FDA: Page 82
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Marathon Pharma latest company to try for approval of Duchenne drug
Marathon has submitted a new drug application for an older off-patent steroid, unlike previous developmental drugs from BioMarin or Sarepta.
By Ned Pagliarulo • June 15, 2016 -
FDA
FDA warns of kidney risks for diabetes drugs from Janssen, AstraZeneca
Invokana and Farxiga, along with two other related drugs, will now carry strengthened warnings cautioning of the risk of acute kidney injury.
By Ned Pagliarulo • June 14, 2016 -
FDA
FDA approves world's first single-dose cholera vaccine
PaxVax Bermuda's Vaxchora is also the first approved single-dose vaccine for the prevention of cholera in the world.
By Nicole Gray • June 12, 2016 -
Drugmakers plan stronger pushback on state-level price regulation
The efforts include a rapid response shop in Washington.
By Randy Lilleston • June 10, 2016 -
FDA wants to suspend more than 4,000 illegal Rx sites
U.S. consumers have purchased unapproved medications from international sellers to treat depression, narcolepsy, glaucoma and other medical conditions.
By Nicole Gray • June 10, 2016 -
FDA advisory panel backs Teva opioid painkiller
The panel voted 14-3 on Tuesday to recommend Valentra ER.
By Randy Lilleston • June 8, 2016 -
FDA approves Allergan's fixed-dose combo for hyertension
Byvalson combines the beta blocker, nebivolol (5 mg) and the angiotensin II receptor blocker (80 mg).
By Nicole Gray • June 8, 2016 -
FDA asks Sarepta for more data on muscular dystrophy drug
Shares of Sarepta jumped 25% higher in late trading Monday, as investors continue to hope for a path to approval for eteplirsen.
By Ned Pagliarulo • June 7, 2016 -
Novartis cancer drug wins expanded indication in Europe
Although Afinitor brought in $1.6 billion last year, sales have dipped as the drug faces stiffer competition.
By Nicole Gray • June 2, 2016 -
FDA approves liquid biopsy test from Roche
The new diagnostic can detect the presence of EGFR gene mutations in lung cancer patients.
By Nicole Gray • June 2, 2016 -
FDA warns another Indian API supplier on manufacturing lapses
Violations included an admission from an analyst at Megafine Pharma of falsifying stability testing data.
By Ned Pagliarulo • June 1, 2016 -
BioMarin ends Duchenne program, withdraws EU application for drisapersen
The decision brings BioMarin's current Duchenne program to a close, two years after the company paid $680 million to acquire Prosensa for rights to drisapersen.
By Ned Pagliarulo • May 31, 2016 -
FDA knocks back Teva drug for Huntingon's, requests more information
Teva acquired the drug as part of its $3.2 billion deal for Auspex Pharma last year.
By Nicole Gray • May 31, 2016 -
EMA recommends approval for hepatitis C meds from Gilead, Merck
Merck is attempting to challenge Gilead's dominance of the hepatitis C market with its combo drug Zepatier.
By Nicole Gray • May 31, 2016 -
Wellcome Trust scores with startup investment in diagnostic company
Blue Earth Diagnostics, which is owned by the investment arm of Wellcome Trust, received FDA approval for a cancer diagnostic last Friday.
By Nicole Gray • May 31, 2016 -
Multiple sclerosis drug from Biogen, AbbVie clears FDA review
But the new drug will carry a boxed warning for serious safety risks, and is available only through a restricted distribution program.
By Nicole Gray • May 31, 2016 -
Second biosimilar of J&J's blockbuster Remicade approved in Europe
Samsung Bioepis' Flixabi will join rival Celltrion's copy of the anti-inflammatory drug on the European market.
By Nicole Gray • May 31, 2016 -
EMA knocks back multiple myeloma drug from Takeda
While the FDA approved Ninlaro in the U.S. last year, the EMA found Takeda's evidence to be insufficient.
By Ned Pagliarulo • May 27, 2016 -
Three more pharma giants subpoenaed in charity investigation
Gilead, Biogen and Jazz Pharmaceuticals all have disclosed they have been subpoenaed about the relationship between pharma companies and nonprofits that help cover copayments for needy patients.
By Randy Lilleston • May 27, 2016 -
FDA rejects AstraZeneca hyperkalemia drug, boosting competitor Relypsa
AstraZeneca had acquired the drug last fall in a $2.7 billion deal for ZS Pharma.
By Ned Pagliarulo • May 27, 2016 -
FDA
FDA approves first implanted buprenorphine for opioid dependence
The implanted drug, which will carry a boxed warning, is co-marketed by Titan Pharma and Braeburn Pharma.
By Nicole Gray • May 27, 2016 -
Sanofi diabetes drug wins adcomm support, keeping pace with Novo
The positive opinion comes one day after the FDA advisory panel had recommended approval for a similar drug from Novo Nordisk.
By Ned Pagliarulo • May 26, 2016 -
In unanimous vote, FDA panel recommends Novo diabetes drug
Advisory committee members were able to look past concerns raised in a preliminary review of IDegLira. Rival Sanofi has a similar diabetes drug up for a panel vote today.
By Nicole Gray • May 25, 2016 -
Sandoz's biosimilar rituximab gets regulatory review in EU
The regulatory submission for rituximab is the sixth of 10 biosimilar applications Sandoz plans to file by 2017.
By Nicole Gray • May 25, 2016 -
Sarepta shares jump after FDA delays decision on Duchenne drug
An advisory panel last month recommended against approval for eteplirsen, but strong advocacy from patient groups has complicated the FDA's decision.
By Ned Pagliarulo • May 25, 2016
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