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Pink Sheet
By Brenda Sandburg 06 Dec 2019
Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
In Vivo
By Ian Schofield 06 Dec 2019
Three Brexit deadlines have come and gone, and the UK is still a member of the European Union. It will remain so until it agrees a withdrawal deal or leaves without one at the end of January 2020. Alternatively, it could secure yet another extension to the Article 50 period beyond January 31. Or it could decide not to leave at all.
HBW Insight
By Malcolm Spicer 06 Dec 2019
Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.
HBW Insight
By Tom Gallen 06 Dec 2019
GSK has launched Flunase in Japan following the switch of fluticasone propionate. JSMI’s Toshi Tominaga gives his assessment of the product’s prospects as an OTC drug.
Generics Bulletin
By Aidan Fry 06 Dec 2019
US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.
Medtech Insight
06 Dec 2019
Swedish cancer diagnostics firm Biovica International announces a new R&D director; Convergent Dental, a dental equipment company, and XACT Robotics, a robotics system developer, pick sales veeps; and more.
Topic Medtech
Medtech Insight
By Amanda Maxwell 06 Dec 2019
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”
Scrip
By Leah Samuel 06 Dec 2019
Early adopters of artificial intelligence are discovering how best to use it. Some of them are sharing lessons they have learned.
Scrip
By Anju Ghangurde 06 Dec 2019
Cipla’s global chief operating officer is leaving the company to pursue new interests, amid a spate of top-level exits that have marked the pharma sector in India in 2019.
Scrip
By Jessica Merrill 28 Nov 2019
Administration under the medical benefit/Medicare Part B could mean easier reimbursement. The company outlined early plans for the launch of inclisiran after announcing it will buy The Medicines Company for $9.7bn.
Scrip
By Andrew McConaghie 28 Nov 2019
John Thero insists company is focused on approval and launch, as interest in European rights grow.
In Vivo
By Jo Shorthouse 28 Nov 2019
Europe’s patchwork of reimbursement agencies make it a daunting place for a small US biotech to do business. Traditionally large pharma partners or CMSOs have provided an experienced hand to hold, but as a new wave of gene therapies and orphan drugs get the EMA green light, smaller drug developers are applying innovation to commercialization and choosing to go solo.
Pink Sheet
By Michael Cipriano 28 Nov 2019
From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.
HBW Insight
By Ryan Nelson 28 Nov 2019
Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.
Generics Bulletin
By David Wallace 28 Nov 2019
Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.
Medtech Insight
06 Dec 2019
Pink Sheet
06 Dec 2019
Scrip
06 Dec 2019
Scrip
06 Dec 2019
Scrip
06 Dec 2019
Scrip
06 Dec 2019
Pink Sheet
06 Dec 2019
Pink Sheet
06 Dec 2019
Scrip
06 Dec 2019
Pink Sheet
06 Dec 2019
In Vivo
06 Dec 2019
In Vivo
06 Dec 2019
Pink Sheet
06 Dec 2019
Scrip
06 Dec 2019
Scrip
06 Dec 2019
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