The pharma industry’s rep hits absolute. rock. bottom.

September 4, 2019 02:45 PM EDT

The pharma industry's rep hits absolute. rock. bottom.

John Carroll

Editor & Founder

After two years of being pilloried by the president and lawmakers for drug pricing, sparking headlines about huge judgments levied for triggering the opioid epidemic (J&J) and hiding manipulated data during an FDA review (Novartis), it may come as no surprise to hear that the industry’s reputation has suffered some.

But it’s worse than that.

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The Price of Relief: Exploring Solutions to the Rising Costs of Oncology Drugs

Checkpoint Therapeutics

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

January 15, 2022 06:00 AM ESTUpdated 07:59 AM

Weekly

Latest news on Pfizer's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the numbers; Biogen's Aduhelm reckoning; The story of sotrovimab; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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January 14, 2022 04:29 PM ESTUpdated January 14, 07:04 PM

Pharma

FDA+

A $3B+ peak sales win? Pfizer thinks so, as FDA offers a tardy green light to its JAK1 drug abrocitinib

John Carroll

Editor & Founder

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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ENDPOINTS CAREERS

Director/Group Head of Platform Biology

Siduma Therapeutics, Inc.

New Haven, CT, USA

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

January 13, 2022 10:07 AM EST

Pharma

Biogen vows to fight CMS' draft coverage decision for Aduhelm before April finalization

Zachary Brennan

Senior Editor

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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January 12, 2022 10:25 AM EST

Pharma

‘Skinny labels’ on generics can save patients money, research shows, but recent court decisions cloud future

Zachary Brennan

Senior Editor

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

January 14, 2022 06:47 AM EST

FDA+

Rob Califf advances as Biden's FDA nominee, with a close committee vote

Zachary Brennan

Senior Editor

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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January 11, 2022 04:39 PM ESTUpdated January 12, 08:06 AM

Pharma

UPDATED: CMS to restrict coverage of Biogen's controversial Alzheimer's drug to only clinical trials

Zachary Brennan

Senior Editor

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

ENDPOINTS CAREERS

Director-Regulatory

Icosavax, Inc.

Seattle, WA, USA

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January 13, 2022 07:02 AM EST

Outsourcing

FDA+

CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data

Zachary Brennan

Senior Editor

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

January 13, 2022 06:56 AM ESTUpdated 10:56 AM

R&D

Cancer powerhouse AstraZeneca rolls the dice on a $75M cash bet on a buzzy upstart in the oncology field

John Carroll

Editor & Founder

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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