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Regulatory
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Japanese shield and coronavirus

Shionogi’s COVID-19 antiviral pill fails again to impress MHLW panel for conditional approval

July 26, 2022
By Tamra Sami
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir.
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Patent gears

PTO eyes revised subject matter eligibility guidance for patents

July 26, 2022
By Mark McCarty
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
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IC-8 Apthera IOL box

Acufocus secures FDA approval for Apthera lens

July 26, 2022
By Annette Boyle
The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.
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US appeals court denies copay help for only treatment for rare heart disease

July 26, 2022
By Mari Serebrov
Although Pfizer Inc. has the only drugs approved in the U.S. to treat a rare, progressive heart disease, the U.S. Court of Appeals for the Second Circuit agreed this week with the Department of Health and Human Services, and a lower court, that Pfizer’s proposed copay assistance program for middle-income Americans covered by Medicare would violate the federal Anti-Kickback Statute – even if the company has no “corrupt” intent.
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FDA Approved stamp with blister pack

FDA approvals down by 20%

July 26, 2022
By Karen Carey
The U.S. FDA has approved fewer drugs and biologics in the first half of 2022 than in each of the five prior years and only one new molecular entity has received clearance since the end of May. While the volume of regulatory news is slightly down from last year, FDA approvals are showing a much deeper decline of 19.8%.
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Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 26, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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Regulatory actions for July 26, 2022

July 26, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Northeast Scientific.
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Regulatory actions for July 26, 2022

July 26, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, B.More, Bridgebio, Hookipa, Lepu, Matinas, Medexus, Qbiotics, Veru.
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Gavel and scales

Life sciences face ever-increasing exposure to False Claims Act litigation in 2022

July 25, 2022
By Mark McCarty
The U.S. Department of Justice has been intensely focused on illicit billings to federal government agencies, so much so that the agency reclaimed more than $500 million in the first half of calendar year 2022 under the False Claims Act. However, 80% of that amount came from companies in the life sciences, a fact which combines with pending federal and state legislation to amplify the risk for these companies in the coming years, according to a new report by the law firm of Gibson Dunn & Crutcher, LLP.
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WTO arbitrators side with EU in pharma dispute with Turkey

July 25, 2022
By Mari Serebrov
Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU.
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