Dennis Kwiatkowski
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kwiatberlin.bsky.social
Dennis Kwiatkowski
@kwiatberlin.bsky.social
Likely a mix of biotech, GPCRs & misc. | Mostly in English, sometimes in German
Boehringer's Jascayd scores US nod for idiopathic pulmonary fibrosis
Boehringer's Jascayd scores US nod for idiopathic pulmonary fibrosis
The FDA on Tuesday approved Boehringer Ingelheim's Jascayd (nerandomilast), ma...
firstwordpharma.com
October 8, 2025 at 5:53 PM
🔟 Efficient health system readiness
Mapping the patient journey, improving disease awareness, and alleviating capacity bottlenecks — launch success depends on understanding the system, not just the science.
October 5, 2025 at 7:44 AM
8️⃣ The first 6 months decide everything
The early launch phase is critical. Motivation to treat, strong patient pipelines, and meaningful HCP engagement are key to early adoption and lasting success.
October 4, 2025 at 2:27 PM
7️⃣ 25 launches per year – and counting
With 127 new active substances launched globally between 2020–2024, the competition for attention, access, and reimbursement has never been fiercer. (Numbers from IQVIA)
October 4, 2025 at 11:25 AM
6️⃣ The future is hybrid
Telehealth, e-prescriptions, and AI-driven decision tools are transforming how patients receive — and physicians recommend — treatment. Pharma needs to meet the system where it happens.
October 3, 2025 at 5:05 PM
5️⃣ Regulation is slowing down innovation
New EU HTA rules and US IRA reforms are redefining launch dynamics — slowing reimbursement, increasing price pressure, and reshaping go-to-market strategies.
October 3, 2025 at 4:37 PM
4️⃣ HCP engagement is evolving
Fewer in-person interactions. More digital & hybrid engagement. Pharma must adapt to an HCP landscape shaped by healthcare shortages and new digital channels.
October 2, 2025 at 6:15 PM
3️⃣ Health system capacity is the new bottleneck
Squeezed budgets, limited HCP capacity & resource bottlenecks are shaping the next era of pharma launches. Optimizing care pathways is becoming as crucial as the product itself.
October 2, 2025 at 5:37 PM
2️⃣ 8 core markets drive 89% of sales
US, Japan, Germany, France, Italy, Spain, UK & China together make up nearly 90% of post-launch sales — the race for launch excellence is global, but the real battle is fought in these 8 markets.
October 1, 2025 at 7:41 PM
1️⃣ $200B at risk by 2030
Pharma faces $200B in revenue loss from LOE by 2030. The answer? Launch excellence. Strong performance of new launches will define the winners of the next decade.
October 1, 2025 at 5:53 PM
Genmab to Acquire Merus, Expanding Late-Stage Pipeline and Accelerating into a Wholly Owned Model

www.globenewswire.com/news-release...
Genmab to Acquire Merus, Expanding Late-Stage Pipeline and Accelerating into a Wholly Owned Model
Company Announcement Genmab to acquire Merus for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0...
www.globenewswire.com
September 29, 2025 at 6:20 AM
Xilio Therapeutics Announces Initiation of Phase 2 Trial for Efarindodekin Alfa (XTX301), a Tumor-Activated IL-12, and Achievement of $17.5 Million Development Milestone Under Exclusive License Agreement with Gilead

www.globenewswire.com/news-release...
Xilio Therapeutics Announces Initiation of Phase 2 Trial for Efarindodekin Alfa (XTX301), a Tumor-Activated IL-12, and Achievement of $17.5 Million Development Milestone Under Exclusive License Agreement with Gilead
Phase 1 data for efarindodekin alfa (XTX301) demonstrate promising anti-tumor activity in patients with advanced solid tumors Achievement of milestone...
www.globenewswire.com
September 11, 2025 at 5:37 PM
Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis

www.globenewswire.com/news-release...
Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces...
www.globenewswire.com
September 10, 2025 at 7:41 PM
Novo Nordisk to >> "streamline" << operations and reinvest for growth aka Cutting jobs so the spreadsheets look healthier than the employees.

www.globenewswire.com/news-release...
Novo Nordisk to streamline operations and reinvest for growth
Transformation to increase speed and redirect resources to growth opportunities within diabetes and obesity, aiming at reaching millions of untreated...
www.globenewswire.com
September 10, 2025 at 5:53 PM
investor.lilly.com/news-release...

I’ll have to keep an eye on that one
investor.lilly.com
September 9, 2025 at 5:14 PM
Ultragenyx Announces Positive Longer-term Data from Phase 3 Study of DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia (GSDIa)

www.globenewswire.com/news-release...
Ultragenyx Announces Positive Longer-term Data from Phase 3 Study of DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia (GSDIa)
At Week 96 participants experienced even greater reductions in daily cornstarch intake while maintaining low levels of hypoglycemia, improved levels of...
www.globenewswire.com
September 9, 2025 at 6:45 AM
Amgen and Kyowa Kirin Announce Top-Line Results From Rocatinlimab Phase 3 ASCEND Long-Term Extension Study in Adults With Moderate to Severe Atopic Dermatitis

www.globenewswire.com/news-release...
Amgen and Kyowa Kirin Announce Top-Line Results From Rocatinlimab Phase 3 ASCEND Long-Term Extension Study in Adults With Moderate to Severe Atopic Dermatitis
THOUSAND OAKS, Calif. and TOKYO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced preliminary...
www.globenewswire.com
September 9, 2025 at 6:45 AM
Data published in The New England Journal of Medicine demonstrate RYBREVANT®▼(amivantamab) plus LAZCLUZE®▼ (lazertinib) could re-set survival expectations in first-line EGFR-mutated advanced lung cancer

www.globenewswire.com/news-release...
Data published in The New England Journal of Medicine demonstrate RYBREVANT®▼(amivantamab) plus LAZCLUZE®▼ (lazertinib) could re-set survival expectations in first-line EGFR-mutated advanced lung cancer
Chemotherapy-free combination regimen has the potential to usher in new era for first-line treatment, with median overall survival projected to exceed four...
www.globenewswire.com
September 7, 2025 at 8:09 AM
Encaleret Showed Parathyroid Hormone-Independent Normalization of Blood and Urine Calcium in Phase 2 Proof-of-Concept Study in Post-Surgical Hypoparathyroidism

www.globenewswire.com/news-release...
Encaleret Showed Parathyroid Hormone-Independent Normalization of Blood and Urine Calcium in Phase 2 Proof-of-Concept Study in Post-Surgical Hypoparathyroidism
- 80% of post-surgical hypoparathyroidism participants achieved concomitant blood and 24-hour urine calcium in the normal reference range within 5 days of...
www.globenewswire.com
September 6, 2025 at 7:48 PM
New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD)

www.globenewswire.com/news-release...
New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD)
In AVONELLE-X, the largest long-term extension trial in nAMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on...
www.globenewswire.com
September 6, 2025 at 2:27 PM
Novo Nordisk to present new semaglutide data on ‘food noise’, body composition and cardiovascular benefits, as well as pipeline data at the EASD diabetes congress

www.globenewswire.com/news-release...
Novo Nordisk to present new semaglutide data on ‘food noise’, body composition and cardiovascular benefits, as well as pipeline data at the EASD diabetes congress
The INFORM real-world evidence study shows impact of semaglutide on reducing ‘food noise’, and the STEP UP clinical trial highlights semaglutide’s effect...
www.globenewswire.com
September 6, 2025 at 11:25 AM
RYBREVANT®▼ (amivantamab) plus LAZCLUZE®▼ (lazertinib) reduces acquired resistance versus osimertinib in first-line EGFR-mutated advanced non-small cell lung cancer

www.globenewswire.com/news-release...
RYBREVANT®▼ (amivantamab) plus LAZCLUZE®▼ (lazertinib) reduces acquired resistance versus osimertinib in first-line EGFR-mutated advanced non-small cell lung cancer
New data demonstrate amivantamab combination significantly reduces common EGFR and MET resistance mutations seen with EGFR TKIs1 BEERSE, BELGIUM , Sept. ...
www.globenewswire.com
September 6, 2025 at 9:01 AM
PathAI Expands Clinical Leadership - Announcing Partnerships with Mindpeak, Stratipath, and Primaa

www.globenewswire.com/news-release...
PathAI Expands Clinical Leadership - Announcing Partnerships with Mindpeak, Stratipath, and Primaa
BOSTON, Sept. 04, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in AI-powered digital pathology solutions and the developer of the market-leading...
www.globenewswire.com
September 4, 2025 at 5:04 PM
Arrowhead inks global licensing and collaboration deal with Novartis for ARO-SNCA, its preclinical siRNA therapy targeting alpha-synuclein in Parkinson’s disease. Arrowhead gets $200M upfront + up to $2B in milestones and royalties. Clinical trials coming soon. #RNAi
September 3, 2025 at 5:53 PM