FDA sets record for num­ber of gener­ic drug ap­provals again

The FDA has ap­proved and ten­ta­tive­ly ap­proved more gener­ic drugs in FY 2018 than any oth­er year pri­or, the agency an­nounced Thurs­day.

The 971 to­tal in­cludes 781 fi­nal ap­provals and 190 ten­ta­tive ap­provals, which com­pares with 937 to­tal in FY 2017, which was the high­est num­ber of ap­provals since 2016, which at the time set the pre­vi­ous record.

Scott Got­tlieb

“When I start­ed as FDA com­mis­sion­er, I made clear that one of my top pri­or­i­ties would be en­sur­ing the agency does all it can to help en­sure Amer­i­can pa­tients have ac­cess to af­ford­able, qual­i­ty med­i­cines that meet their needs. To ac­com­plish this, we have tak­en many im­por­tant ac­tions to en­cour­age the time­ly de­vel­op­ment and ap­proval of low­er-cost gener­ic drugs and are be­gin­ning to see re­sults,” FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment.

Of the ap­provals in FY 2018, the FDA said about 12% were for com­plex gener­ics, like EpiPens, while 95 first gener­ics were ap­proved in the fis­cal year.

In ad­di­tion, three new ap­provals re­ceived a Com­pet­i­tive Gener­ic Ther­a­py (CGT) des­ig­na­tion this year, which is meant to ex­pe­dite the de­vel­op­ment and re­view of gener­ic ver­sions of prod­ucts that lack com­pe­ti­tion. The first gener­ic to re­ceive the des­ig­na­tion came for sev­er­al strengths of potas­si­um chlo­ride oral so­lu­tion, which is in­di­cat­ed for the treat­ment and pre­ven­tion of hy­pokalemia (low potas­si­um blood lev­els) in pa­tients who are on di­uret­ics, and when di­etary man­age­ment with potas­si­um-rich foods is in­suf­fi­cient or di­uret­ic dose re­duc­tion is not pos­si­ble.

​Got­tlieb added: “Our work is not done. We’ll con­tin­ue tak­ing ad­di­tion­al steps to help en­sure pa­tients have ac­cess to the drugs they need by mak­ing gener­ic drug ap­proval more ef­fi­cient and pre­dictable. We are do­ing this by con­tin­u­ing to stream­line the gener­ic drug re­view process to get more com­peti­tors on the mar­ket. We have found that hav­ing three or more gener­ic com­peti­tors brings prices down more sharply than with on­ly one or two gener­ic com­peti­tors.”

And with the record num­ber of ap­provals, the FDA al­so set a record for most com­plete re­spons­es in one year. But the gap be­tween this year and years past – 2,548 com­plete re­spons­es have been is­sued in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be at­trib­uted to a spike in ap­pli­ca­tions or be­cause as part of the mi­gra­tion to GDU­FA II, there was a bridg­ing process that es­tab­lished a goal date of 31 Ju­ly for about 800 ap­pli­ca­tions that did not have an of­fi­cial goal date in GDU­FA I.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

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About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

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Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

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The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

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BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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