SKYLARK sings: Sage, Biogen hatch positive phase 3 data in postpartum depression GO! Astellas picks up partner in convertibleCAR for backloaded $780M antibody project Bristol Myers Squibb, with new positive lupus data in hand, readies TYK2 inhibitor for final test Amgen's heart drug reduces cardiovascular disease risk factor in phase 2 trial BioMarin's hemophilia A gene therapy further delayed amid new FDA questions Sanofi’s Hemlibra rival gets step closer to approval with FDA breakthrough tag Who needs Humira? AbbVie projected to be the top pharma company by sales in 2028: analysts SEC reaches $628K settlement with SCWorx over 'false and misleading' COVID test scheme Startup Homeward inks partnership with Rite Aid to provide primary care in rural communities Pfizer, already flush with cash, will reap $16B from selling shares in GSK consumer health spinoff Featured Story | By Nick Paul Taylor Sage Therapeutics and Biogen have delivered a clear win for zuranolone in the phase 3 SKYLARK trial of women with postpartum depression (PPD), although questions about the commercial opportunity led to a muted response to the data. read more |
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Top Stories By Nick Paul Taylor Astellas has floored the accelerator on an immuno-oncology R&D project, putting down $20.5 million to team up with GO Therapeutics in a race to find antibodies with high affinity to two different glycoprotein targets. read more By James Waldron Bristol Myers Squibb will push its TYK2 inhibitor into phase 3 trials for lupus later this year off the back of positive midstage data as the drug awaits an FDA decision for psoriasis. read more By Annalee Armstrong Back in 2020, Amgen cast aside a cardiovascular disease hopeful from Cytokinetics and pointed the spotlight at a small interfering RNA treatment it thought could make up for the lost partnership. Now, in some limited phase 2 data, the pharma is making its case. read more By Max Bayer BioMarin’s commercial aspirations for its hemophilia gene therapy remain on ice after the FDA lobbed additional questions for the company to address, pushing back an expected approval submission to September. read more By James Waldron The FDA granted Sanofi’s hemophilia drug breakthrough status as the French pharma works toward challenging Roche’s blockbuster Hemlibra. The agency based the decision on data from the phase 3 XTEND-1 study. read more By Kevin Dunleavy Analysts surveyed by Evaluate Pharma predict AbbVie will generate more prescription drug sales than any company in 2028. They see AbbVie's $66 billion in expected 2028 sales closely followed by Roche at $65 billion. Johnson & Johnson, Merck and Pfizer round out the top 5 in their projections. read more By Andrea Park SCWorx agreed to a settlement with the SEC that will see it pay a $125,000 penalty and a disgorgement of $471,000, plus prejudgment interest of just over $32,700. read more By Heather Landi Two months after launching her new rural healthcare startup Homeward, former Livongo executive Jennifer Schneider, M.D., has landed a big partnership with retail pharmacy Rite Aid. read more By Angus Liu Pfizer intends to exit its stake in Haleon, the GSK consumer health joint venture that’s on track to become a standalone company, GSK said. The sale is expected to once again boost Pfizer’s cash position significantly. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA @Philly Cell and Gene Therapy Annual Conference 2022 June 17-18th 2022; King of Prussia, PA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 