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FDA approves Roche's Hemlibra for haemophilia A without factor VIII inhibitors - GlobeNewswire (press release)

  • First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient comparison
  • Only medicine that can be self-administered subcutaneously once weekly, every two weeks or every four weeks for haemophilia A with and without factor VIII inhibitors
  • The efficacy and safety of Hemlibra has been demonstrated in one of the largest pivotal clinical trial programmes in haemophilia A

Basel, 4 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with haemophilia A with and without factor VIII inhibitors that can be administered subcutaneously (under the skin) and at multiple dosing options (once weekly, every two weeks or every four weeks). This approval is based on positive results from the phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis (primary endpoint) and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study.

"Many preventative treatment options for people with haemophilia A without factor VIII inhibitors require intravenous infusions several times a week. Even then, people can still experience bleeds, and there has been a need for more treatment options," said Michael Callaghan, MD, haematologist, Children's Hospital of Michigan, Detroit. "The approval of Hemlibra is an important advancement for the entire haemophilia A community, as we now have a new class of medicine for the first time in nearly 20 years. Hemlibra can reduce bleeds, and it offers a new subcutaneous administration once weekly, every two weeks or every four weeks."

"Today's approval of Hemlibra reflects our commitment to groundbreaking science and the development of medicines with the potential to redefine the standard of care," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Hemlibra is now the only FDA-approved medicine for people with haemophilia A with and without factor VIII inhibitors, based on the efficacy and safety profile demonstrated across four pivotal studies. We want to thank the haemophilia community for their partnership in helping us bring this new option to everyone living with haemophilia A."

In the phase III HAVEN 3 study, adults and adolescents aged 12 years or older with haemophilia A without factor VIII inhibitors who received Hemlibra prophylaxis once weekly (n=36) or every two weeks (n=35) experienced a 96% (95% CI: 92.5; 98.0, p<0.0001) and 97% (95% CI: 93.4; 98.3, p<0.0001) reduction in treated bleeds, respectively, compared to those who received no prophylaxis (n=18). Hemlibra is the first medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, which has been the recommended standard of care, as demonstrated by a statistically significant reduction of 68% (95% CI: 48.6; 80.5, p<0.0001) in treated bleeds in a prospective intra-patient comparison (n=48) of people who previously received factor VIII prophylaxis in a non-interventional study and switched to Hemlibra prophylaxis. In the single-arm phase III HAVEN 4 study of adults and adolescents aged 12 years or older with haemophilia A with factor VIII inhibitors (n=5) and without factor VIII inhibitors (n=36), Hemlibra prophylaxis every four weeks (n=41) led to clinically meaningful control of bleeding. The most common adverse reactions occurring in 10% or more of people treated with...

Source: globenewswire.com

Speedo took inspiration from humpback whales when creating Nemesis Fins - Geek

Speedo’s new Nemesis Fins don’t look like the traditional webbed flippers divers have been using for decades. Instead, they’re sort of lumpy and rounded — what’s up with that? Speedo looked to Humpback Whales, the graceful giants of the sea , for inspiration when designing the new Nemesis Fins. Apparently, humpback whales can really move when they want to.

The Nemesis Fins are made from buoyant EVA foam instead of rubber, and aren’t just designed to increase your kicking power. The shape is actually intended to give your body a nudge into a more efficient swimming positions, which should make you go faster. That’s not to say you won’t get more of a boost from each kick, though. The channels and square holes along the surface of the flippers increase the amount of water you displace with each kick. Speedo isn’t talking about the specifics of how that happens just yet.

Source: www.geek.com

Two mahouts killed due to elephant's liquor aversion in Karnataka? - The New Indian Express

MADIKERI: A young male elephant in Kodagu’s Dubare camp that killed two mahouts in quick succession was found to be allergic to alcohol. And this, forest department sources say, may have provoked seven-year-old Karthik to trample the two mahouts, who were in an inebriated state. While one mahout Annu was killed on April 17, the other trainer Mani was killed on Thursday.


Though there have been instances of elephants known to be attracted to liquor and going on a rampage, this case has confounded the department. It has also prompted the officials to cage Karthik again and make him undergo a second round of domestication.


“Domesticated elephants rarely kill human beings without provocation, but this elephant has killed two of its mahouts. We are not taking any chances as thousands of tourists visit Dubare elephant camp daily,” officials said. Karthik is the offspring of Vijaya (40), who was captured in Kattepura reserve forest in 1998. Vijaya, a Dasara elephant, was known to be gentle.


The Dubare camp has around 30 jumbos and trains Dasara elephants too. According to wildlife experts, elephants show aggressive behaviour only when they are in musth (characterised by a large rise in reproductive hormones).


DCF Surya Sen said, “We have decided to cage Karthik for three months and it will be treated like a newly caught wild elephant.”

Elephant expert and professor at the Centre for Ecological Sciences, IISc, Raman Sukumar, said it is difficult to explain why the elephant attacked the mahouts. “It is possible that the mahouts, allegedly under the influence of alcohol, may have illtreated the elephant. It is also true that elephants are attracted to the smell of alcohol. In Chhattisgarh a herd had attacked a village where they brew liquor and in Assam another herd had smashed the liquor storage in the army barracks,” he said, adding that it is safer to have mahouts who are sober and professionally trained.


DCF Surya Sen told Express that the staff were alerted about Karthik’s behaviour, but mahouts ignored it. He added that a deaddiction camp will be organised for workers in Dubare. Kodagu circle CCF Manoj Kumar also revealed that they plan to send mahouts to Indonesia for specialised training and this will be a maiden initiative by the state.

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Source: www.newindianexpress.com









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