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新冠肺炎研发时间线COVID-19 Timeline
A timeline of major events in the history of COVID-19 vaccine and therapy development. 新冠肺炎疫苗与药物研发时间线。
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新冠疫苗文献汇总与摘要
COVID-19 Vaccine Publications
CompanytechPrePhase1/2Ph2/3Efficacy Symptoms%Eff. InfectEff. SevereSafety FeverSev. FatigueSev. HeadacheNotesSinovacInactivatedLancet, mR SSRN50100SinoPharm WHInactivatedJAMASinoPharm BJInactivatedLancet7979-100ValnevaInactivatedCanSinoAAV Ad5 S.WTLancet(Ph1, Ph2)66-7591-100AZNAAV ChAd S.WTLancetLancet,2761003 Neuro SAEs,Flawed trialJNJAAV Ad26…
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Biotech Industry of Orange County – Part II
This is the second part of Orange County biotechnology companies. I cover the smaller 7 of 14 biotechnology companies in…
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Moderna v. Arbutus Inter Partes Review on LNP Patents: Hearing Transcripts Summary
Update 2020.01.03: It turns out my naive assessment was wrong again. '435 patent is partially upheld and '127 is fully…
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Biotech Industry of Orange County – Part I
OC has 14 companies. They are dominated by medical device companies, reflecting strong root of the medical device industry in…
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Biotech Industry in La La Land
This post was originally written for and published at BC-LA blog. By Yi Liu, PhD (
[email protected]) Yi is a project…
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Trial Design and Updates Suggest Positive Results for AZD1419
If AZD1419 has no effect, the trial should have ended by March update. The trial is still ongoing and worth…
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Moderna’s Futile Challenge against Arbutus ‘127 Patent
09.15.2018 Update: IPR challeange to be instituted So I was naively wrong and wishful to believe the IPR challenge will…
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Location, Location, Location: PD-1 Combination Clinical Trial Landscape
I pulled clinical trials data from clinicaltrials.gov on Keytruda (Merck), Opdivo (BMS) and Tecentriq (Roche). I analysed how many locations…
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AcelRx: Smarter Pain Relief in the Shadow of Opioid Epidemic
[caption id="attachment_2438" align="alignnone" width="1024"] How much morphine should I use ??? [source: akutne.cz][/caption]pStrand found ACELRX in mid 2014 prior to…
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Investment Decision Making Using FDA’s Structured Benefit-Risk Assessment Framework
[caption id="attachment_2574" align="aligncenter" width="640"] stevepb@Pixabay[/caption] FDA's Structured Benefit-Risk Assessment Framework In the wake of PDUFA V, FDA committed and is…
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Victims of Biotech Insider Selling
[caption id="attachment_1852" align="aligncenter" width="960"] From QuateFancy. Photo by Radek Grzybowski CC-BY-ND[/caption] Investing: fairytale, drama and tragedy. All the world's a…
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Arbutus: Will Lasker Laureate Dr. Michael J. Sofia Repeat Success of Sovaldi with Hepatitis B?
[caption id="attachment_1756" align="aligncenter" width="604"] Arbutus: branch of green leaves, white flowers and red fruits[/caption] (My) brief history of Arbutus BioPharma…
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Agile Twirla Risk Benefit Analysis: Superior Safety Profile Outweighs “Disappointing” Pearl Index
We at PSIC originally studied Agile Therapeutics (NASDAQ:AGRX) in early 2015. Now it has been two years, the long waited…
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Ophthotech: Massive Insider Selling Precedes U-Turn in Drug Efficacy
OPHT Phase III failure On December 12th 2016, Ophthotech (Nasdaq: OPHT) released its much speculated Phase 3 trial results for…
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Dynavax’s 2nd CRL, Overburdened FDA and Could I Have Invested Better?
Dynavax's Heplisav-B got 2nd CRL This analyst note summarizes the CRL: First, the FDA wants more details in regards to…
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10 Reasons Why FDA Will Approve Dynavax’s Heplisav-B
Here is my 10 reasons for my approval opinion/speculation on Dynavax's Heplisav-B. Higher rate of protection Better regime/compliance. Two dose…
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Dynavax SD-101 Early Clinical Data: Efficacy Analysis with Small Cohort of Patients
Update 06/02/2017: Dynavax released more data for ASCO17. Now SD-101 is getting 100% ORR 7 out of 7 anti-PD-1 naive…
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AZD1419 vs CYT003: Dynavax and AstraZeneca Have A Better Route for Asthma
Asthma: The Obvious Unmet Medical Needs Asthma affects almost 20 million people in the United States and more than 300…
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Introduction to FDA and Case Studies
Introduction to FDA and Case Studies by Positive Strand Where is FDA from? Who is FDA? Where is FDA going?…
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GW Pharma: World Leader in Cannabis Science
GW Pharma: World Leader in Cannabis Science from Yi Liu Slides Transcripts: Project 10: GWPH Liu, Yi and Zhou, Bo…
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Biotechnology Equity Research
Introduction Value in biotech FDA regulatory statistics Success rates of drug development Reasons of CRL from Sun Yu Likelihood of…
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DVAX: Nobel Prize Winning Science for a Better Adjuvant
TLR Biology and Nobel Prize Toll-like Receptor (TLR) is truly one of the most important discoveries in immunology. It opens…
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Keytruda Merck: the popular girl in the town of Immuno-Oncology and her recent suitors
In the wake of Dynavax’s 3rd DSMB positive review, I complied a non-exhaustive list of current Merck Keytruda collaborations: Dynavax:…
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Kite Pharma: What’s the formula for flying high?
Event: The Kite Pharma senior management team came to UCLA CTSI Auditorium and gave a very nice seminar about the…
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Agile (AGRX): Finding Pearl in the Index
Unmet medical needs As modern women gain control of their own body and career, contraceptive market is growing at a…
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Acadia (ACAD): Will FDA Be Convinced by Placebo Effect “Run-In”?
Research Done 12.21.2014 Post Written on 2.6.2015 Unmet medical needs Psychosis of Parkinson's Disease is tough and dangerous for patients.…
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Q4 2014 NDA/BLA Round-up Part II: Can Sarepta Succeed with Only n=12?
For project 6 at PSIC, we shift our time horizon longer and decide to look at candidates which will have…
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Q4 2014 NDA/BLA Round-up Part I: So Deoxycholic Acid Can Remove My Fat?
For project 6 at PSIC, we shift our time horizon longer and decide to look at candidates which will have…
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InterMune: Forward-looking Patient Base and What Roche is Buying
What happened: PSIC selected ITMN as 5th project on Aug 5th when price was at $43; on August 12th, rumor…
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AcelRx’s Zalviso: Approval Does Not Come in the “First-Round”
Update 11.06.2014 Bad things usually follow each other. And wishful thinking usually burst. After CRL, the delay followed and class…
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Cubist (CBST): a promising niche company needs to prove itself with profit
Events at the time of writing 05/04/2014 $71.46 04/21/2014 NDA submitted for Ceftolozane/tazobactam 03/31/2014 Cubist received FDA Advisory Committee 14-0…
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Lesson Learned on CHTP (Northera) Case
CHTP Northera FDA results: A clean approval: FDA approved Northera with very little negative comments: saying long term effect is…
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BioEquity Initiating Coverage on BRLI – Buy
Price target: $42 (trailing p/e 30) Industry Business Peer comparison Valuation Technical Analysis Currently BRLI just pulled back from all…
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Kyprolis (Carfilzomib)_Onyx Pharmaceuticals
Kyprolis Overview Kyprolis is an inhibitor of 20S proteasome, which is an enzyme responsible for degrading polyubiquitinated proteins. Treatment of…
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Bioequity Analysis Onyx Pharmaceuticals (ONXX) Buy
NASDAQ: ONXX Current Price: $70.15-$76.38 (as of July 20, 2012) Target Price: $85 Rating: Outperform Analyst: Dandan Sun, Ph.D., CFA…
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Bubbles, Booms, and Busts: Will it Happen to Biotech?
In the end of 20th century, with the advent of internet, the world expected a great increase in productivity due…
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[Reading Notes] Investing in Unknown and Unknowable by Richard Zeckhauser
Outline I. Risk Uncertainty and Ignorance II. Behavioral Economics and Decision Traps III. Math Whizzes in Finance and Cash…
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Biotech Patent Litigation
Short Version: If you read only one article on biotech patent litigation, read this one: Litigating Biotechnology Patents: The Next…
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Reflections of Qiu Guolu’s Value Investing Ideas on Biotech
Value Trap Outdated, Inferior technology: such as IONSYS, Afrezza. Commercial failure: Mediocure follower, non-leader: such as Mirna Therapeutics (eventually reversed…
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Qiu Guolu Series on Value Investing
I translated a series of articles written by one of the best value investors in China -- Mr. Qiu Guolu.…
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Book Notes: The Lock and Key of Medicine
Preface Started around the same time as recombinant DNA technology (Genentech), monoclonal antibody generated much less buzz. But its impact…
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What John Brooks Business Adventures Tells Us About Biotech Investing
Business Adventures is Bill Gates and Warren Buffet's favorite book on business. This book was written in 1969 by John…
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Genentech: the Beginnings of Biotech – An Investor’s Review
[caption id="attachment_2447" align="alignnone" width="1024"] Genentech Founders Statue [flickr][/caption]I read this Genentech book after reading the Amgen book (my review: Science…
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Science Lessons: What Amgen and Gordon Binder Teach Us About Biotech Investment
In Jim Collins's book Great By Choice, he compared two biotech pioneer companies: Amgen Vs. Genentech. I was surprised to…
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First-in-Class vs. Best-in-Class Strategies in Biotechnology
[caption id="attachment_2537" align="alignnone" width="640"] First or Best? by TBIT@Pixabay[/caption] In recently announced Celgene-Beigene deal, the press release highlighted Beigene's potential…
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Buffett FAQ eBook: His Wisdom in Q&A Format
Note: This eBook format is authorized by the compiler Nick Webb (nick[at]sweetspot.com) at buffettfaq.com Download Buffett FAQ the eBook: Note:…
