Bio Pharma Dive

OCTOBER 3, 2022

The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. ” More checks from PhRMA to politicians are coming up.

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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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Outsourcing Pharma

MARCH 26, 2024

Under the agreement, Closed Loop Medicine â a leading TechBio company â and pharmaceutical company, Teva UK, will investigate opportunities to use Closed Loop Medicineâs proprietary software as a medical device (SaMD) technology platform.

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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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Outsourcing Pharma

MAY 29, 2024

UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.

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STAT News

NOVEMBER 15, 2022

Antitrust regulators in Spain have fined a drugmaker $10.6 million for years of “excessive” price hikes on a rare disease medicine, the latest instance in which European authorities have cracked down on the pharmaceutical industry for harming consumers and taxpayers. There was a low-cost version available for decades.

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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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Bio Pharma Dive

JUNE 23, 2022

The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

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Pharma in Brief

DECEMBER 8, 2022

On December 5, 2022, the Federal Court of Appeal ( FCA ) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board ( PMPRB ). The FCA rejects a hyperdeferential standard of review for regulations. The FCA affirms statutory limits on the PMPRB.

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Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

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BioPharma Reporter

FEBRUARY 20, 2023

In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Finding the best commercial packaging suppliers in contract marketing.

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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.

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pharmaphorum

APRIL 23, 2021

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.

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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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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.

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pharmaphorum

JANUARY 27, 2023

So, here are three “best guesses” for what 2023 will hold for the off-patent medicines segment — which accounts for roughly 70% of medicines prescribed worldwide (including the vast majority of system-critical antibiotics and ICU therapies), but only about 20% of the total cost.

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BioPharma Reporter

MARCH 26, 2024

Teva UK and Closed Loop Medicine have announced a strategic partnership to advance the development of personalized medicine.

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Advarra

JULY 26, 2022

with 37 states approving medicinal use and 18 approving recreationally. Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Currently, cannabis use is legal across many states in the U.S.,

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Outsourcing Pharma

NOVEMBER 24, 2023

Calliditas Therapeutics AB announced today (November 24) that its partner Everest Medicines has revealed that China's National Medical Products Administration (NMPA) has approved Nefecon.

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BioPharma Reporter

FEBRUARY 29, 2024

The European Medicines Agencyâs (EMA) Committee for Medicinal Products for Human Use (CHMP) recently refused marketing authorization for Nezglyal (leriglitazone).

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Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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pharmaphorum

JANUARY 13, 2022

In 2020, over half of total spending on brand medicines went to the supply chain, middlemen and other stakeholders, overtaking the amount going to drug manufacturers for the first time, according to a new study. ” The post Supply chain middlemen ‘pocket half of US branded medicine spending’ appeared first on. .

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BioPharma Reporter

NOVEMBER 21, 2023

A partnership combining an integrated drug creation platform with a company specializing in dermatological expertise will deliver life-changing medicines to patients.

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pharmaphorum

DECEMBER 14, 2021

The first publication focused on market and patient access, whereas the new report concentrates on the final part of the route to marketing authorisation: from the final scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) to the final decision of the European Commission (EC). Tide of change.

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Drug Discovery World

NOVEMBER 22, 2023

The European Commission (EC) has granted marketing authorisation for YORVIPATH (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. YORVIPATH is Ascendis Pharma’s prodrug of parathyroid hormone (PTH 1-34), administered once daily.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Drug Discovery World

MARCH 17, 2023

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203.

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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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pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. Trelegy Ellipta is already approved in four markets to date including the US and Japan for the treatment of asthma.

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BioPharma Reporter

NOVEMBER 18, 2021

Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.

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pharmaphorum

APRIL 30, 2021

It’s fair to say this is the most interesting time ever for market access. A recent analysis delves into the challenges companies face in getting digital health technologies reimbursed and presents recommendations for how they can find a smoother path to market. Time for a NICE change. How will NICE fare in a post-Brexit world?

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA).

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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pharmaphorum

FEBRUARY 23, 2022

Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars.

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