FDA: Page 94
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Federal task force narrows aspirin use guidelines, suggests cancer benefit
According to new guidelines, low-dose aspirin use in the target group can help prevent heart attacks and stroke, while also reducing colon cancer risk.
By Nicole Gray • Sept. 15, 2015 -
A tale of two painkillers: Collegium gets FDA panel rec that eludes Purdue
Concerns over dosing compliance led the panel to overwhelmingly reject Purdue's pain pill despite abuse-deterring properties.
By Nicole Gray • Sept. 14, 2015 -
Amgen goes after once-monthly dosing option for Repatha
For most patients treated with the PCSK9 med, dosing is 140 mg every other week.
By Nicole Gray • Sept. 14, 2015 -
Retrieved from Flickr.
Deep DiveHow to stop a biopharma compliance breach before it happens
We spoke with two experts from PA Consulting to find out why the number of compliance breaches seems to be increasing—and what the industry can do about it.
By Nicole Gray • Sept. 10, 2015 -
FDA concerned about dosing risk with Collegium's opioid painkiller
Unlike most opioid painkillers, Xtampza, which is under FDA review, should be taken after eating to maximize effectiveness.
By Nicole Gray • Sept. 10, 2015 -
Roche CEO slams 'stupid,' 'arbitrary' UK decision to cut 17 cancer meds' funding
"It's stupid from a cost point of view," said Roche CEO Severin Schwan of the decision. "How the hell can you ignore all these [drugs'] benefits?"
By Nicole Gray • Sept. 9, 2015 -
A big win for AZ as FDA clears Brilinta for long-term use
Brilinta (ticagrelor) was approved in 2011 for secondary prevention of acute coronary syndrome (ACS) events for up to one year.
By Nicole Gray • Sept. 8, 2015 -
The key facts to know about the FDA's new 340B drug discount guidance
The Health Resources and Services Administration (HRSA) has released updated proposed guidance outlining six criteria a patient must meet to receive discounted drugs.
By Nicole Gray • Sept. 3, 2015 -
Deep Dive
Biosimilars Council chief answers 6 key questions about biosims in the US
Dr. Bert Liang spoke with us to answer questions about the rapid pace of developments as biosimilars become a permanent part of healthcare in America.
By Nicole Gray • Sept. 2, 2015 -
Pharma takes major offense to French law promoting off-label Avastin use
France allows off-label use of Roche's Avastin (bevacizumab) for age-related macular degeneration (AMD), and the industry doesn't like it.
By Nicole Gray • Sept. 2, 2015 -
Alexion wins EU nod for newly acquired enzyme-replacement drug
Less than three months after completing the $8.4 billion acquisition of Synageva Biopharma, Alexion got an approval for Kanuma.
By Nicole Gray • Sept. 2, 2015 -
Pharma lobbies Congress for big—and expensive—changes to patent rules
According to the Congressional Budget Office (CBO), Inter Partes Review (IPR) exemptions being pursued by the industry could cost Medicare $1.3 billion over the next decade.
By Nicole Gray • Sept. 2, 2015 -
How do you solve a problem like drug shortages?
In 2011, there were 251 new drug shortages. That number has dwindled significantly—but there's still work to be done.
By Nicole Gray • Aug. 31, 2015 -
FDA warns: DPP-4 inhibiting diabetes meds may cause severe joint pain
The DDP-4 class includes major drugs from Merck, AstraZeneca, and Lilly/BI.
By Nicole Gray • Aug. 31, 2015 -
FDA's new draft guidance on naming biosimilars already drawing pushback
One main goal of the guidance is to prevent inadvertent substitution of non-interchangeable products.
By Nicole Gray • Aug. 28, 2015 -
Lilly/BI snag another FDA approval for a diabetes drug—Synjardy
This is the fifth FDA approval for the Eli Lilly/Boehringer Ingelheim Diabetes Alliance.
By Nicole Gray • Aug. 28, 2015 -
FDA demands another study for uniQure's ultra-pricey gene therapy
Glybera has courted its fair share of controversy.
By Nicole Gray • Aug. 27, 2015 -
J&J/Genmab unveil promising data for a potential multiple myeloma superstar
Daratumumab made waves at the American Society of Clinical Oncology meeting earlier this summer.
By Nicole Gray • Aug. 27, 2015 -
FTC to FDA: Ramp up oversight on homeopathic drug makers
The trade regulatory agency points out that many of the advertising claims from homeopathic drug makers are not evidence-based.
By Nicole Gray • Aug. 27, 2015 -
Deep Dive
Pfenex at the forefront: How a different biosim approach is becoming a disruptive force
We spoke with Dr. Bert Liang, Chairman of the Biosimilars Council and CEO of Pfenex, Inc., about the rapidly growing biosimilars industry in the U.S., and what comes next for Pfenex.
By Nicole Gray • Aug. 27, 2015 -
Sarepta wins priority review for hotly anticipated Duchenne drug
The target action date for Sarpeta's eteplirsen, a candidate for treatment of Duchenne muscular dystrophy, is February 26, 2016.
By Nicole Gray • Aug. 26, 2015 -
How Japan is trying to beef up its pharmaceutical industry
One proposed tactic is raising government-set drug prices to spur more innovation in R&D.
By Nicole Gray • Aug. 26, 2015 -
UK's NHS commissions new TB drugs for first time in 50 years
In the wake of drug-resistant TB, the NHS is taking action.
By Nicole Gray • Aug. 26, 2015 -
Sarepta, Biomarin vie for DMD approval, priority review voucher
Both companies are developing drugs for the rare pediatric disease Duchenne muscular dystrophy (DMD).
By Nicole Gray • Aug. 24, 2015 -
AbbVie snaps up priority review voucher from United Therapeutics for $350M
The pharma giant now has two priority review vouchers in its arsenal.
By Nicole Gray • Aug. 19, 2015
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