FDA: Page 111
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Ranbaxy loses $250M while US consumers lose a Nexium generic
The FDA yanked tentative approval of generic versions of Roche's Valcyte and AZ's Nexium manufactured by Indian firm Ranbaxy Laboratories on Thursday. It could be a hefty financial blow.
By Nicole Gray • Nov. 7, 2014 -
FDA approves JNJ's Olysio in combo with Sovadi for hep C treatment
There are now two all-oral treatment options for hepatitis C patients.
By Nicole Gray • Nov. 7, 2014 -
UPDATED: Novartis cancer hopeful panobinostat not on track for FDA approval
Panobinostat, which Novartis developed as part of a combo therapy for multiple myeloma, did not show superiority in clinical trials—and it was associated with an increased risk of death.
By Nicole Gray • Nov. 6, 2014 -
Some payments exempt from Sunshine Act pharma database reporting
The Obama admin has decided that in certain cases, companies don't have to report payments to physicians who participate in CME events, especially if they're funded by non-commercial sources.
By Nicole Gray • Nov. 5, 2014 -
India-based Wockhardt's profits plummet as it faces continued FDA export ban
Indian exports have dropped by 90% compared with 2012 since last year's export ban, which probably won't be lifted until at least next year. But Wockhardt's stock is up 70% this year on buy-out rumors.
By Nicole Gray • Nov. 4, 2014 -
Will Boehringer win an asthma indication for Spiriva Respimat?
If approved, Spiriva Respimat Inhalation Spray will provide asthma patients with another treatment option—and be the first new approved inhaled therapy for asthma patients in over a decade.
By Nicole Gray • Nov. 4, 2014 -
Feds probe whether US officials engaged in insider trading over Dendreon drug
The SEC is aggressively investigating insider trading allegations that date back to 2010 and center on a review of Dendreon's prostate cancer drug, Provenge.
By Nicole Gray • Nov. 3, 2014 -
Uh-oh: 2/3 of UK docs defying new statin guidelines
The controversial and aggressive new statin guidelines continue to expose rifts within the medical community.
By Sy Mukherjee • Nov. 3, 2014 -
Express Scripts gearing up to snub Gilead in favor of AbbVie hep C drug
Express Scripts' medical chief made it clear last week that the company's looking for an HCV treatment that is as effective as Gilead's Sovaldi (sofosbuvir)—but cheaper.
By Nicole Gray • Nov. 3, 2014 -
FDA panel endorses approval of Daaichi's blood clot, stroke drug
If approved, edoxaban, a once-daily factor Xa inhibitor, will become the third FXa inhibitor available in the U.S.—and it may become the biggest seller in its class, according to experts.
By Nicole Gray • Nov. 3, 2014 -
Pfizer's meningitis drug becomes first FDA-approved breakthrough therapy
Trumenba, Pfizer's meningococcal group B vaccine, was approved by the FDA's Center for Biologics Evaluation and Research (CBER) after an expedited four-month review.
By Nicole Gray • Oct. 31, 2014 -
AZ scores FDA approval of once-daily diabetes fixed-dose combo pill
Xigduo XR is the first once-daily fixed-dose combination of an SGLT2 inhibitor (Farxiga/dapagliflozin) and metformin to win FDA approval.
By Sy Mukherjee • Oct. 30, 2014 -
US senators propose FDA vouchers to expedite Ebola drug development
Lawmakers have proposed a voucher system that would give drug developers an expedited review in order to encourage the creation of as many Ebola treatments as possible.
By Nicole Gray • Oct. 30, 2014 -
Deep Dive
Diving into the future of fixed-dose combos
From respiratory disease to HIV therapeutics, fixed-dose combinations are an important part of drug development. The regulatory hurdles are high—but so are the rewards.
By Nicole Gray • Oct. 30, 2014 -
India to ban use of plastic bottles for liquid drugs
Drug manufacturers aren't pleased with the decision.
By Nicole Gray • Oct. 30, 2014 -
Feds announce new Ebola guidelines
The new guidelines establish four tiers of risk.
By Katie Bo Williams • Oct. 29, 2014 -
UPDATED: Judge slashes Actos class action award from $9 billion to $36.8 million
Lilly and Takeda breathe a sigh of relief.
By Nicole Gray • Oct. 29, 2014 -
Sarepta's mega-orphan Duchenne's drug faces more roadblocks
The FDA's demand for yet more data means eteplirsen approval is not likely before 2016. Sarepta's stock was down 35% on the news.
By Nicole Gray • Oct. 28, 2014 -
EU panel recommends approval of Clinuvel's sunburn-prevention drug
Scenesse (afamelanotide) was developed by Australia-based Clinuvel for prevention of severe sunburn in patients with a rare genetic disease that renders them intolerant to light.
By Nicole Gray • Oct. 27, 2014 -
FDA approves Baxter's hemophilia orphan drug
Obizur (antihemophilic factor, porcine sequence) is the breakthrough FDA-approved treatment for acquired hemophilia A—an extremely rare disease.
By Nicole Gray • Oct. 27, 2014 -
EMA recommends approval of AZ's ovarian cancer drug
Lynparza (olararib) is a first-in-class treatment for ovarian cancer that is being widely hailed as a breakthrough.
By Nicole Gray • Oct. 27, 2014 -
EU reverses course, won't cede drug-related decisions to pharma
President-elect Jean-Claude Juncker's plan to shift the EMA from the Directorate General (DG) for Health and Consumers to DG Enterprise and Industry has been scrapped after considerable backlash.
By Nicole Gray • Oct. 24, 2014 -
EMA establishes expedited review framework for Ebola vaccines
The European Medicines Agency (EMA) has established an elite group of infectious disease specialists to help rapidly review Ebola vaccine submissions.
By Nicole Gray • Oct. 24, 2014 -
Deep Dive
Best of BD: Biosimilars in China: The coming revolution
Despite a less rigorous approach to approving biosimilars, China has several approved follow-on biologics—and a growing number of biotechs want to develop biosimilars that meet global standards.
By Nicole Gray • Oct. 22, 2014 -
Lilly, Boehringer fixed-dose diabetes combo could win FDA blessing soon
The FDA has agreed to review the empagliflozin/metformin fixed-dose combo from Eli Lilly and Boehringer Ingelheim.
By Nicole Gray • Oct. 22, 2014
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