Pharma Pathway

OCTOBER 6, 2022

Steril-Gene Life Sciences, Pondicherry (A Group Unit of the Madras Pharmaceuticals) one of the most reputed FDA approved Pharmaceutical manufacturing Company looking suitable Candidates for the below positions. Management Trainee. Department: QC/ QA/ QC-Micro/ Production/ Technology Transfer. Positions: Jr.

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eMediWrite

JULY 13, 2023

The CDSCO headquarters conduct regulatory supervision over drug importation, approval of new pharmaceuticals and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of some licences as the Central Licence Approving Authority.

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PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. Certain markets (e.g.,

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European Pharmaceutical Review

DECEMBER 18, 2023

As a treatment designed to help halt disease progression before symptom onset, “Zolgensma will be the first treatment to be routinely commissioned for presymptomatic babies in England,” Imran Kausar, General Manager at Novartis Gene Therapies UK explained. According to CPI, the facility is set to be completed in late 2025.

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PM360

AUGUST 9, 2022

The foundation of the platform is the PHR (Personal Health Record), which puts the patient firmly in control of their health management by helping them gather and access their personal health data anywhere. remote care, care path management, etc.) ACT ICS Patient Relationship Management. For some countries (typically the U.S.),

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Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. It also has the potential to reduce the high carbon footprint associated with manufacturing.

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pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. In brief, the European plan for Chiesi is in-house drug development of biologicals and rare disease targeting. Going beyond the standards of care; improving drug safety and efficacy.

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pharmaphorum

OCTOBER 26, 2022

The status isn’t awarded lightly and Chiesi is the largest pharmaceutical manufacturer to be named a B Corp. “We We promptly discussed this need with the FDA and the agency agreed to a proposed amendment of the protocol to accommodate, in a safe manner, the patient access to the EAP.”.

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PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. In Canada, the government, and Juvenile Diabetes Research Foundation Canada, jointly invested a sum of $33 million for diabetes prevention, management, and treatment.

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Pharmaceutical Technology

MAY 11, 2008

Domino Printing Sciences European business development manager Tony Walsh says his UK-based company has come up with another solution – marking each individual blister (containing a tablet) with individual expiry dates and lot number coding. The pilot scheme for this has been observed by the FDA and EU Commission.

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Pharma Marketing Network

JUNE 11, 2020

PM360 is the go-to when it comes to the product manager and the, how-to manual, if you will, for product managers. I mean, every aspect of the industry from FDA approvals and regulations to the actual nuts and bolts of marketing and what works and what doesn’t work.

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pharmaphorum

JULY 28, 2022

While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. Building supply chain resilience.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. In perhaps the most significant moment for the U.S. Switching patients from brand to biosimilar, as well as between biosimilars, was also highlighted in the survey.

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Pharmaceutical Technology

MARCH 22, 2023

Right shoring’ – trends and innovations While global interdependence will never disappear, Berden suggests it is vital to each territory is import diversification and managing levels of dependence. “For that reason, getting better demand forecasts is as important as focusing on supply chain solutions,” says Berden.

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PM360

MAY 25, 2023

The pandemic had a huge impact on the way population health decision-makers (PHDMs) navigate our industry, and now that it’s clear many of these shifts are here to stay, pharmaceutical manufacturers need to adjust accordingly. Finding new ways to empower “tech-enabled” account managers is an important first step.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. Globalisation and supply chain complexity are a factor.

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PM360

DECEMBER 20, 2023

Reimbursement Procedure of BMI Insurers Although China is working towards providing public coverage for 100% population, the reimbursement policies vary among regions due to the “localized management” principle which indicates that BMI is mainly coordinated at the regional or city level.

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European Pharmaceutical Review

APRIL 8, 2025

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.

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Clarivate

AUGUST 20, 2024

drugs more recently approved by the FDA, those with an orphan drug designation for a single indication, or those facing current or looming biosimilar threat) can escape negotiations. CMS is targeting those therapies with the greatest Medicare spending, although therapies meeting certain criteria (e.g.,

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