Pfizer’s $3.3 billion acquisition of King eliminates the primary opportunity for investors to play in the abuse-resistant formulation space and renewed questions about the logic of perpetual expansion atop Big Pharma. But the realities of the abuse resistant marketplace suggest it makes a good case for scale and diversity. Is this a sign of things to come in other drug classes?
By Michael McCaughan and Cole Werble
When Sanford Bernstein analyst Tim Anderson was called upon during Pfizer Inc.'s Oct. 12 conference call to discuss a...
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Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
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 developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
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.
