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.

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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). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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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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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.,

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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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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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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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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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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.

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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.

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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.

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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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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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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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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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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.”

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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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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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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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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.

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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.

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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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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.

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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.”

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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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European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT. Q13 Continuous Manufacturing of Drug Substances and Drug Products.

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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?

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