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HBW Insight
By Eileen Francis 13 Nov 2019
In latest study casting doubt on the nutrients' effect on chronic illness, researchers find vitamin D and fish oil ineffective in staving off type 2 diabetics' kidney failure. Editorial also published in JAMA says further research is needed to analyze the nutrients’ possible benefits to diabetics with chronic kidney disease.
Topic Clinical trials
Pink Sheet
By Sue Sutter 13 Nov 2019
REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.
Topic Drug review FDA
HBW Insight
By David Ridley 13 Nov 2019
Following a landmark win against the German government for the Rx-to-OTC switch of desloratadine last month, Novartis has again secured a victory in the German Higher Court system, this time to continue marketing its Biosan probiotics range in the country.
Generics Bulletin
By David Wallace 13 Nov 2019
Aurobindo has taken home the awards for Company of the Year and Acquisition of the Year at the Global Generics & Biosimilars Awards 2019, held in Frankfurt, Germany. Accord also received two awards, among a host of other recognized companies.
Topic Biosimilars
Generics Bulletin
By Vibha Ravi 13 Nov 2019
Lupin plans to invest in acquisitions and organic growth in the US and India after selling Japanese subsidiary Kyowa Pharma for an enterprise value of around $525m to Japan private equity group Unison Capital. But the Indian firm stresses it is not exiting Japan and will continue to look for marketing partnerships.
Topic Deal trends Strategy
Scrip
By Alex Shimmings 13 Nov 2019
Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.
Medtech Insight
By Sue Darcey 13 Nov 2019
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.
Topic FDA Policy and regulation
Medtech Insight
By Sue Darcey 13 Nov 2019
While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.
Topic FDA Policy and regulation
Scrip
By Brian Yang 13 Nov 2019
AstraZeneca has pledged $1bn to a healthcare fund to support local innovation in China, joining big pharma peers J&J and Merck KGaA in fresh moves to embrace this market, where a new wave of digital technology transformation and fast-shifting trends now favor novel new therapies and the rise of local health start-ups.
Topic Digital Health
In Vivo
By William Looney 08 Nov 2019
Former Amgen R&D lead Sean Harper talks exclusively to In Vivo about his new role as a venture capitalist, joining veteran industry investor Beth Seidenberg as co-founder of Los Angeles-based Westlake Village BioPartners.
HBW Insight
By Malcolm Spicer 08 Nov 2019
"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.
Topic FDA Policy and regulation
HBW Insight
By Tom Gallen 08 Nov 2019
Recalling Zantac in North America over contamination concerns and tightening regulatory requirements in Europe combined to impede growth at Sanofi Consumer Healthcare in Q3. New CEO Paul Hudson says he is still taking time to get to know the business before making any strategic moves.
Topic Policy and regulation
Medtech Insight
By Catherine Longworth 08 Nov 2019
With a new CEO at its helm, Laboratory for Advanced Medicine is preparing to take on the cancer-diagnostics market. Former AncestryDNA executive Kenneth Chahine has joined the company as it plans to drive global commercialization of its artificial intelligence liquid biopsy pipeline.
Topic Cancer Company analysis
Pink Sheet
By Mandy Jackson 08 Nov 2019
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
Topic Infectious diseases
Medtech Insight
By Ferdous Al-Faruque 08 Nov 2019
Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.
Topic FDA
Medtech Insight
14 Nov 2019
Pink Sheet
14 Nov 2019
Scrip
14 Nov 2019
Scrip
14 Nov 2019
In Vivo
14 Nov 2019
Scrip
14 Nov 2019
In Vivo
14 Nov 2019
Scrip
14 Nov 2019
In Vivo
14 Nov 2019
Medtech Insight
14 Nov 2019
Pink Sheet
14 Nov 2019
Medtech Insight
14 Nov 2019
Medtech Insight
14 Nov 2019
Scrip
13 Nov 2019
Scrip
13 Nov 2019
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