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Novo Nordisk Inks $2.1B Deal with Vivtex for Oral Obesity, Diabetes Meds
Novo Nordisk brings to the deal its expertise in peptide and protein therapeutics, whereas Vivtex will be licensing its oral drug-delivery technologies. read more
Vanda Gets FDA Nod for Schizophrenia, Bipolar Antipsychotic Tablet
Bysanti, an atypical antipsychotic, is expected to become commercially available in Q3 2026. read more
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. read more
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. read more
Sanofi Expands India Global Capability Center
The expansion will create one of the top three pharmaceutical GCCs in India. read more
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. read more
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. read more
FDA Removes 'Black Box' Label from Menopause Drugs
The action removes risk statements related to cardiovascular disease, breast cancer and probable dementia. read more
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. read more
IMA Buys ProSys to Boost Isolation Offerings
Ireland-based ProSys will continue to operate as an independent business. read more
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. read more
White House Launches TrumpRx DTC Prescription Drug Portal
Currently, TrumpRx offers 43 drugs from five companies to treat a variety of conditions. read more
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. read more
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. read more
Ardena Divests Sweden API Site to Nanologica
The Södertälje site offers CDMO services with a focus on small molecule APIs for programs from early development to commercial manufacturing. read more
Pharming Group Hit with CRL for Joenja Use in Kids with APDS
The drug is approved for adults with the rare primary immunodeficiency, but the agency has raised concerns of underexposure in kids of lower weight. read more
Antidumping and Countervailing Duty Investigation of Hard Empty Capsules
Recent developments could significantly affect capsule sourcing and pricing for U.S. buyers and manufacturers. read more
Administration Delays Launch of DTC Prescription Drug Portal
TrumpRx looks to gain drug prices comparable to other developed countries through deals with pharma companies on blockbuster drugs. read more
How Animal Welfare Bolsters Research Reliability
One element that is sometimes overlooked is data integrity from in vivo testing. Specifically, is data garnered from stressed species valid and/or reliable? Is it reproducible? read more
Making 2026 Pop
Much like the winemakers who learned to harness pressure rather than fear it, OSD manufacturers are leveraging advances in manufacturing processes, formulation science, excipients and packaging technologies. read more

January/February 2026

2026 Annual Buyer’s Guide
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