Few biotechs are acquired by their partners -- only about a half dozen in each of the last two years, making the Bayer acquisition of Algeta an exception to the rule. Like other recent billion-dollar partner acquisitions, expectations for subsequent performance seem high.
Pharma companies use a variety of means to become familiar with emerging candidates and technologies, including partnership and corporate venture investment. Only very rarely do they go on to seal the deal by acquiring their own partner or investment, demonstrating a vast preference for acquiring other companies’ partners and investments ([A#2012900190]).
Algeta ASA proved an exception to the rule, when it disclosed on Dec. 19 that its board recommended shareholders...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
