STAT2 min read
STAT+: Pharmalittle: FDA Finds Problems At Novo’s Main U.S. Factory; Polarizing ALS Drug Heads For FDA Scrutiny
FDA inspectors issued a report detailing quality control lapses at Novo Nordisk's main factory in North America as early as May last year.
STAT2 min read
STAT+: Pharmalittle: Lilly Sues Spas And Compounders Over ‘Unapproved’ Mounjaro; Nasal-spray EpiPen Alternative Suffers Setback
Eli Lilly sued several compounding pharmacies, spas, and wellness centers for selling unapproved versions of Mounjaro.
STAT1 min read
STAT+: How A Cash-prize System That Phases Out Patents May Lower Drug Prices
"The idea here is you can still get a patent but it wouldn’t be implemented as a monopoly on a drug or vaccine or other medical technology."
STAT2 min read
STAT+: Pharmalittle: Cepheid Agrees To Sell A TB Test At Cost; Mallinckrodt Weighs Selling Some Or All Businesses
A company that makes a crucial TB test has agreed to sell its product at cost for use in poor countries.
STAT2 min read
STAT+: Pharmalittle: U.S. Chamber And Feds Clash On Medicare Price Negotiation; South Africa Probes J&J Over TB-drug Pricing
Chamber and government lawyers sparred over whether drugmakers have enough say in Medicare’s drug price-negotiation program.
STAT2 min read
STAT+: Pharmalittle: House Panel Inches Into Fixing Drug Shortages; Pharma Could Face Legal Action Over Improper Patent Listings
A House committee took a first step toward legislation to fix hospital drug shortages, but do not expect a new law soon.
STAT1 min read
Opinion: The Morally Ground-shifting Legacy Of Ian Wilmut And Dolly The Sheep
Ian Wilmut, the British scientist behind the first-ever cloning of a mammal, died Sept. 10, leaving behind a twofold legacy.
STAT2 min read
STAT+: Pharmalittle: White House Imposes Price Limits For Regeneron Covid Drug; Lawmakers Push Federal Agencies To Prevent Patent Abuses
A HHS deal for a Regeneron drug marks the first time the administration has directly used its leverage to challenge list prices.
STAT2 min read
STAT+: Pharmalittle: FDA Panel Says Popular Decongestant Doesn’t Work; U.S. Warns Companies Over Illegally Marketed Eye Products
The leading decongestant used by millions of Americans is no better than a dummy pill, FDA scientiific advisers concluded.
STAT1 min read
STAT+: Neurocrine Biosciences Drug For Congenital Adrenal Hyperplasia Succeeds In Late-stage Trial
Neurocrine Biosciences announced on Tuesday that an experimental drug for congenital adrenal hyperplasia succeeded in a late-stage trial.
STAT1 min read
STAT+: FDA Proposes Changes To Key Approval Pathway For Medical Devices, Five Years After Promising
The FDA issued new guidelines clarifying the way they plan to evaluate medical devices that go through the controversial 510(k) pathway.
STAT2 min read
STAT+: Pharmalittle: Is Pascal Soriot Leaving AstraZeneca? PBMs Try To Counter Congressional Crackdown
AstraZeneca appeared to play down speculation about CEO Pascal Soriot after a U.K. tabloid report that he was considering leaving.
STAT1 min read
STAT+: Pharmalittle: Biden’s NIH Nominee Will Get A Hearing; Top Democrat Backs Bill To Ban PBM Spread Pricing
President Biden’s nominee to lead NIH will get a hearing next month, perhaps thanks to a drug-pricing deal.
STAT1 min read
STAT+: Pharmalittle: Novartis R&D Hub’s Name Change Reflects Strategy Shift; Lilly’s Mounjaro Backed By U.K. Watchdog
Novartis is changing the name — and the guiding strategy — of its research and development hub in Cambridge, Mass.
STAT1 min read
STAT+: Lawsuit Raises Antitrust And Kickback Allegations Around Cancer Patient Referrals
Oncologists in Philadelphia are alleging Jefferson Health system is violating federal antitrust and kickback laws by creating a “concerted campaign to eliminate” the group’s “presence in the oncology marketplace.”
STAT1 min read
Not Yet Free From Heroin’s Grip, An ‘Honest, Funny Man’ Finds His Way Off The Streets
“Maybe somebody is not yet ready for recovery, but that does not mean that they don’t deserve safety and peace and rest.”
STAT2 min read
STAT+: Pharmalittle: South Africa ‘Bullied’ Into One-sided Covid Vaccine Deals; Astellas Drops Medicare Price-negotiation Suit
Vaccine contracts show South Africa was “bullied” into one-sided deals with Covid-19 shot suppliers.
STAT1 min read
STAT+: Amazon’s Chief Medical Officers On Where The Company’s Health Care Bets Are Headed Next
“If we're going to do it, let's make sure we're leveraging things that Amazon does really well, which is connecting buyers and sellers,” said Nworah Ayogu, Amazon Clinic’s chief medical…
STAT2 min read
STAT+: Pharmalittle: Novartis Is Losing Its Chief Commercial Officer; Vaccine Experts Urge More Inclusivity In Clinical Trials
Novartis is losing its chief commercial officer, Marie-France Tschudin, who has been seen as a rising star.
STAT1 min read
STAT+: Graduate Students Accuse University Of California Of Wage Theft, Just Months After Strike Was Settled
University of California students expected big pay hikes after an unprecedented strike, but they say it hasn't worked out that way.
STAT2 min read
STAT+: Pharmalittle: Novartis Is Latest Drugmaker To Sue Over Medicare Negotiations; Illumina Names A New CEO
Novartis sued in an attempt to halt Medicare drug-price negotiations, which include its top-selling heart-failure medicine Entresto.
STAT2 min read
STAT+: Pharmalittle: How 98 Days May Cost J&J Big Bucks; Walgreens CEO Departs
J&J's Stelara was approved 98 days too early to qualify for an exemption from Medicare drug-price negotiations.
STAT2 min read
STAT+: Pharmalittle: U.S. Pharma Layoffs Continue To Climb; Senators Push Insulin Makers For Details Of Low-cost Programs
Layoffs in the U.S. pharmaceutical industry dipped in August, but the total for 2023 to date continues to outpace 2022.
STAT2 min read
STAT+: Pharmalittle: Winners And Losers From Medicare Drug-negotiation List; Novo Strikes Deal To Keep Lead In Weight-loss Drugs
On Tuesday, the U.S. government named 10 medicines that will be subject to Medicare price negotiations in 2026.
STAT1 min read
Opinion: How Learning The Truth About Chaos Theory Has Helped Me As An Inpatient Child Psychologist
A new understanding of the butterfly effect has changed how one inpatient child psychologist approaches her patients.
STAT2 min read
STAT+: Pharmalittle: U.S. Se­lects First 10 Drugs For Medicare Price Ne­go­ti­a­tions; Pfizer May Soon Restart Tornado-hit Plant
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a
STAT1 min read
STAT+: Winners And Losers From Medicare’s List Of Drugs Subject To Price Negotiation
Here's a look at winners and losers from Medicare’s newly released list of drugs subject to price negotiation.
STAT2 min readAmerican Government
STAT+: Pharmalittle: FTC Suspends Challenge To Amgen Deal For Horizon; AstraZeneca Is Latest To Challenge Medicare Drug Negotiations
The U.S. Federal Trade Commission suspended its challenge to Amgen's $27.8 billion acquisition of Horizon Therapeutics.
STAT1 min read
STAT+: Pharmalittle: This Fall’s COVID Booster Rollout; Approval For Pfizer’s RSV Vaccine
Good morning Pharmalittle students. This is Allison DeAngelis, filling in for Ed Silverman while he’s away from the Pharmalot campus. I debated assigning you a “What I did on my…
STAT1 min read
STAT+: Pharmalittle: Mid-year Price Hikes For U.S. Drugs Reaches New Heights; Onetime Biotech CEO Vivek Ramaswamy Sparks Debate At GOP Debate
Good morning, Pharmalittle readers. Reporter Andrew Joseph here filling in for Ed from STAT’s London outpost, where we’re feeling a bit of panic having just looked at the calendar and…
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