How Five Prime suitor Amgen battled multiple companies for the biotech—and won Idera's TLR9 drug flunks melanoma phase 3, tanking stock Medigene loses CMO after slashing staff, blood cancer program In Partnership: Meeting the challenge to deliver COVID-19 relief around the world Pfizer ships out two cancer ADCs alongside its tech platform to Pyxis Oncology, and its familiar CEO Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues Takeda bags mRNA translation modulators in $120M Anima deal UBiome co-founders charged with fraud by SEC How a map of cell signaling networks could identify new targets for pain drugs Fierce Pharma Asia—Pfizer's China biosim retreat; WuXi Bio's buying spree; Fujifilm's $2B plant Chutes & Ladders—Cloonan quits Sage to pursue CEO post as bluebird CMO heads for exit Featured Story | By Ben Adams It’s that time when the company bought out by a parent files the saga with the SEC, and, with Amgen and Five Prime Therapeutics, we found out Amgen was not the only interested party. read more |
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Top Stories By Nick Paul Taylor Idera Pharmaceuticals’ TLR9 agonist has failed to improve on Yervoy in a phase 3 melanoma trial. The miss on the objective response rate endpoint sent shares in Idera down 55%, but the biotech is yet to give up on the drug. read more By Amirah Al Idrus Medigene's chief medical officer and chief development officer, Kai Pinkernell, is bidding the immuno-oncology biotech adieu. His departure comes two months after the company culled a blood cancer program and six months after it revealed it would cut its staff by about 25%. read more In Partnership With: AmerisourceBergen Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis. read more By Ben Adams The hype around antibody-drug conjugates (ADCs) has been growing in recent years after big bucks deals and approvals from the likes of AstraZeneca/Daiichi and Immunomedics putting a spotlight on the approach. read more Sponsored By: Catalent Cell & Gene Therapy Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays. read more By Nick Paul Taylor Takeda has teamed up with Anima Biotech to discover mRNA translation modulators. The Japanese drugmaker is set to pay up to $120 million in upfront fees and preclinical research milestones to work with Anima on the treatments for genetically defined neurological diseases. read more By Conor Hale The founders of microbiome-testing startup uBiome have been charged with defrauding investors out of $60 million by convincing them it was a successful business before being forced to shutter operations, declare bankruptcy and flush all its assets in late 2019, according to the Securities and Exchange Commission. read more By Angus Liu Scientists at the University of Texas at Dallas created maps of the pain “interactome” that display likely signaling networks between tissues and neurons that send pain signals to the brain. They used the maps to show that inhibiting the ErbB family of proteins with Novartis' Tykerb could block pain signals in mice. read more By Angus Liu Pfizer pulled the plug on three biosimilar programs in China amid crowded market and sold a plant to WuXi Biologics. The Chinese CDMO also bought a near-100% stake in a local rival. Fujifilm picked Holly Springs, North Carolina to build its $2 billion cell culture facility. And more. read more By Fraiser Kansteiner Delix has tapped a Shire neuro veteran as its new CEO. Sage's chief operating officer is stepping down to pursue a CEO post. And bluebird's CMO is hitting the exit amid the company's gene therapy problems. read more Resources Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. 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Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Global Clinical Quality April 7-8, 2021 | Virtual Event Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
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