FDA: Page 67
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Medeor gets FDA go-ahead for Phase 3
The biotech is developing an immunotherapy that could replace immunosuppressants for transplant patients should it be successful.
By Suzanne Elvidge • May 1, 2017 -
Radius targets quick ramp up for newly approved osteoporosis drug
Tymlos, priced at a wholesale acquisition cost of $19,500 per year, will challenge Eli Lilly's aging Forteo for market share.
By Ned Pagliarulo • April 30, 2017 -
Prescribed Reading: Rough start for pharma, but optimism abounds
First quarter earnings were not particularly strong, but there were several bright spots; Gottlieb confirmation rolls forward; and The Medicines Co. lays down cash for its CV outcomes trial.
By Lisa LaMotta • April 28, 2017 -
BioMarin's Batten disease drug gets a yes at a cost of $702K
Brineura, BioMarin's drug for the ultra-rare CLN2 pediatric brain disorder, could have a price tag of almost half a million dollars a year, even after discounts.
By Suzanne Elvidge • April 28, 2017 -
FDA busts 14 companies for selling bogus cancer cures
The regulator sent warning letters to all 14 firms demanding removal of the mostly digital ads and videos that fraudulently touted miraculous new treatments.
By Ned Pagliarulo • April 25, 2017 -
Cel-Sci withdraws 2016 study protocol amendment
Could this be the light at the end of the tunnel for Cel-Sci's Multikine development?
By Suzanne Elvidge • April 25, 2017 -
Biogen, BioMarin secure orphan drug endorsements in Europe
The European regulator also recommended approval of three biosimilar drugs, all from Novartis' generics unit, Sandoz, in its April review meeting.
By Ned Pagliarulo • April 24, 2017 -
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
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