Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. We also explore how AI is being used to design digital twins for clinical trials.

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Pharmaceutical Technology

SEPTEMBER 29, 2022

Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn). Among these facilities, four are approved by the US Food and Drug Administration (FDA). Having a presence in 40 countries, the company has seven manufacturing plants.

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Pharmaceutical Technology

JULY 21, 2022

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData. 3D bioprinting offers an alternative to animal testing in drug development.

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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. It is specialised in innovative processes for producing difficult-to-manufacture speciality and generic drugs.

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European Pharmaceutical Review

MARCH 31, 2023

The pharma companies who will manufacture the generic versions are Viatris, Aurobindo and Cipla. Only seven months after the first regulatory approval of cabotegravir LA for PrEP by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a voluntary licence agreement in July 2022.

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Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid. FDA Approves Leqembi for the Treatment of Alzheimer’s Disease.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. Citizen Petitions before the FDA. Senate Bill 562 (S.

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PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public. FDA Update. Drug Approvals.

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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European Pharmaceutical Review

MARCH 8, 2023

To mark International Women’s Day, EPR talked to Dr Ekaterina Malievskaia, Chief Innovation Officer and Co-founder of COMPASS Pathways about her inspiration, the challenges as a woman working in pharma and advice for women entering the industry. What challenges have you faced as a woman in pharma?

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Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Pharma Marketing Network

MAY 11, 2023

However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease. One of the most notable breakthroughs in Alzheimer’s treatment is the approval of Aduhelm, a new drug developed by Biogen, by the U.S. Food and Drug Administration (FDA) in June 2021.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. The post Data integrity considerations in Pharma and Life Sciences appeared first on European Pharmaceutical Review.

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PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We We are thrilled to welcome Timmy to the Ardelis leadership team.

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Viatris has signed definitive agreements to acquire Oyster Point Pharma and Famy Life Sciences in a deal totalling nearly $700m-$750m in cash to establish an ophthalmology franchise. Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and Drug Administration (FDA) to treat dry eye disease, in November last year.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Valeo Pharma and Veru have signed a commercial services agreement in Canada for sabizabulin as a treatment for Covid-19. In June, Veru sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the therapy. . reduction in deaths compared to placebo. “It

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European Pharmaceutical Review

JUNE 27, 2023

For World Microbiome Day on 27 June 2023, EPR put questions to Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences, to find out how the field is progressing and what innovations could transform future microbiome-based therapies.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. These differentiators can inform commercial strategies.

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European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

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Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. What Influence the Future of the Large-Cap Pharma Industry?

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Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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Clarivate

NOVEMBER 14, 2023

Figure 1: Timeline of GLP-1 RA development [9] , [10] Abbreviations: EMA, European Medicines Agency; US FDA, United States Food and Drug Administration. 9] Food and Drug Administration. Drug approvals and databases. What’s next in diabetes? Reviews in Endocrine and Metabolic Disorders.

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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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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. Where to start?

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Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Pharmaceutical Technology

MARCH 22, 2023

In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. He adds that in the early 2000s there were no set standards for RFID in the pharma industry, so the compatibility between systems was not guaranteed.

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Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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World of DTC Marketing

MARCH 17, 2022

Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found. Pharma companies are making billions from cancer treatments.

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