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BioWorld - Monday, April 27, 2026
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Patent gears

Australian government unveils framework for a patent box to offset R&D for drugs and devices

Aug. 17, 2021
By Tamra Sami
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
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ICMRA advises on AI regulatory challenges

Aug. 17, 2021
By Mari Serebrov
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
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ICER report makes case for atopic dermatitis drugs

Aug. 17, 2021
By Mari Serebrov
As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
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FDA sets out 2022 menu of fees

Aug. 16, 2021
By Mari Serebrov
New PDUFA, BsUFA and GDUFA user fees go into effect Oct. 1 in the U.S.
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ICMRA advises on AI regulatory challenges

Aug. 16, 2021
By Mari Serebrov
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
Read More
Psychiatric disorders illustration

Beckley Psytech raises $80M in upsized B round as first psychedelic programs enter the clinic

Aug. 16, 2021
By Cormac Sheridan
DUBLIN – Beckley Psytech Ltd. raised $80 million in an oversubscribed series B round to move its early stage pipeline of psychedelic therapies into the clinic and to continue research on novel compounds with enhanced properties.
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Patent gears

Australian government unveils framework for a patent box to offset R&D for drugs and devices

Aug. 13, 2021
By Tamra Sami
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
Read More
Vaccine administration

FDA allows mRNA vaccine booster for some immunocompromised patients

Aug. 13, 2021
By Lee Landenberger
The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc.
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Biden drug-pricing agenda more a direction than a roadmap

Aug. 12, 2021
By Mari Serebrov
Reiterating prescription drug pricing provisions included in an executive order issued in July, U.S. President Joe Biden provided a bit of context and a little more detail about what he has in mind during a brief Aug. 12 speech on how his “Build Back Better” agenda would lower drug prices. Part of that agenda is to allow Medicare to directly negotiate prescription drug prices. “The only thing Medicare is not allowed to negotiate are prices for prescription drugs. My plan gets rid of that prohibition,” Biden said, adding that Medicare negotiates every other health care cost.
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New India rule on active substances expected to have minimal impact on companies, at least for now

Aug. 12, 2021
By T.V. Padma
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
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