Sarepta CEO Doug Ingram pins gene therapy delay on Covid-burdened FDA, can’t offer timeline for fix

Doug Ingram, Sarepta CEO (Sarepta Therapeutics)

September 11, 2020 09:13 AM EDT

Sarepta CEO Doug Ingram pins gene therapy delay on Covid-burdened FDA, can't offer timeline for fix

Jason Mast

Associate Editor

There are few dull days when it comes to Sarepta and the FDA.

The muscular dystrophy-focused biotech, whose back-and-forth travails with the agency have stoked controversy, said late Wednesday that the FDA requested a new assay for potency for the Phase III trial of their Duchenne gene therapy, a requirement that could delay the study’s start and set them back in a race with Pfizer. Then yesterday, CEO Doug Ingram said that the pandemic and an overburdened FDA contributed heavily to that delay and that the same factors make it difficult to forecast when they’ll be back on track.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

September 20, 2020 10:16 AM EDTUpdated 01:15 PM

Pharma

Trump’s HHS claims absolute authority over the FDA, clearing path to a vaccine EUA

Arsalan Arif

CEO & Founder

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

September 20, 2020 12:30 PM EDTUpdated 05:03 PM

R&D

#ESMO20: Eli Lilly shows off the data for its Verzenio success. Was it worth $18 billion?

Jason Mast

Associate Editor

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

September 20, 2020 08:25 AM EDTUpdated 10:37 AM

R&D

#ESMO20: Amgen team nails down solid early evidence of AMG 510’s potential for NSCLC, unlocking the door to a wave of KRAS programs

John Carroll

Editor & Founder

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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ENDPOINTS CAREERS

Clinical Operations Lead

Vigeo Therapeutics

Cambridge, MA

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September 20, 2020 08:25 AM EDTUpdated 09:07 AM

R&D

#ESMO20: Out to beat Tagrisso, J&J touts 100% ORR for EGFR bispecific/TKI combo — fueling a quick leap to PhIII

Amber Tong

Editor

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

September 20, 2020 03:44 PM EDT

R&D

Pharma

#ESMO20: AstraZeneca aims to spur PROfound shift in prostate cancer treatment with Lynparza OS data

Amber Tong

Editor

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

September 19, 2020 12:30 PM EDT

R&D

#ESMO20: Look out Merck. Bristol Myers and Exelixis stake out their combo’s claim to best-in-class status for frontline kidney cancer

John Carroll

Editor & Founder

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

September 19, 2020 09:10 AM EDTUpdated 11:22 AM

Pharma

Pricing deal collapses over Big Pharma's refusal to issue $100 'cash cards' before the election — report

Arsalan Arif

CEO & Founder

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Dan Skovronsky, Eli Lilly CSO

September 16, 2020 07:16 AM EDTUpdated September 17, 12:03 AM

R&D

Coronavirus

Analysts are quick to pan Eli Lilly's puzzling first cut of positive clinical data for its Covid-19 antibody

John Carroll

Editor & Founder

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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September 20, 2020 10:20 AM EDTUpdated 12:35 PM

R&D

#ESMO20: It’s not just Keytruda anymore — Merck spotlights 3 top early-stage cancer drugs

John Carroll

Editor & Founder

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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