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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
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
Medtech Insight
By Amanda Maxwell 10 Jan 2019
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
Topic Brexit
Scrip
By Eleanor Malone 10 Jan 2019
Scrip journalists asked industry executives, consultants and analysts what they believe the big themes, trends and events will be in 2019. Here's what they told us about advances in therapeutic technologies and areas of clinical innovation.
Scrip
By Jessica Merrill 10 Jan 2019
News and notes from the 2019 J.P. Morgan Healthcare Conference. Pfizer CEO Bourla underscores need for scientific and commercial innovation, Gilead makes M&A a priority, Novartis' new R&D chief reflects on first meeting with CEO Narasimhan, Sarepta CEO Ingram clarifies regulatory path for micro-dystrophin, J.P. Morgan outlines deal and macro biopharma trends in 2019, and cell therapy panel discusses manufacturing challenges.
Pink Sheet
By Ian Schofield 10 Jan 2019
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Topic Drug approval Drug review
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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