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Home » Topics » Pharmaceuticals

Pharmaceuticals
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Astellas and Sutro Ink Collaboration and Licensing Deal Over iADCs

June 30, 2022
Sutro will receive an upfront payment of $90 million to develop iADCs for three biological targets. Read More

EU Approves Sanofi’s Xenpozyme and Nexviadyme

June 30, 2022
The FDA granted a Breakthrough Therapy designation to olipudase alfa, but it has yet to approve the drug. Nexviadyme, branded as Nexviazyme in the U.S, is already FDA-approved. Read More

FDA Expands Approval of Vivus’ Qsymia for Chronic Weight Management in Obese Teenagers

June 30, 2022
The FDA is requiring a risk evaluation and mitigation strategy (REMS) for Qsymia because of the risk of birth defects from fetal exposure during pregnancy. Read More

Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

June 30, 2022
Gilead is seeking approval of lenacapavir for treatment of HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. Read More

FDA Posts Final Guidances on Adjuvant Therapies for Renal Cell and Bladder Cancer

June 30, 2022
The FDA outlined its latest thinking for sponsors of adjuvant therapies for renal cell and bladder cancer in two guidances released yesterday. Read More

One Hundred Lawmakers Urge HHS to Help Lower Prescription Drug Prices

June 30, 2022
In a letter to HHS Secretary Xavier Becerra, 100 members of Congress called for the use of several controversial federal authorities — including compulsory licensing, “march-in rights” and royalty-free rights — to help lower the prices of prescription drugs. Read More

FDA Releases Guidance on ‘Fit-for-Purpose’ Clinical Outcome Assessments

June 30, 2022
In its latest guidance on patient-focused drug development, released yesterday, the FDA calls for high-quality clinical outcome assessments (COAs) for drug trials. Read More

Sanofi Drops Monthly Out-of-Pocket Insulin Cost to $35 for Uninsured Patients Amid Controversy Over Insulin Prices

June 30, 2022
Sanofi will begin offering 30-day supplies of its insulin products to uninsured patients in the U.S. for $35 on July 1, the company announced Wednesday. Read More

Oklahoma Settles With Three Opioid Distributors at Over $250 Million

June 29, 2022
The state plans to use the settlement to help fund addiction prevention and treatment programs. Read More

EU Expands Approval of Novartis’ Cosentyx for Pediatric Arthritis

June 29, 2022
Cosentyx, a human interleukin-17A antagonist, is also FDA-approved. Read More

Ipsen Acquires Epizyme in Initial Deal Worth $247 Million

June 29, 2022
Ipsen plans to seek FDA approval for Tazverik in combination with rituximab and lenalidomide for second-line follicular lymphoma. Read More

FDA Puts Clinical Hold on Astellas Late-Onset Pompe Disease Clinical Trial

June 29, 2022
Astellas said the site investigator has classified the serious adverse event as “mild in severity.” Read More
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