The fallout of the Covid-19 pandemic is still playing out more than two and a half years after it began, and the newest effects impacting the biopharma industry fall directly on real estate.

Real estate developer BXP said Wednesday that it acquired a building in Cambridge, MA from Biogen for $592 million. The building, located at 125 Broadway in Cambridge, MA, is in Cambridge’s biotech hub in Kendall Square, home to other companies such as Thermo Fisher Scientific and Moderna.

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The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy Planning in advance to continuously deliver data that illustrate value and post-launch, to not only the regulator, but payers, healthcare professionals, and patients results in more clinically meaningful benefits By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met

While it’s been only a few days since more manufacturers of generic Adderall capsules announced upcoming shortages, the FDA is also raising concerns on the issue.

The regulator announced that there was a shortage of the immediate release version of the generic, which treats ADHD and narcolepsy.

In a statement, the FDA said it is in communication with all manufacturers, with Teva reporting to the agency that it is experiencing “ongoing intermittent manufacturing delays.” The FDA estimates that some products will return to stock this month, but some won’t be on the market until November or December.

Drug pricing watchdog ICER keeps its eye on what price point a drug is best suited for based on clinical benefit — and the group’s newest draft report takes a closer look at MS treatments compared to a new one awaiting the FDA’s final say.

The watchdog focused on TG Therapeutics’ new, potential blockbuster ublituximab, which is pending FDA review, and compared it to other classes of disease-modifying therapies (DMTs, as ICER calls them) that are currently on the market.

The FDA put all of its highest-ranking CDER officials on display Monday in the first day of a two-and-a-half-day hearing on whether to pull Covis Pharma’s pre-term birth drug Makena (hydroxyprogesterone caproate) and its generic versions from the market.

After winning an accelerated approval in 2011, Makena failed to beat placebo on neonatal morbidity and mortality from complications of preterm birth in a confirmatory trial ending in 2018, and a prior adcomm in 2019 voted to pull the drug as Covis has continued to fight back.

Pfizer is taking a hotly-contested kickback case all the way to the Supreme Court, with a petition filed late last week seeking to overturn a lower court decision that barred the Big Pharma from providing financial assistance to help Medicare beneficiaries access its drug for a rare and fatal cardiac condition.

The lower courts went too far in their “sweeping interpretation” of the anti-kickback statute, Pfizer contends, noting that the view of HHS and the courts put “everyday interactions with participants in the federal health system in the statute’s crosshairs.”

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Attempting to push forward an ALS drug despite a failed Phase III study, Biogen saw its FDA review date delayed Monday.

The big biotech announced that the agency pushed back its decision deadline by three months to April 25, 2023 for tofersen, an antisense drug designed to treat a genetic subset of ALS. Biogen had previously received priority review for the application, which will fall under the accelerated approval pathway.

On a continual search for more baskets to put its oncology eggs in, Gilead has landed on a hot target: CD123.

Specifically, Gilead is grabbing a bispecific antibody from MacroGenics, a seasoned biotech player that’s seen its share of setbacks. For $60 million upfront, Gilead buys an exclusive option to license MGD024 after MacroGenics wraps up the ongoing Phase I study and calls dibs on two other early-stage bispecific research programs.

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SpringWorks Therapeutics is tackling the little-known and misunderstood rare desmoid tumor condition — and connecting with patients.

Striking images on the “Rethink Desmoid Tumors” campaign website show the unpredictable and tendril-like desmoid tumors growth. The landing page shows a woman sitting on the floor holding her right bicep while a long wiry root-like growth winds out and across the floor in front of her.

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More than two years after Milestone Pharmaceuticals’ stock got hammered after their lead heart drug flopped in a crucial Phase III study, the biotech is looking for some redemption now that its redesigned Phase III pivotal has come through with positive results.

Milestone went public $MIST back in 2019 on the back of a plan to create a self-administered nasal spray version of a calcium channel blocker to treat cases of paroxysmal supraventricular tachycardia (PSVT) — nonfatal bursts of heart rate that often send patients running to the ER.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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