Image credit: Shutterstock, AP
April 28, 2020 09:37 AM EDTUpdated 11:38 AM
FDA+
Coronavirus
In Focus

Bank­ing on hope, swayed by hype? Hy­drox­y­chloro­quine in the time of Covid-19

Natalie Grover

Reporter

As coronavirus deaths amassed and already stretched health care systems in Europe, and the United States groaned with the added weight of the pandemic, the FDA and EMA agencies adopted contradictory tones over the use of a pair of decades-old malaria drugs to fight the virus — epitomizing the desperation to combat an uncharted disease.

“This is just another example that points to the fact that while EMA and FDA oftentimes take the same position, they also take contrary positions,” said Peter Pitts, who served as the FDA’s associate commissioner for external relations between 2002 and 2004. “We are addressing Covid-19 in a variety of ways, and so is the EMA — the circles are concentric, but they are not identical.”

Endpoints News

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SPONSORED
May 16, 2022 06:00 AM EDT

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Corning Life Sciences

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)
May 16, 2022 09:28 AM EDT
People
Discovery
In Focus

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

Jason Mast

Editor

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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May 17, 2022 10:13 AM EDT
Bioregnum

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)
May 17, 2022 02:46 PM EDT
Pharma
FDA+

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

Zachary Brennan

Senior Editor

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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May 17, 2022 01:43 PM EDT
FDA+

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Zachary Brennan

Senior Editor

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)
May 17, 2022 01:42 PM EDT
Cell/Gene Tx
FDA+

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

Zachary Brennan

Senior Editor

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

May 17, 2022 01:39 PM EDT
Pharma
FDA+

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

Zachary Brennan

Senior Editor

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.

May 17, 2022 06:37 AM EDT
FDA+

A CRL lat­er, Gilead clears clin­i­cal hold on next-gen HIV drug — af­ter find­ing a new glass vial for it

Amber Tong

Senior Editor

Back in late December, the FDA flagged concerns about the glass vials Gilead used to contain its experimental HIV therapy lenacapavir, citing risks of forming sub-visible glass particles in the drug solution.

Those issues were serious enough to trigger a clinical hold on 10 trials — and ultimately a rejection.

FDA rejects Gilead’s next big HIV drug over glass vial issues

Two months after the complete response letter, Gilead said it’s finally found a solution that satisfies the FDA, which is lifting the clinical hold.

Endpoints News

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Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)
May 16, 2022 06:48 AM EDTUpdated 11:48 AM
People

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

Amber Tong

Senior Editor

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

Endpoints News

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Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Bank­ing on hope, swayed by hype? Hy­drox­y­chloro­quine in the time of Covid-19

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

A CRL lat­er, Gilead clears clin­i­cal hold on next-gen HIV drug — af­ter find­ing a new glass vial for it

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims