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. We get so little comparative effectiveness data from pharma.” References: 1.

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European Pharmaceutical Review

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. Water quality from an Annex 1 and Pharma 4.0 Conclusion.

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Pharma Leaders

MAY 19, 2023

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals.

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European Pharmaceutical Review

NOVEMBER 8, 2022

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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European Pharmaceutical Review

DECEMBER 18, 2023

In 2023, the pharma industry has] witnessed tremendous advances in CAR T-cell immunotherapy of solid tumours” Another treatment modality that has witnessed significant advancement this year in the pharmaceutical industry, is cell and gene therapy. According to CPI, the facility is set to be completed in late 2025.

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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. Job Description.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1.

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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.

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European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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PM360

AUGUST 9, 2022

Pharma Manufacturer Solutions. GM of Manufacturer Solutions. 1 GoodRx’s partnerships with pharma manufacturers and other key stakeholders in the healthcare industry enable them to offer discounts which have helped patients fill at least 80 million prescriptions that they otherwise could not afford. Patty Riskind.

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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.

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Pharma Marketing Network

JUNE 11, 2020

RJ Lewis (EHS): Hello, this is RJ Lewis and we’re back for Episode 2 with John Mack and Don Langsdorf, and we’re talking about the rebirth of Pharma Marketing and Pharma Guy. So, you continue with Pharma Marketing news. Where do you see it going? RJ Lewis (EHS): So, thanks for that question. That’s our vision.

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PM360

DECEMBER 20, 2023

Thus, this article aims to outline the healthcare system and key market access pathways that are opening in China for pharmaceutical products, including vaccines. Additionally, it will delve into the current trends and challenges that pharma companies need to consider when devising successful market access strategies for this unique market.

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World of DTC Marketing

DECEMBER 10, 2020

However, because of manufacturer discounts and rebates, the extent to which increases in wholesale list prices are associated with amounts paid by patients and insurers is poorly characterized. Pharma companies continue to be among the most profitable industries, even outperforming tech companies. The Pharma Spin.

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pharmaphorum

OCTOBER 26, 2022

When people think about pharma, they often think about “big” pharma: large, faceless corporations. The status isn’t awarded lightly and Chiesi is the largest pharmaceutical manufacturer to be named a B Corp. “We But rare diseases are a particularly important and challenging focus area.

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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. The EMA and the FDA also joined hands to advance precision medicine for rare disease patients. Roche expanded its collaboration with Janssen Biotech Inc.,

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Pharmaceutical Technology

MARCH 22, 2023

In light of the Covid-19 pandemic, the war in Ukraine, and the Russian gas supply issue, several countries have called for onshoring, also referred to as reshoring; the bringing back of pharma production to locations within national borders to mitigate costs, supply issues, and concerns regarding bilateral relations.

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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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