Move over Facebook, pharma marketers are getting hip to TikTok. Amgen and AstraZeneca are two of the newest — with branded work for co-marketed severe asthma med Tezspire — joining the influx of pharma companies piloting marketing efforts on the social video channel.
Amgen and AZ debuted their effort by adopting popular TikTok trends to better connect with users. For instance, the team is using the “Tell me without telling me” trend in its newest post in which a young woman says, “Tell me you have severe asthma without telling me. I’ll go first.” She then runs down a daily checklist including checking air quality, never leaving home without her inhaler and taking the Tezspire her allergist added to her treatment plan.
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Key takeaways:
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.
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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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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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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An $8 billion exit from Eli Lilly and a short-lived stint heading up oncology work at the Big Pharma post-Loxo sale have persuaded Josh Bilenker to be hush-hush about his new venture, which ever-so-slightly broke cover last year and remains almost 100% under wraps, save for investor names.
Bilenker, who was a life sciences VC investor prior to Loxo and before that, a medical officer at the FDA, is working on a 130-employee startup with co-founder Jeffrey Engelman, the former head of oncology at Novartis Institutes for BioMedical Research. The CEO and CSO duo put out word Monday morning that KKR led an expansion to its existing pool of backers for Treeline Biosciences, which they claim is focused on the “outer edge of scientific possibility.”
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Geneticist and serial entrepreneur Dietrich Stephan had hoped that his antisense oligonucleotide platform at NeuBase Therapeutics could expand the field that Ionis pioneered to new areas. But in the end, he concluded now is not the right time to explore it.
NeuBase has decided to shift its whole focus to gene editing, deferring preclinical activities for antisense programs targeting myotonic dystrophy type 1, Huntington’s disease and KRAS-mutant cancers.
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Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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