Pink Sheet, Citeline Regulatory @PharmaPinkSheet
Pink Sheet delivers analysis & commentary focused on regulatory implications, including high value perspectives from insiders & thought leaders across the globe pink.pharmamedtechbi.com Global Joined December 2012-
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AstraZeneca’s Farxiga Authorized Generic Aims To Broaden Access As Medicare Price Cut Looms bit.ly/3WnqGyI #PinkSheet
US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes? bit.ly/4aXjvRZ #PinkSheet
It’s Official: FDA Drops Final Rule On LDTs bit.ly/44Cri5H #PinkSheet
MHRA Needs ‘Rebuilding’ After Post-Brexit Loss Of Capacity And Industry Investment bit.ly/4a4gzBU #PinkSheet
EU And South Korea Sign Deal On Exchange Of Confidential Information bit.ly/3Qtx7fF #PinkSheet
EU CHMP Opinions And MAA Updates bit.ly/44jlYE0 #PinkSheet
MHRA Needs ‘Rebuilding’ After Post-Brexit Loss Of Capacity & Industry Investment bit.ly/3UGGXgY #PinkSheet
EU & South Korea Sign Deal On Exchange Of Confidential Information bit.ly/4bdMBwn #PinkSheet
Recent And Upcoming FDA Advisory Committee Meetings bit.ly/3UirNNi #PinkSheet
Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity bit.ly/44fGPIn #PinkSheet
Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy bit.ly/3Wbn4j8 #PinkSheet
Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List bit.ly/4a3QEdO #PinkSheet
Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics bit.ly/3QlsYuq #PinkSheet
Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod bit.ly/3Qn1X9H #PinkSheet
AI Used In Drug R&D Likely Exempt From Tough EU AI Rules, Says EFPIA bit.ly/4bdf8Su #PinkSheet
EU Parliament OKs New Rules On Use Of Patient Data In Research bit.ly/3WhoPv9 #PinkSheet
Danes Advise Pharma Firms To Test Their Anti-Tamper Devices bit.ly/44hiTnS #PinkSheet
Joint Clinical Assessments: EU Guidance On Evidence May Be Flexible For ATMPs And Single Arm Trials bit.ly/3UAo8fh #PinkSheet
Cancer Trials: FDA Wants Lower Performance Status Eligibility But Primary Analysis Exclusion OK bit.ly/3xQ3PkR #PinkSheet
US FDA's Califf Defends Agency Work On Marijuana Rescheduling, Animal Testing bit.ly/3Wb3CmB #PinkSheet
Sarah Karlin-Smith @SarahKarlin
17K Followers 3K Following Covering intersection of pharma, policy & politics for @pharmapinksheet. @smpagwu adjunct Past @politico. Inflexible Yogi, Volunteer Clown. @amaxsmith fan.
Zach Brennan @ZacharyBrennan
10K Followers 1K Following Senior Editor, Endpoints News - covering the FDA, Capitol Hill, regulatory policy, and all things biotech/pharma - reach me at [email protected]
John Maraganore 🇺�.. @JMaraganore
14K Followers 412 Following Founding CEO of @Alnylam. Pioneered RNAi therapeutics as a whole new class of medicines for patients. Now bioentrepreneur-at-large. Opinions are my own.
STAT @statnews
165K Followers 5K Following Reporting from the frontiers of health & medicine. Sign up for any of our 10 free newsletters here: https://t.co/CBx3GZBv31
Alexander Gaffney @AlecGaffney
7K Followers 940 Following Executive Director, Regulatory Policy & Intelligence @Politico's @AgencyIQ. Tweeting about @US_FDA's regulation of #Pharma, #MedicalDevice, #Biotech & #Health.
Scott Gottlieb, MD @ScottGottliebMD
575K Followers 2K Following Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA. Boards: @Pfizer @Illumina
Mandy Jackson @ScripMandy
6K Followers 778 Following I am Managing Editor, US Commercial News, for the Citeline Commercial publications Scrip and The Pink Sheet. Views expressed here are strictly my own.
Drew Armstrong @ArmstrongDrew
31K Followers 3K Following Executive Editor, Endpoints News (@endpts). Got a tip? DM me for my Signal handle.
BioCentury @BioCentury
16K Followers 2K Following The leading voice for decision-makers throughout the global biopharma ecosystem. Follow us on LinkedIn for exclusive insights & analysis: https://t.co/V33Z1gfUfZ
Reshma Ramachandran @reshmagar
3K Followers 3K Following @YaleMed Assistant Prof, @Yale_CRRIT Co-Director, @UAEM NA Board Prez, @Drsforamerica FDA Task Force Chair #access2meds #patientsbeforeprofits #openaccess
Brian Skorney @BrianSkorney
9K Followers 398 Following Biotech Sell side analyst at @rwbaird. Probability of a false positive = 1 - (1 - alpha value)^n. De omnibus dubitandum est. Inventor of 𝕊𝕒𝕣𝕔𝕒𝕤𝕞 𝔽𝕠𝕟𝕥
Vibha Ravi @scripvibha
664 Followers 614 Following Senior Editor, Citeline - Scrip, Pink Sheet. Tweets on pharma, health, environment, other topics of interest to those who read beyond headlines, social media
Jessica Merrill @Jessicaemerrill
3K Followers 346 Following biopharma reporter, writer, reader, vermonter, mom.
Rachel Sachs @RESachs
5K Followers 594 Following Professor of Law, Washington University in St. Louis. Researching and writing about innovation policy, mostly in health law, FDA law, and patent law.
GIL BASHE @Gil_Bashe
13K Followers 10K Following Voice for health innovation and patient care with @finnpartners | @medikalife | @healthtechworld | @HCNowRadio. Championing #biopharma #digitalhealth #ecohealth
C. Michael Gibson MD @CMichaelGibson
436K Followers 374K Following Non-Profit Founder/Leader | ❤️ Doc | Artist Scientist Educator | News Anchor https://t.co/7OIKCgMVAT | RT ≠ endorse | Disclaimer: https://t.co/bwmE2O3U5W
Scrip, Citeline Comme.. @PharmaScrip
22K Followers 2K Following Scrip goes beyond the headlines to deliver insight & analysis on drug discovery, development and product life cycle value chain.
Nicholas Florko @NicholasFlorko
6K Followers 2K Following I report @statnews on the business reasons why Americans are so unhealthy, and what's being done about it. Lover of public records and @terrorhardcore.
Albert Bourla @AlbertBourla
63K Followers 157 Following Chairman and CEO of @Pfizer. Father. 🇬🇷🇺🇸 Working every day for breakthroughs that change patients’ lives.
FDA Oncology @FDAOncology
38K Followers 377 Following FDA Oncology Center of Excellence expedites medical product development to improve the lives of people with cancer.
Peter Maybarduk @Maybarduk
2K Followers 906 Following Access to Medicines Director @Public_Citizen, Governance Board @MedsPatentPool, public interest IP lawyer, songwriter under Creative Commons licenses
jenniferA86 @jenniferA86
798 Followers 398 Following ALS (Lou Gehrig's disease) Advocate. Boat owner. ALS TDI Board Member.
Julia Etkin @juliaetkin
135 Followers 355 Following @HarvardMed @HMSbioethics MBE Candidate | @YaleMed @Yale_CRRIT Postgraduate-Predoctoral Associate
Ligand @Ligand_LGND
11K Followers 148 Following The official X channel for Ligand Pharmaceuticals Incorporated.
Oliver Barnes @mroliverbarnes
13K Followers 6K Following US pharma & biotech correspondent @FT 📩 [email protected]
Kartik Narayanswamy @nkartik74
9 Followers 24 Following
J Coultry @JCoultry
55 Followers 527 Following
Phanindra @Phanindra2007
38 Followers 192 Following
Chico#XIII @ChicoFieldwork
531 Followers 5K Following Entre o sucesso e a lama- trabalhando com arqueologia_ Ariramba Esporte Clube
Aggarwal Tripod @shpeky
2 Followers 89 Following
Dr Gordon Smith Baxte.. @baxtergo
5 Followers 89 Following Molecular Pharmacologist, Technology Entrepreneur, Muscian & Photographer.
PharmD Eye @PharmdEye
29 Followers 239 Following Pharm.D, Pharma/Biotech, Drugs, Biologics, Generics, Biosimilars and more…
Arie Blitz @BioPharmTrader
63 Followers 381 Following Retired Cardiac Surgeon, Healthcare Investor/Trader
KanzakiS@職探し中 @nchdaks
601 Followers 265 Following 再生医療、遺伝子治療、カルタヘナ法、ES細胞、生命倫理、ヒト胚、ゲノム編集、ライソゾーム病、中枢神経系、免疫、中央省庁関連（徒然𝕏なので所属組織非公表、公式見解含まれてないです）。
Kaushik ram reddy Chi.. @MavericKaushik
4 Followers 54 Following
Neil @Neil113849
13 Followers 94 Following
Kris Lang @krissyblang
115 Followers 328 Following Mom, social worker, Lyle Lovett superfan, ghost & shark tooth hunter, navigating life with S4 ALK+ lung cancer - Anyone with lungs can get lung cancer. She/her
ISCT @ISCTglobal
5K Followers 646 Following Driving the translation of cell & gene therapies for the benefit of patients worldwide.
Angela M @AMPharmD2000
3 Followers 159 Following
JB @jjb6481
299 Followers 4K Following
Rafael Doye @rafael_doye
515 Followers 3K Following Managing Partner at Doye & Chalmel Frères | We invest in Biotech & Tech companies
hemanth sk @Sk61Sk
62 Followers 68 Following
Integoz @integoz
19 Followers 332 Following
Sarah Mishek @SarahMishek
1 Followers 78 Following
朱凯旋 @zhu963396
26 Followers 857 Following
EJ @notthefakeEJP
85 Followers 143 Following strong opinions, loosely held. sometimes my own. here to learn, argue, and troll. prefer talking sports
Kok Seong Lim @kokseonglim2
12 Followers 309 Following
Liz Robinson @lizrobinson_pr
211 Followers 2K Following 🐈 Cat mom 👩💻 Public Relations ⚽️ Soccer fan ✉️ [email protected] #biotech #lifesciences #PR at @cglifeagency
Carrie Pugh @CarrieP31225845
85 Followers 470 Following
Lajos Toth @LToth24476
96 Followers 1K Following
Jessi Colund Rennekam.. @JypsyJBook
344 Followers 1K Following In pursuit of ideas, meaning, & good conversation. Communications guru for biotech, coffee drinker, runner, reader, reflective Christian, working mom, INFJ.
Alison Borris @alisonborris
432 Followers 1K Following Proud mama & wife. Tech Corp Comms. Outdoor enthusiast - Horses, Tennis, Hiking. Bay Area sports fan. Dual citizen. Musings my own.
Owen Blaschak @oebbiotech
0 Followers 480 Following
Terence Linehan @VTKCDriver
6 Followers 33 Following
SWHR @SWHR
6K Followers 2K Following The Society for Women's Health Research (SWHR) is dedicated to improving women's health through science, policy, & education. Follow/RT does not = endorsement.
Krishna nath Chakma @NathChakma52640
107 Followers 1K Following
Alex z @Alexz00595256
86 Followers 467 Following
iGXP Solutions @iGXPSolutions
54 Followers 247 Following
Deepesh Shah @deepeshshah_
0 Followers 3 Following
Documen Tweet @Docatweet
0 Followers 579 Following
JO_0531 @JO_0531_
50 Followers 80 Following
The Med13L Foundation @Med13L_Fdn
69 Followers 646 Following Supporting MED13L families through awareness, research, and community. Connecting hearts and minds to overcome challenges. #NDD #Epilepsy #Autism #ID 🧬💙🧠
Jodie Tillman @jtillmantimes
733 Followers 1K Following
See-Won Seo @see_seo
81 Followers 174 Following AACP Global Engagement Advisory Committee, Chair AACP Global Education SIG Chair, Former CAP Government Relations Co-Lead
evgenia @evgenia47488565
97 Followers 3K Following
Adam Feuerstein ✡�.. @adamfeuerstein
114K Followers 750 Following Reporter @statnews. The Harry Kane of biotech. Dog ❤️er. Polk Award winner. #COYS. Said one analyst: The likes of Adam Feuerstein attack viciously.
Matthew Herper @matthewherper
111K Followers 3K Following Writing and events at STAT. This is biology's century; Every data point has a face. ‘21 Polk Award. Mastodon: @[email protected]
Bruce Booth @LifeSciVC
50K Followers 731 Following Early stage biotech VC. Recovering scientist. Opinions expressed are solely my own and do not express the views or opinions of Atlas Venture.
Michael Gilman @michael_gilman
24K Followers 785 Following Scientist, entrepreneur, ex-biopharm exec, former FM radio jock, lifelong hockey fan, aspiring guitar player, #immigrant. CEO @ArrakisTx. Just @gilman on...
Sarah Karlin-Smith @SarahKarlin
17K Followers 3K Following Covering intersection of pharma, policy & politics for @pharmapinksheet. @smpagwu adjunct Past @politico. Inflexible Yogi, Volunteer Clown. @amaxsmith fan.
Zach Brennan @ZacharyBrennan
10K Followers 1K Following Senior Editor, Endpoints News - covering the FDA, Capitol Hill, regulatory policy, and all things biotech/pharma - reach me at [email protected]
John Carroll @JohnCendpts
70K Followers 94 Following Working journalist for 46 years, invented FierceBiotech, founded Endpoints News now majority-@FT owned. 201,000 subscribers. These are personal opinions.
Luke Timmerman @ldtimmerman
35K Followers 231 Following Biotech Journalist. Founder @TimmermanReport. Mountaineer. Volunteer. @LS_Cares @DamonRunyon
Daphne Zohar @daphnezohar
22K Followers 885 Following Founder & CEO of @SeaportTX. Founding CEO & now Senior Advisor @PureTechH. I share biotech news & commentary. Co founder/host @BiotechCH. Board @IamBiotech
Alexander Gaffney @AlecGaffney
7K Followers 940 Following Executive Director, Regulatory Policy & Intelligence @Politico's @AgencyIQ. Tweeting about @US_FDA's regulation of #Pharma, #MedicalDevice, #Biotech & #Health.
Scott Gottlieb, MD @ScottGottliebMD
575K Followers 2K Following Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA. Boards: @Pfizer @Illumina
Madeleine Armstrong @ByMadeleineA
7K Followers 1K Following Senior reporter at @ApexOnco; cat lover; Croydon Harrier
Mandy Jackson @ScripMandy
6K Followers 778 Following I am Managing Editor, US Commercial News, for the Citeline Commercial publications Scrip and The Pink Sheet. Views expressed here are strictly my own.
Drew Armstrong @ArmstrongDrew
31K Followers 3K Following Executive Editor, Endpoints News (@endpts). Got a tip? DM me for my Signal handle.
BioCentury @BioCentury
16K Followers 2K Following The leading voice for decision-makers throughout the global biopharma ecosystem. Follow us on LinkedIn for exclusive insights & analysis: https://t.co/V33Z1gfUfZ
Jonathan Rockoff @jonathanrockoff
20K Followers 2K Following Deputy Coverage Chief, Health & Science and Health Business editor at the @WSJ. Email me at [email protected]
U.S. FDA @US_FDA
563K Followers 145 Following Our posts are FDA Approved! Privacy Policy - https://t.co/LbTJXYRXVP FDA Authentic Accounts - https://t.co/w2LNbzG7M0
Jessica Merrill @Jessicaemerrill
3K Followers 346 Following biopharma reporter, writer, reader, vermonter, mom.
Rachel Sachs @RESachs
5K Followers 594 Following Professor of Law, Washington University in St. Louis. Researching and writing about innovation policy, mostly in health law, FDA law, and patent law.
Boris Veldhuijzen van.. @borisvvz
91K Followers 9K Following this is my other account. I mainly tweet at @Boris
Edward Thomason @Liberum_ET
90 Followers 121 Following Equity Research analyst at Liberum specialising in UK small- to mid-cap Healthcare and Pharmaceutical stocks
Zachary McLellan @biotechzm
314 Followers 181 Following Analyst covering the pharmaceutical and healthcare industry. Views expressed are my own.
Citeline @Citeline
4K Followers 1K Following Trusted partner of the top 50 global pharmaceutical companies and the top 10 CRO’s – providing timely intelligence and insight to make authoritative decisions.
Peyton Howell @PeytonRHowell
796 Followers 2K Following Chief Operating & Growth Officer @Parexel. Patient access to new innovative treatments is my passion. Opinions are my own.
PPD @PPDCRO
12K Followers 330 Following As a global provider of clinical development and laboratory services, we improve health by helping customers deliver life-changing therapies.
MMS @mmsholdings
2K Followers 2K Following MMS is a leading, global clinical research organization (CRO) focused on regulatory submission support for the #pharma, #biotech and medical device industries.
Ani B @AniB75383019
102 Followers 248 Following Pharma sales and marketing , fitness enthusiast, philosophy, science , travelling, classic literature , poetry and music.
ZorgNL @zorgnl
15K Followers 421 Following Nederlandse Twitterlijst voor zorgprofessionals. Volg het medisch nieuws. Powered bij @medicalfacts & Janine Budding
Marion Webb @medtechMarion
2K Followers 1K Following Managing Editor, Citeline, dog mom, avid runner, recovering triathlete. All views are my own. #medtech #digitalhealth #robotics #agetech #femtech
Medical Device Guru @MedDeviceGurus
8K Followers 1K Following With 25+ yrs in the #MedicalDevice industry, our #recruiting expertise extends to #sales, diagnostic & therapeutic #imaging, #engineering, & #robotics
Grace Powers @gracepowers
551 Followers 542 Following Regulatory Affairs #FDA #RAC, Medical Device Engineer, life science networker, entrepreneur, consultant, football fan #medtech #medicaldevice #regulatory
Laura Strong @scientre
7K Followers 314 Following Sci(entist)Entre(preneur) Data science + analytics; Former cancer drugs and early detection #pharma #healthtech #healthcare #innovation Teach #biotech UWMadison
Vikas Dandekar @VikasReports
14K Followers 448 Following Journalist - Indian pharma & healthcare. Views own [email protected]
Les Yonemoto, MD MBA @protoninfo
77K Followers 77K Following Radiation Oncologist. My tweets on #CancerResearch #Cancer #Health #Medicine #Oncology #RadOnc T/RT/F≠Endorsement/Advise https://t.co/SAf2YBUInF
Pebble Biotechnology .. @James_Fildes
574 Followers 374 Following Accelerating your innovations into healthcare, without the need for laboratory animals.
Cello Health Global @cellohealth
2K Followers 869 Following Cello Health consists of 3 core global capabilities: Insight, Consulting and Communications, providing medical/marketing services to #Pharma and #biotech
Anna Maxwell @amannamaxwell
256 Followers 279 Following Building a pipeline of new consumer healthcare brands by converting prescription medicines into versions that people can buy in a pharmacy
Bionow @Bionow
4K Followers 1K Following Membership organisation delivering specialist services, support and tangible value to biomedical/life science companies in the North of England.
ApconiX @ApconiXLtd
457 Followers 272 Following Nonclinical experts, providing the right advice at the right time to help you make better decisions on drug safety.
Alderley Park @AlderleyPark
4K Followers 2K Following Where world leading science, innovation & stylish living come together to create a place like no other. 💻🔬🏡🌿 By @BW_SciTech.
Sanofi UK @SanofiUK
6K Followers 388 Following We chase the miracles of science to improve people’s lives. Interactions with this account must comply with the Terms: https://t.co/YkvonXhwzm
ISPE @ISPEorg
4K Followers 246 Following The International Society for Pharmaceutical Engineering (ISPE) is a nonprofit association serving its 20,000+ Members worldwide.
FDA Law Blog @fdalawblog
5K Followers 125 Following Food and Drug Attorneys at Hyman, Phelps & McNamara, P.C.
Emergo by UL @EmergoGroup
3K Followers 213 Following Consultants for #MedDevice #regulatory compliance with a global presence. Follow up for fresh QA/RA news & updates!
TOPRA @TOPRANEWS
3K Followers 709 Following TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
Dr. Stephen M. Hahn @SteveFDA
75K Followers 713 Following 24th Commissioner of Food and Drugs - @US_FDA This account is now archived.
Global Regulatory @GlobalReg
1K Followers 1K Following Innovative International Regulatory Solutions for regulated industries such as #Pharmaceuticals #MedicalDevices #Biologics #DietarySupplements #Food #Cosmetics
GSK US @GSKUS
99K Followers 1K Following We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://t.co/woIbYTUlEv
AstraZenecaUS @AstraZenecaUS
83K Followers 2K Following The official Twitter feed for AstraZeneca US. For more info visit http://t.co/5VlUaVGyiC.
Boehringer Ingelheim @boehringerus
68K Followers 2K Following Join the conversation on the latest news from Boehringer Ingelheim in the U.S.
biosimilars101 @biosimilars101
7K Followers 650 Following Providing news & information about biosimilars—biologic medicines that are FDA-approved based on similarity to an existing biological. RT ≠ Endorsement.
Michael Cipriano @mcipriano93
453 Followers 212 Following Long-suffering fan of the @Mets, @nyjets, @nyknicks and @NYIslanders
WHO/Europe @WHO_Europe
213K Followers 1K Following The WHO Regional Office for Europe is one of 6 WHO regional offices around the world. It collaborates with a range of public health stakeholders in the Region.
EFPIA @EFPIA
26K Followers 4K Following EFPIA is the voice of the research-based pharmaceutical industry in Europe #WeWontRest #TeamVaccines https://t.co/y1FLniUcoT
EU Medicines Agency @EMA_News
118K Followers 354 Following Latest news from the European Medicines Agency, the European Union agency responsible for the evaluation and supervision of medicines. RTs ≠ endorsement.
Citeline Awards @Citeline_Awards
236 Followers 446 Following The Citeline Awards (formerly CARE Awards) celebrates the very best of those in the biopharmaceutical, CRO and diagnostic industries. #CitelineAwards
Lars Bo Nielsen @LMST_LBNielsen
8K Followers 1K Following Director General, Danish Medicines Agency / Direktør, Lægemiddelstyrelsen @LMSTdk. Tweeter officielt.
AdaptSmartIMI @AdaptSmartIMI
175 Followers 83 Following
Niharika Dandamudi @Datamonitor_ND
142 Followers 165 Following Epidemiologist @Datamonitor_HC based in London. Views expressed are my own.
Fuck this shit I’m .. @fuckTwatter6666
1K Followers 1K Following
Drug Safety Research @DSRUDrugSafety
2K Followers 134 Following The DSRU is the UK’s leading pharmacovigilance and pharmacoepidemiology unit, and the leading provider of drug safety training courses in Europe.
GIL BASHE @Gil_Bashe
13K Followers 10K Following Voice for health innovation and patient care with @finnpartners | @medikalife | @healthtechworld | @HCNowRadio. Championing #biopharma #digitalhealth #ecohealth
IFPMA @IFPMA
9K Followers 1K Following We represent the innovative pharmaceutical industry, partnering for global health progress and access to innovation. #AlwaysInnovating #VaccinesForLife
Bayer AG @Bayer
184K Followers 921 Following Health for All, Hunger for None. That’s what drives us at Bayer. Data Privacy Statement / Imprint: https://t.co/BTRaQM2lGc…
Bayer U.S. 🇺🇸 @BayerUS
55K Followers 2K Following Official profile for Bayer in the United States. Bayer is a life science company focused on health care and agriculture. #HerestotheFarmer #TeamBayer
Ellen 't Hoen @ellenthoen
7K Followers 2K Following Spend most of my time working on access to meds and intellectual property. If not I cook. My book: https://t.co/5Mo9BIQvsk My TED talk: https://t.co/HtLoB86WdZ…
Brian Yang @bhxyang
494 Followers 381 Following Health business writer covering China, mRNA vaccines, new drugs, biotech from Beijing
CBER’s New Gene Therapy Office Director Is Former Blood Research Office Chief Verdun bit.ly/3Kr2tkc #PinkSheet
Several interesting nuggets in this @PharmaPinkSheet notebook ... #pinksheet #pharma: Supplemental Filings: Ycanth Approved For Molluscum; CDER Counter-Terrorism Head Retires; 5 Benzodiazepines Added To Schedule I pink.pharmaintelligence.informa.com/articles/2023/…
The @US_FDA corrected a typo in the FR notice announcing FY 2024 user fee rates today: public-inspection.federalregister.gov/2023-16575.pdf, but if you had read @PharmaPinkSheet on July 27, you would have already known about the typo and what the correct figure was #pharma: pink.pharmaintelligence.informa.com/PS148604/PDUFA…
Check out our special @PharmaPinkSheet podcast! @SarahKarlin, @PinkSheetSutter and I along with special guests from 3D Communications discussed @US_FDA advisory committee reform ... #pinksheet #pharma: soundcloud.com/citelinesounds…
See @PharmaScrip and @PharmaPinkSheet coverage of #BIODigital #BIO2021 Day 4 (Scrip subscription required) for a good cross-section of Thursday’s commercial, regulatory, R&D and manufacturing discussions. scrip.pharmaintelligence.informa.com/SC144558/BIO-2…
Hear from a former #FDA executive, Nancy Myers, as she gives her perspective on changes & impacts within the #pharma industry @PharmaPinkSheet bit.ly/3qDPjUz
Drug agencies in the EU have shown "big willingness" to deal with Brexit, @ThSenderovitz of @DKMA_dk tells @PharmaPinkSheet. But they are working “within the framework and with the resources they have" and "time will tell whether that’s good enough" bit.ly/2NsSoXL
Even if the UK remains a part of the EU network after Brexit it shouldn’t expect its agencies to have the same amount of work as before. It wouldn't be fair on those countries that have staffed up in preparation for 29 March 2019: @ThSenderovitz of @DKMA_dk tells @PharmaPinkSheet
Last of five articles with me in @PharmaPinkSheet on #brexit and the #European #Regulatory #Network #sundpol pink.pharmaintelligence.informa.com/PS123829/Well-…
#BioPharmUSA $NVS Philip Gotwals on what’s unique about cell/gene partnering: easier to develop products in academic settings, points to UPenn deal as “small biotech w/in walls of academic institution”
This webinar covers the key topics impacting the Global Pharma R&D market today, and offers a glimpse into the rest of 2018. #Pharma #Research
In the Global Pharma R&D Review webinar, our experts hit all the right notes as they used a music theme to explore key issues affecting R&D today, and offered a glimpse of what the rest of 2018 may look like. #Pharmaprojects bit.ly/2n0z316 #PharmaIntelligence
Senior EU regulator @ThSenderovitz from @DKMA_dk tells @PharmaPinkSheet “significant number” of national agencies have taken on extra staff/added resources to take on some of the work hitherto done by @MHRAgovuk. #Brexit #pharma bit.ly/2Cw3y9N (no paywall)
$PBYI's Nerlynx gets the nod in the EU following the negative CHMP in February and subsequent positive CHMP in June. Its been quite a ride. pumabiotechnology.com/pr20180904.html
Some common themes so far at @US_FDA hearing on #biosimilar competition: get ahead of potential issues with switching b/n multiple biosimilars deemed interchangeable to the same reference product but not each other; adopt “umbrella exclusivity” for biologics ...
"We need to work very hard to find common ground among the member states and to make sure this very important collaboration is ready for the future.” @ThSenderovitz of @DKMA_dk talks to @PharmaPinkSheet about future of EU Heads of Medicines Agencies. bit.ly/2wK6bib
#BioPharmUSA discussion on pharma/VC collaborations, $PFE Anthony Barry says Pfizer invests as limited partner on funds as way to diversify, expand reach
Chi-Med's #fruquintinib becomes 1st fully Made in #China #cancer drug to receive unconditional approval @PharmaPinkSheet reports #pharma New Drug Bonanza as ChiMed, Eisai, Alexion Harvest Big Wins In China pink.pharmaintelligence.informa.com/articles/2018/…
This is the first of four free @PharmaPinkSheet articles based on our interview with @ThSenderovitz of @DKMA_dk. He talks about the opportunities of #bigdata and the challenges involved in incorporating it into #pharmaceutical regulatory decision-making. bit.ly/2CszdZC
Read about 'FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals' here bit.ly/2LrYKSc Joanne Eglovitch, @PharmaPinkSheet
@PhillyCooke @US_FDA @SGottliebFDA @FTC That would be interesting! @PharmaPinkSheet
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