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

MAY 3, 2024

Related: New Rapid Salmonella Test Could Accelerate Poultry Safety Protection for Consumers: Should Salmonella exceed allowed levels, the affected products will be withdrawn from the market to safeguard consumers from the severe health risks these infections pose.

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Pharmaceutical Commerce

JUNE 17, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Fran Gregory, PharmD, Vice President of Emerging Therapies, Cardinal Health discusses the growing biosimilars market and the challenges associated with regulation and adoption.

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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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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. GLP-1-RA […]

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Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 18, 2024

These measures are specifically tailored to ensure regulatory compliance, particularly for exports destined for the EU market, thereby bolstering the reputation of Indian […]

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World of DTC Marketing

FEBRUARY 21, 2022

The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. With over 80% of voters aligned that drug prices are too high big pharma continues to act recklessly as if to say, “we’ll do what’s best for investors and us regardless of the effects on society.”

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Pharma Mirror

SEPTEMBER 6, 2023

by Nataliya Andreychuk, Co-founder and CEO of Viseven Many pharma brands still shy away from marketing directly to patients, depending on conversion through healthcare providers (HCPs). And it is not hard to see why.

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Pharmaceutical Technology

AUGUST 1, 2023

During the process of qualifying Cyltezo, Boehringer Ingelheim took the uncommon step of showing its interchangeability with Humira.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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Pharmaceutical Technology

AUGUST 15, 2023

A deep understanding of regional differences in regulations and marketing is critical for global launches.

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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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Bio Pharma Dive

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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Bio Pharma Dive

AUGUST 4, 2023

The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.

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Scienmag

JUNE 29, 2022

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of new medicines before they hit the market.

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Fierce Pharma

MARCH 22, 2024

and China, Eli Lilly’s CEO said the Indianapolis-based company remains committed to the Chinese market. David Ricks’ visit to China comes as Lilly has several key drug applications under review at local regulators. At a time of heightened geopolitical tensions between the U.S.

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pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. Engagement channels. Joanna Carlish.

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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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Pharmaceutical Technology

JULY 26, 2022

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

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Pharmaceutical Technology

APRIL 24, 2023

Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. The marketing applications are based on the data obtained from the Phase III OAKS and DERBY trials at 24 months.

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BioTech 365

FEBRUARY 9, 2021

On exclusion of shares from the regulated market On exclusion of shares from the regulated market On exclusion of shares from the regulated market JSC “Grindeks” hereby informs that according to the decision of the unscheduled General Meeting of JSC … Continue reading →

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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.

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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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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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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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STAT News

OCTOBER 12, 2022

— Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

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BioSpace

MAY 16, 2024

A European Medicines Agency panel on Friday cited a possible but unconfirmed risk of cancer and recommended that hydroxyprogesterone caproate drugs be suspended from the European Union market.

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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 Marketing Network

JULY 12, 2023

The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. They are individuals with unique needs, concerns, and experiences.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. No product is mentioned for help-seeking advertising.

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STAT News

FEBRUARY 3, 2023

Certification by the Food and Drug Administration that these products are safe and useful against many common ailments could unleash a $60 billion annual market by 2030. But the FDA turned down industry trade groups , and for good reason.

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BioTech 365

AUGUST 30, 2021

Global Testing Laboratories Markets, 2021-2027 – Highly Regulated Food & Beverage Industry Presents Opportunities for Testing Market – ResearchAndMarkets.com Global Testing Laboratories Markets, 2021-2027 – Highly Regulated Food & Beverage Industry Presents Opportunities for Testing Market – ResearchAndMarkets.com (..)

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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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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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XTalks

JANUARY 9, 2024

Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This capability will usher in a new era in healthcare marketing, moving beyond traditional methods that rely on past data to a future-focused approach.

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Bio Pharma Dive

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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