STAT Plus: AC Immune bets that its Alzheimer’s trial design could provide a cleaner test of the amyloid hypothesis
The fate of aducanumab, a potential Alzheimer’s treatment from Biogen, is widely seen as the…
Category: STAT Plus
STAT Plus: Lawmakers’ coronavirus response means delays for drug pricing legislation
WASHINGTON — Before the coronavirus pandemic became Congress’ sole focus, late May was widely viewed…
STAT Plus: New drug from Merck, Bayer reduces hospitalizations for heart failure patients
An experimental drug from Merck and Bayer cut hospitalizations for heart failure by 10% in…
STAT Plus: Pharmalittle: Conservative group pushes for malaria drug approval for Covid-19; OTC drug industry to get an overhaul
And so, another working week will soon come to a close. Not a moment too…
STAT Plus: Could real-world evidence help shape the future of drug development?
Real-world evidence has been generating a stir in the world of drug development — and…
STAT Plus: DEA proposes new rule to approve new suppliers of marijuana for research
After years of inactivity, the Drug Enforcement Administration has finally taken steps toward approving more…
STAT Plus: Congress set to overhaul the way the U.S. regulates over-the-counter drugs
WASHINGTON — The over-the-counter drug industry is about to get overhauled. Congressional lawmakers tucked a…
STAT Plus: Pharmalittle: Gilead asks FDA to rescind orphan status for Covid-19 drug; Bristol delays MS drug launch due to coronavirus
Good morning, everyone, and how are you today? We hope you are finding ways to…
STAT Plus: STAT Plus video chat: Biotech in uncharted territory
Every corner of the biotech industry is being impacted by the coronavirus pandemic. There will…
STAT Plus: Digital therapy for chronic insomnia gains FDA signoff
The U.S. Food and Drug Administration has authorized the use of a digital product that…
STAT Plus: Bristol’s MS drug approval is good news for shareholders but patients will have to wait
A new multiple sclerosis medicine from Bristol Myers Squibb (BMY) was approved Thursday by the…
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STAT Plus: The tables are turned: Chinese regulator scolds a U.S. company for drug-manufacturing problems
The shoe is on the other foot, so to speak. For the past few years,…
STAT Plus: Pharmalittle: Scientists say coronavirus is not mutating significantly; WHO is asked to pool Covid-19 patent rights
Hello, everyone, and welcome to the middle of the week. Under the circumstances, this is…
STAT Plus: Bellus Health hopes to be one of biotech’s more improbable turnarounds
About a dozen years ago, Bellus Health was teetering on the brink of insolvency after a would-be…
STAT Plus: Pharmalittle: Pharmacy boards limit prescriptions for drugs touted by Trump; Nearly half of trial sites expect disruptions
Hello, everyone, and how are you this morning? Despite the chaos, we are hanging in…
STAT Plus: Despite investments and advocacy, pharma’s still making its drugs in batches that can take months — rather than continuously. Why?
WASHINGTON — Former FDA Commissioner Scott Gottlieb said so-called continuous manufacturing would prevent drug shortages,…
STAT Plus: An Indian drug maker is slammed by FDA for tossing ‘cartloads of trash bags’ filled with documents
Amid global anxiety over the novel coronavirus, a newly issued warning letter by the Food…
STAT Plus: AbbVie waives all worldwide restrictions on making generic copies of its Kaletra HIV pill
In an unexpected development, AbbVie (ABBV) is waiving restrictions on licenses held by a nonprofit…
STAT Plus: Startup Spotlight: Carisma Therapeutics wants to make a cell therapy that will work in solid tumors
When Michael Klichinsky was rotating through University of Pennsylvania hospitals as a pharmacy student more…
STAT Plus: Pharmalittle: Researchers identify 70 drugs for possibly fighting Covid-19; Gilead pauses access to experimental drug
Good morning, everyone, and how are you today? We hope the weekend break was something…
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STAT Plus: Congress’s coronavirus stimulus package contains plenty of unrelated wins for the health industry
WASHINGTON — A $1 trillion stimulus proposal unveiled Thursday evening by Senate Majority Leader Mitch…
STAT Plus: Pfizer’s top-selling vaccine won’t prevent Covid-19, but could get a boost because of it
Vaccines tend to get a bad reputation among biotech investors. Which makes it easy to…
STAT Plus: Pharmalittle: Trump adviser slams PhRMA pushback against ‘American-made’; drug makers boost production of malaria pill for Covid-19
And so, another working week will soon draw to a close. Not a moment too…
STAT Plus: Preventing other Shkreli-like debacles may not save the government much money
After Martin Shkreli took a 5,000% price hike on a decades-old medicine and thwarted rivals,…
STAT Plus: ‘Organ-on-a-chip’ maker Emulate names new CEO, announces new funding
A Boston startup known for its plastic chips that simulate human organs announced the appointment…
STAT Plus: Biotech in the time of the coronavirus: Disruptions continue, but there’s some good news, too
Back again with another semi-regular column on the Covid-19 pandemic. You can read my first…
STAT Plus: Pharmalittle: WHO to launch expansive coronavirus clinical trial; FDA halts some domestic inspections
Rise and shine, everyone, another intense day is on the way. The world seems to…
STAT Plus: How to rebrand a clinical trial? For one study, Instagram influencers and a dash of wit go a long way
For the better part of four years, Samantha Meltzer-Brody has been trying to recruit thousands…
STAT Plus: Pharmalittle: Blood samples are lacking for coronavirus treatments; Europe counters Trump offer to vaccine maker
Good morning, everyone, and welcome to the middle of the week. You made it this…
STAT Plus: Sage has a backup plan for its depression drug: Three new studies aiming for 2022 approval
After meeting with the Food and Drug Administration, Sage Therapeutics said Wednesday that it will…
STAT Plus: Despite coronavirus disruption, major microbiome companies are cautiously optimistic about upcoming data
This was supposed to be the microbiome’s breakthrough year — and pandemic or not, it…
STAT Plus: Biotech in the time of the coronavirus: A semi-regular column on the outbreak’s impact on drug makers
This is the first in a series of semi-regular columns on the Covid-19 pandemic. In…
STAT Plus: Pharmalittle: FDA gives states an OK to authorize coronavirus tests; more companies race to combat Covid-19
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT Plus: Merck drug reduces cough frequency but taste alterations could cloud prospects
An experimental pill from Merck significantly reduced the frequency of chronic coughing compared to a…
STAT Plus: Global spending on drugs may hit $1.1 trillion by 2024, but the rate of growth is forecast to slow
Global spending on prescription medicines is forecast to increase between 2% and 5% annually over…
STAT Plus: As the market craters, Keros Therapeutics files for an IPO
Keros Therapeutics is filing for an IPO, according to plans made public Monday — a…
STAT Plus: Mallinckrodt loses a court case and is told to pay $650 million in overdue Medicaid rebates
In a setback to Mallinckrodt (MNK), a federal court judge upheld a move by the…
STAT Plus: Novartis is scolded by Finnish regulators over hospital sales of a migraine drug
Regulators in Finland threatened to fine Novartis (NVS) for violating laws governing the distribution of…
STAT Plus: Pharmalittle: Will countries nationalize anti-coronavirus supplies? Pandemic halts some academic labs
Good morning, everyone, and welcome to another working week. This week, however, ushers in a…
STAT Plus: To quell unpredictable allergic reactions, an experimental drug takes aim at a genetic cause, not symptoms
The last time Melanie Wardell was thrown into anaphylactic shock, an ad for Macy’s was…
STAT Plus: Trump official behind health data rules has a message for privacy critics: Try helping patients, instead of your bottom line
For the past year, Don Rucker has been in the middle of one of the…
STAT Plus: Pharmalittle: Drug makers scramble to develop Covid-19 vaccines; Qiagen vows to ramp up production of test chemical
And so, another working week will soon draw to a close. Not a moment too…
STAT Plus: Will Trump’s new plan to cap insulin costs in Medicare actually save seniors much money? It’s complicated
WASHINGTON — The Trump administration claims its newest plan to cap insulin copays could solve…
STAT Plus: Two dead, four hospitalized after receiving Open Biome stool transplants
Two people died and four were hospitalized after they received stool transplants from OpenBiome, the…
STAT Plus: Kymera announces $102 million in new funding to develop treatments for diseases such as blood cancers
Four years after it was founded, Kymera Therapeutics said Thursday that it has now raised…
STAT Plus: Pharmalittle: A move to fund U.S. production of pharma ingredients; White House issues ‘principles’ for drug pricing reform
Good morning, everyone, and how are you today? We are coping, thank you, despite the…
STAT Plus: Hospitals turn to big tech companies to store and analyze their data — leaving patients in the dark on privacy protections
The nation’s largest hospital systems are rapidly shifting sensitive health data into cloud storage platforms…
STAT Plus: Engage touts long-awaited positive data for its inhaler for seizures
After scrabbling for early financing, Engage Therapeutics has some positive clinical data to show the…
STAT Plus: Danish regulator eyes sanctions — including prison time — against trial sponsors that fail to post results
In the latest effort toward greater clinical trial transparency, the Danish Medicines Agency is threatening…
STAT Plus: Under pressure, Trump administration looks to cap insulin costs with a Medicare program
The Trump administration announced a new voluntary program that would lower the out-of-pocket cost Medicare…