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Pink Sheet

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

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.

View article
In Vivo

Brexit To And Fro Continues Into Fresh Decade

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.

Topic Business Strategies Policy and regulation

View analysis
HBW Insight

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

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.

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HBW Insight

GSK Launches OTC Fluticasone In Japan Following Switch

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.

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Generics Bulletin

Ophthalmics Are Next Frontier For Teligent

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.

View article
Medtech Insight

Execs On The Move: New Research Chief At Biovica; Convergent Dental And XACT Robotics Find Sales VPs

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

View article
Medtech Insight

Competent Authorities Drive Unilateral Eudamed Delay Decision Onto Council Of EU Agenda

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.”

View article
Scrip

Pharma Finds Its Way in AI

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.

View analysis
Scrip

More Top Level Pharma Exits In India As Cipla COO Departs

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.

View article
Scrip

Novartis Sees Reimbursement Advantage For PCSK9 Launch

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.

Topic Business Strategies Deal trends Reimbursement

View analysis
Scrip

Amid New M&A Rumors, Amarin CEO Focused On Vascepa Approval

By Andrew McConaghie 28 Nov 2019

John Thero insists company is focused on approval and launch, as interest in European rights grow.

View article
In Vivo

From US To EU: Young Biotechs Going It Alone

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.

View analysis
Pink Sheet

Former FDA Commissioner Frank Young Passes Away At 88

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.

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HBW Insight

Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

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.

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Generics Bulletin

Celltrion's Remsima SC Ready For Early 2020 Launch

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.

View article

Latest headlines

Scrip

08 Dec 2019

J&J Quickly Advances BCMA-Targeting CAR-T As JNJ-4528 Shows 100% Response

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Scrip

08 Dec 2019

Chiesi Files India Legal Action Against Cipla Over Respiratory Therapy Patent

Link
Medtech Insight

06 Dec 2019

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

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Pink Sheet

06 Dec 2019

Recent And Upcoming FDA Advisory Committee Meetings

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Scrip

06 Dec 2019

Novartis Targets Ten Indications For Cosentyx

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Scrip

06 Dec 2019

Zydus Cadila Strides Ahead With NASH Filing In India

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Scrip

06 Dec 2019

Interview: Double Delight For ImmuPharma's Dimitriou

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Scrip

06 Dec 2019

Roche Continues To Make The Case For Gantenerumab In Alzheimer’s Disease

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Pink Sheet

06 Dec 2019

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

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Pink Sheet

06 Dec 2019

Patient Voice Makes Impact In Scientific Advice From EU HTA Network

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Scrip

06 Dec 2019

Fledgling Pharma FerGene Makes Quick Debut With Gene Therapy Candidate

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Pink Sheet

06 Dec 2019

MSF Wants Faster Deployment Of Ebola Vaccine At ‘Fair’ Price

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In Vivo

06 Dec 2019

Deals Shaping The Medical Industry, December 2019

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In Vivo

06 Dec 2019

Changing China Is Opening Up For Health Care Entrants

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Pink Sheet

06 Dec 2019

Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan

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Pharma Intelligence latest insights

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

Brexit To And Fro Continues Into Fresh Decade

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

GSK Launches OTC Fluticasone In Japan Following Switch

Ophthalmics Are Next Frontier For Teligent

Execs On The Move: New Research Chief At Biovica; Convergent Dental And XACT Robotics Find Sales VPs

Competent Authorities Drive Unilateral Eudamed Delay Decision Onto Council Of EU Agenda

Pharma Finds Its Way in AI

More Top Level Pharma Exits In India As Cipla COO Departs

Novartis Sees Reimbursement Advantage For PCSK9 Launch

Amid New M&A Rumors, Amarin CEO Focused On Vascepa Approval

From US To EU: Young Biotechs Going It Alone

Former FDA Commissioner Frank Young Passes Away At 88

Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

Celltrion's Remsima SC Ready For Early 2020 Launch

Latest headlines

J&J Quickly Advances BCMA-Targeting CAR-T As JNJ-4528 Shows 100% Response

Chiesi Files India Legal Action Against Cipla Over Respiratory Therapy Patent

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Recent And Upcoming FDA Advisory Committee Meetings

Novartis Targets Ten Indications For Cosentyx

Zydus Cadila Strides Ahead With NASH Filing In India

Interview: Double Delight For ImmuPharma's Dimitriou

Roche Continues To Make The Case For Gantenerumab In Alzheimer’s Disease

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Patient Voice Makes Impact In Scientific Advice From EU HTA Network

Fledgling Pharma FerGene Makes Quick Debut With Gene Therapy Candidate

MSF Wants Faster Deployment Of Ebola Vaccine At ‘Fair’ Price

Deals Shaping The Medical Industry, December 2019

Changing China Is Opening Up For Health Care Entrants

Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan

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