STAT1 мин. чтения
STAT+: Pharmalittle: AbbVie To Lift $2B Cap On Deals As Humira Rivals Appear; India To Spend $80M To Bolster Regulatory System
India will spend $79.6 million on strengthening its drug regulatory system after the WHO raised concerns about domestically produced cough syrups being linked children's deaths.
STAT1 мин. чтения
STAT+: Pharmalittle: ALS Association And Its Chapters Battle Over Money And Priorities; Eye Drops Recalled Over Links To Drug-resistant Infections
A blistering battle has broken out between the ALS Association and more than a dozen state and local chapters, which are resisting a move to dismantle their offices.
STAT1 мин. чтения
STAT+: Pharmalittle: GSK CEO Warns U.K. Pharma Industry Is At A ‘Tipping Point’; Gavi Tussles With Vaccine Makers Over Refunds
GSK CEO Emma Walmsley warned the U.K. is at a “tipping point” and risks falling short of government ambitions to become a life sciences superpower.
STAT1 мин. чтения
STAT+: Pharmalittle: Pfizer Projects Lower Revenue From Covid-19 Products; Medicare Eyes Policy For Paying Less For Accelerated-approval Drugs
A Medicare official hinted the program might test a policy of paying less for drugs that receive accelerated approvals than for medicines granted traditional approvals.
STAT1 мин. чтения
STAT+: Pharmalittle: Amgen Pricing For Humira Biosimilar May Not Help Patients; Pharma Wins Court Battle Over Drug Discount Program
Amgen's long-awaited pricing for its Humira biosimilar suggests the biggest winners may be health insurers and others in the supply chain, but not patients.
STAT1 мин. чтения
STAT+: Pharmalittle: Pfizer Is Scolded By U.K. Industry Group Over CEO’s Remarks On Vaccination; Amgen To Lay Off 300 U.S. Employees
Pfizer was scolded by a U.K. pharmaceutical trade group after its CEO made misleading statements about the need to vaccinate young children against Covid-19.
STAT1 мин. чтения
STAT+: Pharmalittle: Some Republicans Push To Probe Pfizer Over Covid-19 ‘Mutations’; Warren Urges FTC To Probe Pharma Mergers
CVS and Walmart are cutting pharmacy hours amid a pharmacist shortage that has plagued the nation’s biggest drugstore chains.
STAT1 мин. чтения
STAT+: Pharmalittle: Strange Bedfellows Lobby For Medicare Coverage Of Obesity Drugs; FDA Working With WHO To Probe Cough Syrups
The pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to expand Medicare coverage for obesity drugs.
STAT1 мин. чтения
STAT+: Pharmalittle: Merck Ends Late-stage Trial For Keytruda In Prostate Cancer; Doctor Group Says 60 Minutes Segment On Wegovy Was An Ad
Merck is discontinuing a trial of Keytruda in prostate cancer after interim data showed it was unlikely to meet the study's main goals.
STAT1 мин. чтения
STAT+: Pharmalittle: Amazon Adds $5 Monthly Generic Drug Subscription; PhRMA Ends Lobbying Contract With Brother Of White House Official
Amazon is beefing up its Prime program for U.S. users with a new subscription that will allow members to get generic drugs for a total of $5 a month.
STAT1 мин. чтения
STAT+: Pharmalittle: Obesity Guidelines Cause Backlash; Bayer Is Pushed To Spin Off Its Consumer Health Business
New American Academy of Pediatrics guidelines suggesting early and aggressive treatment to combat obesity are generating a backlash.
STAT1 мин. чтения
STAT+: Pharmalittle: FDA Rejects Lilly Application For Alzheimer’s Drug; Sanofi Offers A Warranty For A Medicine
The FDA denied Eli Lilly accelerated approval for donanemab, a treatment for people with early-stage Alzheimer’s disease.
STAT1 мин. чтения
STAT+: Pharmalittle: India Regulator Finds 5% Of Drug Samples Are Substandard; EMA Claims New Clinical Trial Registry Is Fixed
The European Medicines Agency has not identified any safety signals in the region related to the updated Covid-19 booster shot from Pfizer and BioNTech.
STAT1 мин. чтения
STAT+: Pharmalittle: HIV Vaccine Study Is Stopped Early; Merck Has A Plan To Combat Carcinogen Found In Diabetes Drugs
A large-scale study of a Johnson & Johnson HIV vaccine was stopped early because it was not effective.
STAT1 мин. чтения
STAT+: Pharmalittle: Lilly And AbbVie Exit U.K. Drug-pricing Program; J&J Scales Back Covid-19 Vaccine Production
Johnson & Johnson has vastly scaled back efforts to produce its Covid-19 vaccine as it faces slumping demand.
STAT1 мин. чтения
STAT+: Pharmalittle: Pharma Prioritizes Biologics Over Pills Due To Drug-pricing Law; Former Takeda Employee Accused Of Creating Fake Consulting Firm
Drugmakers are prioritizing biologics over pills because under a new law, they have more time before becoming subject to Medicare price negotiations.
STAT1 мин. чтения
STAT+: Pharmalittle: HHS Readying Details For Medicare Drug-price Negotiations; Doctors Urge FDA To Hold Expert Meeting Before Approving Alzheimer’s Drug
A physicians group is urging the FDA to hold an expert panel meeting to review the Leqembi Alzheimer’s drug before issuing a full-blown approval.
STAT1 мин. чтения
STAT+: Pharmalittle: Pfizer Will Not License Generic Covid-19 Pill In China; BioMarin Signs Outcomes-based Deal In Germany For Gene Therapy
Pfizer 's CEO said the company is not in talks with China to license a generic version of its Covid-19 pill, Paxlovid, for use there.
STAT1 мин. чтения
STAT+: An FDA Pathway To Clear Medical Devices Is Putting Patients At Risk, Research Suggests
“This regulatory loophole allows safety issues to propagate for years and years, placing patient safety at risk,” said Kushal Kadakia of Harvard.
STAT1 мин. чтения
STAT+: Pharmalittle: FDA Increasingly Pausing Trials Of Experimental Meds; FDA Commish Isn’t Surprised By Congressional Report On Alzheimer’s Drug
The FDA is pressing pause on testing of experimental medicines more often, a side effect of the drug industry’s move into promising but less-proven technologies.
STAT1 мин. чтенияDiet & Nutrition
STAT+: Pharmalittle: Pediatricians Recommend Obesity Drugs For Children; As JPM Starts, Industry Execs Have A Gloomy Financing Outlook
The American Academy of Pediatrics for the first time recommended physicians offer weight-loss drugs for children with obesity.
STAT1 мин. чтения
‘It’s Taken Longer Than I Thought’: A Former FDA Commissioner On The Loosened Restrictions On Abortion Pills
"We always thought that as there was more experience with mifepristone and misoprostol, that at some point, some of those distribution restrictions would be able to be lifted."
STAT1 мин. чтения
STAT+: Pharmalittle: Pfizer Scaling Back Early-stage Research Into Rare Diseases; BioNTech And U.K. Partner On Cancer Trials
Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including viral-based gene therapies.
STAT1 мин. чтения
STAT+: Pharmalittle: New Report Gives Glimpse Into Safety Of An Alzheimer’s Drug; Walgreens Looks To Dispense An Abortion Pill
Investigators released a detailed case report about a patient who died after receiving lecanemab, providing a new glimpse into safety concerns with the Alzheimer's drug.
STAT1 мин. чтения
STAT+: Pharmalittle: FDA Rule Change Allows Pharmacies To Offer Abortion Pills; Medicare Could Have Saved Billions If Inflationary Rebate Law Existed
Retail pharmacies will be allowed to offer abortion pills in the U.S. under a regulatory change made by the FDA.
STAT1 мин. чтения
STAT+: Pharmalittle: Pharma Plans To Raise U.S. Drug Prices In January; U.S. Sues AmerisourceBergen Over Opioid Crisis
Good morning, everyone, and welcome to a new year. We hope the holiday respite was refreshing and inspiring, because that oh-so-familiar routine of online meetings, calls, and deadlines — otherwise known as work — has predictably returned. But what c
STAT1 мин. чтения
STAT+: Pharmalittle: ICER Cuts Cost-effective Price For Pfizer Covid Pill; McDonald’s Sets Targets To Reduce Antibiotic Use In Cattle
The Institute for Clinical and Economic Review cut its suggested price range for the Pfizer Covid-19 pill Paxlovid by more than 80%.
STAT1 мин. чтения
STAT+: Pharmalittle: Pharma Wins Changes In Bill Concerning Accelerated Approval; Pharmacy Chains Restrict Purchases Of Pediatric Pain Relievers
Provisions opposed by industry were dropped from a bill that makes it easier for the FDA to withdraw drugs approved under an accelerated timeline.
STAT1 мин. чтения
STAT+: Pharmalittle: FDA Adds Lilly Diabetes Drugs To Shortage List; WTO Delays Decision On Extending Covid IP Waiver
The FDA added Lilly's Mounjaro to its list of drugs facing shortages, highlighting the company's struggles to meet booming demand for the new diabetes injection.
STAT1 мин. чтения
STAT+: Pharmalittle: AbbVie Leaves Pharma Industry Trade Groups; Net Drug Prices See Big Drop After Inflation
AbbVie is leaving PhRMA and BIO, the two prominent pharmaceutical trade associations representing its interests in Washington.
…Или откройте для себя что-то новое