Tag: trial

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SRAM & RockShox Announce Crankworx Whistler Events – Pinkbike

SRAM & RockShox Announce Crankworx Whistler Events - Pinkbike
PRESS RELEASE: SRAM

SRAM, RockShox, and Zipp are excited to announce a schedule full of interactive events we will be hosting August 6-12 during Crankworx Whistler. Everything from athlete and ambassador-led rides to suspension tuning on the trails, skills clinics, and more! Space is limited for many of these activities, so be sure to register early! We look forward to seeing you all at Crankworx.

SATURDAY AUGUST 6TH
1:00 – 3:00 PM Get to Know the Bike Park with SRAM Ambassadors (meet at SRAM booth)
REGISTER HERE
SUNDAY AUGUST 7TH
9:00 am – 4:00 pm Indigenous Women Outdoors (IWO)

IWO’s vision is to hold space for Indigenous Women and Girls to experience mountain biking with their peers on the World Stage of “Crankworx”.

In partnership with Hilltop MTB and SRAM Mountain Bike, we would like to invite Indigenous Women and Youth, living or visiting the Whistler area during Crankworx, for a fun-filled day of connecting to the land, each other and the mountain bike community, through sport and mentorship.

We are excited to bring Indigenous women and youth together to experience the joys of mountain biking in the Whistler Bike Park, on the shared traditional territory of the Sḵwx̱wú7mesh Lil̓wat7úl nations.

MONDAY AUGUST 8TH
12:30 pm – 4 pm Ride with The Free Radicals (meet at SRAM booth)
REGISTER HERE

4:30 – 5:30 pm Here, There, and Everywhere with Miranda Miller (at SRAM booth)

TUESDAY AUGUST 9TH
9:00 am – 10:00 am Basic Skills Clinic (co-ed) with Braydon Bringhurst (meet at SRAM booth)

11:00 am- 12:00 pm Basic Skills Clinic (co-ed) with Braydon Bringhurst (meet at SRAM booth)

2:00 pm – 3:30 pm Suspension Tuning on the Trail (meet at SRAM booth)
REGISTER HERE

WEDNESDAY AUGUST 10TH
10:00 am – 11:30 am Suspension Tuning on the Trail (WTFNB) with SRAM Ambassadors (meet at SRAM booth)

1:30 pm – 3:30 pm WTFNB Skills Clinic with SRAM Ambassadors (meet at SRAM booth)
REGISTER HERE

THURSDAY AUGUST 11TH
9:00 am – 10:00 am Basic Skills Clinics (co-ed) with Braydon Bringhurst

11:00 am – 12:00 pm Basic Skills Clinics (co-ed) with Braydon Bringhurst (meet at SRAM booth)

2:00 pm – 3:30 pm Suspension Tuning on the Trail with SRAM ambassadors (meet at SRAM booth)
REGISTER HERE

FRIDAY AUGUST 12TH
10:00 am – 11:30 am Suspension Tuning on the Trail (WTFNB) with SRAM ambassadors (meet at SRAM booth)

1:30 pm – 3:30 pm WTFNB Skills Clinic with SRAM Ambassadors (meet at SRAM booth)
REGISTER HERE

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FMBA Announces 2022 Calendar Ahead of First Event of the Season – Pinkbike

FMBA Announces 2022 Calendar Ahead of First Event of the Season - Pinkbike
PRESS RELEASE: FMBA

Here we go again. The FMB World Tour is back and getting things rolling on the 2022 season. With 24 events, and counting, coming down the pipeline, the 2022 FMB World Tour is set to deliver a season not experienced since pre-pandemic. From the return of Red Bull District Ride to a new stop being added to the Crankworx FMBA Slopestyle World Championship (SWC) to the homecoming of esteemed FMB Gold level events like O Marisquino and Big White Invitational, the calendar is filling up fast.

With the 2022 FMB World Tour kicking off in less than two weeks, the FMBA is stoked to share what riders can expect from the season ahead. So, what exactly is on offer this year?

The 2022 FMB World Tour will see five FMB Diamond level events in the same calendar year for the first time since 2017. As well as the SWC will feature four events for the first time in three years. Yup, it’s been that long… As to where the new tour stop is though, Crankworx hasn’t spilled the beans just yet. Expect an announcement in the coming weeks!

Riders can also get pumped for the return of many beloved FMB Gold level events, as well as the introduction of an entirely new event in Canada with SilverStar Slopestyle. Remember that epic Slopestyle course that Brett Rheeder and Matt MacDuff debuted during Crankworx BC last year? A course like that can’t just sit around…

The 2022 FMB World Tour is also on track to host three National Series in support of regional freeride mountain bike events creating their own ranking – Australian Slopestyle Tour, Freebird Slopestyle Series, and Swiss Dirt Series.

Above all else, the mountain biking community can expect to witness one of the most progressive seasons yet. With sanctioned Women’s Divisions already scheduled at 13, and counting, FMB Bronze and Silver level events, 2022 is history in the making.

2017 was the last time that FMB Diamond level events were so plentiful, and athletes are already chomping at the bit to earn their place on those coveted rosters.

bigquotes My dream is to be back in Nurnberg again for Red Bull District Ride – such an iconic event that you won’t [want to] miss – but also a new Crankworx stop sounds very interesting!—Diego Caverzasi

With the return of Red Bull District Ride and the Crankworx FMB SWC announcing the addition of a fourth stop, the 2022 FMB World Tour calendar is shaping up to be an exciting one. Szymon Godziek is one of the numerous riders impatiently awaiting the homecoming of Crankworx Whistler.

bigquotes I have some unfinished business in Slopestyle there. I feel super motivated for the 2022 season. After my last year in 2018, lots of things happened and the progression of the sport went up so quick. I see riders like Emil [Johansson] doing tricks that I was always dreaming of [and it] gives me even more motivation. Unfortunately, my 2021 plan didn’t go exactly as I wanted, and I haven’t got back into Crankworx yet. That’s my main goal for this year.—Szymon Godziek

The 2022 FMB World Tour calendar will also see the return of esteemed FMB Gold level events O Marisquino and Big White Invitational after a two-year hiatus.

bigquotes This blank space of two years has served us all to reflect on the future of O Marisquino and see how we want to approach it for the next editions. This 2022 it seems that we have returned to pre-pandemic normality, so we hope to see thousands of people from the public cheering on the riders, a great atmosphere, and the best Dirt Jumps we have seen so far in Vigo. This year the riders are going to find a circuit similar to the 2019 edition, but a little faster and with bigger jumps. We have decided to extend the receptions and improve the speed so that they arrive more comfortably at the jumps and can comfortably demonstrate their best tricks.—Pablo Moreno, O Marisquino Dirt Jump Director

With these, the new SilverStar Slopestyle competition in Canada, and two more highly anticipated FMB Gold level events on the calendar (stay tuned for more details!), the upcoming season is set to include nearly triple the amount of FMB Gold level events that were on the 2021 schedule. Based on what’s coming down the pipeline, it is expected that six FMB Silver level events and 16 FMB Bronze level events will round out the 2022 FMB World Tour calendar, increasing the total number of events by more than 50% in comparison to last year.

Of the upcoming FMB Bronze and Silver level events, nine will fall under one of three National Series competitions taking place – Australian Slopestyle Tour, Freebird Slopestyle Series, Swiss Dirt Series. While Freebird Slopestyle Series and Swiss Dirt Series are returning to the calendar, the Australian Slopestyle Tour will be making its debut this 2022 season. With three FMB Bronze level events all featuring both a Men’s and Women’s Category, the newest National Series is set to confidently enter 2022.

Despite fewer contests taking place around the world last year, riders’ progression was still on point, and many are ready to get back to competition.

bigquotes My overall goal is to win the Freebird Slopestyle Series. I want to learn as much as I can, unlock more tricks, make new friends around the world, and of course, go to as many dirt parks as possible.—Renata Wiese

Many are also keen to see what athletes have in store for the upcoming season.

I think 2022 is going to be one of the most progressive years ever seen, with opportunities opening up for both up and comers and established riders, it’s going to be mind-blowing and I’m excited to be a part of it.—Mike Ross bigquotes

bigquotes Some of the athletes, like Lucas Huppert, have been competing at [Züri Dirt Contest] since 2015. It’s very nice to see how the athletes improve from year to year. Even if you look at the results over the years, it is very exciting to see that they are constantly higher up in the rankings.—Dominik Bosshard, Züri Dirt Contest Event Organizer

Kicking off the 2022 FMB World Tour in less than two weeks is Australia’s Highline Mountain Bike Festival.

bigquotes With only a few to go until the festival kicks off, the pressure and excitement is building! Our Mini and Pro Slopestyle courses are prime and ready for competition; we have done plenty of test tune sessions to ensure the best quality riding experience. [The] goal for this event is to showcase the quality of Australian male and female riders across the Slopestyle categories on offer.—Shannon Rademaker, Event Manager

This is the first year that the event is sanctioned as a FMB Silver level event. Combined with 25 new amateur Slopestyle riders competing for the first time and the addition of a Women’s category, Highline Mountain Bike Festival is boldly entering the 2022 season. Mike Ross is one of the many athletes ready for its return to the Land Down Under.

bigquotes Highline Mountain Bike Festival is definitely the event I’m most excited for. It’s kicking off the season and it’s a great event to showcase the Australian Slopestyle scene we have down here. Bring it on!—Mike Ross

A recent addition to the FMB World Tour, that will be coming into effect this year, is the FMB World Tour Women’s Division, which gives FMB Bronze and Silver level events the option to host a sanctioned Women’s Category.

Competing in her first Slopestyle event back in 2016, Kathi Kuypers reflected on how opportunities haven’t always been readily available for Women in freeride.

bigquotes I couldn’t focus on developing my skills on the Slopestyle bike because my sponsors didn’t see a market, so I rode all the other disciplines like Enduro, a little bit of Downhill, [did] loads of magazine story productions, and so on. But I never gave up and continued progressing. Now brands are hiring [Women], especially for freeride events and content, and [with] the FMB World Tour Women’s Division, there will be even more attention on [Women in freeride] and their accomplishments. This is all I’ve ever wanted.—Kathi Kuypers

On how this will transform the competitive landscape of mountain biking in 2022 and beyond, many in the industry see nothing but positive change.

It will definitely broaden the horizons of all of us. New brands will emerge, new sponsors, new opportunities will arise, and a new image will be cast on the sport. Women like Kathi Kuypers ride FMB World Tour events and have been fighting for this moment for over 10 years. I am very pleased to see that this effort is now paying off.—Dominik Bosshard bigquotes

bigquotes I love it!! I feel like it is going to be awesome to see what the girls can do! I like what the FMBA is doing by adding a Women’s Division and giving us the chance to compete equally.—Renata Wiese

Most of all, it seems as though the riding community is ready to once again experience the feeling of comradery that is so deeply rooted in mountain biking culture. On track to visit 12 different countries across three continents, the 2022 FMB World Tour is more than a circuit of mountain bike competitions. On what unites such a widespread, diverse community, many shared their perspectives.

Biking is fun and it’s the same all over the world, no matter where you [are] from or where you live.—Diego Caverzasi bigquotes

bigquotes The desire to have fun and the desire to excel are aspects that are universal.—Pablo Moreno

And at the end of the day, that’s really what it’s all about.

See the entire list here.

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Hearing-related events for real-world use of Tepezza comparable with trial results

Hearing-related events for real-world use of Tepezza comparable with trial results

February 17, 2022

1 min read


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A post-marketing safety analysis showed that the real-world rate of hearing-related events linked with Tepezza treatment was comparable to that found in clinical trials, according to a press release.

The 19-month analysis included data from thousands of patients with thyroid eye disease treated with Tepezza (teprotumumab-trbw, Horizon Therapeutics) since the drug’s FDA approval in 2020.

According to the release, about 10% of all cases reported to the safety database have included a hearing-related event. The most frequent hearing event was hypoacusis, followed by tinnitus. There were no new safety concerns.

In the pooled OPTIC phase 3 and OPTIC-X open-label extension trials, 9.5% of patients who received Tepezza had a hearing-related event compared with 0% of patients who received placebo. These events were mild or moderate and caused few discontinuations or therapy interruptions, according to the release.

“Managing the disabling symptoms of thyroid eye disease can be difficult for patients, both physically and emotionally, and before Tepezza, there was a significant unmet medical need for an effective treatment,” Jeffrey W. Sherman, MD, FACP, executive vice president and chief medical officer at Horizon, said in the release. “Ongoing research reinforces the significant impact Tepezza can have on people living with this devastating disease.”


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New Post-Marketing Safety Analysis Shows Rate of Hearing-Related Events Associated with TEPEZZA® (teprotumumab-trbw) Comparable with Clinical Trial Observations

New Post-Marketing Safety Analysis Shows Rate of Hearing-Related Events Associated with TEPEZZA® (teprotumumab-trbw) Comparable with Clinical Trial Observations

DUBLIN–()–Horizon Therapeutics plc (Nasdaq: HZNP) today announced results from a new post-marketing safety analysis of hearing events associated with TEPEZZA for the treatment of Thyroid Eye Disease (TED). These findings, along with data on the sustainability of response to TEPEZZA, were presented at the 48th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS 2022), Feb. 12-17, in Austin, Texas. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease.1

Since the FDA approval in 2020, Horizon has conducted post-marketing monitoring to understand the overall safety profile of TEPEZZA, including hearing-related events. Among the thousands of patients included in this 19-month analysis (Jan. 2020 – Aug. 2021), approximately 10% of all cases reported to the safety database have included a hearing-related event. The most frequently reported hearing event was hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears). The mean age of the patient, where known, was 59.3 years. No new safety concerns were observed in the post-marketing database.2

This is comparable with what was seen in the pooled OPTIC Phase 3 and OPTIC-X open-label extension trials for TEPEZZA. Hearing-related adverse events were reported in 9.5% (8/84) of patients treated with TEPEZZA, which were mild or moderate in severity, versus 0% of patients who received placebo. Adverse events experienced in the clinical trials were manageable, with few discontinuations or therapy interruptions.3,4

“The majority of hearing-related adverse events in the pivotal trials and post-approval have been mild to moderate and reversible, but as with any medicine, it is important to monitor patients,” said Kimberly Cockerham, M.D., adjunct clinical associate professor, Department of Ophthalmology, Stanford University School of Medicine, and a primary author of the report. “Notably, we continue to see high patient adherence to TEPEZZA, with more than 90% of patients completing their full course of treatment in the clinical studies and post-approval. This speaks to the favorable benefit-risk profile of TEPEZZA for people living with Thyroid Eye Disease.”

A separate analysis presented at NANOS 2022 examined the sustainability of response to TEPEZZA over the follow-up periods from the Phase 2 and OPTIC Phase 3 clinical trials and the OPTIC-X open-label extension study. A total of 121 patients were analyzed, with 9 patients receiving additional medications and/or surgery during the follow-up periods. Of those with data available, the majority of patients treated with TEPEZZA were proptosis, diplopia and European Group on Graves’ Orbitopathy (EUGOGO) composite outcome responders up to 51 weeks after their last infusion.5

“Managing the disabling symptoms of Thyroid Eye Disease can be difficult for patients, both physically and emotionally, and before TEPEZZA, there was a significant unmet medical need for an effective treatment,” said Jeffrey W. Sherman, M.D., FACP, executive vice president, chief medical officer, Horizon. “Ongoing research reinforces the significant impact TEPEZZA can have on people living with this devastating disease. We are committed to continuing our research to support a positive patient experience with this important medicine.”

About Thyroid Eye Disease (TED)

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease.1 TED often occurs in people living with Graves’ disease, but is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.6,7 This leads to a cascade of negative effects, which may cause long-term, irreversible damage. TED begins with an acute (active) phase where inflammatory signs and symptoms, such as eye pain, swelling, proptosis (eye bulging) and diplopia (double vision), progress over time.1,8 The disease then enters a chronic phase where inflammation is no longer present or has markedly diminished, but significant signs and symptoms may remain. As TED progresses, the serious damage it can cause includes proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision) – and in some cases can lead to blindness.8,9

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

References

  1. Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:249125.
  2. Cockerham, K, et al. Post-Marketing Surveillance of Hearing-related Adverse Events in Patients With TED Treated With Teprotumumab. Poster session presented at: 48th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS); 2022 Feb. 12-17; Austin, TX.
  3. Smith TJ, et al. Teprotumumab for Thyroid-Associated Ophthalmology. N Engl J Med. 2017;376:1748-1761.
  4. Douglas RS, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382:341-352.
  5. Subramanian, P, et al. Sustainability of Teprotumumab Efficacy in Thyroid Eye Disease. Paper presented at: 48th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS); 2022 Feb. 12-17; Austin, TX.
  6. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
  7. Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
  8. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves’ Orbitopathy [published online ahead of print]. Eur J Endocrinol. 2021 Jul 1:EJE-21-0479.R1. doi: 10.1530/EJE-21-0479.
  9. McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves’ Orbitopathy (EUGOGO) survey. Br J Ophthalmol. 2007;91:455-458.

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Events leading up to ex-Goldman banker’s 1MDB graft trial

Events leading up to ex-Goldman banker's 1MDB graft trial

NEW YORK, Feb 14 – Former Goldman Sachs (GS.N) banker Roger Ng is accused of bribery and money laundering charges in connection with the multibillion-dollar looting of Malaysia’s 1MDB sovereign wealth fund.

Here is a timeline of key events leading up to the trial.

April 2014 – Ng, Goldman Sachs’ managing director and head of Southeast Asia sales for fixed income, currencies and commodities, leaves the bank for unspecified reasons. Ng had helped the company win business with Malaysian state fund 1Malaysia Development Berhad (1MDB).

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July 2015 – The Wall Street Journal reports that Malaysian investigators have traced nearly $700 million from entities linked to 1MDB to bank accounts in the name of Malaysian Prime Minister Najib Razak. He denies the allegations, calling the reports “political sabotage.”

February 2016 – Tim Leissner, senior Goldman Sachs investment banker and chairman of its Southeast Asia business, leaves the bank. Leissner had helped arrange the sale of U.S. dollar bonds for 1MDB. The bank drew criticism from Malaysian politicians over the hefty amount it earned from these transactions.

July 2016 – The U.S. Department of Justice files lawsuits seeking to seize dozens of properties tied to 1MDB, saying that over $3.5 billion was misappropriated. The funds were used to purchase high-end real estate, jewelry and artwork, and finance the production of the Hollywood film “The Wolf of Wall Street,” the lawsuits allege.

July 2018 – Najib is arrested by Malaysian authorities on charges linked to the 1MDB scandal. He had led the country for nearly a decade and recently lost a bid for reelection.

November 2018 – U.S. prosecutors in Brooklyn unveil criminal charges against Leissner, Ng and Malaysian financier Low Taek Jho, alleging they conspired to launder money and bribe government officials in Malaysia and Abu Dhabi through the 1MDB bond offerings. Leissner pleads guilty to conspiracy charges and agrees to forfeit $43.7 million. Ng is detained in Malaysia.

December 2018 – Malaysia files criminal charges related to the scandal against Goldman Sachs, Leissner, Ng, Low and other individuals.Low has not been arrested by U.S. or Malaysian authorities.

May 2019 – Ng is extradited to the United States and pleads not guilty to criminal charges.

August 2019 – Malaysia files criminal charges against 17 current and former directors at subsidiaries of Goldman Sachs as a result of its 1MDB probe.

July 2020 – Najib is convicted of corruption and sentenced to 12 years in jail.

October 2020 – Goldman says it will claw back $174 million in executive compensation and pay $2.9 billion to settle with the U.S. Department of Justice and other U.S. and overseas regulators over its role in the scandal. The bank’s Malaysia subsidiary pleads guilty to conspiracy in a U.S. court.

December 2021 – A Malaysian court upholds Najib’s conviction on corruption charges over the 1MDB scandal. He says he will appeal the decision to Malaysia’s top tribunal.

Feb. 8, 2022 – Chief Judge Margo Brodie selects 12 jurors and six alternates to hear the case, which is estimated to last five to six weeks.

Feb. 14, 2022 – Opening arguments begin.

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Reporting by Jody Godoy in New York; Editing by Richard Chang

Our Standards: The Thomson Reuters Trust Principles.