European Pharmaceutical Review

JANUARY 25, 2023

Collaboration between Vertex and CRISPR Therapeutics Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2015; 13:8-17. 2015; 12(10):931-934. Tuijin Jishu / Propuls. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Pharmaceutical Technology

AUGUST 28, 2022

“This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective Covid-19 vaccine in record time after the pandemic struck.”. 5 Omicron-targeting bivalent booster vaccine for Covid-19, mRNA-1273.222.

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Food and Drug Administration Food Marketing Pharmaceutical 98

Pharmaceutical Technology

MAY 19, 2023

The US Supreme Court has unanimously voted in favour of Sanofi and Regeneron in a years-long legal feud with Amgen over the potential patent infringement surrounding the companies’ anti-cholesterol drugs. This marks a milestone in the dispute nearly a decade after the first lawsuit filed by Amgen against the two companies.

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Food and Drug Administration Food FDA Pharma 59

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. was established in China in 2015 and is a subsidiary of MicroPort Scientific Corporation.

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Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.

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Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

Legacy MEDSearch

DECEMBER 7, 2022

Food and Drug Administration market clearance for the ArthroFree System. 2015), and has raised more than $25M from institutional investors, family offices, and more than 70 physician champions. The company hit an important milestone in March 2022 when it received U.S. Lazurite is located in Cleveland, OH (est.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Food and Drug Administration Manufacturing Engineering Pharmacology 97

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).

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Food and Drug Administration FDA Side effects Food 52

European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drug development. Yet in 2021, 100 nanomedicines had been marketed.

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Food and Drug Administration Manufacturing Pharma Pharmaceutical 95

Pharmaceutical Technology

JUNE 14, 2023

With approximately ten million units sold in Europe and Australia since its launch in 2015, our water-free EyeSol technology is proven to be safe and well-accepted.” Novaliq has also received US Food and Drug Administration approval for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat dry eye disease.

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Food and Drug Administration Pharmaceutical Safety Prescription 52

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Sitra joined Avexis in 2019 as Head of Clinical Development for SMA.

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Food and Drug Administration Government Healthcare Healthcare 95

European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. State Government of Victoria, Australia; 2015 [Cited 2022Nov]. Standards of Care.

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Food and Drug Administration Healthcare Healthcare Food 69

Pharmaceutical Technology

JUNE 23, 2022

As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. Allowing for real-time process monitoring during drug production can help with continuous manufacturing. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.

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Manufacturing Government Food and Drug Administration FDA 64

Pharmaceutical Technology

MAY 18, 2023

These obstacles have prompted the letter from concerned parliamentarians , which urges a return to “commitments to invest in the prevention and control of NTDs”, originally made during the 2015 Elmau Summit.

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Food and Drug Administration Government Food Manufacturing 52

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). founded in 2015, is a privately held company creating a new standard of care in spine surgery that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life.

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FDA Food and Drug Administration Recruitment Patients 94

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

Legacy MEDSearch

MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. About Advamedica Founded in 2015 and based in Cambridge, MA (USA), Advamedica Inc. Advamedica Inc., Visit [link] for more info. Advamedica Inc.

FDA 52

FDA Food and Drug Administration Recruitment Networking 52

Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. About BionicM BionicM has been researching on innovative technologies since 2015 at the University of Tokyo, utilizing the world’s most advanced robotics research.

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FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

SEPTEMBER 13, 2022

Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Since then, it has transformed the treatment of chronic myeloid leukaemia and non-Hodgkin’s lymphoma. 2002 – Emergence of CAR-T therapy.

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Food and Drug Administration Patients Engineering Physicians 98

Legacy MEDSearch

MAY 23, 2022

Developed by Cleveland-based Lazurite Holdings LLC, ArthroFree recently became the first wireless camera for arthroscopy and general endoscopy to receive market clearance from the Food and Drug Administration. 2015) designs devices to set new operating-room standards for efficiency and patient safety.

Food and Drug Administration 52

Food and Drug Administration Medicine Recruitment Physicians 52

World of DTC Marketing

MARCH 17, 2022

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. 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.

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Food and Drug Administration Medical Patients Ethics 255

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. An FDA warning letter delivered to Edge Biologicals Inc.

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FDA Food and Drug Administration Media Pharmaceutical 98

Pharmaceutical Technology

MARCH 30, 2023

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. The HHS Overdose Prevention Strategy aims to tackle the growing number of drug overdoses in the US, which is particularly an issue with opioid overdoses.

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Food and Drug Administration FDA Prescription Manufacturing 52

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. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules.

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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Food and Drug Administration FDA Medicine Competition 98

European Pharmaceutical Review

SEPTEMBER 12, 2022

Jynneos is approved by the US Food and Drug Administration for administration by two subcutaneous injections 28 days apart for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

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Food and Drug Administration Safety FDA Food 98

World of DTC Marketing

MAY 6, 2021

Some say pharma should be allowed to make as much as they want because we live in a capitalist society but JAMA recently found out that price increases in branded drugs means that people will often go without their medications. But what about the costs to develop new drugs and the failure rates?

Pharma 185

Pharma Food and Drug Administration Government Insurance 185