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FDA Approves Humira Biosimilar Cyltezo for Ulcerative Colitis, Crohn’s Disease, Other Illnesses – IBD News Today

Posted: Published on August 30th, 2017

The U.S. Food and Drug Administration(FDA) has approved Boehringer IngelheimsCyltezo a biosimilar of Abbvies Humira (adalimumab) to treat Crohns disease,ulcerative colitis and a host of other diseases ranging from rheumatoid arthritis toankylosing spondylitis. Cyltezo is the German companys first FDA-approved biosimilar and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients, Ivan Blanarik, senior vice-president and head of Boehringer Ingelheims therapeutic area biosimilars, said in a press release. The FDAs Aug. 29 decision is thesecond biosimilar of Humira after the approval of AmgensAmjevitain September 2016. Another biosimilar of Humira, Imraldiby Samsung Bioepis, won approval by the European Medicines Agency (EMA) on Aug. 24. The FDA granted its approval based on pharmacological, non-clinical and clinical data showing that Cyltezo is a biosimilar of Humira. The EMA is also expected to provide an opinion this year. A biosimilar is a drug that is shown to be highly similar to another existing biological drug, according to the FDA. It should have no clinically meaningful differences in terms of safety and effectiveness from the reference product. It is usually manufactured by a concurrent company after the patent for the original product has expired. … Continue reading

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European Commission Approves Biosimilar Imraldi for Crohn’s Disease and Ulcerative Colitis – IBD News Today

Posted: Published on August 30th, 2017

The European Commission has approved Imraldi, an adalimumab biosimilar referencing AbbVies Humiramaking the medication available to treat the same therapeutic indications as Humira, including Crohns disease, pediatric Crohns disease and ulcerative colitis. The Aug. 24 decision followed a positive recommendation by the European Medicines Agencys Committee for Medicinal Products for Human Use, released in June. Todays decision marks another positive step in transforming the lives of people with chronic autoimmune conditions, Jean-Paul Kress, Biogens executive vice-president and head of global therapeutic operations, said in a press release. As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics. Imraldi was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics. It is Biogens tgurd anti-TNF biosimilar medicine to receive European marketing approval following Benepali, an etanercept biosimilar referencing Enbrel,and Flixabi, an infliximab biosimilar referencing Remicade. The approvalwas supported by strong preclinical and clinical data demonstrating Imraldis safety and efficacy profiles. Clinical data included results from a Phase 1 trial (NCT02144714) in healthy volunteers, and a Phase 3 study (NCT02167139) in rheumatoid arthritis patients that compared Imraldi with Humira. That Phase 3 trial of544 patients with moderate-to-severe … Continue reading

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M v F & SM (Human Fertilisation and Embryology Act 2008) [2017] EWHC 2176 (Fam) (23 August 2017) – Family Law Week

Posted: Published on August 29th, 2017

Home > Judgments Case summary coming soon Neutral Citation Number: [2017] EWHC 2176 (Fam)Case No: LE17P00251IN THE HIGH COURT OF JUSTICEFAMILY DIVISIONBirmingham Civil Justice CentreB4 6DS Date: 23/08/2017 Before : MR. JUSTICE KEEHAN- - - - - - - - - - - - - - - - - - - - -Between : M Applicant- and - F 1st RespondentSM2nd Respondent- and -A (BY HIS GUARDIAN)3rd Respondent - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - Andrew Powell (instructed by JMW Solicitors LLP) for the The ApplicantThe 1st Respondent did not attend and was not representedKatherine Duncan (instructed by Mills & Reeve) for the The 2nd RespondentMartin Kingerley (instructed by CAFCASS) for the The 3rd Respondent Hearing dates: 4th July 2017- - - - - - - - - - - - - - - - - - - - -Judgment Approved MR. JUSTICE KEEHAN This judgment was delivered in private. The judge has given leave for this version of the judgment to be published on condition … Continue reading

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Rise in MTP Rates – Financial Tribune

Posted: Published on August 29th, 2017

According to data released by the Health Ministry, last year (ended in March), 12,281 women put in applications for the medical termination of their pregnancies. The figure was 23.4% higher compared to the preceding year.Permission was granted to 8,537 applicants, which indicates that the number of permits increased by 19.8% compared to the preceding year, said Ahmad Shojaee, head of the Legal Medicine Organization, ILNA reported.Provinces with the highest number of medical abortions were Tehran (1,145), Khorasan Razavi (966), Khuzestan (911), Fars (606), Isfahan (516), Kerman (330), and Alborz (320).Termination of pregnancy is legal in Iran unless the woman can prove that giving birth would pose a health risk to herself or her baby.Verified genetic testing, ultrasound, written consent of mother, gestational period of less than 19 weeks of the fetus, besides approval by three medical specialists is mandatory for therapeutic abortion, Shojaee said.The reason for the increase can be attributed to the peoples raised awareness of genetic counseling. Counseling and genetic tests are the most effective ways of preventing congenital defects in new born babies. Unsafe AbortionsAccording to the World Health Organization (WHO) induced abortion rate declined significantly in the developed world between 1990 and 2014, but not in … Continue reading

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Man wins right to be a single dad through surrogacy – Metro

Posted: Published on August 29th, 2017

The man argued that laws around surrogacy arrangements discriminated against single people (Picture: Getty) A man has won the right to be a single dad through surrogacy. The single man who fathered a child via a surrogate mother had last year arguedthat laws around surrogacy arrangements discriminated against single people. He claimed the wording of part of the 2008 Fertilisation and Embryology Act meant only a couple could apply to become a childs legal parents. Sir James Munby, the most senior family court judge in England and Wales, agreed with him. The judge, President of the Family Division of the High Court, made a declaration of incompatibility after analysing the case at a hearing on London. Following this, another judge has said ministers are now actively considering a change to address the incompatibility. Mr Justice Keehan, who is also based in the Family Division of the High Court, has outlined Government plans in a ruling on a similar case. He said in the hearing in Birmingham a single woman wanted to become a childs legal parent following an arrangement with a surrogate mother. The judge said the woman had been in a relationship with a man when the surrogacy arrangement … Continue reading

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Americans OK with Genetic Modification for Health Care, but Not … – Hoosier Ag Today

Posted: Published on August 29th, 2017

More than three-quarters of Americans would accept release of genetically modified mosquitoes to decrease risk of the Zika virus, but fewer than half accept genetic modification (GM) of animals, grain crops and produce, according to a Purdue University study. Nicole Olynk Widmar, associate professor of agricultural economics, and Wally Tyner, the James and Lois Ackerman Professor of Agricultural Economics, led the study to understand attitudes toward genetic engineering in the wake of last years heightened coverage of the Zika virus. The results suggest people are far more accepting of genetic modifications that benefit human health but are still somewhat wary of modifications to food. Whenever you have a newly perceived health risk, there are calls for technology to solve the problem. If you think about the Ebola virus, everybody said, Wheres an Ebola vaccine? They wanted technology to mitigate the risk, Widmar said. Food is an everyday choice. In some ways, I can understand why people may be more cautious about what theyre ingesting on an ongoing basis.Data also show that acceptance of genetic modification may be related to sex, education, income and awareness of GM technology. Zika, a virus spread primarily through mosquito bites, can cause severe birth defects … Continue reading

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Prime Minister Justin Trudeau says he’s excited about having two ministers teaming up on the Indigenous Affairs … – TheChronicleHerald.ca

Posted: Published on August 29th, 2017

TheChronicleHerald.ca Prime Minister Justin Trudeau says he's excited about having two ministers teaming up on the Indigenous Affairs ... TheChronicleHerald.ca Canadian golfer Brooke Henderson finished tied for 12th at the CP Women's Open in Ottawa on Sunday. The 19-year-old from Smiths Falls, ... Jadine Baldwin says some people don't see her as a person due to her cerebral palsy. Baldwin and another teen, ... and more » Read the rest here: Prime Minister Justin Trudeau says he's excited about having two ministers teaming up on the Indigenous Affairs ... - TheChronicleHerald.ca … Continue reading

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FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments – NPR

Posted: Published on August 29th, 2017

Adult stem cells can be extracted from human fat. Patrick T. Fallon /The Washington Post/Getty Images hide caption Adult stem cells can be extracted from human fat. The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells. Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency. "There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements." The clinic is one of many around the country that claim to use stem cells derived from a … Continue reading

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ICMR’s stem cell research guidelines soon to be released – ETHealthworld.com

Posted: Published on August 29th, 2017

Representative imageBy Priyanka V Gupta New Delhi: Indian Council of Medical Research (ICMR) will soon release the final document on guidelines for stem cell research, the draft of which was available on the ICMR and the DBT (Department of Biotechnology) websites for public reviews till July 31 this year. The guidelines are expected to help in curbing the unethical practices in regenerative medicine. The information was shared by Dr Geeta Jotwani, deputy director general, ICMR, at a recent event where MoU was signed between ABLE (Association of Biotechnology Led Enterprise) and FIRM (Forum for Innovative Regenerative Medicine) for industry research collaborations. Dr Jotwani said, On the directives of DCGI (Drug Controller General of India), ICMR has been framing the guidelines for stem cell research and therapy since 2001. Unfortunately, there is no therapy available other than bone marrow transplantation, for which also no standard of care has been laid out. In that direction, we have been making periodic efforts by releasing the guideline documents in 2002, 2007, 2013 and now the updated documentation for 2017 is under finalization. ICMR has been proactively working towards educating the stakeholders about the ethical practices in stem cell research and therapy, for which a … Continue reading

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Bone Marrow Protein May Be Target for Improving Stem Cell Transplants – Penn: Office of University Communications

Posted: Published on August 29th, 2017

Bone marrow contains hematopoetic stem cells, the precursors to every blood cell type. These cells spring into action following bone marrow transplants, bone marrow injury and during systemic infection, creating new blood cells, including immune cells, in a process known as hematopoiesis. A new study led by University of Pennsylvania and Technical University of Dresden scientists has identified an important regulator of this process, a protein called Del-1. Targeting it, the researchers noted, could be an effective way to improve stem cell transplants for both donors and recipients. There may also be ways to modulate levels of Del-1 in patients with certain blood cancers to enhance immune cell production. The findings are reported this week in The Journal of Clinical Investigation. Because the hematopoetic stem cell niche is so important for the creation of bone marrow and blood cells and because Del-1 is a soluble protein and is easily manipulated, one can see that it could be a target in many potential applications, said George Hajishengallis, the Thomas W. Evans Centennial Professor in the Department of Microbiology in Penns School of Dental Medicine and a senior author on the work. I think that Del-1 represents a major regulator of the … Continue reading

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