Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1 (mRNA-1273.214) booster for usage in children aged six to 11 years.

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Copyright Clearance Center

JULY 18, 2023

As an engaged member of the scholarly communications community, CCC works to create first-to-market, award-winning solutions that serve all stakeholders, including publishers, institutions, funders, and authors.” The solution combines sophisticated institutional affiliation disambiguation with easy-to-use analysis and export capabilities.

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Pharma Pathway

FEBRUARY 11, 2023

Note – Candidates with injectables -RnD or complex analytical characterization experience and willing to transition to RA are also welcome (NOT for routine analytical or validation folks) Kindly send your CV to rahul.roy1@viatris.com with the following nomenclature else your profile will not be shortlisted 1.

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Management Marketing 40

Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. 5 subvariants of Omicron. 1 subvariant, mRNA-1273.214.

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Pharmaceutical Medicine Marketing 59

European Pharmaceutical Review

MAY 18, 2023

There is a need to optimise the notifications of potential and actual shortages, including earlier submission of notifications in advance of potential shortages and improving the accuracy of the detail provided to maximise the opportunities to prevent potential shortages from being realised or limiting their impact,” the document concludes.

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Pharmaceutical Technology

AUGUST 9, 2022

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy.

Safety 98

Safety Management Patients Pharmaceutical 98

pharmaphorum

DECEMBER 23, 2022

And technology like digital asset management (DAM), medical, legal, and regulatory review (MLR), and content authoring tools will help drive further acceleration.”. “As Dynamic digital content will drive MLR, health authority collaboration. For example, allowing one submission for 20 versions of an email to support personalisation.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted

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European Pharmaceutical Review

JANUARY 12, 2024

In the regulatory space, Levy explains that AI/ML is already used to pre-populate submissions to the authorities, for example, by pre-filling set fields. With proper oversight, GenAI has potential to drive efficiencies and cut the time needed for a regulatory submission, Levy says. These are all questions to answer, he says.

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Pharma Pharmaceutical Recruitment Pharmaceutical products 78

Pharmaceutical Technology

SEPTEMBER 15, 2022

Veru intends to file an application through the ‘NDS CV’ submission type with Health Canada for the therapy. In June, Veru sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the therapy. . in morality versus placebo. . reduction in deaths compared to placebo. “It

Food and Drug Administration 52

Food and Drug Administration Food Pharma Safety 52

European Pharmaceutical Review

JULY 4, 2023

These include: Quality of starting materials Upstream manufacturing (thaw, expansion, harvest) Downstream processing (purification, filtration, sterilisation, filling) Contamination prevention Scalability Aseptic sampling practices Potency Purity Safety Data integrity Evolving regulatory authority expectations. How can they be addressed?

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Food and Drug Administration Manufacturing Management Safety 83

European Pharmaceutical Review

JANUARY 24, 2023

Marketing authorisation submissions for fruquintinib are planned in the US, Europe and Japan in 2023. In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the US Food and Drug Administration (FDA). This is planned to be completed in the first half of 2023.

Food and Drug Administration 52

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Pharmaceutical Technology

JULY 1, 2022

Paxlovid received emergency use authorization to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above who are at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

MAY 11, 2023

AstraZeneca stated that regulatory submissions for Ultomiris are currently under review with health authorities, including those of Japan and the US. The therapy’s safety and tolerability were found to be consistent with that observed in previous clinical trials and real-world use.

Safety 52

Safety Healthcare Provider Medicine Patients 52

World of DTC Marketing

AUGUST 19, 2022

The authors found that service price and intensity made up more than 50% of the increase. These are overhead costs related to medical billing, including services like claims submission, reconciliation, and payment processing. Other factors, which comprised the rest of the cost increase, varied by type of care and health condition.

Healthcare 204

Healthcare Healthcare Insurance Competition 204

European Pharmaceutical Review

APRIL 26, 2023

We look forward to our first submissions to regulatory authorities for PNH in the first half of this year,” noted Dr David Soergel, Global Head of the Cardiovascular, Renal and Metabolism Development Unit at Novartis.

Medicine 84

Medicine Patients Pharmaceutical 84

Pharmaceutical Technology

APRIL 4, 2023

Furthermore, regulatory submissions for the medication are now under review with several health authorities, including those of Japan and the US. According to the findings, Ultomiris met the trial’s primary endpoint of time to first on-trial relapse, as confirmed by an independent adjudication committee.

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Marketing Medicine Medical Patients 52

Pharma Pathway

JANUARY 4, 2023

The Company has its own Research & Development Centre at Kandivli (West), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. Greetings from Rusan Pharma Limited!!! Vacancies: 02.

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Pharma Manufacturing Pharmaceutical Marketing 52

PM360

MAY 15, 2023

She also launched pharmacy alerts, which is a critical pathway at point of prescribing that has helped to ensure physicians write the NRx to the correct pharmacy over 90% of the time when a specialty drug can only be filled at specific specialty pharmacies.

Physicians 59

Physicians Electronics Prescription Manufacturing 59

Pharmaceutical Technology

SEPTEMBER 30, 2022

InflaRx has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its lead candidate, vilobelimab, to treat Covid-19 patients who are critically ill. The latest development comes after the company had encouraging discussions with the agency at a Type B meeting.

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

Pharmaceutical Technology

JULY 25, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an update to the conditional marketing authorization (CMA) to include Moderna ’s 50µg booster dose of Covid-19 vaccine, Spikevax, for usage in adolescents aged 12 to 17 years.

Medicine 59

Medicine Safety Pharmaceutical Marketing 59

Pharmaceutical Technology

NOVEMBER 20, 2022

In June this year, the company filed a Supplement to a New Drug Submission with the regulatory agency for the vaccine usage as a primary series in adolescents aged 12 to 17 years. Currently, trials are underway to evaluate the immunogenicity and safety of the vaccine administered as a heterologous booster.

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Food and Drug Administration Food Safety Pharmaceutical 59

Pharmaceutical Technology

NOVEMBER 2, 2022

The company made the submission after the pre-IND consultation with the regulatory agency. At present, the company is working with several regulatory authorities to further progress the clinical development of ASC10. An oral small molecule inhibitor, ASC11 acts on 3-chymotrypsin like protease (3CLpro).

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Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy.

Food and Drug Administration 52

Food and Drug Administration Food Safety Medicine 52

Pharmaceutical Technology

APRIL 5, 2023

The EMA will also begin submission readiness meetings to be held approximately one year before a company plans to submit a marketing authorization application (MAAs). Under the new structure, the EMA will give organisations enrolled in the scheme expedited scientific advice in case of any issues with their development programs.

Medicine 52

Medicine Marketing 52

Pharmaceutical Technology

NOVEMBER 7, 2022

In September, the European Medicines Agency (EMA) accepted the company’s submission seeking Conditional Marketing Authorization (CMA) variation for mRNA-1273.222 for use in individuals aged 12 years and above. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharma Marketing Network

NOVEMBER 6, 2020

These articles typically highlight facts and/or author opinions, market research data, and offer expertise within the pharmaceutical and healthcare landscapes. Once an article is accepted, authors assign the copyright to PMN, but retain the right to create derivative works and revise their articles for publication and presentation elsewhere.

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Pharmaceutical Technology

DECEMBER 12, 2022

The European regulator extended Comirnaty’s authorized use to those between the ages of six months and four years. The National Institute for Health and Care Excellence (NICE) is the authority that recommends the use of therapies based on a cost effectiveness analysis for the National Health Service system.

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Legacy MEDSearch

MARCH 17, 2023

It is an honor to have been selected to present data at the AAD from our two major clinical validation studies, which are two of our four studies serving as principal support for our FDA submission,” said DermaSensor’s CEO, Cody Simmons. There were no device-related safety issues reported in either study.

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Legacy MEDSearch

JULY 28, 2023

million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. RIVANNA ® , developers of imaging-based medical solutions, announced that they have received funding totaling $30.5

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Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. 5 Omicron-targeting bivalent booster vaccine for Covid-19.

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FDA Food and Drug Administration Food Pharmaceutical 52

Clarivate

NOVEMBER 17, 2021

By actionable and meaningful, I mean for example, to comment on draft guidelines, to influence policy or to give strategic advice on how to build a robust submission plan. Regulatory is involved quite a way out of sort of the actual regulatory submission approval review aspect.

Pharma 52

Pharma Healthcare Healthcare Specialization 52

pharmaphorum

OCTOBER 3, 2022

We look forward to seeing the results of the ongoing EASE 2 and 3 long term extension trials and engaging with the regulatory authorities as we plan for submission of our NDA,” he continued. An EASE 4 phase 3b trial is also planned to assess long-term effects of glepaglutide on intestinal fluid and energy uptake.

Pharma 59

Pharma Patients Medicine Medical 59

pharmaphorum

DECEMBER 7, 2022

The majority of CT submissions (9/15) did not include the cohort-level real-world patient data collected in the ATUc period. About the authors. The views expressed herein are the authors’ and not those of Charles River Associates (CRA) or any of the organisations with which the authors are affiliated.

Patients 86

Patients Manufacturing Consulting Marketing 86

European Pharmaceutical Review

AUGUST 22, 2022

8 As such, detection of an API nitrosamine with an MDI of 4000 mg/day may be feasible for FDA submissions, but probably not with the EMA. 9 The authors catalogued these complex nitrosamines based on common structural features, identifying 13 groups in total. About the author. He is now an independent GMC consultant.

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Food and Drug Administration Prescription Food Medicine 59

European Pharmaceutical Review

JANUARY 29, 2024

At this current time, the risks posed by N-nitrosamine impurities in medicines have been addressed on a case-by-case basis with some divergence evident between different regulatory authorities, eg, NNV [400 ng/day (EMA) vs 37 ng/day (FDA)]. FDA Emergency Use Authorization. Eur Pharm Rev. 2023; 28(1): 5. Ghadanian M, Schafheutle E.

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Pharmaceutical Food and Drug Administration Medicine FDA 99

European Pharmaceutical Review

DECEMBER 20, 2023

About the authors Sean Dyson is a Partner in L.E.K.’s Figure 1: Changes in the European Commission’s proposal for pharmaceutical legislation fall under seven key themes, based on L.E.K. analysis (Source: L.E.K) s European Life Science practice.

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