AstraZeneca's $39B Alexion buyout bears fruit, yielding late-phase win for potential blockbuster rare disease drug Inovio heads to Brazil for phase 3 COVID-19 vaccine trial, months after U.S. sent biotech packing Sesen, still reeling from FDA rejection, pulls filing for EU approval of cancer drug Replimune axes CMO role and CMO Pirzkall along with it Neurogastrx assembles ex-Ironwood team with $60M to take on jam-packed gastrointestinal market Preclinical DiCE Molecules will roll its dice to Wall Street amid biotech IPO frenzy NovaRock takes stomach cancer program global through Flame BioSciences deal worth up to $640M Unraveling the link between migraines and protection against diabetes Pfizer taps McKinsey veteran Malik as its new dealmaking czar Insurers take cue from providers, begin requiring vaccines for employees Synchron bags $10M NIH grant to kick off U.S. trial of brain implant that uses thoughts to navigate digital apps Featured Story | By Nick Paul Taylor The chances of AstraZeneca’s $39 billion bet on Alexion paying off just ticked up a notch. ALXN1840, a drug Alexion has hailed as a potential blockbuster, has hit the primary endpoint in a phase 3 rare disease trial, clearing the path for filings for approval. read more |
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Top Stories By Annalee Armstrong Inovio will take a trip to sunny Brazil to run a phase 3 trial testing a COVID-19 vaccine, months after the U.S. turned off the lights for the late-stage study. The Plymouth Meeting, Pennsylvania-based company received authorization from Brazilian health officials to run the phase 3 portion of the phase 2/3 trial called Innovate which will test the company’s vaccine INO-4800. read more By Nick Paul Taylor The rapid unraveling of Sesen Bio goes on. Two weeks ago, the biotech was on the cusp of winning FDA approval for cancer drug Vicineum and working its way toward authorization in Europe. Now, with the FDA rejecting Vicineum days before a media report of misconduct, Sesen has pulled its filing to the European Medicines Agency. read more By Ben Adams In a strange and seemingly out of nowhere change-up, immuno-oncology biotech Replimune is culling its chief medical officer role and its incumbent. read more By Kyle LaHucik Neurogastrx is attempting to go up against a long-standing class of GERD drugs and others in the gastrointestinal disorder space. The biotech now has $60 million to bankroll a phase 3 study in erosive esophagitis and an ongoing phase 2 trial in patients with gastroparesis. read more By Kyle LaHucik DiCE Molecules raised $60 million in a series C extension on Tuesday. The next day, the eight-year-old preclinical biotech filed for an initial public offering to take its oral small-molecule therapeutics into the clinic. read more By Amirah Al Idrus NovaRock Biotherapeutics is taking its antibody programs global through a new partnership. For $7.5 million upfront and a potential $633 million in milestones, the New Jersey-based biotech is licensing a treatment it’s developing for pancreatic and stomach cancers to Pennsylvania’s Flame BioSciences. read more By Kyle LaHucik University of Tennessee researchers found that the peptides behind migraine pain can trigger insulin production in mice, and the study could lead to better methods for preventing or treating diabetes. read more By Angus Liu Pfizer has found a new top dealmaker to manage its war chest, rapidly swelling with cash from its COVID-19 vaccine. Aamir Malik from McKinsey & Company will replace retiring Chief Business Officer John Young, who helped orchestrate the BioNTech pact. read more By Paige Minemyer Major insurers are beginning to follow in the footsteps of big-name providers in mandating COVID-19 vaccines for their workforces. read more By Andrea Park A newly awarded grant from the National Institutes of Health is just the cherry on top of an already groundbreaking year for Synchron, which received the go-ahead from the FDA to begin the first U.S. trial of its brain-computer interface technology last month, mere weeks after reeling in $40 million to fund the study. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. The MedTech Conference 2021 September 27 - 30, 2021 DPHARM: Disruptive Innovations in Clinical Trials September 28-29, 2021 | Boston, MA w/Virtual Option Let A Digital Sherpa Uncomplicate The Path for Patients Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 | 