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Volume 16 Issue 1
 
Regional News

FDA’s Marks takes over vaccines office as agency prepares to part ways with 2 key officials

Amid the heated debate over COVID-19 booster shots, two key FDA vaccine experts said they'd be leaving the agency last month. In an effort to smooth over the transiti...
29 September 2021 Regional News booster shots | Center for Biologics Evaluation and Research
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Regional News

Former Mylan executive pleads guilty to insider trading that netted him $4.27M

A former Mylan executive has pleaded guilty to an insider trading scheme that netted him $4.27 million. After leaving the company in 2017, Dayakar Mallu received info...
22 September 2021 Regional News FDA | insider trading
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Regional News

Biogen beefs up in biosimilars—again—with FDA nod for Samsung-partnered Lucentis copycat

Even as Biogen dominates biopharma headlines with its high-profile Aduhelm launch, the company's budding biosimilar business has been quietly building up—and now, it ...
22 September 2021 Regional News Biogen | biosimilars
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Regional News

Pfizer plans to seek FDA nod for COVID-19 shot in kids 5 to 11 after positive data

With coronavirus cases on the rise among children, Pfizer and BioNTech brought welcome news on Monday, reporting their COVID-19 vaccine is safe and generated a strong...
22 September 2021 Regional News COVID-19 | FDA
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Regional News

ALS Ice Bucket Challenge advocacy group calls for speedy FDA approval of Amylyx now-pending drug

The ALS Association, known for its Ice Bucket Challenge fundraising, is pushing for a speedy FDA approval of Amylyx's now-pending ALS candidate submission—but is hist...
16 September 2021 Regional News ALS Ice Bucket Challenge | Amylyx
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Regional News

Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval

Friendly epinephrine? Meet Neffy, ARS Pharmaceuticals’ nasal spray epinephrine to treat severe allergic reactions to food, medicines and insect bites. Neffy, now awa...
8 September 2021 Regional News Anaphylaxis | ARS Pharma
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Regional News

Key vaccine leaders departing FDA as COVID-19 booster questions linger

Two key vaccine leaders will leave the FDA this fall, just as the agency faces key decisions over COVID-19 booster shots and as variants take a bite out of the shots’...
1 September 2021 Regional News booster | COVID-19
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Regional News

FDA approval of Pfizer’s COVID-19 vaccine spurs American confidence: Harris Poll

Last week's FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people. A Harris Poll survey over the weeke...
1 September 2021 Regional News COVID-19 | FDA
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Regional News

Manufacturing issues force delay for PolarityTE’s skin repair hopeful

Manufacturing issues are common with regenerative medicines. And so it goes for PolarityTE's investigational new drug submission for SkinTE. On Tuesday the Salt Lake...
25 August 2021 Regional News chemistry manufacturing and control | FDA
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Regional News

Merck’s Welireg scores FDA nod in cancers spurred by rare disease—and its label is broader than expected

Merck’s $1.1 billion bet on Peloton Therapeutics is starting to pay off. Belzutifan, one of the most lucrative assets Merck picked up through its 2019 Peloton buy, s...
18 August 2021 Regional News Belzutifan | central nervous system
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