Cytiva pledges $52.5M into South Korean operations as it expands global plans

September 30, 2021 12:52 PM EDTUpdated 02:27 PM

Cytiva pledges $52.5M into South Korean operations as it expands global plans

Josh Sullivan

Associate Editor

When Cytiva decided it would play a role in the Covid-19 pandemic, it moved quickly to open new manufacturing sites and adapt existing ones. Now, the company will send that investment overseas as the company announced a multimillion-dollar memorandum of understanding with South Korea last week.

South Korean President Moon Jae-in was present for the announcement, which took place at a New York ceremony. Cytiva has pledged $52.5 million in South Korea for the next two years, starting in 2022, Moon said.

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Biotech and Big Pharma: A blueprint for a successful partnership

Noël Brown

Managing Director and Head of US Biotechnology Investment Banking

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

October 25, 2021 06:32 AM EDTUpdated 07:01 AM

R&D

Novartis' second attempt to replicate a stunning cancer result falls flat

Jason Mast

Editor

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Credit: Shutterstock

October 26, 2021 08:03 AM EDTUpdated 10:45 AM

China

In Focus

How China turned the tables on biopharma's global dealmaking

Amber Tong

Senior Editor

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

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October 26, 2021 10:58 AM EDTUpdated 11:27 AM

Manufacturing

As pressure to share technology mounts, BioNTech selects Rwanda for latest vaccine site

Josh Sullivan

Associate Editor

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

October 26, 2021 10:23 AM EDT

R&D

Pharma

Novartis dumps AveXis program for Rett syndrome after failing repeat round of preclinical testing

Paul Schloesser

Editorial Intern

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

October 26, 2021 07:17 AM EDT

Deals

With Sandoz continuing to drag on Novartis, Vas Narasimhan says he may finally be ready for a sale or spinoff

John Carroll

Editor & Founder

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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October 26, 2021 07:16 AM EDTUpdated 07:51 AM

R&D

FDA+

FDA is much worse than its regulatory peers at proactively disclosing data, researchers find

Zachary Brennan

Senior Editor

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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October 26, 2021 07:05 AM EDTUpdated 09:14 AM

Financing

Brent Saunders joins $100M Series C for a company out to be the BridgeBio of aging

Jason Mast

Editor

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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October 26, 2021 11:18 AM EDT

News Briefing

ARCH-backed SciNeuro kicks off search for CNS autoantibodies with new deal; Merck + Gilead announce PhII trial for HIV combo

Endpoints Staff

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.