Pharmaceutical Technology

JUNE 1, 2023

On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations. 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.

Food and Drug Administration 97

Food and Drug Administration FDA Food Safety 97

World of DTC Marketing

MAY 19, 2021

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S.

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European Pharmaceutical Review

SEPTEMBER 29, 2023

The Phase III clinical trial demonstrated significant improvement in progression-free survival (PFS) in patients receiving Rybrevant with lazertinib compared to osimertinib. A planned interim overall survival (OS) analysis will determine the statistical and clinical significance of overall survival for these patients.

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Pharmaceutical Technology

JANUARY 23, 2023

The term LN refers to a major predictor of poor prognosis in SLE patients, with inflammation of the kidney that encompasses diverse patterns of renal disease, including glomerular and vascular pathology. in 2018 across the 7MM despite being an off-label therapy for lupus.

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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.

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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]

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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.

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Food and Drug Administration Safety Recruitment Medical 98

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

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.

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Manufacturing Medical Medicine Pharmaceutical 119

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.

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Safety Medicine Leads Pharmaceutical 105

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. .

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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.

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Safety Medical Marketing Sales 111

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.

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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.

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Food and Drug Administration Distribution Food Safety 52

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.

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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

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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.”

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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.

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Food and Drug Administration FDA Medical Physicians 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.

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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.

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Pharma Food and Drug Administration Side effects Safety 180

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

AUGUST 15, 2024

Second generation BTKi, acalabrutinib, was designed to be more specific against the target to mitigate some of the toxicities associated with ibrutinib and has demonstrated an improved safety profile in head-to-head clinical trial ELEVATE-RR (acalabrutinib vs ibrutinib) but with similar efficacy (non-inferiority trial with hazard ratio (HR)=1.0).

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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.

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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.

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Doctors Media Patients Safety 97

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.

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Safety Medicine FDA Pharma 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 97

Food and Drug Administration FDA Safety Food 97

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.

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FDA Patients Electronics Medical 82

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.

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

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pharmaphorum

DECEMBER 1, 2022

According to Diabetes UK, the prevalence of T2D is on the rise in Scotland – with a 40% increase in diagnosed cases recorded between 2008-2018 – and now, more than 300,000 people are living with T2D in Scotland, including those not yet diagnosed.

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Consulting Safety Patients Medicine 59

PM360

MARCH 22, 2024

“For many years, our expertise in vision technology has been key in developing automotive solutions that improve driver safety,” said Neil Boehm, Chief Technology Officer at Gentex. These new therapies require significant HCP education and engagement to reach and benefit the patients who need them.

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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?

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Patients FDA Pharmaceutical Pharma 119

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].

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

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.

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Food and Drug Administration Transportation FDA Medical 98

PM360

SEPTEMBER 30, 2024

Marotta has two decades of experience leading global companies in life sciences, medical devices, and diagnostics, and is joining Azenta from Patient Square Capital, a leading healthcare investment firm, where he serves as Executive in Residence. Schwartz will remain as an advisor to Azenta to ensure a smooth transition.

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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.

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