Clinical trial transparency improves at (some) biopharmas as J&J, Sanofi lead a pack trailed by Valeant and Allergan

Drug makers appear to be more transparent with their clinical trial data than they used to be, according to a new analysis by a coalition of researchers. But not all pharmas are not equally forthright.

The group, led by not-for-profit Bioethics International, looked at clinical trial registration, results reporting, clinical study report synopsis sharing and journal publication rates for new drugs approved by the FDA in 2014. Specifically, they zeroed in on large pharmaceutical companies, and ranked them by transparency metrics.

Jennifer Miller

The researchers reviewed 505 trials for 19 novel drugs and found the public availability of data results was up. Compared to the group’s first analysis in 2015, the proportion of new drugs with all Phase II or III trials disclosed from their NDAs went up from 50% to 67%, and the public availability of results for trials conducted in patients for each drug went up from a median of 87% to 96%.

Some companies fared better than others. Johnson & Johnson and Sanofi/Genzyme both ranked high, while Valeant settled at the bottom of the list, which Bioethics calls its “good pharma scorecard.”

“This year’s scorecard shows clear corporate leaders in clinical trial transparency and industry improvement on several metrics,” said Jennifer Miller, founder of Bioethics and lead author on the analysis, in a statement. “We hope this improvement continues year after year, because clinical trial transparency is critical for advancing innovation, respect for trial participants, and patient health.”

Here is Bioethics’ full list of clinical trial transparency rankings, first by drug maker and then by drug.

William Pao (L) and Hans Clevers

Pfizer raids Roche executive committee for new drug development chief — and Schwan plucks his replacement from the board

Pfizer has found its new chief of drug development, and they’ve dispatched a raiding party to Basel to pluck him off the executive committee at Roche.

William Pao, who took over as head of pRED after John Reed exited to take the R&D chief post at Sanofi in 2018, is headed to the executive committee at Pfizer now, where he’ll report to Albert Bourla in New York. And he has a big remit that includes “inflammation and immunology, internal medicine, hospital, oncology and rare disease, as well as regulatory affairs in support of Pfizer’s R&D pipeline and portfolio of marketed therapies.”

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UPenn sues Genentech over patent infringement with four cancer drugs

The University of Pennsylvania is suing Roche’s Genentech again, this time seeking an unidentified amount of damages for infringing on a Penn patent that’s linked to four of the California biotech’s cancer treatments and which has helped bring in billions in sales over the years.

The patent in question from 2009 — known as the ‘588 patent — relates to therapies for treating ErbB protein-mediated cancer tumors, which relate to Genentech’s cancer drugs Herceptin, Herceptin Hylecta, Perjeta, and Phesgo.

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Joe McCann, Point Biopharma CEO

Point unveils new Indy site to shore up supply chain in fight against prostate cancer

With a new manufacturing facility and a candidate for prostate cancer in clinical trials, Point Biopharma is moving fast to bring its radioligand operations online. Now, it will get some help from the US Department of Energy.

Point will receive actinium-225 from the DOE’s Isotope Program to support its early-stage pipeline and in-house manufacturing of lutetium-177, a radioactive medicine that binds itself to tumor cells. The help will allow Point to stay on track to launch in 2023 and will supplement the company’s supply chain from TerraPower, NorthStar Medical and Ionetix. All of these partnerships will help bolster the company’s internal production, the company said.

GSK grabs $1.25B cash and a cut of Gilead's megablockbuster Biktarvy sales as HIV rivals settle patent suit

Three years after ViiV Healthcare, the HIV specialist majority owned by GlaxoSmithKline, first sued Gilead over alleged patent infringement on one of its top drugs, the two companies have settled the case.

Gilead will pay ViiV $1.25 billion in cash — while agreeing to set aside a 3% royalty on all US sales of Biktarvy until October 2027.

A megablockbuster triplet therapy given as a daily pill, Biktarvy brought in $6.09 billion from the US alone in 2020. By 2027, Jefferies analysts estimate that cumulative US sales would reach about $50 billion — translating to about $2 billion in total royalties for ViiV.

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That partial hold on Gilead's $5B cancer drug? It's worse than we were initially told

Gilead’s trouble with its $5 billion drug magrolimab is considerably worse than it disclosed in a press release last week.

Originally, the big biotech alerted investors that they had to slam the brakes on enrolling patients in a slate of clinical trials that combined the CD47 drug magrolimab with azacitidine (Vidaza). That came after the agency flagged an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.

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Rick Gonzalez, CEO of AbbVie (AP Images)

AbbVie's Gonzalez: Skyrizi and Rinvoq to become Humira 2.0 — while adding an indication for atopic dermatitis

While AbbVie’s Humira still holds the crown for the best-selling non-Covid drug last year, the Big Pharma has its eyes on Humira’s potential successor. Scratch that, successors.

AbbVie CEO Rick Gonzalez told investors and analysts on the pharma’s Q4 call this morning that AbbVie expects to add several new indications to Skyrizi and Rinvoq’s “list of approved uses” over the next few months. For Skyrizi, they got the FDA’s OK a few weeks ago to use the drug for psoriatic arthritis — and they’re also looking for the thumbs up from the agency on Crohn’s disease.

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Vas Narasimhan reveals a disappointing outlook for Novartis' generics unit, while laying out the pharma's M&A strategy

As Novartis CEO Vas Narasimhan figures out exactly what he wants to do with Sandoz, the company revealed in its Q4 report that US sales for the generics unit are expected to continue on a downhill slide in the new year — potentially putting a damper on the prospects of a buyout.

Narasimhan says he’ll wrap up his strategic review of Sandoz and make a decision by the end of the year at the latest. Meanwhile, he laid out the company’s M&A strategy going into 2022, as public stocks tumble and all signs point to a Big Pharma M&A hunt this year.

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PhRMA goes on the offensive, attacking the WHO and putting the EU, UK, Australia and others on notice

Each year, industry groups like PhRMA offer their views on which countries around the globe might be harming biopharma innovation as a result of their intellectual property protections or lack thereof, which can contribute to a report produced by the White House’s trade representative on the global state of IP.

This year’s 273 pages worth of comments from PhRMA not only take issue with the Biden administration’s pledge to support an IP waiver for Covid-19 vaccines at the WTO, but also raise concerns about the WHO and other countries on the priority watch list, like Canada, and the industry group has requested that the US trade representative add Australia, Taiwan, the EU, UK, Egypt and Israel to its “watch list.”

Organon's social media posts will draw attention to its new campaign to encourage companies to give women a day off to take care of her health.

Organon launches day-off campaign to encourage business leaders to prioritize women's health

Organon wants to get women out of the office and focused on their own health — for one day at least. The Merck women’s health spinoff is rallying to encourage companies to give women a paid day off on March 8, which is International Women’s Day, and it’s starting with its own 9,500 employees.

In a Wall Street Journal full-page ad Wednesday, Organon CEO Kevin Ali wrote an open letter to business leaders asking them to join the effort and help female employees focus on their health.

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