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Lonza to Sell Capsule & Health Ingredients Unit to Lone Star for $3B
Lonza will retain a 40% equity position in the business.
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Sanofi Bets $1.53B on Sino Biopharm Oral JAK/ROCK Inhibitor
The drug is approved in China as treatment for myelofibrosis, but Sanofi wants to explore its potential to treat cGVHD.
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Digital, Continuous and Data-Rich
Advances in technologies, data, and development strategies are reshaping how oral solid dosage drugs are designed and manufactured, with a clear emphasis on lowering cost, shortening timelines, and improving quality and ...
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Aardvark Pauses Prader-Willi Trials in Wake of Cardiac Concerns
The company observed reversible cardiac issues in healthy volunteers who were taking above target therapeutic doses.
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Novo Nordisk to Invest $510M in Ireland Tableting Facility for Oral GLP-1s
The company will use the investment to turn Ireland into a hub for producing high-quality oral medications to distribute outside the U.S.
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Merck Releases Data from Phase 3 Trials for HIV Drug Regimen
If approved, DOR/ISL may provide an important new option to help meet the evolving treatment needs of people living with HIV.
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Genentech Releases Positive Phase 3 Data for Oral BTK Inhibitor
Results are comparable to another phase 3 trial, solidifying the oral drug’s potential to become the first BTK inhibitor for relapsing multiple sclerosis.
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Vanda Gets FDA Nod for Schizophrenia, Bipolar Antipsychotic Tablet
Bysanti, an atypical antipsychotic, is expected to become commercially available in Q3 2026.
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FDA Issues CRL for Disc Rare Disease Drug, Despite National Priority Voucher
The FDA says it needs to see the results of the phase 3 Apollo study, which is currently in progress, before it is able to come to a decision.
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Altesa BioSciences Closes $75M Series B to Advance Oral COPD Drug
The drug saw positive results in a previous study, reducing symptoms and the duration of illness in COPD patients with a rhinovirus infection.
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Sanofi Expands India Global Capability Center
The expansion will create one of the top three pharmaceutical GCCs in India.
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Angles of Insight: Exploring the Geometry of XRPD
X-ray powder diffraction provides a window into the crystalline structure, enabling developers to identify and quantify phases with precision.
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PTC Withdraws FDA Submission for Duchenne Drug
Per the FDA, Translarna does not meet the threshold of evidence of effectiveness and is unlikely to receive approval.
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FDA Removes 'Black Box' Label from Menopause Drugs
The action removes risk statements related to cardiovascular disease, breast cancer and probable dementia.
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Compass Psychedelic Shows Efficacy, Durability in Treatment-Resistant Depression
Based on the data, Compass has submitted a request for a meeting with the FDA to discuss a rolling submission and review.
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IMA Buys ProSys to Boost Isolation Offerings
Ireland-based ProSys will continue to operate as an independent business.
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Novo Threatens Legal Action Over Hims Knockoff Wegovy Pill
The drugmaker has cited concerns about the safety, quality and effectiveness of the compounded GLP-1.
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White House Launches TrumpRx DTC Prescription Drug Portal
Currently, TrumpRx offers 43 drugs from five companies to treat a variety of conditions.
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FDA Hands Aquestive CRL for Oral Allergy Drug, Citing Packaging Issues
Issues with opening the pouch and film placement could be dangerous for patients suffering from anaphylaxis.
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Bayer Factor XIa Inhibitor Cuts Stroke Risk by 26%
The trial is the first phase 3 study of a Factor XIa inhibitor which demonstrated superiority in reducing recurrent ischemic stroke.
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January/February 2026
2026 Annual Buyer’s Guide
2026 Annual Buyer’s Guide
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