FDA: Page 90
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FDA questions AstraZeneca about safety of phase 3 gout drug
The company has submittted a dossier for the candidate, lesinurad, to the FDA and is awaiting a panel recommendation.
By Nicole Gray • Oct. 22, 2015 -
REPORT: American man in India illegally exported execution drugs to Nebraska, other states
Chris Harris set up an office in India from which he offered sodium thiopental to states, which wanted to stock execution drugs, according to an investigative report by BuzzFeed. The sales date back to 2010.
By Nicole Gray • Oct. 21, 2015 -
The Amarin effect? FDA removes warning letter aimed at Pacira from web site
This is the latest action resulting from pharma companies pushing back against what they see as FDA over-regulation and attempting to protect their First Amendment rights.
By Nicole Gray • Oct. 21, 2015 -
23andMe relaunches expanded genetic tests after 2-year, FDA-mandated hiatus
The firm will begin presenting users with health data once again—and this time, with regulators' approval and at a far higher price.
By Sy Mukherjee • Oct. 21, 2015 -
Deep Dive
A Boehringer SVP and BioSig's CEO dish on the 'heart' of innovation
BioPharma Dive spoke with Dr. Sabine Luik, Senior Vice President of Medicine & Regulatory Affairs at Boehringer Ingelheim and Greg Cash, CEO of BioSig Technologies, about different strategies for reducing the risk of stroke in patients with atrial fibrillation—and what makes their products innovative.
By Nicole Gray • Oct. 20, 2015 -
A bipartisan bashing: Rubio slams drug prices, pharma's 'pure profiteering'
The GOP presidential hopeful from Florida joins Democrats Hillary Clinton and Bernie Sanders in criticizing what he sees as the industry's excesses and calls for pay-for-performance.
By Sy Mukherjee • Oct. 20, 2015 -
FDA tells Theranos to stop using its tech except for approved herpes test
The agency's request comes on the heels of a bombshell report alleging that the company has been misrepresenting the use and efficacy of its pioneering blood test technology, which uses tiny vials of blood.
By Nicole Gray • Oct. 19, 2015 -
Shire's case for a Baxalta takeover dims as FDA spurns lead eye drug
Lifitegrast, which is intended to treat chronic dry eye disease, has long been considered one of the strongest candidates in Shire's pipeline. The company says it will refile the therapy in Q1 2016.
By Nicole Gray • Oct. 19, 2015 -
FDA approves first-ever Pradaxa 'antidote,' BI's Praxbind
Praxbind (idarucizumab), which is designed to reverse the effects of the anticoagulant Pradaxa (dabigatran), is a fully humanized antibody fragment.
By Nicole Gray • Oct. 19, 2015 -
Deep Dive
Breast Cancer Awareness Month: A look at recent innovations in breast cancer
This month marks the 30th year of Breast Cancer Awareness Month (BCAM). In recognition of the milestone, here is a brief look at recent innovations in diagnosis, surgery, and medical treatment for the disease.
By Nicole Gray • Oct. 16, 2015 -
FDA schedules separate meetings to review BioMarin, Sarepta Duchenne drugs
The agency has raised some eyebrows by scheduling panel meetings two months apart for drugs designed to address the same rare disease.
By Nicole Gray • Oct. 15, 2015 -
23andMe nabs $115M in new financing and a $1.1B valuation
The consumer genetic testing firm comes surging back with a strong Series E.
By Nicole Gray • Oct. 15, 2015 -
Why Bernie Sanders' opposition to Califf's FDA nomination is misguided
Presidential candidate Bernie Sanders said he was proud to call pharma his number one enemy during the Democratic presidential debate last night. But that antipathy may have led him to a misleading argument against Dr. Califf.
By Nicole Gray • Oct. 14, 2015 -
FDA delays decision on Collegium's painkiller
Last month, an FDA panel recommended the long-acting opioid painkiller, Xtampza, for approval with on a 23-0 vote.
By Nicole Gray • Oct. 13, 2015 -
Good news on the horizon for Indian pharma as FDA ramps up approvals
Analysts expect the period between March 2015 and March 2016 to be much better in terms of earnings than the comparable period last year, thanks in large part to more FDA drug approvals.
By Nicole Gray • Oct. 13, 2015 -
Controversy erupts over pediatric OxyContin guidance
Critics say the FDA's decision to expand the painkiller's use to children as young as 11 could fuel an addiction crisis.
By Nicole Gray • Oct. 13, 2015 -
Bristol-Myers' Opdivo nabs expanded lung cancer indication
It's now approved for treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC) tumors in patients whose disease progressed during or after platinum-based chemotherapy.
By Nicole Gray • Oct. 12, 2015 -
Senators propose adding nurses, physician assistants to Open Payments database
A bipartisan duo of senators has introduced the bill as a way to "close the loop" and bolster overall transparency surrounding drug company payments.
By Nicole Gray • Oct. 9, 2015 -
Pharma CEOs head to WH to hear Obama's TPP pitch; Clinton comes out against trade deal
President Obama certainly has his work cut out for him in selling execs like Pfizer CEO (and PhRMA chairman) Ken Frazier and others on the 12-nation trade agreement's biologics exclusivity compromise.
By Sy Mukherjee • Oct. 8, 2015 -
Pharma giants join forces to squash CA drug price cap initiative
J&J, Pfizer, Bristol-Myers Squibb, and Eisai are among the firms doling out millions to a PhRMA-backed effort to defeat the AIDS Healthcare Foundation-supported California Drug Price Relief Act.
By Sy Mukherjee • Oct. 8, 2015 -
Pharma loves priority review vouchers—The FDA? Not so much
The goal of priority review vouchers is to encourage companies to focus on rare pediatric or tropical diseases. But not all voucher holders are doing that.
By Nicole Gray • Oct. 8, 2015 -
FDA halts Advaxis immuno-oncology trials after patient death
A woman with cervical cancer died during a clincal trial involving axalimogene, stoking fears that the drug was involved. The company says it wasn't.
By Nicole Gray • Oct. 8, 2015 -
FDA commish-in-waiting removes name from papers criticizing agency
Dr. Robert Califf has requested that his name be removed from papers he co-authored for the October issue of Clinical Trials that criticizes certain clinical trial oversight measures and recommends some controversial policy changes.
By Nicole Gray • Oct. 8, 2015 -
Study: Merck hep C combo effective in kidney disease patients
Although Merck will most likely be third to market with its next-generation HCV drug, it's aiming to democratize treatment options even further.
By Nicole Gray • Oct. 7, 2015 -
Feds lose dietary supplement case against Bayer
The U.S. Department of Justice and the Federal Trade Commission had alleged that the company made false claims about Philip's Colon Health, an OTC product.
By Nicole Gray • Oct. 6, 2015
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