FDA: Page 69
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Second biosimilar of Remicade approved in the US, but J&J not rattled
Merck and Samsung Bioepis secured approval for another copy of the blockbuster biologic, but J&J hasn't seen much of an impact — yet.
By Suzanne Elvidge • April 24, 2017 -
Brexit and biopharma: The UK/EU divorce begins
By invoking Article 50, the U.K. has begun the formal process to leave the economic and political partnership that is the European Union.
By Suzanne Elvidge • April 21, 2017 -
Prescribed Reading: What J&J says about the rest of pharma
J&J earnings predict a rough first quarter for big pharma, AbbVie has a bad week, and Lilly's surprise rejection is great news for Pfizer.
By Lisa LaMotta • April 21, 2017 -
High prices shock Japan, prompting dramatic changes
Once a predictable market, Japan is changing the way it assesses drug pricing after some drugs cause sticker shock for the country.
By Tamra Sami • April 19, 2017 -
Roche gets nod for Tecentriq in first-line bladder cancer
While Roche's checkpoint inhibitor was first to market in bladder cancer, the space is becoming more competitive as other pharmas push in.
By Suzanne Elvidge • April 19, 2017 -
FDA
CytRx set to file cancer drug NDA
The clinical-stage company plans to file the first part of a rolling submission for aldoxorubicin, a drug for soft tissue sarcomas, in the fourth quarter.
By Jacob Bell • April 19, 2017 -
Hanmi charged for late reporting of fatal side effect
The Asian drug company delayed reporting a patient clinical trial death after confusion over cause, resulting in the withdrawal of Boehringer Ingelheim from its partnership.
By Suzanne Elvidge • April 18, 2017 -
FDA
After EU yes, FDA says no to Lilly's baricitinib
Following a three-month wait, the FDA rejected Lilly and Incyte's closely watched arthritis drug baricitinib, previously pegged by many as a future blockbuster.
By Suzanne Elvidge • April 16, 2017 -
In more bad news, Mylan receives CRL for Indian facility
The FDA criticized the drugmaker for not addressing the root cause of many of the manufacturing violations at its Maharashtra, India, plant.
By Jacob Bell • April 13, 2017 -
FDA warns Teva over violations at China plant
The drugmaker said it is already taking corrective action to fix the regulator's concerns, which are related to manufacturing control and sampling processes.
By Ned Pagliarulo • April 13, 2017 -
FDA digests Ritter's mid-stage microbiome data
The drug developer plans to milk the lactose intolerance market as it pushes its lead microbiome drug towards Phase 3.
By Suzanne Elvidge • April 13, 2017 -
Gilead works on lifecycle management for Sovaldi as Hep C franchise wanes
The FDA's approval of Harvoni and Sovaldi in patients 12 and older is the latest example.
By Jacob Bell • April 12, 2017 -
NICE opts not to recommend Opdivo for head and neck cancer
For the U.K. National Health Service, Opdivo's benefits don't outweigh its costs for head and neck cancer patients. But the company and other stakeholders still have time to comment on the draft guidance.
By Suzanne Elvidge • April 12, 2017 -
Maryland general assembly sends drug price gouging bill to gov.'s desk
The bill would give the state's attorney general the ability to levy civil penalties against unexplained pricing increases for essential generic medications.
By Jacob Bell • April 10, 2017 -
Deep Dive
Clinical trial enrollment gets harder as patient populations shrink
It can be a long shot to find patients for some rare disease clinical trials. Recruiting challenges, however, often make those odds even smaller.
By Jacob Bell • April 10, 2017 -
How the Orphan Drug Act changed the development landscape
The 1983 law opened the doors to a flood of treatments for rare diseases, but rising costs and hundreds of still-untreated conditions have raised questions about whether changes are needed.
By Malorye A. Branca • April 10, 2017 -
Prescribed Reading: AACR, Gottlieb and recalls
Scott Gottlieb faced a Senate committee for the top slot at the FDA, while data pours in from AACR and Mylan and GSK issue U.S. recalls.
By Lisa LaMotta • April 7, 2017 -
FDA shoots down Merck's bid to expand Januvia label
Merck sought to add cardiovascular outcomes data to the label of its blockbuster DPP-4 inhibitor in an effort to improve competitiveness and extend its lifecycle.
By Ned Pagliarulo • April 7, 2017 -
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
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