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Pharmaprojects
13 Jul 2018
The discovery and deep investigation of the microbiome has been one of the most significant recent biomedical advances. Extensive research suggests that dysbiosis of the gut microbiome plays a significant role in multiple gastrointestinal (GI) disorders such as; Crohn’s disease, ulcerative colitis, and irritable bowel syndrome (IBS).
Pharmaprojects
13 Jul 2018
Welcome to Pharmaprojects’ roundup of key trends in pharmaceutical R&D in 2018, focusing on five key takeaways from our full annual report
Scrip
By Jung Won Shin 13 Jul 2018
South Korean financial authorities conclude Samsung BioLogics violated accounting standards by omitting certain information on its joint venture agreement with Biogen from public disclosures, and have ordered further investigation of a corporate governance decision on the handling in accounts of the JV, Samsung Bioepis. The latest ruling in the prolonged affair could hurt the credibility and business of Samsung BioLogics going forward, although the firm maintains it has done nothing improper.
Topic Policy and regulation
Scrip
By Jessica Merrill 13 Jul 2018
Mylan has priced its biosimilar version of pegfilgrastim at a 33% discount to Amgen's WAC for Neulasta, steeper than the 15% discount Pfizer initially offered for Inflectra. The commercial outcome for Fulphila could set the tone for future US biosimilars, which have yet to take off.
In Vivo
By William Looney 12 Jul 2018
Strong foundational research in immunology and some promising early phase trial results have so far failed to expedite the validation of vaccines to treat cancer. In Vivo examines biopharma’s enduring optimism about the future of cancer vaccinology, including a closer look at one company’s platform to tackle the incurable malignancies that beset the mother of all organs: the human brain.
Rose Sheet
By Lauren Nardella 12 Jul 2018
As in the case of plastic microbeads some four years ago, the personal-care industry finds itself in the position of having to reformulate potentially on a mass scale due to environmental rather than human safety concerns. And once again the legislation was driven in large part by shoddy science, industry says.
Topic Policy and regulation
Rose Sheet
By Ryan Nelson 12 Jul 2018
EU sources update Rose Sheet on contentious initiatives to cement the Commission’s pathway for banning carcinogenic, mutagenic or reprotoxic substances in cosmetics and to promote fragrance allergen awareness and risk management.
Topic Policy and regulation
Scrip
By Brian Yang 11 Jul 2018
Bagging a $200m box office in its opening week in China, "Dying to Survive" is a sentimental movie about a Chinese businessman selling cancer drugs smuggled from India but unapproved in China that sees his life taking a drastic turn, from convicted felon to a Robin Hood-like hero as he helps those in need. The Chinese film authority’s clearance for the screening of the movie and the smash success signal three key messages about the future potential direction of oncology drugs in the country.
Topic Cancer
Scrip
By Jessica Merrill 11 Jul 2018
After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.
Topic Policy and regulation
Medtech Insight
By Shawn M. Schmitt 10 Jul 2018
Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.
Topic Company analysis Strategy
Medtech Insight
By Sue Darcey 10 Jul 2018
Although the 25% tariffs initiated July 6 by the US Trade Representative will impact about $836m worth of medical technology entering the US from China, the administration late last week offered a process for gaining exclusions for specific products. AdvaMed members are “looking into” the process, the group said, and Medical Imaging and Technology Alliance members have already started to try to use it.
In Vivo
By Lucie Ellis 06 Jul 2018
Lars Rebien Sørensen scrutinizes the pharmaceutical industry and shares with In Vivo his vision for the future of the Novo Nordisk Foundation. With 16 years as CEO of Novo Nordisk under his belt, as well as many more years in leadership roles at the Danish company, Sørensen reflects on the past and gives his predictions for the future of the innovative drug development sector.
Pink Sheet
By Cathy Kelly 06 Jul 2018
Regulations allow manufacturers to request that drug production and marketing costs and price contracting information provided to the state be kept confidential.
Topic Drug approval
Pink Sheet
By Ian Schofield 06 Jul 2018
A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.
Medtech Insight
By Amanda Maxwell 06 Jul 2018
UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?
Scrip
13 Jul 2018
Pink Sheet
13 Jul 2018
Pink Sheet
13 Jul 2018
Medtech Insight
13 Jul 2018
Scrip
13 Jul 2018
Pink Sheet
13 Jul 2018
Pink Sheet
13 Jul 2018
Scrip
13 Jul 2018
Scrip
13 Jul 2018
Scrip
13 Jul 2018
Medtech Insight
13 Jul 2018
Medtech Insight
13 Jul 2018
Scrip
13 Jul 2018
Medtech Insight
13 Jul 2018
Medtech Insight
13 Jul 2018
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