STAT+: After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug
In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug…
Category: legal
STAT+: Former Celgene shareholders claim Bristol Myers reaped a $6.4 billion windfall by delaying a drug approval
A lymphoma drug that was approved later than expected by regulators is at the center…
STAT+: What’s in a name? Spark Therapeutics sues Bluebird Bio over the use of the word ‘spark’
A promotional campaign has sparked a legal dispute between Spark Therapeutics and Bluebird Bio (BLUE)…
STAT+: Brazil’s Supreme Court rules that patent extension rules are unconstitutional
The Brazilian Supreme Court ruled that a provision in the country’s intellectual property law allowing…
STAT+: Sanofi is accused of ‘widespread destruction’ of company e-mails tied to Zantac recalls
As litigation proceeds over the Zantac heartburn pill and a possible carcinogen, a court filing…
STAT+: Incyte pays $12.6 million to resolve claims it paid drug kickbacks through charity
Incyte (INCY) agreed to pay $12.6 million to settle allegations that donations amounted to kickbacks…
STAT+: Gilead sues Russia over a compulsory license issued to a company making remdesivir
Amid worldwide clamoring for Covid-19 vaccines and other therapies, Gilead Sciences (GILD) last month filed…
A new book traces the roots of the opioid crisis through the secretive Sackler family
The family behind the OxyContin maker Purdue Pharma was already under intense legal and public…
STAT+: A drug maker sues a medical journal, its editor, and several authors for libel
In an unusual move, Pacira Biosciences (PCRX) has filed a libel lawsuit against a medical…
STAT+: A U.S. appeals court upholds the FTC view of controversial pay-to-delay settlements
In what is being called a win for consumers, a U.S. appeals court upheld a…
STAT+: Brazilian judge temporarily suspends pharmaceutical patent extensions amid push to lower drug costs
A Brazilian Supreme Court judge suspended extensions for pharmaceutical patents in the country, and although…
Judge rules Purdue must answer questions about documents showing any link between OxyContin, birth defects
A federal judge has given a green light to lawyers representing children with birth defects…
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STAT+: Bristol Myers agrees to pay $75 million to settle allegations of underpaying Medicaid rebates
After years of litigation, Bristol-Myers Squibb (BMY) agreed to pay $75 million, plus interest, to…
STAT+: FTC seeks to block Illumina from buying Grail, citing threats to competition
The Federal Trade Commission is once again trying to block Illumina, a dominant maker of…
Universities launch opioid litigation archive to ‘ensure history doesn’t repeat itself’
After two decades in which opioid overdoses claimed more than 400,000 lives in the U.S.,…
STAT+: AbbVie accuses a company of recruiting an employee in order to steal Humira secrets
Two years ago, a manufacturing team leader at AbbVie (ABBV) took a similar job at…
‘The public is being denied the truth’: A legal expert blasts Purdue’s bankruptcy plan to end opioid lawsuits
Earlier this week, Purdue Pharma filed a bankruptcy plan that would have some members of…
SEC charges co-founders of shuttered microbiome startup uBiome with $60 million fraud
Federal authorities on Thursday charged two co-founders of uBiome, a microbiome startup that rose to…
STAT+: Pharma wins a round in a battle with HHS over a drug discount program for hospitals
In a victory for the pharmaceutical industry, a federal judge temporarily blocked the federal government…
STAT+: Insulin makers win a significant round in Minnesota lawsuit accusing them of racketeering
In a setback to efforts to control insulin prices, a U.S. court judge tossed key…
STAT+: Insulin makers win a significant round in Minnesota lawsuit accusing them of racketeering
In a setback to efforts to control insulin prices, a U.S. court judge tossed key…
STAT+: Pharmalittle: U.S. sits on millions of AstraZeneca vaccine doses; WTO again fails to act on Covid-19 proposal
And so, another working week will soon draw to a close. Not a moment too…
Opinion: Choosing the right director for the U.S. Patent and Trademark Office can help lower drug prices
As the Biden administration fills key Cabinet positions, its attention must turn to other critical…
Opinion: Reining in drug patents isn’t a silver bullet against high drug prices
One of the top orders of business for the Biden administration is curbing drug prices….
STAT+: Ohio attorney general sues a health plan over its PBM contracts and Medicaid costs
In the latest bid to pull back the curtain on pharmacy benefit managers, the Ohio…
Opinion: Instead of prior authorization, insurers should go back to the old ‘pay-and-chase’ model
The news Jennifer G. and her husband got from her medical team was devastating. If…
STAT+: New Mexico attorney general accuses Gilead of blocking competition to its HIV medicines
The New Mexico attorney general has filed a lawsuit against Gilead Sciences (GILD) and two…
Andrew Cuomo’s Covid-19 nursing home fiasco shows the ethical perils of pandemic policymaking
WASHINGTON — The humbling of New York Gov. Andrew Cuomo on pandemic policy has been…
STAT+: A U.S. court ruling may force biologics makers to review patent protections
In a decision with broad implications for the pharmaceutical industry, a U.S. appeals court recently…
Opinion: Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA
Ever since the Food and Drug Administration granted emergency use authorization for two new vaccines,…
‘Held to ransom’: Pfizer plays hardball in Covid-19 vaccine negotiations with Latin American countries
Pfizer has been accused of “bullying” Latin American governments during negotiations to acquire its Covid-19…
STAT+: Bristol Myers and Sanofi ordered to pay $834 million to Hawaii for withholding Plavix label
After years of litigation, a Hawaii court judge ordered Bristol Myers Squibb (BMY) and Sanofi…
STAT+: Drug maker agrees to plead guilty to hiding and destroying records before FDA inspection
A unit of Fresenius Kabi, a major supplier of infused and intravenously administered drugs, has…
STAT+: To delight of generic drug makers, federal appeals court tosses controversial ‘skinny labeling’ decision
In a surprising move, a federal appeals court panel may revisit a controversial decision that…
McKinsey agrees to $573 million settlement over advice given Purdue and other opioid makers
The McKinsey & Co. consulting firm has reached a $573 million settlement with 47 states…
STAT+: Biden administration pumps brakes on signature Trump drug pricing proposal
WASHINGTON — The Biden administration has agreed to delay for a year the implementation of…
‘Use that money wisely’: Coalition urges governments to spend opioid settlement funds on evidence-based efforts
As state and local governments consider how to spend proceeds from settlements with opioid makers,…
STAT+: FTC sues drug makers over allegedly illegal deal over an opioid painkiller
For the second time, the Federal Trade Commission has filed a lawsuit alleging Endo International…
STAT+: PhRMA sues to block Trump administration 340B rule
WASHINGTON — The trade group for the pharmaceutical industry on Friday sued to block a …
STAT+: Drug makers sue HHS over a discount program serving low-income populations
In a clutch of lawsuits, three drug makers argue the federal government is wrong to…
STAT+: Former Merck employee arrested for stealing trade secrets on cancer research
A former Merck (MRK) cancer researcher was arrested and charged with stealing a raft of…
Opinion: Keep Covid-19 vaccination decisions out of the courtroom
Given the mounting frustration over the slow pace of vaccinations, yesterday’s HHS announcement broadening the…
STAT+: Middlemen sue to block a signature Trump drug pricing proposal
WASHINGTON — The Pharmaceutical Care Management Association, which represents drug middlemen in Washington, filed a…
STAT+: Generic drug makers fear a ‘skinny labeling’ court ruling will pose a huge threat
An arcane regulatory term known as skinny labeling may have a funny ring to it,…
Opinion: Emergency department physicians should have the right to due process protection. Many don’t
Your doctor should be your biggest advocate, doing what Ming Lin, an emergency medicine physician…
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STAT+: A historian was cited to support making Purdue a public benefit company. He actually thinks it’s a bad idea
For the past few weeks, a U.S. bankruptcy court has heard objections to a plan…
Opinion: STAT+: In biopharma mergers and acquisitions, managing regulatory compliance early protects return on investment
Mergers and acquisitions have long been a vehicle for growth in the pharmaceutical industry. They…
STAT+: Supreme Court upholds controversial Arkansas law that regulates pharmacy benefit managers
In a blow to pharmacy benefit managers, the U.S. Supreme Court ruled that an Arkansas…
STAT+: To maintain opioid sales, Purdue was advised to pay rebates to health insurers for each overdose
As Purdue Pharma faced serious challenges to OxyContin sales, the company was advised to consider…
STAT Plus: For the first time, drug makers and PBMs must jointly face an insulin price fixing lawsuit
A federal judge ruled that a Texas county can proceed with a lawsuit accusing several…