You know you're exhausted when you fall asleep right in the middle of a meal! This newborn is so adorable!
You know you're exhausted when you fall asleep right in the middle of a meal! This newborn is so adorable!
It’s quite likely national marijuana laws will be reformed sometime this year. Fortunes will be made and lost here no doubt. But more importantly, lives won’t be ruined over smoking something that through capricious historical precedents became verboten.
British TV icon Sir David Attenborough has remembered his friend Prince Philip at the head of the BBC’s coverage of the Duke’s funeral. The Duke Of Edinburgh was widely praised for his appreciation for conservation and the environment, something to which broadcaster and naturalist Attenborough has devoted his life. Attenborough said of Prince Philip: “He […]
The duke's naval career will permeate the funeral service.
He had faced allegations of misconduct.
Fears frontline NHS staff are refusing to get Covid vaccineConcerns grow after sharp drop in numbers coming forward, with almost 15% of staff still unprotectedCoronavirus – latest updatesSee all our coronavirus coverage Only 6,259 NHS staff had their first dose in the seven days to 11 April, official figures show. Photograph: Neil Hall/EPA
The cost of renewable energy is plunging, but there are still sound reasons to encourage its adoption through subsidies.
Most charges against George Floyd protesters dropped, analysis showsSome prosecutors and law enforcement observers say departments carried out mass arrests as crowd control tactic Police officers make an arrest during a rally calling for justice over the death of George Floyd, in Brooklyn, New York, on 1 June 2020. Brooklyn’s prosecutor dropped 83% of 136 more serious criminal cases, and Manhattan’s prosecutor dropped about 64% of nearly 1,000 cases. Photograph: Wong Maye-E/AP
After the COVID-19 pandemic hit, the Federal Reserve dropped interest rates to 0% and pledged low interest rates through 2023. What that means for you is that most savings products are offering pretty slim returns right now, and they probably will for a while. The best high-yield savings accounts are currently offering an APY of around 0.40% to 0.60%.
The stock isn't cheap by any means, but investors would be wise to bet on any industry's leading name. It's leading for a reason.
BNY Mellon Wealth Management CEO Catherine Keating joins Influencers with Andy Serwer to discuss the recent issue of voting rights and its impact on the economy. This comes after the passing of new voting laws in the state of Georgia.
The deal creates a $44-billion-asset bank in the South, but so far the market has questioned the merger.
Autobahn Therapeutics Presents Preclinical, Proof of Concept Data for ABX-002 for the Treatment of Adrenomyeloneuropathy
Garner posted a photo with her teddy bear in honor of National Teddy Bear Day, sharing a side-by-side of herself as a child and now, snuggling her furry friend. It doesn't get much cuter than this photo of young Jennifer Garner on the swings in a tiny sweater! Garner posted this throwback from Halloween as a child simply captioned, "boo."
Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021. “The positive results previously disclosed from the REST-ON trial, regarding the three co-primary endpoints, are further bolstered by the secondary endpoints presented at AAN. The consistency with which FT218, or once-nightly sodium oxybate, improved both subjective and objective symptoms of narcolepsy – including disturbed nocturnal sleep – represent the promise of a potential new treatment strategy for physicians and patients. I am particularly impressed by the consistency of results as early as three weeks, with only a 6 g dose,” said Michael J. Thorpy, M.D., Investigator on the REST-ON Phase 3 trial and Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. “I know that clinicians have been eager to learn more about a once-nightly form of sodium oxybate, and we appreciate this forum to present these data.” Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel, added, “FT218 demonstrated significant (P<0.001) and clinically meaningful results versus placebo at all doses tested for secondary endpoints of the Epworth Sleepiness Scale, sleep quality and refreshing nature of sleep, sleep paralysis, and disturbed nocturnal sleep, representing an improvement on important narcolepsy symptoms. We are pleased that neurologists attending AAN will have the opportunity to learn about a once-nightly form of sodium oxybate. We believe that patient perspective is critical to successful long-term therapy, and we are presenting several positive endpoints supporting symptomatic improvement as determined directly by patients.” To register for the meeting, visit AAN’s website: www.aan.com/conferences-community/annual-meeting. Data highlights from the poster presentations are outlined below: Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation FT218 demonstrated significant consolidation of sleep on polysomnography (randomized, n=212) for the 6 g dose at Week 3, the 7.5 g dose at Week 8, and 9 g dose at Week 13 compared to placeboData from the randomized, double-blind, placebo-controlled, multicenter, parallel-group study showed that the mean difference between FT218 and placebo for disturbed nocturnal sleep (shifts from deeper to lighter stages of sleep and wake) was statistically significant (P<0.001) at all doses tested: –22.63 at 9 g (week 13), –17.70 at 7.5 g (week 8), and –11.00 at 6 g (week 3).The mean difference between FT218 and placebo for number of arousals was –23.68 (P<0.001) at 9 g, –19.41 (P<0.001) at 7.5 g and –11.29 (P<0.021) at 6 g.FT218 was generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions. Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation FT218 demonstrated significant (P<0.001) improvement in the Epworth Sleepiness Scale (ESS) versus placebo at all doses tested: LS mean difference –3.86 at 9 g (week 13), –3.16 at 7.5 g (week 8), and –2.06 at 6 g (week 3).FT218 showed a statistically significant (P<0.001) improvement compared to placebo at all doses tested for sleep quality and refreshing nature of sleep on a visual analogue scale, and for sleep paralysis on a sleep symptom diary (P=0.037, 0.021, 0.039 at 9, 7.5, 6 g, respectively). FT218 did not demonstrate significant improvement for hypnagogic compared to placebo. Adverse events were similar to the known sodium oxybate safety profile. About Avadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. About FT218FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release (CR) technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, our expectations of the therapeutic benefits of FT218, the timing of the FDA’s review of our NDA for FT218, the sufficiency of data supporting our NDA for FT218, the commercial launch of FT218 (if approved), and the market acceptance of FT218 (if approved). In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable). Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include: the risk that positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; the risk that the NDA for FT218 is not approved by the FDA or such approval is delayed; the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity; the risk that commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market performance for FT218 (if approved) may differ materially from projections; and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, which we filed with the Securities and Exchange Commission (SEC) on March 9, 2021 and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Contacts: Investor ContactsTom McHughChief Financial OfficerPhone: (636) 449-1843Email: email@example.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915.2564Email: firstname.lastname@example.org Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: email@example.com
The Queen will lead a small group of mourners during a service at St George’s Chapel in Windsor.
The 'Big Brother' star passed away last week after a lengthy battle with anorexia.
Philip’s insignia, laid out on the altar of St George’ Chapel, provided a reminder of his family links and his many roles in the nation’s life.
Follow all the live action from St James’ Park
Le date certe per le riaperture di bar e ristoranti sono "un grande passo in avanti, la richiesta che è stata fatta anche nelle manifestazioni dei giorni scorsi era infatti di uscire dall'incertezza per poter programmare l'apertura al pubblico dei locali". Così la chef stellata Cristina Bowerman commenta con l'Adnkronos le nuove comunicazioni del governo sulle riaperture graduali degli esercizi pubblici, laddove si prevede che il 26 aprile, nelle zone gialle, possano aprire anche a cena ma solo all'aperto e dal 1 giugno anche all'interno, ma solo a pranzo. "Quello che ritengo ingiusto è che ci sia una penalizzazione senza che sia preannunciato un ristoro nei confronti di chi non può aprire perché non ha i tavoli all'aperto", afferma Bowerman, in qualità anche di presidente dell'associazione Ambasciatori del Gusto, in rappresentanza della categoria visto che il suo ristorante a Trastevere a Roma ha questa possibilità. Altro aspetto penalizzante è il mantenimento del coprifuoco alle 22 di sera. "E' un grosso danno il coprifuoco per i ristoranti" sostiene Bowerman che sul tema degli assembramenti e delle misure per eliminarli è categorica: "Bisogna eliminare totalmente il consumo di alcol per strada - spiega - io sono vissuta tanti anni in America è lì c'è il divieto, anche da noi c'è, ad esempio a Roma c'è l'ordinanza che dopo le 23 non si può bere alcol per strada ma le misure vanno fatte rispettare con rigore, finché non c'è l'esecutività e non si individuano le responsabilità non se ne esce". "Ad esempio, - suggerisce Bowerman - se ragazzi quattordicenni girano ubriachi per strada, si devono multare i genitori. Anche durante il giorno poi, ci sono assembramenti fuori dai bar o dagli empori dei bangladini che vendono un po' di tutto, magari anche per bere un cappuccino. Ma allora servono pattugliamenti seri".
Staff and students on board Gordonstoun's sailing boat pay tribute to their former pupil, the Duke of Edinburgh, on the day of his funeral. Pupils aboard the 80ft sail training boat lay a wreath off the coast of Hopeman Harbour, where Prince Philip first learned to sail. At the age of 13, the Duke joined Gordonstoun School in Moray, Scotland, in September 1934, and spent five years at the boarding school.