A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.
|Articles|February 1, 2004
- BioPharm International-02-01-2004
- Volume 17
- Issue 2
Editorial—BioPharm Reflects the Industry
Author(s)Carol L. Fisher
Welcome to the inaugural issue of the new BioPharm International. We are pleased to unveil our new logo and redesign after collaborating for four months with award-winning designer Virginia Dickens of Vision Advertising. One of our redesign goals was for the magazine to reflect the same innovative, cutting-edge qualities that are characteristic of the evolving biopharm industry. Probably more important to you is how the new format will better accommodate the expression of your day-to-day challenges.
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Welcome to the inaugural issue of the new BioPharm International. We are pleased to unveil our new logo and redesign after collaborating for four months with award-winning designer Virginia Dickens of Vision Advertising. One of our redesign goals was for the magazine to reflect the same innovative, cutting-edge qualities that are characteristic of the evolving biopharm industry. Probably more important to you is how the new format will better accommodate the expression of your day-to-day challenges.
Carol L. Fisher
We understand you must juggle the development of new technologies while streamlining operations. You create strategic alliances that require your adjustment to new business paradigms. You build cGMP-compliant plants and strive to meet FDA guidelines and requirements. You implement new business models to ensure rewarding career paths for your employees and long-term value for the shareholders. Then there's the science — the foundation of your professional existence and the primary focus of BioPharm International.
We've added new elements to make BioPharm the first "must-read" publication on your desk. Global News Network offers developments most likely to affect your professional efforts. You'll know how regions, states, and countries are preparing to become the next biotech hubs by reading Regional Round-Up and International BioMarket
Besides upgrading the magazine, we've made changes to our website (
The staff has evolved too. With the addition of Ivette Litt as art director, the transition of BioPharm headquarters from Eugene, OR to Iselin, NJ is complete. Ivette bravely accepted the task of introducing the redesign while also preparing the 21 CFR Part 11 supplement.
Michael McGregor recently joined the team as senior editor in charge of news, supplements, and primers. Previously, Michael worked with the Manisses Communications Group, Princeton Review, and Brown University. Peter Silverberg, associate editor, trained at MIT in chemical engineering and has extensive editorial experience plus a broad base of practical knowledge as a chemical and analytical engineer.
BioPharm appreciates your challenges, and we intend to support you with the most sophisticated tools, processes, and staff in the business.
Carol L. Fisher, Editor in Chief
BioPharm International
Articles in this issue
almost 23 years ago
Site Expansion - Regional Round-Up: Virginiaalmost 23 years ago
Qualification of Raw Materials for Biopharmaceutical Usealmost 23 years ago
Outsourcing Report: Big Pharma Promises to Focus on Productivityalmost 23 years ago
Costing Issues in the Production of Biopharmaceuticalsalmost 23 years ago
Canada: On the Biopharmaceutical Fast Trackalmost 23 years ago
The State of Intellectual Property in Canada: Pending and Spendingalmost 23 years ago
Site Expansion - Regional Round-Up: MarylandAdvertisement
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FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
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