FDA: Page 49
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FDA mulls new incentives to stem antimicrobial resistance
The agency is working to smooth approval pathways for new products, while proposing changes to reimbursement to account for limited use.
By Suzanne Elvidge • June 13, 2018 -
CMS sets goals to tackle opioid crisis
The plan calls for greater data transparency, as well as use of a Medicare heat map to pinpoint areas that can benefit from targeted safe prescribing efforts.
By Meg Bryant • June 12, 2018 -
AbbVie, Roche win key US approval for blood cancer drug
Venclexta, when paired with Rituxan, is now cleared for second-line treatment of two related types of leukemia, positioning the drug behind Imbruvica.
By Ned Pagliarulo • June 11, 2018 -
EMA moves forward with Amsterdam relocation
The board of the EU's medicines agency signed off on a plan to keep business moving as the agency moves from London post-Brexit.
By Suzanne Elvidge • June 11, 2018 -
'Patient-focused' drug development guidance coming, FDA chief says
Speaking at the BIO International convention, FDA Commissioner Scott Gottlieb also laid out his vision to balance workloads among therapeutic areas.
By Lisa LaMotta • June 8, 2018 -
BIO18: FDA to issue guidance on cell and gene therapy in July
Commissioner Scott Gottlieb also said the industry needs to move toward continuous manufacturing of these treatments.
By Lisa LaMotta • June 7, 2018 -
FDA lays out biosimilar guidance for agency meetings
One aim of the draft guidance is to speed biosimilars' path to market by improving communication with the regulator.
By Suzanne Elvidge • June 6, 2018 -
First Neulasta biosimilar headed to US market
The FDA has approved Mylan and Biocon's copycat pegfilgrastim, putting even more pressure on the already weakening Amgen franchise.
By Jacob Bell • June 6, 2018 -
FDA puts illegal opioid websites on notice, issues warning letters
Commissioner Scott Gottlieb said the effort is one piece of a broader effort to crack down on opioids sold online and shipped by mail.
By David Lim • June 6, 2018 -
AMA trumpets physician efforts in opioid epidemic fight
The doctors' group said opioid prescriptions are down while prescription drug monitoring program queries are up.
By Les Masterson • June 1, 2018 -
Lilly's baricitinib gets FDA OK, but faces hurdles
The big pharma finally garnered approval for its rheumatoid arthritis drug, but only got clearance for the lower dose.
By Lisa LaMotta • June 1, 2018 -
FDA working to mitigate critical drug shortages
Drug shortages can impede access to important drugs — something the agency aims to prevent in the future.
By Suzanne Elvidge • June 1, 2018 -
Column
Prescribed Reading: M&A slow ahead of BIO, ASCO
With two of the industry's biggest conferences coming up, the biopharma deal space took a breath.
By Lisa LaMotta • June 1, 2018 -
Vertex, CRISPR gene-editing therapy hit with clinical hold
Though CTX001 now faces a delay in the U.S., CRISPR and Vertex still plan to initiate a Phase 1/2 study of it in Europe later this year.
By Jacob Bell • May 31, 2018 -
FDA launches medical device 'innovation challenge' to combat opioid crisis
The agency is dangling its Breakthrough Device designation to spur products, including diagnostics to identify those at high risk of addiction and pain.
By David Lim • May 31, 2018 -
TherapeuticsMD garners FDA OK for Imvexxy
After a prior rejection, the women's health company gets the go-ahead for its estrogen capsule for pain during sex.
By Lisa LaMotta • May 30, 2018 -
EU refines IP rules to boost biosimilars and generics
The European Commission is loosening an IP law to improve the competitiveness of EU drugmakers in the global generic and biosimilar market.
By Suzanne Elvidge • May 29, 2018 -
BioMarin cleared to bring new PKU drug to market
A wholesale acquisition cost of $192,000 puts Palynziq at a premium compared to BioMarin's other marketed PKU drug Kuvan.
By Jacob Bell • May 25, 2018 -
Column
Prescribed Reading: J&J seen with most M&A potential; Drug pricing plan ripples
The pharma giant has the greatest flexibility to ink a deal, according to a recent Leerink report. Elsewhere, drug pricing remained center stage in D.C.
By Lisa LaMotta • May 25, 2018 -
Recro plummets on CRL
Stock in the Pennsylvania biotech swung from a 52-week high to a low after the FDA rejected its intravenous, non-opioid pain drug.
By Jacob Bell • May 24, 2018 -
FDA issues draft guidance on topical drug ingredients
The agency is taking a closer look at how API are absorbed through the skin now that better technologies allow for more accurate monitoring.
By Suzanne Elvidge • May 24, 2018 -
Right to Try bill clears House, headed for Trump signature
FDA chief Scott Gottlieb had expressed reservations about the impact on agency authority.
By David Lim • May 22, 2018 -
Early 340B hospitals gave more uncompensated care than later participants
The research comes as Congress and President Donald Trump have called into question whether the program has outgrown its intent.
By David Lim • May 22, 2018 -
FDA approves first TPO agonist for chronic liver disease
Dova's Doptelet, available in June, will be the first oral option for liver disease patients with thrombocytopenia.
By Suzanne Elvidge • May 22, 2018 -
Senate Dem says raising drug prices abroad won't help US
The generic drug lobby has concerns that tariffs proposed by the Trump administration, including on pharmaceutical ingredients and products from China, would lead to increased manufacturing costs and higher drug prices.
By David Lim • May 21, 2018