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. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

OCTOBER 14, 2022

The report stated that 39 biosimilar products have been approved and 22 products have been launched since 2015, the year the first biosimilar was approved in the US. ” According to the report, the reduction in drug spend for classes with biosimilar competition is estimated to have been $21 billion within a six-year period. .”

Competition 97

Competition Healthcare Healthcare Food and Drug Administration 97

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

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

World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. million, his first big raise since 2015, thanks to incentive pay that jumped by about $1.2 prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 ” Ouch.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies. Empirical Spine, Inc.,

FDA 94

FDA Food and Drug Administration Recruitment Patients 94

Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss.”

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

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.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

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.

Food and Drug Administration 52

Food and Drug Administration Government Food Manufacturing 52

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.

Manufacturing 64

Manufacturing Government Food and Drug Administration FDA 64

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.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

Legacy MEDSearch

DECEMBER 7, 2022

Food and Drug Administration market clearance for the ArthroFree System. Lazurite designs medtech devices, and its ArthroFree System is the first wireless camera with FDA clearance for arthroscopy and general endoscopy. The company hit an important milestone in March 2022 when it received U.S. About Lazurite.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

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

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.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Engineering Pharmacology 97

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. While Zolgensma is also being investigated in the form of an injection, the MOA currently approved by the FDA is a single infusion.

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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.

Food and Drug Administration 69

Food and Drug Administration Healthcare Healthcare Food 69

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

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 FDA is doing this through the publications of Guidance for Industry. .” For example, in September 2022, the company Rebiotix, Inc.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

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

pharmaphorum

SEPTEMBER 13, 2022

2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Today, the bone marrow donor registry comprises more than 39,527,166 donors and 804,246 cord blood units.

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Food and Drug Administration Patients Engineering Physicians 87

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. Eight FDA warning letters were handed to European companies in 2018.

FDA 98

FDA Food and Drug Administration Media Pharmaceutical 98

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

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. from 2001 to 2022.”

Food and Drug Administration 98

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.

Food and Drug Administration 98

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