More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
By Tristan Manalac Pictured: Blue sign outside FDA building/JHVEPhoto/Adobe Stock The FDA has approved Krystal Biotech’s topical gene therapy beremagene geperpavec-svdt, now to be marketed as Vyjuvek, for the treatment of the rare skin disease dystrophic epidermolysis bullosa, the company announced Friday. Vyjuvek’s label covers its use in dystrophic epidermolysis bullosa (DEB) patients aged six months and above bearing mutations in the COL7A1 gene. Friday’s approval makes Vyjuvek therapy the first-ever redosable gene therapy and the first DEB therapeutic to hit the market. “Until now, there have been no approved treatment for DEB in the United States, and patients, families and physicians were limited to palliative care,” Andy Orth, chief commercial officer at Krystal Biotech, said in an investor call Friday evening, adding that there are likely around 3,000 DEB patients in the U.S., of whom some 1,100 have confirmed diagnoses, according to claims analytics. The company expects to launch ...
Qdenga’s approval is supported by the data obtained from 19 clinical trials, and follows similar decisions in other countries. The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda’s tetravalent dengue virus vaccine, Qdenga. The vaccine, previously known as TAK-003, has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. Qdenga is purported to be the only dengue vaccine approved in Brazil for use in people without the need for pre-vaccination testing and regardless of previous exposure. ANVISA’s approval follows similar decisions by the European Commission in December, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month. The company continues to advance regulatory filings in other dengue-endemic countries in Asia and Latin America. In ...
After a strong 2017, Sanofi Pasteur got off to a less-than-stellar start this year. In China, inspectors put a temporary kibosh on imports of the pediatric shot Pentaxim, thanks to vaccine batches that failed to pass inspection. That move hobbled the shot's sales—and dragged the rest of the unit down, too.
Takeda's inflammatory bowel disease treatment Entyvio has already been delivering blockbuster-plus sales, and the Japanese drugmaker sees fertile territory for more growth in the Asia-Pacific region.
The 2018 MEDICARE TAIWAN (Taiwan International Medical & Healthcare Exhibition) and SenCARE (Taiwan International Senior Lifestyle and Health Care Show), the biggest medical and healthcare show in Taiwan, will be held from June 21 – 24, 2018, at Taipei World Trade Center Exhibition Hall 1(TWTC).
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
Global efforts to combat tuberculosis (TB) have saved an estimated 53 million lives since 2000 and reduced the TB mortality rate by 37%, according to the Global TB Report 2017, released by WHO today.
The addition of “manufacturer assessment” stipulated in the Registration Regulations for Imported Drugs in Vietnam in July this year, has created some disruptions for various medical companies.
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