of Medicine Irvine, CA – June 25, 2021 – New research from the University of California, Irvine reveals how the circadian regulation of glucose production in the liver is lost during lung cancer progression, and how the resulting increase (..)

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pharmaphorum

AUGUST 17, 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments. The post Global regulators seek permanent working group on AI appeared first on.

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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).

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BioTech 365

JANUARY 22, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Regulating the ribosomal RNA production line.The enzyme that makes RNA from a DNA template is altered to slow the production of ribosomal RNA (rRNA), the most abundant … Continue reading →

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Camargo

JANUARY 27, 2021

The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation. Where is the regulation found? 21 CFR §814 Subpart H.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). b) of the Regulations. Link: Health Canada, Notice: Application of the definition of Canadian Reference Product (January 26, 2024)

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Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. The 2018 Farm Bill.

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STAT News

SEPTEMBER 28, 2022

The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products.

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Drug Discovery World

MAY 29, 2023

Scientists are calling for tighter regulation of stem cell treatments, claiming clinics worldwide are offering unproven ‘therapies’ for conditions as varied as hair loss and Parkinson’s. They are calling on regulators to halt these products until they can be proven safe and effective in clinical trials.

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Scienmag

JUNE 21, 2022

Diabetes is a lifelong, chronic health condition caused by abnormalities in the body’s production and use of the hormone insulin. Research has shown that the feel-good hormone, dopamine (DA), plays a key role in how the body regulates the production of insulin.

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STAT News

DECEMBER 19, 2022

WASHINGTON — The Food and Drug Administration’s Center for Tobacco Products is lacking clear goals — and that lack of vision is hampering its ability to regulate millions of tobacco products currently on the market, according to an external review of the center released Monday.

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XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. New regulations are often reflective of the supply chain, food safety and consumer trends. But one question remains: what can those products be called?

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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.

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Drug Discovery World

FEBRUARY 7, 2024

It is also under review with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The post Japanese regulator reviews first-line bladder cancer combination appeared first on Drug Discovery World (DDW). The US Food and Drug Administration approved the combination therapy in December 2023.

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XTalks

JULY 20, 2023

A new deforestation regulation has finally come into effect in the European Union (EU) and it’s poised to send shockwaves through the world’s food system. On June 29, 2023, a game-changer came into force: the EU’s deforestation regulation. With this new regulation, a major shift is underway.

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.

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