European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. New hope for stomach cancer patients.

Patients 85

Patients Food and Drug Administration Side effects Safety 85

Pharmaceutical Technology

MAY 5, 2023

Following observations of an appetite-reducing effect using PBF-999, Palobiofarma designed a clinical trial to assess its efficacy and safety in reducing hyperphagia (excessive hunger) in PWS adults. In 2018, Palobiofarma commenced recruitment of participants for a Phase I clinical trial of PBF-999 in patients with solid tumours.

Safety 52

Safety Recruitment Patients 52

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. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

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

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. As of October 2023, 62.93

Safety 113

Safety Medicine Competition Networking 113

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 108

Manufacturing Medical Medicine Pharmaceutical 108

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 98

Safety Medicine Leads Pharmaceutical 98

World of DTC Marketing

AUGUST 12, 2022

In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV , cable , radio , and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. First, let’s clarify how the bill saves taxpayers billions.

Pharma 255

Pharma Retail Pharmaceutical manufacturing Pharmaceutical 255

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 80

Food and Drug Administration Manufacturing Safety Transportation 80

Healthcare Success

MAY 9, 2022

The QR code allows hospitals and healthcare providers to satisfy this need with immediate physician-patient interaction and engagement – all through smartphones and tablets. . In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. .

Leads 52

Leads Patients Healthcare Provider Healthcare 52

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

Pharma Marketing Network

MAY 15, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence.

Pharmaceutical 59

Pharmaceutical Marketing Electronics Media 59

Pharmaceutical Technology

JANUARY 18, 2023

In June last year, Eli Lilly submitted a new drug application to the National Medical Products Administration (NMPA) of China for Galcanezumab to prevent episodic migraine in adult patients. In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults.

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. They are there to do a job and ultimately to keep patients safe. You’ve got to work with regulators in a very constructive way – that’s really the key lesson.”

Medicine 130

Medicine Manufacturing Specialization Pharmaceutical 130

Pharmaceutical Technology

JANUARY 12, 2023

Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

Pharma Marketing Network

MARCH 23, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence.

Pharmaceutical 52

Pharmaceutical Marketing Electronics Media 52

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

DECEMBER 8, 2022

Like Holmes, former president and chief operating officer Balwani was found guilty of wire fraud, but he was also convicted of defrauding patients who used Theranos’ tests in an attempt to diagnose illness, raising the maximum sentence he faced to 20 years. The company folded in 2018. He is also expected to appeal the sentence.

Doctors 103

Doctors Media Safety Patients 103

Pharmaceutical Technology

MAY 25, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

Side effects 52

Side effects Medicine Recruitment Doctors 52

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

FDA 90

FDA Patients Electronics Medical 90

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

European Pharmaceutical Review

JANUARY 5, 2023

The IMerge Phase III trial assessed the effect of the oligonucleotide in lower risk myelodysplastic syndromes (LR MDS) in patients who were relapsed, refractory or ineligible for erythropoiesis stimulating agents (ESAs). Data showed that 40 percent of patients did not need blood transfusions for eight weeks. IMerge Phase III trial.

Safety 52

Safety Patients Medical Pharmaceutical 52

Clarivate

MAY 11, 2023

Mainland China has streamlined regulatory protocols for testing and approving prescription drugs in recent years, making dozens of urgently needed treatments, from domestic and international manufacturers alike, available to patients in the process. CDE also released guidelines on Clinical trial requirements for overseas drugs.

Marketing 52

Marketing Patients Management Insurance 52

European Pharmaceutical Review

FEBRUARY 22, 2023

This ‘quick-approval, quick-withdrawal from the market’ utilised in accelerated approval can benefit both industry and patients alike. Furthermore, certain drugs awarded accelerated approval have subsequently been proven inefficacious or not safe in impacted patients. FDA; 2018 [cited 2023Jan]. 2019; 116(3): 168-169.

Food and Drug Administration 78

Food and Drug Administration FDA Safety Food 78

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. However, balancing effectiveness, immunogenicity, cost as well as patient convenience and acceptance remains essential.

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

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. The UK’s approach has been regarded as “consistently slow”, Mansfield wrote.

Ethics 88

Ethics Medicine Education Competition 88

Pharmaceutical Technology

JANUARY 8, 2023

While options like bronchodilator inhalers are available for COPD patients, these have limitations. Biologics have the potential to impact disease-driving processes if we hit the right target in the right patient,” Adcock continues. Still, patients require an individual-led approach. Biologics: From asthma to COPD?

Patients 119

Patients FDA Pharmaceutical Pharma 119

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

Management 83

Management Side effects Patients Safety 83

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. Unfortunately, such a chain of custody is not intended to provide patients with the ability to verify their own medicines. 2019; Available from: [link].

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

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

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

AUGUST 24, 2022

The UK is a good place to run such a study, as around 3,000 of the 38,000-plus cases of monkeypox worldwide have been reported within its borders since the first patients were identified in May. The drug has, however, been given to over 400 healthy people in order to test its safety, with no concerns identified.

Recruitment 52

Recruitment Government Consulting Patients 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. Patients may be reluctant to switch to biosimilars and doctors may have limited incentives to choose biosimilars.

Competition 59

Competition Marketing FDA Physicians 59

pharmaphorum

JANUARY 12, 2023

Physically threatening and emotionally significant for patients, such exacerbations can be fatal. Avillion – clinical co-development partner with AZ – conducted the global phase 3 trial of over 4,000 patients across four studies (including the MANDALA and DENALI trials). Commenting on the approval, Bradley E.

FDA 52

FDA Food and Drug Administration Medical Patients 52

European Pharmaceutical Review

MARCH 6, 2023

The application was accepted by the European Medicines Agency (EMA) on 26 January, signalling another significant breakthrough for both patients and experts working to address the disease. 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 75

Food and Drug Administration Safety Medicine FDA 75

pharmaphorum

DECEMBER 21, 2022

The deal doesn’t include the follow-up to a prostate-specific membrane antigen (PSMA) directed prostate cancer therapy that was abandoned last year after two patient deaths linked to neurotoxicity, which will be spun out along with another solid tumour programme targeting prostate stem cell antigen (PSCA).

Pharma 52

Pharma Manufacturing Engineering Safety 52

pharmaphorum

SEPTEMBER 8, 2022

The problem with this form of treatment is that it is not targeted and, as a result, there are a number of short- and long-term side effects which can impact patients’ lives. billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone.

Manufacturing 101

Manufacturing Pharma Side effects Patients 101