FDA: Page 58
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Courtesy of Sanofi
Sanofi's Humalog follow-on gets FDA nod
With its diabetes unit on the decline, Sanofi is banking on a "more affordable" treatment to help prop up revenue.
By Jacob Bell • Dec. 12, 2017 -
Prescribed Reading: Dealmaking begins to pick up as 2018 approaches
It's been a slow year for deals, but it looks like Gilead's buy of Kite could be a catalyst for more M&A.
By Lisa LaMotta • Dec. 8, 2017 -
FDA lays groundwork for regulating 3D-printed drugs
The agency says it's the first regulator in the world to provide technical guidelines for manufacturers seeking to make medical products on 3D printers.
By Jacob Bell • Dec. 7, 2017 -
Novo gains FDA OK for semaglutide
The Danish drugmaker won regulatory approval for its once-weekly GLP-1, strengthening its foothold in the diabetes market.
By Lisa LaMotta • Dec. 6, 2017 -
Amazon pulls pharmacy wholesaler application in Maine
Amazon told regulators last month it does not intend to sell drugs, and the state filings alone would not allow them to do so.
By Shannon Muchmore • Dec. 6, 2017 -
The Brexit countdown continues
With a new home for the EMA now established, the next steps of separating the U.K. from the EU will continue for pharma.
By Suzanne Elvidge • Dec. 4, 2017 -
Mylan wins first US approval of Herceptin biosimilar
Earlier this year, the generics maker reached a settlement with Roche to market the biosimilar, although launch timing in the U.S. remains unclear.
By Ned Pagliarulo • Dec. 4, 2017 -
Senate passes tax bill that repeals individual mandate
Lawmakers will now attempt to work out the differences between the Senate bill and a similar tax bill the House passed last month that preserves the mandate.
By David Lim • Dec. 2, 2017 -
Prescribed Reading: Industry CEOs talk PRVs, IPR, PCSK9
Leschly suggests PRVs should be an alternative source of revenue for biotechs; ear health R&D is all clogged up; and execs agree the IPR process should be thrown out.
By Lisa LaMotta • Dec. 1, 2017 -
Sanofi to propose limits on use of dengue vaccine after safety signal
Recently analyzed clinical data showed the shot could intensify subsequent cases of the disease for individuals who had not previously been infected.
By Ned Pagliarulo • Nov. 30, 2017 -
FDA knocks generic maker for misbranding sleep aid
The warning letter to Magna Pharmaceuticals is only the third such notice issued this year by the FDA office in charge of regulating prescription drug promotion.
By Ned Pagliarulo • Nov. 29, 2017 -
Elizabeth Regan/BioPharma Dive
Catalyst eyes 2018 filing for rare disease drug candidate
Positive data from a second Phase 3 study has Catalyst on track to resubmit Firdapse for potential U.S. approval.
By Suzanne Elvidge • Nov. 28, 2017 -
BioMarin sells latest PRV for $125M
The biotech monetized its coveted priority review voucher, boosting its finances.
By Lisa LaMotta • Nov. 27, 2017 -
FDA pushes for more abuse-deterrent opioid generics
Under new Commissioner Gottlieb, the FDA has been looking to increase competition across markets by ushering more drugs through the system more efficiently.
By Jacob Bell • Nov. 21, 2017 -
EMA lands new home in Amsterdam
The European drugs regulator will leave London to take up residence in Amsterdam after the U.K.'s Brexit vote forced a relocation.
By Lisa LaMotta • Nov. 20, 2017 -
New FDA framework points to boost for cell and gene therapies
The framework may act as a bonus for the industry by speeding development of cell and gene therapies while improving safety and efficacy.
By Suzanne Elvidge • Nov. 20, 2017 -
Elizabeth Regan/BioPharma Dive
Proposed Medicare policy could shift drug rebates to consumers
Currently, rebates and discounts for Part D drugs are "rarely" passed on directly to consumers, although they can lower overall premiums.
By Ned Pagliarulo • Nov. 17, 2017 -
Prescribed Reading: FDA on approval streak, I/O shines
The regulatory agency granted seven approvals this week, including the first pill with a digital sensor, as well as the go-ahead for a new hemophilia drug.
By Lisa LaMotta • Nov. 17, 2017 -
Ultragenyx wins first drug approval, valuable PRV
The FDA OK'd Mepsevii for a rare genetic disease sometimes known as Sly syndrome. But the priority review voucher UltraGenyx received in the process might end up being just as valuable.
By Lisa LaMotta • Nov. 16, 2017 -
What you need to know about the new nominee to lead HHS
Alex Azar's previous stint at the agency is a plus in the eyes of many, but his more recent time as an executive for pharma giant Eli Lilly casts doubt on the Trump administration's promise to rein in drug prices.
By Shannon Muchmore • Nov. 15, 2017 -
AstraZeneca wins US approval for asthma biologic
The British drugmaker, long a leader in respiratory disease, has turned to biologics like Fasenra to fuel growth over the next decade.
By Ned Pagliarulo • Nov. 15, 2017 -
Hospitals file lawsuit to block 340B drug payment cut
Plaintiffs including the AHA argue the reimbursement change exceeds the authority of the HHS secretary and is "arbitrary and capricious."
By Shannon Muchmore • Nov. 14, 2017 -
Trump nominates former pharma exec Azar for head of HHS
Alex Azar was deputy secretary for HHS under President George W. Bush and more recently served as president of Lilly USA up until January.
By Shannon Muchmore • Nov. 13, 2017 -
Ocrevus, Mvasi and 8 other drugs get CHMP go-ahead
The EMA advisory committee's latest approval recommendations included copycat and generic offerings that could sap money from blockbuster franchises.
By Jacob Bell • Nov. 10, 2017 -
Prescribed Reading: Buyer's remorse for biopharma
Most of the major deal developments of late have been companies handing back the rights to assets they previously licensed as they try to right-size portfolios.
By Lisa LaMotta • Nov. 10, 2017
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