‘Only 13 calls to make’: a Q&A with executive search firm partner Darren Raycroft on diversity in the biotech C-suite Altimmune ditches COVID-19 nasal spray vaccine, halts therapeutic enrollment after trial setbacks Pfizer spinout Cerevel sees stock double on success of early phase schizophrenia trial Sponsored: The Far-Reaching Value of Deeply Understanding the Patient Journey Gilead files long-acting HIV med for patients running out of options Roche and Atea's small, early data peek sees experimental COVID drug slash viral load in hospital patients ArriVent raises $150M to bring Chinese drugs to Western markets Moderna locks up Spikevax name in Europe, joins Pfizer's Comirnaty in wait for official brand approval in U.S. OIG: CMS lacks the teeth to ensure hospitals are ready for emerging infectious diseases Medtronic kicks off virtual clinical research app with afib study Featured Story By Annalee Armstrong Just 13 CEOs are women out of 224 surveyed small-cap biotechs in a new report on board and executive compensation from the Bedford Group/Transearch. The study covered publicly traded companies with market caps below $2 billion with headquarters in the U.S. read more |
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| Top Stories By Kyle LaHucik After not-so-promising results from a phase 1 trial, Altimmune is scrapping its COVID-19 vaccine nasal spray candidate and stopping further enrollment in a COVID-19 therapeutic program. The news comes just as the Delta variant picks up steam around the world. read more By Nick Paul Taylor Cerevel Therapeutics’ schizophrenia prospect has impressed in a phase 1b clinical trial, triggering a 136% surge in the stock price. The Pfizer spinout is now preparing to move into phase 2 and looking into additional indications including dementia-related psychosis. read more Sponsored by: Alexion An experiential learning program where Alexion employees “walk in the shoes” of patients to deepen understanding of the rare disease journey and develop impactful solutions. Learn more about LEAP. read more By Amirah Al Idrus As Gilead works with Merck to combine their long-acting HIV drugs, the antiviral giant is hustling its prospect as a single therapy to the FDA. The treatment, lenacapavir, could become a new hope for patients whose infection has evaded current treatments and who have few options. read more By Ben Adams Infectious disease biotech and Fierce 15 winner Atea Pharmaceuticals alongside partner Roche have shown their antiviral can cut the viral load of SARS-CoV-02 in ill patients, though more data from a bigger trial will be needed to detail the level of success. read more By Nick Paul Taylor ArriVent Biopharma has raised up to $150 million to in-license assets from China and other emerging biotech hubs and develop them for use in other markets. The biotech has already picked up ex-China rights to an EGFR TKI that it plans to study in non-small-cell lung cancer (NSCLC) patients in the U.S. read more By Beth Snyder Bulik Moderna has officially earned European Medicine Association approval for Spikevax as its COVID-19 vaccine brand name. Now, it joins Pfizer and BioNTech’s Comirnaty and AstraZeneca’s Vaxzevria, all with European name approvals, in awaiting a U.S. nod. read more By Dave Muoio A new watchdog report commended CMS' design of preparedness requirements for emergencies like COVID-19, but found that enforcement requires the agency to have more authority over the private accreditation organizations that survey hospitals. read more By Andrea Park With the COVID-19 pandemic still making it difficult to initiate studies in research centers, virtual clinical studies have become all the rage—and Medtronic is hopping on the bandwagon. read more | Health Care Is Home Care From study drug administration to blood draws, Marken’s fully integrated home healthcare solutions make participation in clinical research as simple as possible for patients. Learn more. | Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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. Diversity, Equity & Inclusion Week August 9-11, 2021 | Virtual Event Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA |