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HBW Insight
By Tom Gallen 23 Jan 2019
Vegans and vegetarians looking to supplement their diet with calcium and iron helped boost overall sales of VMS products in the UK in 2018, according to data from Mintel. Total VMS sales reached £442m in 2018, with the market forecast to grow by 8% over the next five years.
Medtech Insight
By Elizabeth Orr 23 Jan 2019
Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.
Topic FDA
Medtech Insight
By Amanda Maxwell 23 Jan 2019
There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?
Topic Medtech
HBW Insight
By Eileen Francis 23 Jan 2019
Amazon’s Solimo supplement and Basic Care OTC lines unlikely to expand much, says Jefferies analyst Brian Tanquilut. Still, brands are well positioned against retail private label competitors, as most products are priced lower than similar products by Walgreens and CVS.
Topic Drug review
Pink Sheet
By Ian Schofield 23 Jan 2019
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
Scrip
By Brian Yang 23 Jan 2019
As a promising market for orphan drugs, China has seen several approvals in this space in the past six months, mostly from multinationals. But Beijing-based CANbridge believes that a smaller biotech also has a good shot at a leadership role, despite a lack of funding and reimbursement and prickly pricing issues.
Scrip
By Jessica Merrill 23 Jan 2019
CEO Alex Gorsky highlighted growing public concern over US drug costs during J&J's Q4 earnings call, pressing for more transparency and value-based health care. The company's net drug prices declined more than 6% in 2018, he added.
Medtech Insight
16 Jan 2019
There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.
Topic Medtech
Pink Sheet
By Michael Cipriano 16 Jan 2019
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
Topic FDA
Medtech Insight
By David Filmore 16 Jan 2019
US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.
Topic FDA
Scrip
By Jung Won Shin 16 Jan 2019
2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.
Topic FDA Business strategies
Scrip
By Jessica Merrill 16 Jan 2019
Annual payment plans for gene therapies appear closer to becoming reality now that bluebird bio detailed plans at J.P. Morgan. Novartis, Sarepta and others are also talking to payers about alternative payment models. Harvard Pilgrim's Michael Sherman applauded the effort in an interview.
In Vivo
By Alex Chiang + Adrian Watson 15 Jan 2019
What are the top 10 most common drug forecasting errors, and how can these be avoided? Life sciences consulting firm, Trinity Partners, explores the ins and outs of forecasting.
Topic Drug approval Drug review
Datamonitor Healthcare
By Louisa Joseph 10 Jan 2019
The three urological cancers are undergoing tremendous changes in treatment practices as a result of new product launches and indication expansions.
Topic Cancer
In Vivo
By William Looney 10 Jan 2019
The clinical trial embodies the hope and the hassle of biopharma’s mission to develop new drugs for patients. It is an endlessly imperfect process: C-suite calls for more efficiency and speed at lower cost has been the story for decades. But an In Vivo conversation with a leading expert on trial management pinpoints three key trends that suggest better days are ahead for this central pillar of the innovation imperative.
Topic Clinical trials
Scrip
23 Jan 2019
Scrip
23 Jan 2019
Scrip
22 Jan 2019
Pink Sheet
22 Jan 2019
Medtech Insight
22 Jan 2019
Scrip
22 Jan 2019
Scrip
22 Jan 2019
Pink Sheet
22 Jan 2019
Medtech Insight
22 Jan 2019
Scrip
22 Jan 2019
Scrip
22 Jan 2019
Medtech Insight
22 Jan 2019
Pink Sheet
22 Jan 2019
Pink Sheet
22 Jan 2019
Pink Sheet
22 Jan 2019
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