FDA: Page 50
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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FDA issues draft guidance on topical drug ingredients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 -
FDA warns of decreased survival in 2 studies of Keytruda, Tecentriq
Early reviews of the trials found bladder cancer patients with low PD-L1 levels treated first with immunotherapy were performing worse than those on chemo.
By Ned Pagliarulo • May 21, 2018 -
Celgene, J&J top complaint list to FDA for blocking generics
Hoping to boost competition, the agency published a list of 52 medicines for which generic drugmakers say are difficult to obtain needed samples.
By Ned Pagliarulo • May 18, 2018 -
Column
Prescribed Reading: FDA, CMS take aim at drug pricing
Government agencies announced moves to bring down high drug prices, though the market doesn't seem worried just yet.
By Lisa LaMotta • May 18, 2018 -
Amgen, Novartis' closely watched migraine drug approved
Aimovig heads to the U.S. market with a $6,900 annual price tag — which analysts say falls below expectations and bodes well for payer pickup.
By Jacob Bell • May 18, 2018 -
Alex Wong via Getty Images
CMS weighing National Coverage Decision for CAR-T
The agency is considering whether there is enough evidence to support national Medicare coverage of the pricey cancer therapies.
By Lisa LaMotta • May 17, 2018 -
FDA clears new tool in fight against opioid epidemic
Regulators approved US WorldMeds' Lucemyra, the first non-opioid for easing the withdrawal process.
By Jacob Bell • May 17, 2018 -
Pfizer's Epogen biosimilar finally gets FDA go-ahead
On the third try, Retacrit becomes the first epoetin alfa copycat to secure U.S. approval.
By Suzanne Elvidge • May 16, 2018 -
FDA to call out branded drugmakers for blocking generics
The effort, which will be published online, seeks to highlight pharmaceutical companies abusing the system to stall generic competition.
By David Lim • May 15, 2018 -
340B scrutinized in Senate, targeted by Trump
Lawmakers questioned the program's vague intent, lack of transparency and what they called an "inadequate" level of oversight.
By David Lim , Tony Abraham • May 15, 2018 -
Pharma breathes easy as Trump's drug pricing plan fizzles
While Trump vowed to bring drug prices down, pharma and biotech stocks jumped higher after his speech delivered few immediate actions.
By David Lim • May 11, 2018
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