Michael Cipriano (@mcipriano93) / Twitter

No. Just no.

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Feb 10, 2020

nypost.com/2020/02/10/mlb EXCLUSIVE: MLB is planning a radical change to their postseason perhaps by 2022, hoping to move from 5 to 7 teams in each league and -- get this -- have the teams with the best records pick their playoff opponents.

Michael Cipriano Retweeted

Evan Roberts

@EvanRobertsWFAN

Feb 3, 2020

Congrats to the Chiefs...but I’m getting sick of congratulating other teams breaking long Championship droughts

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Michael Cipriano

@mcipriano93

Jan 30, 2020

US FDA's Yim Hopes To See European-Like Robustness For US Biosimilars Market In 10 Years pink.pharmaintelligence.informa.com/articles/2020/

Michael Cipriano Retweeted

In

's latest Drug Review Profile, we take a deep dive into

@US_FDA

review documents for $SRPT's Vyondys pink.pharmaintelligence.informa.com/articles/2020/

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Fantastic read from

on the controversial $SRPT approvals: pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 16, 2020

GIF

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Ken Rosenthal

@Ken_Rosenthal

Jan 16, 2020

Beltran stepping down as #Mets manager, sources tell The Athletic.

Michael Cipriano

@mcipriano93

Jan 16, 2020

If you are so concerned about cheating, you should throw back every home run your steroid-using teammates hit.

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New York Post

@nypost

Jan 15, 2020

Mark Teixeira: Mets must fire Carlos Beltran after cheating scandal trib.al/B8pX01R

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Michael Cipriano Retweeted

's superb piece includes Richard Padzur's response to NYT/WSJ criticisms of FDA with historical details and '90s headlines pink.pharmaintelligence.informa.com/PS141499/US-FD

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Michael Cipriano Retweeted

's Judy Staffa - Purdue has submitted all of its required postmarketing studies for OxyContin and they are under review, to be followed by a public discussion on the data

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Michael Cipriano

@mcipriano93

Jan 15, 2020

My story on the meeting:

pink.pharmaintelligence.informa.com

Nektar's Novel Opioid Unanimously Rejected by US FDA Advisory Cmte.

But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year...

Many of the panelists saw a potential regulatory path forward, although $NKTR notes in its release that "will afford Nektar cost savings of between $75 million to $125 million in 2020."

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ICYMI: $NKTR announced it is pulling its oxycodegol NDA hours after a

@US_FDA

advisory committee unanimously voted against approval.

ir.nektar.com

Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol | Nektar Therapeutics

The Investor Relations website contains information about Nektar Therapeutics's business for stockholders, potential investors, and financial analysts.

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Michael Cipriano Retweeted

Michael McCaughan

@RPMReportMike

Jan 15, 2020

The good news is that no one can do WORSE than Nektar. 27-0 "no" sets a high bar...

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Sue Sutter

@PinkSheetSutter

Jan 15, 2020

Taking on odds on whether opioid-containing products go 0-for-3 at @US_FDA Adcomm this week... twitter.com/RPMReportMike/…

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Michael Cipriano

@mcipriano93

Jan 14, 2020

It's a unanimous NO Do you recommend approval of $NKTR's #oxycodegol? A) Yes, for the management of chronic low back pain in adults - 0 B) Yes, for a general extended-release/long-acting opioid analgesic chronic pain indication - 0 C) No - 27

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Michael Cipriano

@mcipriano93

Jan 14, 2020

Vote on $NKTR's oxycodegol coming up momentarily...

Michael Cipriano

@mcipriano93

Jan 14, 2020

Panel overwhelmingly disagrees with $NKTR conducting only a single efficacy trial for oxycodegol.

Michael Cipriano

@mcipriano93

Jan 14, 2020

And finally ... We are on to the discussion questions. There are four discussion questions on the agenda, followed by a voting question.

Michael Cipriano

@mcipriano93

Jan 14, 2020

$NKTR speaker: I agree with FDA that oxycodone is a metabolite of oxycodegol, but I don't think it's accurate to equate it with oxycodone because it doesn't account for oxycodegol's slow rate of onset. FDAer notes that agency puts more weight on drug liking, take drug again.

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Michael Cipriano

@mcipriano93

Jan 14, 2020

It's 3:00, and the panel is back to asking clarifying questions to $NKTR. Yeah, we're going to be here for a while.

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Michael Cipriano

@mcipriano93

Jan 14, 2020

Open public hearing concludes after 12 speakers. Most support approval of $NKTR's oxycodegol, though a few speakers oppose, including

and

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's James Tolliver: Human abuse potential study shows $NKTR's oxycodegol has an abuse potential similar to that of oxycodone via the oral route of administration.

.

's Joshua Lloyd: $NKTR maintains oxycodegol has lower abuse potential than other opioids, particularly in therapeutic dose range. Only viewing abuse liability through lens of therapeutic range is arbitrary and flawed. Similar abuse potential to other Schedule II opioids.

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presentations starting now - 45 minutes behind schedule. Panel still has more clarifying questions for $NKTR.

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Michael Cipriano Retweeted

SAC Tracker

@FDAadcomm

Jan 14, 2020

Note: The Guest Speaker on the draft agenda for today's #oxycodegol adcomm didn't make the final agenda. U Penn's Dr. John Farrar was initially slated for a talk entitled, "A 12 Month Assessment of Continued Opioid Efficacy and Safety in Chronic Non-cancer Pain Patients." $NKTR

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It's going to be a long time before we get to discussion. Ad comm still has at least a dozen clarifying questions for the sponsor $NKTR. We are more than 40 minutes into clarifying questions so far.

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Michael Cipriano

@mcipriano93

Jan 14, 2020

This is the first product-specific ad comm for an opioid analgesic since November 2018.

@US_FDA

postponed all such meetings in 2019 as it reassessed its risk/benefit framework for opioids.

pink.pharmaintelligence.informa.com

Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion

Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.

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Packed advisory panel here today at

@US_FDA

, which will evaluate $NKTR's novel opioid NKTR-181 (oxycodegol). I'm counting 27 voting members between the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

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Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 9, 2020

CRLs In 2019: Steady In Number, But Biosimilar Performance Improves pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 8, 2020

US FDA's Stein To Sponsors: New Leadership From OND Reorganization Won't Change Your Development Plans pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano Retweeted

Sue Sutter

@PinkSheetSutter

Jan 7, 2020

Hertz and former review division associate director Ellen Fields recently left the agency to set up their own consulting firm focused on analgesic drug development

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Sue Sutter

@PinkSheetSutter

Jan 7, 2020

In today's @PharmaPinkSheet, @RPMReportMike previews the four pain drugs heading to @US_FDA AdComm next week under the analgesic review division's new leadership following retirement of agency veteran Sharon Hertz pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 7, 2020

CDER Reviewers Showcase Speed In 2019 With 11 Novel Drugs Approved Within Six Months pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 6, 2020

Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019 pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Jan 2, 2020

Our quick take on the 2019 novel drug approval numbers. We'll have deeper dives in the coming days. pink.pharmaintelligence.informa.com/articles/2020/

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Michael Cipriano

@mcipriano93

Dec 20, 2019

With the approval of $DSKYF's Enhertu (fam-trastuzumab deruxtecan-nxki), the

@US_FDA

has now approved 11 novel drugs in 2019 following a review time of 6 months or less (review time = date of application submission ➔ time of approval).

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Great story from

on The

Effect. pink.pharmaintelligence.informa.com/articles/2019/

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Michael Cipriano Retweeted

taps Sarah Yim for permanent director of Office of Therapeutic Biologics and Biosimilars, a position she has held on an acting basis since March following Leah Christl's departure for $AMGN

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Michael Cipriano Retweeted

Derrick

@dgingery

Dec 19, 2019

New #FDA commish Stephen Hahn is introducing himself to the twitterverse...

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Dr. Stephen M. Hahn

@SteveFDA

Dec 19, 2019

I am eager to begin working with the staff at the FDA, who bring incredible expertise and a deep commitment to agency’s mission. I look forward to learning and working alongside the many experts at FDA to fulfill our important work.

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