STAT+: FDA and Covis release dueling documents over the fate of a controversial drug for premature births
In the run-up to an extremely unusual hearing later this month, newly released documents underscore…
Category: Pharmalot
STAT+: Pharmalittle: Vertex exec says prices for gene therapies are ‘in the ballpark’; insulin access in poor countries remains spotty
Rise and shine, everyone, another busy day is on the way. And this is especially…
STAT+: ‘Patchy efforts’ by major insulin makers mean access lags in many poor countries
The three companies that dominate the global market for insulin have launched various programs to…
STAT+: Pharmalittle: Nobel awarded for novel chemistry used in drug development; Biden will nominate surgeon general for WHO post
Good morning, Pharmalitte students. I’m Allison DeAngelis, substituting for Ed today. It’s a rainy day…
STAT+: Pharmalittle: U.S. Supreme Court asks solicitor general for views on ‘skinny label’ case; Express Scripts and Kroger are mired in dispute
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT+: Pharmalittle: Price of new ALS drug prompts criticism; many drug price hikes exceeded U.S. inflation rate
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Many trials to confirm benefits of drugs granted accelerated approvals are running late
Amid heightened debate over a regulatory program for speeding the approval of some medicines, a…
STAT+: Pharmalittle: FDA approves a medicine to combat ALS; Medicare drug-price talks are poised to become a legal battle
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Pharmalittle: Medicare plans sizable infrastructure for negotiating drug prices; Alzheimer’s data also boost Roche and Lilly
Rise and shine, everyone, another busy day is on the way. We can tell by…
STAT+: Pharmalittle: Biogen Alzheimer’s drug slowed cognitive decline in a trial; European pharma warns energy costs may halt some generic production
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT+: Lilly is accused by the federal government of discriminating against older sales reps
In an unusual move, the U.S. Equal Employment Opportunity Commission has filed a lawsuit accusing…
STAT+: Pharmalittle: Democrats concede on passing ‘clean’ FDA funding bill; Biogen whistleblower nets $250 million
Good morning, one and all. Damian here, filling in for Ed Silverman once more. Here…
STAT+: Pharmalittle: GSK picks its first female CFO; Pfizer advances Omicron booster for kids
Good morning, everyone. Damian Garde here, filling in for Ed Silverman at the outset of…
.jpg)
STAT+: Some European regulators are starting to take steps to ensure clinical trial results are reported
Regulators in half a dozen European countries are now taking steps to enforce requirements that…
STAT+: Pharmalittle: U.S. drug net prices fell nearly 8% in the second quarter; FDA panel favors fecal-based therapy for bacterial infections
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Solicitor general recommends Supreme Court shouldn’t review an Amgen patent case
In a setback to Amgen, the U.S. solicitor general recommended that the Supreme Court not…
STAT+: Inflation caused another big drop in net drug prices, analysis finds
Amid ongoing debate over the cost of prescription medicines, a new analysis finds that brand-name…
STAT+: Pharmalittle: Biogen ALS drug trial yields mixed signals; Novartis makes U.S. growth its top priority
Hello, everyone, and how are you today? A dank cloudy cover greeted us this morning,…
STAT+: Pharmalittle: FDA scolds Catalent over quality control at plant making Covid shots; Novartis will ask SCOTUS to protect a key patent
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it…
STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines
Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the…
STAT+: Pharmalittle: Haleon argues it’s not liable for any Zantac claims; FDA steps up surprise inspections in India
Top of the morning to you, and a fine one it is. Crystal clear blue…
STAT+: Pfizer accused of running a fellowship program that discriminates on racial grounds
In a move reflecting simmering controversy over diversity and equity, Pfizer has been accused of…
STAT+: Pharmalittle: Advances in treating the sickest Covid patients have stalled; Moderna aids WHO effort to develop mRNA coronavirus shots
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Pharmalittle: CRISPR-based drug shows promise in preliminary study; FDA user fee program prompts fresh worries over conflicts
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Brazil dismisses antitrust complaint against Gilead over pricing for a hepatitis C drug
In a victory for Gilead Sciences, Brazilian antitrust authorities dismissed a complaint filed by several…
STAT+: Pharmalittle: Swiss authorities probe Novartis over patent used to block rivals; Medicare underserves older Americans with opioid use disorder
Rise and shine, everyone, another busy day is on the way. This morning is getting…
STAT+: Swiss authorities raid Novartis offices seeking info on patents used to block rivals
The Swiss Competition Commission has begun an investigation into Novartis over the possible unlawful use…
STAT+: Pharmalittle: Pharma pursues the ‘dream’ of online prescribing; EC chief under fire over Pfizer vaccine contract
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it…
STAT+: Pharmalittle: Biden picks biotech exec to lead new biomedical research agency; FDA to hold meeting for OTC birth control pill
Hello, everyone, and how are you today? The skies over the Pharmalot campus remain gloomy…
STAT+: Pharmalittle: FDA approves new type of psoriasis drug; U.S. starts late-stage trial to test an antiviral against monkeypox
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: USDA starts cracking down on companies that ship animals without timely inspections
Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research…
STAT+: J&J wins a partial appeal against the U.K.’s cost-effectiveness watchdog over ‘unfair’ review
In an unusual turn of events, an appeals panel ruled that the U.K.’s cost effectiveness…
STAT+: Pharmalittle: FDA approves a new wrinkle drug; running remote clinical trials can save pharma money
And so, another working week will soon draw to a close. Not a moment too…
STAT+: What disclosure? Clinical trials run in Canada fail to take basic steps toward transparency
Amid ongoing controversy over clinical trial transparency, a new analysis found that just 3% of…
STAT+: Even before Covid-19, remote trials saved money. Will pharma now rely on them more than ever?
Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, according…
STAT+: Pharmalittle: FDA advisers recommend approval of controversial ALS drug; judge rules against coverage of HIV prevention drugs
Rise and shine, everyone, another busy day is on the way. We can tell by…
STAT+: Pharmalittle: FDA holds rare second meeting over an ALS drug; U.S. to expand distribution for monkeypox vaccine
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT+: Pharma donations to patient charities may violate the ‘spirit’ of anti-kickback laws
There is a federal law that prohibits drug companies from directly covering out-of-pocket spending by…
STAT+: Bayer agrees to $40 million settlement over kickbacks and downplaying drug safety risks
After nearly two decades of litigation, Bayer agreed to pay $40 million to settle a…
STAT+: Pharmalittle: Illumina deal for Grail is blocked after EU veto; CVS buys Signify to expand into house calls
Good morning, everyone, and nice to see you again after a much-welcomed and extended break…
STAT+: Pharmalittle: Illumina faces more challenges after winning FTC case; Novo Nordisk buys Forma Therapeutics
Good morning, everyone. I’m Jason Mast, the last of the understudies filling in while Ed…
STAT+: Pharmalittle: FDA authorizes new Covid boosters; a setback for federal efforts to regulate stem cell clinics
Good morning. This is Jonathan with you once more. We’re now close enough to the…
STAT+: Pharmalittle: An emerging star in biotech investment; U.S. government expected to stop paying for Covid shots next year
Good morning from San Diego. I’m Jonathan Wosen, STAT’s West Coast biotech reporter, and I’m…
STAT+: Pharmalittle: FDA expected to authorize new Covid-19 boosters; Biden administration signs a deal to support monkeypox vaccine manufacturing
Good morning, everyone. I’m Allison DeAngelis, and I’m here to lead you through Tuesday’s news….
STAT+: Pharmalittle: The ‘godfather’ of biotech trying to save Biogen; pharma companies grapple with ADHD drug shortages
Happy Monday, folks — Allison DeAngelis here. Ed is away from the Pharmalot campus this…
STAT+: Pharmalittle: Moderna sues Pfizer over Covid-19 vax patents; White House directs quick access to federally funded research
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Centene agrees to pay $33 million to resolve another state probe into its pharmacy benefits business
Centene, one of the largest health insurers in the U.S., agreed to pay $33 million…
STAT+: Pharmalittle: House report shows Trump sought to pressure FDA on Covid response; Pfizer Covid pill provides little benefit to younger adults
Rise and shine, everyone, another busy day is on the way. Or will it be…
STAT+: Pharmalittle: AstraZeneca may exit the vaccine business; Bavarian Nordic looks at expired monkeypox vax doses to boost supplies
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it…
STAT+: Pharmalittle: Biden plan to stretch monkeypox vax supplies hits problems; Pfizer and BioNTech ask FDA to clear Covid shot for variants
Top of the morning to you, and a fine one it is. After a much-needed…