Kala buys time by selling eye disease drugs to Alcon for $60M BD inks deal to work with syringe material at the sweet spot between glass and plastic Zealand pumps up its prospects with late-phase rare disease hit With inhaled version of Tyvaso, United Therapeutics sniffs a potential blockbuster Dermavant looks to dethrone topical steroids with first FDA approval for Vtama in psoriasis Syringe maker ApiJect reels in $111M in private investment round Most influential people in biopharma—the regulators and advocates 'The Top Line' podcast: The aftermath of Roche's failed TIGIT, Big Pharma's Q1 growth vs. mRNA stars, plus this week's headlines Featured Story | By Nick Paul Taylor Alcon has expanded its portfolio of eye disease products by paying $60 million upfront for the rights to two commercial products based on mucus-penetrating particle drug delivery technology. The sale of the assets extends Kala Pharmaceuticals’ cash runway past phase 2/3 data on another drug candidate. read more |
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Top Stories By Nick Paul Taylor BD has turned to Mitsubishi Gas Chemical to look into ways to improve the delivery of biologics, signing a letter of intent that positions it to assess its partner’s alternative to glass for prefilled syringes. read more By Nick Paul Taylor Zealand Pharma has opened up a new frontier for its struggling glucagon analog dasiglucagon, linking the pump-delivered therapy to improved outcomes in kids with congenital hyperinsulinism (CHI) in a phase 3 clinical trial. read more By Kevin Dunleavy The FDA has signed off on an inhaled dry powder version of United Therapeutics' Tyvaso. After FDA delays, the company is set to reap rewards for the drug that treats people with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). read more By Fraiser Kansteiner Psoriasis newcomer tapinarof could be as big for dermatology as the pivot from analog cassettes to high-quality digital streaming. That’s according to Dermavant chief executive Todd Zavodnick, who sat down virtually with Fierce Pharma ahead of the company’s “game-changer” approval Tuesday. read more By Joseph Keenan ApiJect, which was founded in 2015 to make safe, cheap prefilled syringes for developing countries, hauled in $111 million in a private round of investment. read more By Eric Sagonowsky,Annalee Armstrong,Max Bayer,Angus Liu As the biopharma industry develops increasingly specialized treatments, regulators are being forced to adapt. And at the same time, the industry is making strides toward becoming more inclusive. These are the most influential regulators and advocates in biopharma. read more By Teresa Carey This week on "The Top Line," we discuss what's left in the wake of Roche’s failed high-risk bet on an anti-TIGIT cancer drug. We also talk about Big Pharma’s growth in the first quarter and the week's biggest headlines. Plus, Fierce journalists share what it was like to finally be in a newsroom together again. 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: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Free Virtual Event Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Fierce Health Payer Summit October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Drug Development Boot Camp® 2022 November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA | 