European Pharmaceutical Review

SEPTEMBER 29, 2023

An analysis of the efficacy and safety of lazertinib from the Phase III LASER301 study published in the Journal of Clinical Oncology in 2023, demonstrated lazertinib improved PFS compared to the first generation EGFR TKI gefitinib in all prespecified subgroups.

Pharmaceutical 106

Pharmaceutical Safety Patients 106

Pharma Pathway

SEPTEMBER 20, 2022

Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue.

Pharma 86

Pharma Pharmaceutical manufacturing Specialization Safety 86

Pharmaceutical Technology

JUNE 1, 2023

Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. Trials peaked at 115 in 2018 before declining to 91 last year. In comparison, the rPFS and OS for those on placebo with Zytiga and prednisone was 8 months and 23 months, respectively.

Food and Drug Administration 97

Food and Drug Administration FDA Food Safety 97

World of DTC Marketing

MAY 19, 2021

According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. The increase followed total Humira price hikes of 19 percent during 2017 and 2018. billion on R&D from 2013 to 2018. employees and their families at risk. Why the increase? Porter (D-Calif.)

Pharma 181

Pharma Prescription Patients Safety 181

European Pharmaceutical Review

APRIL 27, 2023

Investigating safety and efficiency of the immunotherapy Researchers of the international clinical trial studied the safety and effectiveness of blinatumomab in babies with ALL. Between 2018 and 2021, 30 children in nine countries were treated with blinatumomab.

Safety 101

Safety Medicine Leads Pharmaceutical 101

European Pharmaceutical Review

JANUARY 18, 2023

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. The firm’s medicinal cannabis product will be supplied in oil form as an API.

Manufacturing 111

Manufacturing Medical Medicine Pharmaceutical 111

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

Pharma Pathway

NOVEMBER 30, 2022

Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Greetings from Aurobindo !!!

Pharmaceutical manufacturing 52

Pharmaceutical manufacturing Pharma Education Safety 52

European Pharmaceutical Review

JANUARY 17, 2023

The European Medicines Agency (EMA) determined Ximluci ® to be highly similar to the reference product, Lucentis ® , based on data showing comparable quality, safety and efficacy to Lucentis ®. . A biosimilar for biologic ophthalmic treatments. Ximluci ® is an anti-VEGF (vascular endothelial growth factor) retinal vascular disorders.

Manufacturing 90

Manufacturing Medicine Marketing Safety 90

Pharmaceutical Technology

JULY 4, 2022

The companies signed a partnership, option and license agreement in May 2018 under which Brii Bio gained the option for the acquisition of exclusive rights to some programmes of Vir in Greater China.

Safety 111

Safety Medical Marketing Sales 111

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. 2018; 8(1). EMA/95098/2010.

Safety 114

Safety Medicine Competition Networking 114

World of DTC Marketing

FEBRUARY 4, 2021

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. She recovered very nicely and is now in charge of a team at Amazon.com.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

pharmaphorum

NOVEMBER 3, 2022

Regeneron’s main rival was Pfizer with tanezumab , which got as far as marketing applications in the US and EU for osteoarthritis-related pain before being shot down by regulators on safety grounds. Faced with the regulatory resistance, Pfizer gave up on tanezumab shortly afterwards.

Safety 52

Safety Medicine FDA Pharma 52

Pharma Marketing Network

MAY 15, 2023

Additionally, by analyzing data from completed clinical trials, companies can gain insights into the safety and effectiveness of their products, which can inform the development of new drugs. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence. References 1. 1 (2016) 3.

Pharmaceutical 59

Pharmaceutical Marketing Electronics Media 59

World of DTC Marketing

AUGUST 12, 2022

Data were mainly accessible for smaller firms, products in some therapeutic regions, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products between 2014 and 2018. The most telling data on a disconnect between drug prices and research costs has received almost no public attention.

Pharma 255

Pharma Retail Pharmaceutical manufacturing Pharmaceutical 255

Pharmaceutical Technology

JANUARY 18, 2023

In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults. The double-blind, randomised, placebo-controlled pivotal trial evaluated Galcanezumab’s safety and efficacy in episodic migraine patients from India, China, and Russia.

Food and Drug Administration 52

Food and Drug Administration Distribution Food Safety 52

European Pharmaceutical Review

FEBRUARY 21, 2023

After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. He founded Celadon in 2018. The exciting part for me is the ability to speed up drug development times, as well as unlock the true potential of this incredible plant.

Medicine 131

Medicine Manufacturing Specialization Pharmaceutical 131

Pharma Marketing Network

MARCH 23, 2023

Additionally, by analyzing data from completed clinical trials, companies can gain insights into the safety and effectiveness of their products, which can inform the development of new drugs. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence. References 1. 1 (2016) 3.

Pharmaceutical 52

Pharmaceutical Marketing Electronics Media 52

pharmaphorum

JANUARY 23, 2023

. “These findings are especially meaningful to people living with this aggressive and difficult-to-treat cancer, representing the potential to prolong life with a safety profile consistent with the safety profile of the treatment components,” commented Wainberg. billion in 2018.

Safety 52

Safety Sales Leads 52

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Safety Transportation 84

Pharmaceutical Technology

JANUARY 12, 2023

The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018. It also demonstrated consistent safety and tolerability in both trials with the known profiles of the components. It is claimed to be the first and only rescue medication approved for this indication in the country.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 92

Ethics Medicine Education Competition 92

Pharmaceutical Technology

MAY 25, 2023

According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank. In December 2018, the 100,000 Genomes Project reached its goal of sequencing 100,000 whole genomes. Data from the project was used in other research initiatives looking at mutational signatures in cancer.

Side effects 52

Side effects Medicine Recruitment Government 52

Clarivate

JULY 21, 2022

If the research is used to inform policy decisions around, food safety and public health, for example, then misleading and false research can risk people’s lives. Figure from the 2018 STM report showing the growth in the number of articles indexed from academic journals between 1975-2018 based on data from 4 different databases.

Ethics 105

Ethics Training Food Education 105

pharmaphorum

DECEMBER 8, 2022

The company folded in 2018. Ramesh Balwani, in a desire to become a Silicon Valley titan, valued business success and personal wealth far more than patient safety,” said Stephanie Hinds, US Attorney in the Northern District of California office. “He

Doctors 95

Doctors Media Safety Patients 95

European Pharmaceutical Review

FEBRUARY 22, 2023

6 FDA has also been critical on selection of appropriate dosing levels to balance efficacy and safety considerations with Phosphoinositide 3-kinase (P13K) inhibitors, as resistance could reduce efficacy resulting in long-term safety concerns. He is currently a CMC consultant with an interest in impurities and safety‑based limits.

Food and Drug Administration 82

Food and Drug Administration FDA Safety Food 82

pharmaphorum

DECEMBER 9, 2022

The initial data from the Lumakras combination study was reported earlier this year and demonstrated the safety of the duo, but did not show convincing evidence of efficacy. Going forward, our strategy for developing RMC-4630 is unaffected by [Sanofi’s] decision,” said Revolution’s chief executive, Mark Goldsmith.

Medicine 59

Medicine Safety Pharma Leads 59

European Pharmaceutical Review

JANUARY 5, 2023

percent) using the IWG 2018 criteria for HI-E. Safety results of the IMerge Phase III trial. Treatment emergent adverse events (TEAEs) observed in the Phase III trial were consistent with the known safety profile of imetelstat from prior clinical trials and no new safety signals were found. percent) versus placebo (13.3

Safety 52

Safety Patients Medical Pharmaceutical 52

Pharmaceutical Technology

MARCH 24, 2023

For example, the cost of Humira biosimilars in Denmark decreased by 82% from September 2018 to December 2018. Further, there remains scepticism on the efficacy and safety of biosimilars. Since Humira biosimilars entered Europe, they have been noted to cause steep discounts in price, higher uptake, and big cost savings.

Competition 59

Competition Marketing FDA Physicians 59

Clarivate

MAY 11, 2023

Per the guidelines, while the underlying objective of the review process is to establish the safety and efficacy of the product in the target population, the determination of whether the existing clinical evidence supports use for patients in Mainland China or additional data is needed will be based on the outcomes of the risk-benefit assessment.

Marketing 52

Marketing Patients Management Insurance 52

pharmaphorum

JANUARY 23, 2023

Morphic had previously also entered into a research collaboration with AbbVie focusing on alpha V beta 6 integrin inhibitors, but rights to that was returned to the biotech after a safety signal emerged in the preclinical testing stage.

Safety 52

Safety FDA Pharma 52

European Pharmaceutical Review

MARCH 4, 2024

Therefore, biologics identification and characterisation poses unparalleled challenges, as does their manufacturing processes and routes of administration while maintaining patient safety and clinical efficacy. A Robotic Pill for Oral Delivery of Biotherapeutics: Safety, Tolerability, and Performance in Healthy Subjects. References 1.

Food and Drug Administration 93

Food and Drug Administration Transportation FDA Medical 93

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. Bitter Pills: The Global War on Counterfeit Drugs: Oxford University Press; 2018. The prevalence of fake drugs is a continually growing problem worldwide.

Medicine 95

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 95

European Pharmaceutical Review

MARCH 6, 2023

In clinical trials, we targeted the early AD population with confirmed amyloid in the brain and found the right optimal dose that balanced efficacy and safety in the large Phase II dose-ranging study. Building on these 4R’s, we designed the Phase III Clarity AD study in order to definitively assess the safety and efficacy of lecanemab.

Food and Drug Administration 79

Food and Drug Administration Safety Medicine FDA 79

Clarivate

MAY 24, 2022

6] [7] However, in May 2018, the National Health Commission of China (NHC), together with four other national agencies, formulated China’s First List of Rare Diseases (CRDL) to provide a foundation for policymaking around rare disease treatments. 2018; 40:432-434. (in Source: Clarivate analysis. 10] [11] [12]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

PM360

OCTOBER 28, 2022

Likewise, it enables them to predict the effect of the compound on the target and the compound’s safety risks. Clinical trials: Evaluating the safety and efficacy of new drugs consumes up to half of the total cost of the drug development process. According to a Deloitte report , pharmaceutical investment ROI has declined from 10.1%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

European Pharmaceutical Review

JUNE 29, 2023

In 2018, even before the number of global manufacturing inspections fell off precipitously, the industry was alarmed by the FDA’s report that angiotensin receptor blockers (ARBs) containing the active pharmaceutical ingredient (API) valsartan were found to contain nitrosamine impurities that sparked a series of recalls.

Food and Drug Administration 90

Food and Drug Administration Manufacturing Food Medicine 90