WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST A safety scare and the pausing of AstraZeneca’s trial have sparked some reassessments of the race for a COVID-19 vaccine—and may affect the course of other shots using the same viral vector approach. But while clinical holds aren’t necessarily rare, the importance of getting it right and maintaining the global public’s trust in this moment are paramount to success. In a bid to do so, the CEOs of the leading vaccine developers have taken a joint pledge to not file for FDA approval until they’ve taken the time to successfully complete larger phase 3 studies. Those stories and more follow below. | |
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Featured Story | By Nick Paul Taylor AstraZeneca has put clinical development of its COVID-19 vaccine on hold in response to an adverse event, sparking a reassessment of the race to bring a coronavirus prophylactic to market. read more |
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Top Stories Of The Week By Amirah Al Idrus BioNTech and partner Pfizer have been working on four vaccine candidates against COVID-19, snagging FDA fast-track tags for two of them and pushing one into a 30,000-patient phase 3 study. Now, the duo is adding a fifth shot on goal, slated to enter a phase 1/2 study this month. read more By Eric Sagonowsky Moderna and its investors amid the COVID-19 pandemic, starting with initial vaccine research back in January and progressing to a phase 3 trial this summer at record speed. Now, analysts with SVB Leerink think challenges and competition lie ahead, and they're cautioning investors to the risks. read more By Eric Sagonowsky In the wake of stunning news yesterday that AstraZeneca paused its phase 3 COVID-19 vaccine trial due to a serious safety issue, analysts across the biopharma landscape set out to answer questions, and lay out possible scenarios, about how the race could play out from here. read more By Arlene Weintraub Pfizer and its partner BioNTech said Wednesday that their most advanced COVID-19 vaccine candidate produced neutralizing antibodies against the virus in macaques, as well as T cell responses that are believed to be an indicator of a strong immune attack. The data formed the basis of the current phase 2/3 trial in people. read more By Nick Paul Taylor The CEOs of all the leading Western developers of COVID-19 vaccines have vowed to only file for FDA approval after demonstrating safety and efficacy in phase 3. The pledge comes amid reports that the Trump Administration is pushing for a vaccine to be approved before the November election. read more By Arlene Weintraub The French Competition Authority has levied fines against Novartis and Roche over allegations they improperly marketed macular degeneration drug Lucentis over Roche’s similar and less expensive drug Avastin. It couldn't come at a worse time for Novartis, which is trying to gain traction for its new eye drug, Beovu. read more By Angus Liu With last month’s $2.3 billion Japanese consumer health sale to Blackstone Group, Takeda has arguably achieved its $10 billion divestment goal. But the Japanese pharma is showing no sign of stopping with the selloffs anytime soon, having penned a new, $562 million deal with Cheplapharm focused on Europe and Canada. read more By Conor Hale LabCorp announced plans to launch a new at-home COVID-19 diagnostic that allows people to also get tested for the flu and respiratory syncytial virus from a single sample. read more By Beth Snyder Bulik Novartis has renamed AveXis to Novartis Gene Therapies in a nod to the significance of that business for its future. The swap also nixes a scandal-related name that dragged Novartis and its breakthrough gene therapy Zolengensma through the mud before being cleared of any wrongdoing by the FDA. read more By Ben Adams It’s a good day for Shanghai-based I-Mab, which has penned a $2 billion upfront-biobucks R&D deal with AbbVie while also nabbing $418 million from investors. read more By Fraiser Kansteiner On the heels of an April gene therapy expansion, Merck KGaA and MilliporeSigma are at it again, this time with a scheme to ratchet up antibody-drug conjugate manufacturing capacity through a $65 million addition to the company's Madison, Wisconsin, site, teeing up a new commercial building and 50 new hires. read more |  | Webinar: Accelerating Pharma’s Evolution Towards a Perfect Omnichannel Engagement September 15, 2020 | 11am ET / 8am PT | Presented by: WNS Global Services This webinar reviews the current strategies to better engage with HCPs and patients and covers practical considerations for achieving a perfect omnichannel marketing experience. Panelists will also discuss about the enablers which makes omnichannel experience possible including the types of data needed, and the role AI and predictive analytics play. Register now. |
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