Shivu Sharma
bigpharmasharma.com
Shivu Sharma
@bigpharmasharma.com
12+ year BioPharma strategy pro. Delivering weekly insights, analyses, and takes about BioPharma from an insider’s perspective on my substack.

bigpharmasharma.com

https://t.co/m4a7eb9gdp
Pinned
Who wins: mega-check muscle or platform-seed patience?

Full breakdown, tables, and the ShAbbVie inversion that almost was: www.bigpharmasharma.com/p/changing-o...
Humira built the war chest, but AbbVie’s big-game-hunting era is over.
July 16, 2025 at 4:14 PM
Three #ASCO25 readouts oncology developers can’t ignore:
• TRODELVY + Keytruda: 11 mo mPFS in 1L TNBC
• Tarlatamab: new DLL3 bar in ES-SCLC
• IMA203: 50 % ORR, pressuring TILs in melanoma

Strategy angles unpacked in my latest post

www.bigpharmasharma.com/p/asco-2025-...
Speed, Scale, and Shifting Goal-Posts: What ASCO 2025’s Spotlight Trials Really Mean for the Next Wave of Oncology Players
Discussing a few interesting solid tumor data read outs to close out ASCO 2025 coverage
www.bigpharmasharma.com
June 18, 2025 at 5:57 AM
Bicara’s deeper complete responses could flip 1L head-&-neck cancer on its head—even after Merus grabbed the ASCO buzz. HPV-negative patients may be the real winners. I map the data, sequencing chess, and competitive dynamics.

Dive in ➜ www.bigpharmasharma.com/p/asco-2025-...
ASCO 2025: Bicara vs. Merus in a Set-to-Change Head & Neck Cancer Treatment Paradigm
While Bicara took a hit after Merus released its ASCO data, there is strong reason to believe that Bicara could end up coming out on top in the end
www.bigpharmasharma.com
June 9, 2025 at 5:11 PM
Episode 4 of my podcast, Drug Dealin, is now live. You can watch/listen at bigpharmasharma.com or by subscribing to Drug Dealin on your podcast platform of choice.

In #4 we take dive into oral GLP-1s and GLP-1s are moving into brain diseases

Looking forward to hearing your feedback on this one!
May 19, 2025 at 5:40 PM
Today I wrote about the implications to biotech of his appointment to CBER. Is it all doom and gloom or perhaps is there a glimmer of hope that this won’t be as bad as we think? I guess we’ll find out soon enough.

www.bigpharmasharma.com/p/vinay-pras...
Vinay Prasad at CBER: What His Appointment Signals for the Future of Biotech Regulation
Potential implications of the Prasad appointment and some early evidence that maybe it's not all doom-and-gloom? I guess we'll find out soon enough. Also an addendum on Rev Med's KRAS G12D inh data.
www.bigpharmasharma.com
May 9, 2025 at 6:21 PM
Psychiatry continues to be one of the most difficult areas of drug dev. Perhaps some signs of life for Cobenfy in the non-risperidone group.
news.bms.com/news/corpora...
Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults with Schiz...
Cobenfy as an adjunctive treatment to atypical antipsychotics did not reach the threshold for a statistically significant difference compared to placebo with an atypical antipsychotic for the primary ...
news.bms.com
April 22, 2025 at 10:57 PM
Reposted by Shivu Sharma
GLP-1s are heading into the brain.
In my latest post, I break down the wave of trials testing these blockbuster drugs in:
🧠 Alzheimer’s
🎯 Parkinson’s
🥃 Addiction
🩺 And Other CNS diseases

Can GLP-1s expand beyond weight-loss, diabetes, and common comorbidities?

open.substack.com/pub/bigpharm...
What 2025 Holds for GLP-1s in Brain Health
It feels like every year is “the year of the GLP‑1,” but 2025 may really be the one where we crack how these drugs work in the brain—far beyond weight loss and diabetes.
open.substack.com
April 17, 2025 at 3:45 PM
Impressive oral GLP-1 data from $LLY (+15%)

Related to today's newsletter on GLP-1s for CNS diseases - curious to see what the BBB penetration is. If it's ~jabs, that could make entering CNS smoother.

www.prnewswire.com/news-release...

Post: bigpharmasharma.substack.com/p/what-2025-...
Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of...
www.prnewswire.com
April 17, 2025 at 4:24 PM
GLP-1s are heading into the brain.
In my latest post, I break down the wave of trials testing these blockbuster drugs in:
🧠 Alzheimer’s
🎯 Parkinson’s
🥃 Addiction
🩺 And Other CNS diseases

Can GLP-1s expand beyond weight-loss, diabetes, and common comorbidities?

open.substack.com/pub/bigpharm...
What 2025 Holds for GLP-1s in Brain Health
It feels like every year is “the year of the GLP‑1,” but 2025 may really be the one where we crack how these drugs work in the brain—far beyond weight loss and diabetes.
open.substack.com
April 17, 2025 at 3:45 PM
Reposted by Shivu Sharma
5/5 Want to see how a government-led “Abundance Agenda” for biotech could reshape our industry? Read the full thought experiment here: bigpharmasharma.substack.com/p/biotech-cz...

#biotech #Biopharma #innovation #Abundance
Biotech Czar for a Day: An Abundance Agenda for Biotech
A thought experiment on how we can make our Biotech ecosystem more abundant
bigpharmasharma.substack.com
March 31, 2025 at 3:23 PM
1/5 What if the government could turbocharge biotech innovation—speeding up approvals, boosting breakthrough discoveries, and expanding manufacturing capacity to flood the field with cures? Imagine a day as Biotech Czar!
March 31, 2025 at 3:23 PM
@zachlowenba.bsky.social so glad to have you back doing podcasts!! 🥳
March 31, 2025 at 5:33 AM
Episode 3 of my BioPharma podcast, Drug Dealin', is live. We spoke to Sujal Shah, CEO of CymaBay about the company's ups & downs with seladelpar and resilience leading a company through adversity.

Tap-in wherever you get your podcasts: youtu.be/TixS06gbfQc?...

open.spotify.com/episode/1tct...
March 10, 2025 at 5:01 PM
Hims & Hers built its GLP-1 biz on a temporary FDA shortage—now the cracks are showing. Their “personalized” treatments feel more like a one‑size‑fits‑all approach, and raises serious ethical questions. Read my deep dive on why this model is crumbling: bigpharmasharma.substack.com/p/the-unrave...
The Unraveling of Hims’ GLP-1 Strategy
A Cautionary Tale of Fleeting Fortunes and Structural Blind Spots
bigpharmasharma.substack.com
March 3, 2025 at 4:36 PM
This week I deep dove into one of my favorite areas in biotech - IPF. The landscape is deep and diverse despite all the failures we've seen in this space

[FYI - the link to the full post is here in case you wan to skip the thread and get to the source]: bigpharmasharma.substack.com/p/a-crucial-...
February 20, 2025 at 4:56 AM
2 biopharma stories got me thinking about the placebo effect—GH’s psychedelic data in depression & Vertex’s landmark non-opioid pain drug approval.

Same challenge, opposite sides. Psychedelics = hard to PBO-control. Pain drugs struggle to beat PBO.

bigpharmasharma.substack.com/p/when-the-p...
When the Placebo Wins—and Sometimes Loses: Navigating the Complexities of Psychedelics and Pain Therapies
GH Research's psychedelic drug, Vertex's suzetrigine approval, and why both psychedelics and non-opioid pain drug developers need to think more critically about PBO-effect
bigpharmasharma.substack.com
February 7, 2025 at 10:52 PM
What did Big Pharma really say at #JPM25? 🤔 I dug through Big Pharma's transcripts & slide decks to give you an insider's perspective on the key takeaways. From patent cliffs to pipeline strategies, get the analysis you won't find elsewhere:

substack-proxy.glitch.me/articles/big...
Biotech at a Crossroads: Insights from JPM 2025
Biotech at a Crossroads: Insights from JPM 2025
substack-proxy.glitch.me
January 22, 2025 at 10:09 PM
Interesting decision by $GLPG to split into two cos: a cell tx pure play and a $2.5B BD&L vehicle.

I'll have more to say on substack, but $GILD comes out looking the best, essentially getting a redo on its fruitless GLPG deal and can now influence NewCo BD&L with two BoD seats and pipeline option
January 8, 2025 at 8:14 AM
Reposted by Shivu Sharma
What better way to cap off 2024 than by predicting 2025?

In my latest newsletter I make 5 predictions for BioPharma in the coming year.

Topics covered: AI, GLP-1s, bsAbs, IgAN, and Pharma digital ad $$$ spend

Enjoy!
bigpharmasharma.substack.com/p/looking-in...
Looking into the crystal ball: Five predictions for Biopharma in 2025
As 2024 winds down, the biopharma industry stands at the precipice of significant transformation.
bigpharmasharma.substack.com
December 29, 2024 at 5:50 PM
What better way to cap off 2024 than by predicting 2025?

In my latest newsletter I make 5 predictions for BioPharma in the coming year.

Topics covered: AI, GLP-1s, bsAbs, IgAN, and Pharma digital ad $$$ spend

Enjoy!
bigpharmasharma.substack.com/p/looking-in...
Looking into the crystal ball: Five predictions for Biopharma in 2025
As 2024 winds down, the biopharma industry stands at the precipice of significant transformation.
bigpharmasharma.substack.com
December 29, 2024 at 5:50 PM
Merck shuts down its anti-LAG3 and anti-TIGIT programs.
www.merck.com/news/merck-p...

TIGIT field continues to consolidate, with Gilead/Arcus standing most to gain if its PD-1+TIGIT+Chemo combo proves successful in 1L NSCLC. Very few large cos left in the space now.
Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab - Merck.com
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezeli...
www.merck.com
December 16, 2024 at 9:51 PM
Reposted by Shivu Sharma
ICYMI - my first post on the goings-on at ASH. Dropping another post on ASH in the next day or so.
🚨 New post: I dive into Miltenyi & Galapagos’ novel CD19 CAR-T manufacturing approaches from #ASH24.

What’s working, what’s not, and the challenges ahead for fresh-in/fresh-out CAR-T protocols.

bigpharmasharma.substack.com/p/ash-2024-p...

More #ASH24 content coming soon!
ASH 2024 | Part 1: Miltenyi and Galapagos Aim Big in CAR-T, but Gaps Remain
It’s time for the annual ASH meeting, always a showcase for cutting-edge clinical data in competitive areas like blood cancers and hemoglobinopathies.
open.substack.com
December 10, 2024 at 6:17 PM
Reposted by Shivu Sharma
Anito-cel vs. CARVYKTI: The next big BCMA CAR-T rivalry? 🚨

With strong efficacy, cleaner safety, and Kite's manufacturing edge, can anito-cel disrupt CARVYKTI's dominance?

#ASH2024 #BCMACART #MultipleMyeloma

Full post here: bigpharmasharma.substack.com/p/ash-part-2...
ASH Part 2: Anito-cel is off to the races, but will it be fast enough to catch-up to Cilta-cel?
Arcellx presented Phase 2 pivotal iMMagine-1 data for anito-cel, their BCMA-targeted CAR-T for 5L+ relapsed/refractory multiple myeloma (RRMM), at ASH 2024.
bigpharmasharma.substack.com
December 11, 2024 at 7:24 PM
Anito-cel vs. CARVYKTI: The next big BCMA CAR-T rivalry? 🚨

With strong efficacy, cleaner safety, and Kite's manufacturing edge, can anito-cel disrupt CARVYKTI's dominance?

#ASH2024 #BCMACART #MultipleMyeloma

Full post here: bigpharmasharma.substack.com/p/ash-part-2...
ASH Part 2: Anito-cel is off to the races, but will it be fast enough to catch-up to Cilta-cel?
Arcellx presented Phase 2 pivotal iMMagine-1 data for anito-cel, their BCMA-targeted CAR-T for 5L+ relapsed/refractory multiple myeloma (RRMM), at ASH 2024.
bigpharmasharma.substack.com
December 11, 2024 at 7:24 PM
ICYMI - my first post on the goings-on at ASH. Dropping another post on ASH in the next day or so.
🚨 New post: I dive into Miltenyi & Galapagos’ novel CD19 CAR-T manufacturing approaches from #ASH24.

What’s working, what’s not, and the challenges ahead for fresh-in/fresh-out CAR-T protocols.

bigpharmasharma.substack.com/p/ash-2024-p...

More #ASH24 content coming soon!
ASH 2024 | Part 1: Miltenyi and Galapagos Aim Big in CAR-T, but Gaps Remain
It’s time for the annual ASH meeting, always a showcase for cutting-edge clinical data in competitive areas like blood cancers and hemoglobinopathies.
open.substack.com
December 10, 2024 at 6:17 PM