S Trumpem v Bílém domě má Musk příležitost posunout svůj vliv na novou úroveň a významně ovlivnit pravidla hry v technologickém světě. Těžit může například z možného vlivu na regulace v klíčových sektorech, kde působí. Muskova podpora Trumpovi byla sázkou na nejistotu, ale první reakce trhu naznačují, že se tento risk možná vyplácí.

We’re pleased to note the release of AxiDraw software version 3.9 this week, with a couple of neat new features. One of them is that the “preview mode” button — which lets you simulate plotting to see how the results will come out — is now accessible no matter which function is selected. The other, … Continue reading Hidden line removal for AxiDraw →

JF Oram
Dec 1, 1996; 37:2473-2491
Reviews

In SAS Life Science Analytics Framework 4.6, group membership removal fails with an exception if a user is set as assignee, a candidate, or a notification recipient in a user task for a Process Flow . The Process

The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is "not effective" and has proposed its removal from over-the-counter nasal decongestants.

The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is "not effective" and has proposed its removal from over-the-counter nasal decongestants.

With the plan's approval, North Dakota's educators will experience some of the nation's most dramatic changes under the Every Student Succeeds Act this fall.

The state will be allowed to use competency-based tests developed by local and state officials, trying them out with a handful of districts in lieu of statewide tests.

Chinook salmon spark excitement among local Klamath Tribes, who have advocated for decades to restore the flow of the river in California and Oregon

CME Group, the world's leading derivatives marketplace, today announced it has received approval from the National Futures Association (NFA) to establish a futures commission merchant (FCM). "We...

Noramco Inc. has become the first company in the state to include their facility in Delaware’s Foreign-Trade Zone under the Alternative Site Framework (ASF) and to be granted "Production Authority" by the Foreign Trade Zone Board of the U.S. Department of Commerce.

A look at how American leadership has evolved through major historical events and societal changes over the past century

… Seek targeted relief measures to save media, nation’s economy The Nigerian Guild of Editors (NGE), arising from the three-day All Nigeria Editors Conference (ANEC) in Yenagoa, the Bayelsa State Capital, has called on the federal government to urgently mitigate the negative impact of fuel subsidy removal and the exchange rate volatility on the economy. […]

The post Ease impact of fuel subsidy removal, exchange rate volatility, editors urge FG first appeared on Business Hallmark.

The Egyptian Armed Forces' removal of President Morsi has created a number of challenges related to democracy, political stability and the role of Islam.

Environment Minister Miriam Dalli says project is next step in government achieving its goal of having ‘an open space within a ten-minute walk from home’ at each community in Malta

Title: Polyp Removal Doesn't Always Signal Raised Colon Cancer Risk, Study Says
Category: Health News
Created: 8/27/2014 5:36:00 PM
Last Editorial Review: 8/28/2014 12:00:00 AM

Title: Promacta Approval Expanded to Kids With Rare Blood Disorder
Category: Health News
Created: 8/24/2015 12:00:00 AM
Last Editorial Review: 8/25/2015 12:00:00 AM

Title: Scientists Challenge Key Survival Stat Cited by U.S. Officials in Plasma Approval
Category: Health News
Created: 8/25/2020 12:00:00 AM
Last Editorial Review: 8/25/2020 12:00:00 AM

Title: Moderna Readies for Full Vaccine Approval, as Pfizer Submits Data on Booster Shot
Category: Health News
Created: 8/26/2021 12:00:00 AM
Last Editorial Review: 8/26/2021 12:00:00 AM

Title: FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products
Category: Health News
Created: 8/10/2022 12:00:00 AM
Last Editorial Review: 8/10/2022 12:00:00 AM

[¹⁷⁷Lu]Lu-PSMA-617 was approved by the U.S. Food and Drug Administration for patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC). Since the time of regulatory approval, however, real-world data have been lacking. This study investigated the efficacy, safety, and outcome predictors of [¹⁷⁷Lu]Lu-PSMA-617 at a major U.S. academic center. Methods: Patients with mCRPC who received [¹⁷⁷Lu]Lu-PSMA-617 at the Johns Hopkins Hospital outside clinical trials were screened for inclusion. Patients who underwent [¹⁷⁷Lu]Lu-PSMA-617 and had available outcome data were included in this study. Outcome data included prostate-specific antigen (PSA) response (≥50% decline), PSA progression-free survival (PFS), and overall survival (OS). Toxicity data were evaluated according to the Common Terminology Criteria for Adverse Events version 5.03. The study tested the association of baseline circulating tumor DNA mutational status in homologous recombination repair, PI3K alteration pathway, and aggressive-variant prostate cancer–associated genes with treatment outcome. Baseline PSMA PET/CT images were analyzed using SelectPSMA, an artificial intelligence algorithm, to predict treatment outcome. Associations with the observed treatment outcome were evaluated. Results: All 76 patients with PSMA-positive mCRPC who received [¹⁷⁷Lu]Lu-PSMA-617 met the inclusion criteria. A PSA response was achieved in 30 of 74 (41%) patients. The median PSA PFS was 4.1 mo (95% CI, 2.0–6.2 mo), and the median OS was 13.7 mo (95% CI, 11.3–16.1 mo). Anemia of grade 3 or greater, thrombocytopenia, and neutropenia were observed in 9 (12%), 3 (4%), and 1 (1%), respectively, of 76 patients. Transient xerostomia was observed in 23 (28%) patients. The presence of aggressive-variant prostate cancer–associated genes was associated with a shorter PSA PFS (median, 1.3 vs. 6.3 mo; P = 0.040). No other associations were observed between circulating tumor DNA mutational status and treatment outcomes. Eighteen of 71 (25%) patients classified by SelectPSMA as nonresponders had significantly lower rates of PSA response than patients classified as likely responders (6% vs. 51%; P < 0.001), a shorter PSA PFS (median, 1.3 vs. 6.3 mo; P < 0.001), and a shorter OS (median, 6.3 vs. 14.5 mo; P = 0.046). Conclusion: [¹⁷⁷Lu]Lu-PSMA-617 offered in a real-world setting after regulatory approval in the United States demonstrated antitumor activity and a favorable toxicity profile. Artificial-intelligence–based analysis of baseline PSMA PET/CT images may improve patient selection. Validation of these findings on larger cohorts is warranted.

Depending on PC config you may see up to a 30fps uplift with anti-tamper tech ditched.

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for

Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024.

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

Elliott Vichinsky, MD, University of California, San Francisco (UCSF) Benioff Children's Hospital Oakland

A Technology Development Story: meet the SYNERGY� Stent System engineers

Ryan Lochte explains the feeling of Gentle Laser Hair Removal

The European Commission has approved a Cypriot scheme involving the grant of tax breaks to private investors – both natural persons and corporate investors – who invest into early-stage, innovative SMEs.

Hyderabad-based vaccine manufacturer Biological E has secured World Health Organization (WHO) pre-qualification for its medlinknovel oral polio vaccine type 2/medlink (nOPV2).

Research conducted in Bangladesh could have dramatic implications both for poor households and the entire wastewater value chain.

The post Press Release: New “pay-monthly” poop removal system could revolutionize sanitation in developing world, says new study first appeared on International Water Management Institute (IWMI).

Extended lymph node removal during surgery for localized muscle-invasive medlinkbladder cancer/medlink does not improve patient survival(!--ref1--).

A lawmaker revealed that only 12% of unsafe food imports have been removed from the market, according to government data. According to the data from

Administering medlinkblood pressure/medlink medications to reduce systolic blood pressure readings may not be a safe or effective approach for medlinkacute

Varicose Vein Removal Now Easier and More Affordable Than Ever

Two Hyderabad-based drug companies, Natco Pharma and Hetero have received approval for the sale of Hepatitis- C drug from the Drugs Controller General of India (DCGI).

Avita Medical has gained popularity by developing a medical device called "Spray-on-skin" which helps in treating burns on the skin.The device was first

The US food and Drug Administration has announced that it has approved Amgen's supplemental new drug application for Kyprolis in combination with dexamethasone

A biopharmaceutical company's drug has been approved by the US Food and Drug Administration for treating people with hemophilia B. CSL Behring has

An effective cure for one of the most devastating disease could be in the cards as the Drug Controller of India (DGCI) has granted limited approval for

Amsterdam-based Brineworks, a company specializing in seawater electrolysis technology, says its innovative method is expected to cost under $100 per ton of CO2 at scale.

© 2024 TechCrunch. All rights reserved. For personal use only.