FDA: Page 68
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FDA OK's 23andMe genetic tests, prompting concerns
After some apprehension, the regulator approved direct-to-consumer tests that shows genetic factors related to 10 diseases. But will consumers know what to do with the information?
By Suzanne Elvidge • April 7, 2017 -
Study shows FDA speedier than EU counterpart in reviewing drugs
The comparison highlights the FDA's work to hasten review of drugs for cancers and rare diseases — areas that will likely draw attention as Congress considers PDUFA reauthorization.
By Suzanne Elvidge • April 7, 2017 -
Indoco Remedies handed FDA warning letter
The FDA inspected the Indian finished dose and API manufacturer last August but was unsatisfied with the firm's remediation efforts, leading to the March warning.
By Ned Pagliarulo • April 6, 2017 -
GSK to recall nearly 600,000 asthma inhalers from US market
But the British drugmaker doesn't expect the recall to have any affect on the supply of Ventolin inhalers.
By Suzanne Elvidge • April 6, 2017 -
Scott Gottlieb commits to defend FDA's 'gold standard' for drug reviews
Trump's nominee to head the FDA seemed to have the support of many senators at a committee hearing, but his ties to industry and potential conflicts of interest continue to draw scrutiny.
By Ned Pagliarulo • April 5, 2017 -
Mallinckrodt settles investigations into suspicious opioid orders
The troubled drugmaker admitted no wrongdoing, but agreed to pay $35 million to resolve inquiries into its monitoring protocols.
By Jacob Bell • April 5, 2017 -
Teva scores OK from FDA for Huntington's drug
The Israeli company was finally able to push Austedo across the regulatory finish line after a rejection last May had stalled the drug.
By Lisa LaMotta • April 4, 2017 -
Sponsored by inVentiv Health
How real-world evidence is changing the game
A metaphor for our times: how the demand for real-world evidence is changing the offensive playbook for commercial success.
By David Thompson, Ph.D Senior Vice President, Real World Evidence & Insights at inVentiv Health • April 4, 2017 -
July AdCom will give Dynavax a new shot to prove vaccine safety
The biotech will have to prove to an advisory committee that there are no safety issues with its hepatitis B vaccine after an FDA rejection.
By Suzanne Elvidge • April 4, 2017 -
More problems for Mylan: EpiPen recall expands to US
The generics drugmaker is under further pressure after a small recall of its EpiPen autoinjector expands to the U.S. market.
By Suzanne Elvidge • April 3, 2017 -
New guidelines to make China a more drug-friendly market
CFDA announced draft guidelines that would allow Phase I trials in China to encourage simultaneous development alongside global trials.
By Tamra Sami • April 3, 2017 -
Prescribed Reading: All the approvals
FDA goes on an approval spree, drug manufacturers toe the line on pricing, and Vertex has both good and bad news.
By Lisa LaMotta • March 31, 2017 -
Karyopharm shakes off clinical hold for lead cancer med
The quick reversal of the FDA's partial clinical holds reaffirmed that administrative problems were the main culprit holding up the trials.
By Jacob Bell • March 30, 2017 -
FDA
GSK breathes sigh of relief as Mylan Advair copy rejected
The respite will likely be short-lived. The FDA is set to decide soon on approval of another generic copy to the respiratory drug, and Mylan is sure to resubmit its application.
By Ned Pagliarulo • March 29, 2017 -
Senators launch investigation into opioid manufacturers
The Homeland Security Committee is looking into sales practices for the top-selling opioids in the U.S. in hopes of gleaning more information about the addiction crisis.
By Suzanne Elvidge • March 29, 2017 -
UK regulator reviewing Pfizer's Viagra for over-the-counter use
Pfizer faces declining sales for the little blue pill as generic competition bites into its market. Selling through pharmacies could help boost demand.
By Suzanne Elvidge • March 29, 2017 -
Roche secures FDA approval for Ocrevus for 2 types of MS
The much-anticipated biologic is the first medicine approved to treat the primary progressive form of the debilitating disease.
By Lisa LaMotta • March 28, 2017 -
Sanofi, Regeneron's eczema drug Dupixent gains FDA approval
The highly-anticipated Dupixent is expected to rake in around $3 billion in peak annual sales, according to some industry followers.
By Jacob Bell • March 28, 2017 -
Cempra pulls European marketing application for antibiotic
The clinical-stage drugmaker intends to gather more data on solithromycin to give the anti-infective treatment a better shot at EMA and FDA approval.
By Jacob Bell • March 28, 2017 -
In twisting patent fight, CRISPR Therapeutics scores win in Europe
The European Patent Office intends to grant a patent covering use of CRISPR/cas9 to the University of California, which licenses the gene-editing tech to the company.
By Ned Pagliarulo • March 28, 2017 -
Tesaro's PARP inhibitor approved in ovarian cancer
The FDA gave the go-ahead to Tesaro's niraparib, setting it up to compete with AstraZeneca's Lynparza and Clovis' Rubraca in the emergent market.
By Lisa LaMotta • March 27, 2017 -
Prescribed Reading: Avelumab OK'd, Ultragenyx fails trial
As Washington debates healthcare, pharma continues to make deals and Pfizer joins the checkpoint inhibitor race.
By Lisa LaMotta • March 24, 2017 -
Insys cannabinoid drug Syndros given Schedule II status
The DEA's decision is a far cry from the Schedule IV status the company originally sought, but the drug is still anticipated to rake in hundreds of millions.
By Jacob Bell • March 24, 2017 -
$5B in Humira sales at stake with Amgen EU approval
The big biotech celebrates Humira biosimilar news that could rattle AbbVie's biggest revenue driver.
By Suzanne Elvidge • March 24, 2017 -
Pfizer, Merck KGaA fourth to market with PD-1/L1 inhibitor
The pair secured an FDA approval for avelumab, which will enter the market behind rival drugs Keytruda, Opdivo and Tecentriq.
By Lisa LaMotta • March 23, 2017
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