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Scrip
By Viren Mehta 20 Jul 2018
With money pouring into biopharma in China, and regulatory reforms favoring market growth and R&D speed, western firms should watch their backs, warns Viren Mehta, founding partner of Mehta Partners LLC.
Topic Policy and regulation
Scrip
By Jo Shorthouse 20 Jul 2018
Pharma has been busy making deals this year, while the political winds of change swirl overhead, as our infographic shows. Companies both big and small have been merging to carve out therapeutic niches, return value to shareholders, and position themselves for the next wave of innovation and change.
Topic Business strategies
Scrip
By Emily Hayes 18 Jul 2018
The Japanese pharma says it will discuss the data with US FDA, with hopes of potential to incorporate secondary endpoint data in labeling.
Topic Obesity Clinical trials
Scrip
By Jessica Merrill 18 Jul 2018
J&J told investors to anticipate negative net drug pricing of 4%-6% across its portfolio in 2018, following a 4.6% negative impact in 2017. CEO Alex Gorsky also cautioned against changing drug pricing policy too quickly.
Topic Policy and regulation
Medtech Insight
By Elizabeth Orr 17 Jul 2018
Major medical device companies paid almost $1bn in consulting fees, royalties, research costs and other expenses to physicians in 2017, the most recent data release from the US Open Payments database shows. Zimmer Biomet reported the highest spending on general physician payments, while Roche and Medtronic topped the list of research spending.
Topic Clinical trials
Medtech Insight
By Shawn M. Schmitt 17 Jul 2018
Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.
Topic Business strategies
Pink Sheet
By Cathy Kelly 16 Jul 2018
Companies should introduce same drug under new NDC at lower list price to overcome difficulties of reducing list prices on existing brands, PBM says.
Topic Policy and regulation
Pink Sheet
By Francesca Bruce 16 Jul 2018
The UK government has finally published its white paper on the UK’s future relationship with the EU following Brexit, to the relief of the pharmaceutical industry.
Topic Brexit
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
Pink Sheet
20 Jul 2018
Medtech Insight
20 Jul 2018
Pink Sheet
20 Jul 2018
Scrip
20 Jul 2018
Scrip
20 Jul 2018
Scrip
20 Jul 2018
Scrip
20 Jul 2018
Medtech Insight
20 Jul 2018
Medtech Insight
20 Jul 2018
Scrip
20 Jul 2018
Scrip
20 Jul 2018
Medtech Insight
20 Jul 2018
Medtech Insight
20 Jul 2018
Pink Sheet
20 Jul 2018
Scrip
20 Jul 2018
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23 Sep 2018
USA
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Spain
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28 Nov 2018
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