pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

Competition 95

Competition FDA Pharmaceutical Marketing 95

Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0

Safety 59

Safety Sales Marketing Patients 59

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014.

Medical 59

Medical Ethics Specialization Physicians 59

pharmaphorum

JANUARY 3, 2023

Key secondary endpoints demonstrated a 78% reduction in treated ABR and a 92% reduction in annualised infusion rate, and SPK-9001 was generally well-tolerated, its safety profile consistent with phase 1 and phase 2 results. This resulted in a 71% reduction in ABR after a single dose of 5e11 vg/kg of fidanacogene elaparvovec.

Medicine 96

Medicine Engineering Safety FDA 96

pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 It had been approved since 2014 for moderate to severe cases only. billion oral psoriasis therapy Otezla (apremilast).

FDA 52

FDA Marketing Patients Sales 52

pharmaphorum

JANUARY 23, 2023

Morphic had previously also entered into a research collaboration with AbbVie focusing on alpha V beta 6 integrin inhibitors, but rights to that was returned to the biotech after a safety signal emerged in the preclinical testing stage. The post Morphic loses second partner as J&J exits integrin alliance appeared first on.

Safety 52

Safety FDA Pharma 52

Legacy MEDSearch

JUNE 27, 2022

IOPS® is FDA 510(k) cleared and currently launching in the US at select sites. “Our technology is already yielding excellent clinical benefits and this funding will help realize our mission of improving the outcomes, radiation safety and accuracy in endovascular surgery,” said Philip D.

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

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. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Available from: [link]. Leem JW, Jeon HJ, Ji Y, et al.

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

pharmaphorum

DECEMBER 14, 2022

Researchers cautioned that these are early results, and more follow-up is needed to determine the long-term safety and efficacy, but the data could spell trouble for AZ and Alexion’s C5 franchise, which brought in more than $4 billion in sales in the first nine months of this year.

Side effects 52

Side effects Patients Sales Marketing 52

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. The plant is set to be operational before the end of 2023.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Medicine Pharma 105

Pharmaceutical Technology

NOVEMBER 22, 2022

The company began formulating ERVEBO™ in 2014 while the Ebola Virus Disease (EVD) epidemic raged in West Africa. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

Manufacturing 52

Manufacturing Government FDA Safety 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase I study support the initiation of a Phase II trial of RT-102 in osteoporosis,” Hashim said.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. This t-AI would be used for ≤12 months.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Medicine 98

pharmaphorum

OCTOBER 26, 2022

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.

Patients 77

Patients Pharma Consulting Transportation 77

Legacy MEDSearch

AUGUST 11, 2022

OSSIOfiber Suture Anchors were FDA cleared in March 2022 for use in “fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow” in a variety of specific orthopedic procedures. This is another big step for OSSIOfiber in becoming a new material standard in orthopedic fixation.”. About OSSIO.

Recruitment 52

Recruitment Marketing Safety Medical 52

Pharmaceutical Technology

JUNE 21, 2023

This is the first time the FDA has approved an oral diabetes drug for paediatric patients since its approval of metformin in 2000. The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. The drugs are approved for use along with changes in diet and exercise. in the placebo group.

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

World of DTC Marketing

MAY 6, 2021

A study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million. Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up.

Pharma 185

Pharma Food and Drug Administration Government Insurance 185