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Tuesday, October 11, 2022 | 2pm ET / 11am PT Drug rebates are complex and the subject of legislative influence, creating a uniquely challenging ecosystem where gaps in knowledge, data and technology can create challenges. Register now to learn how manufacturers can respond quickly to changes in policies. 
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‘Politically motivated’: Sublingual delivery firm hits back against SEC fraud complaint Zooming in on clinical data, SpyGlass links drug-eluting lenses to 45% drop in eye pressure Eyeing nicotine replacement market, Qnovia bags $17M to take inhaled delivery device into the clinic Ocugen sniffs out COVID-19 vaccine opportunity, landing rights to nasal candidate with India authorization |
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Wednesday, October 19th 2022 | 2:00 PM ET / 11:00 AM PT Products are being studied for multiple indications while also being developed in multiple presentations. Planning for success has now become multi-dimensional, and organizations must continue to stay launch ready. Register now. 
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| By Nick Paul Taylor The Securities and Exchange Commission has charged a sublingual drug delivery company and its CEO with an alleged offering fraud that raised $6.6 million. The company, Vivera Pharmaceuticals, hit back against what it says are “meritless allegations” made in a “politically motivated” litigation filing. |
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By Nick Paul Taylor SpyGlass Pharma has reported early human data on its drug-eluting intraocular lens. The first-in-human clinical trial linked the bimatoprost delivery devices to a 45% reduction in intraocular pressure in patients with open-angle glaucoma or ocular hypertension. |
By Nick Paul Taylor Qnovia has secured the funding to take its lead inhaled drug delivery candidate into the clinic, rounding up $17 million in series A funding to start testing its nicotine replacement therapy in humans next year. |
By Nick Paul Taylor Ocugen has secured exclusive regional rights to an intranasally delivered COVID-19 vaccine, positioning it to advance an intervention that already has emergency authorization in India toward the market in other parts of the world. |
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This playbook looks at why insolubility is an issue, and the properties that affect solubility, such as the molecule’s structure; its physical attributes (particle size and dissolution rate); its chemical attributes, including compatibility with excipients; and its biological properties. Download now. 
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By Fraiser Kansteiner Kite's viral vector plant in Southern California has been cleared for liftoff, and, with that, the Gilead company is touting its position as the only cell therapy player able to make in-house viral vectors for both its pipeline prospects and pair of commercial CAR-Ts. |
By Max Bayer Merck's Keytruda has dazzled since first nabbing approval in 2014, earning billions of dollars in revenue and expanding its reach to more than a dozen cancers. But as the drug's patent expiration nears, can Merck manufacture a second clinical lightning strike? |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk with many of the Fierce 15 honorees to find out what makes them unique. We also share highlights from the Fierce Biotech Summit on gene editing innovations and battling biotech's bear market. |
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Lipid-based drug delivery systems have found widespread acceptance for development of drug products containing APIs, posing developability challenges for formulators. Download to learn more. 
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