Author | Lightnews

Shivu Sharma @bigpharmasharma.com · Jul 16

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...

Shivu Sharma @bigpharmasharma.com · Jul 16

Rick Gonzalez burned > $100 B on splashy “WTF” acquisitions like Allergan & ImmunoGen.
New skipper Rob Michael? He’s firing cheaper shots-on-goal right after Phase 1 PoC—BBB tech, in-vivo CAR-T, amylin, siRNA—to grow future blockbusters in-house.

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Shivu Sharma @bigpharmasharma.com · Jul 16

Humira built the war chest, but AbbVie’s big-game-hunting era is over.

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Shivu Sharma @bigpharmasharma.com · Jun 18

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

Shivu Sharma @bigpharmasharma.com · Jun 9

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

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Shivu Sharma @bigpharmasharma.com · May 19

Links below:
Spotify: open.spotify.com/episode/4eLk...

YouTube: youtu.be/dv7swppsavo?...

Apple: podcasts.apple.com/us/podcast/d...

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Shivu Sharma @bigpharmasharma.com · May 19

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!

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Shivu Sharma @bigpharmasharma.com · May 9

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

Shivu Sharma @bigpharmasharma.com · Apr 22

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

Reposted by Shivu Sharma

Shivu Sharma @bigpharmasharma.com · Apr 17

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

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Shivu Sharma @bigpharmasharma.com · Apr 17

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

Shivu Sharma @bigpharmasharma.com · Apr 17

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

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Reposted by Shivu Sharma

Shivu Sharma @bigpharmasharma.com · Mar 31

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

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Shivu Sharma @bigpharmasharma.com · Mar 31

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

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Shivu Sharma @bigpharmasharma.com · Mar 31

4/5 We’d also launch a Cure Bounty Program and invest in robust biomarkers and global partnerships to ensure that breakthroughs reach patients faster and more safely.

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Shivu Sharma @bigpharmasharma.com · Mar 31

3/5 My plan focuses on accelerating FDA reviews, redirecting capital toward bold, diverse ideas, and creating new initiatives like a “Warp Speed 2.0” for discovery, plus expanded talent, manufacturing, & trial networks.

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Shivu Sharma @bigpharmasharma.com · Mar 31

2/5 Inspired by my read of @ezrakleinbot.bsky.social & @dkthomp.bsky.social 's new book, "Abundance", I conducted a thought experiment, pretending to be biotech czar, and crafted an agenda that rethinks our scarcity mindset and unlocks a future of rapid, transformative innovation in medicines.

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Shivu Sharma @bigpharmasharma.com · Mar 31

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!

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Shivu Sharma @bigpharmasharma.com · Mar 31

@zachlowenba.bsky.social so glad to have you back doing podcasts!! 🥳

Shivu Sharma @bigpharmasharma.com · Mar 10

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...

Shivu Sharma @bigpharmasharma.com · Mar 3

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

Shivu Sharma @bigpharmasharma.com · Feb 20

The next few years will tell us if IPF is finally evolving—or if we’re doomed to another decade of disappointment.

📩 I break it all down in my latest deep dive—check it out here: bigpharmasharma.substack.com/p/a-crucial-...

💬 Who do you think has the best shot at breaking into this space?

A Crucial Moment in IPF: What Boehringer Got Right, Why Roche Walked, and What’s Next

Idiopathic Pulmonary Fibrosis (IPF) has long been one of biotech’s most unforgiving proving grounds. Despite decades of research, billions of dollars poured into drug development, and a clear unmet me...

bigpharmasharma.substack.com

Shivu Sharma @bigpharmasharma.com · Feb 20

With BI in the lead, who can challenge them? BMS, Pliant (if they recover), and a handful of other players (GSK, Lilly, AZ) are lurking. And let’s not forget the growing number of inhaled and reformulated Ofev/Pirfenidone and novel target plays that could reshape the standard of care.

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Shivu Sharma @bigpharmasharma.com · Feb 20

Last week we saw:

✅ Boehringer Ingelheim’s nerandomilast delivers a second pivotal win (in PPF), ontop of positive data in IPF late last year

❌ Pliant’s bexotegrast study is paused - is this the beginning of yet another failure in IPF?

💰 Roche sells off Esbriet - this feels like a punt to me

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Shivu Sharma @bigpharmasharma.com · Feb 20

And to my surprise, it was startling how little has changed since the days I was covering this space as a young professional. IPF continues to be a graveyard, but maybe we are starting to see some glimmers of hope.

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