Turning Point tracks an impressive ORR rate in NSCLC — but shares skid lower on second look

May 31, 2019 09:30 AM EDTUpdated June 3, 02:12 PM

Turning Point tracks an impressive ORR rate in NSCLC — but shares skid lower on second look

John Carroll

Editor & Founder

CHICAGO — Fresh off of a $166 million IPO raise, Turning Point Therapeutics $TPTX joined the opening-day festivities at ASCO with an update on their lead drug repotrectinib — which they plan to pitch for an early approval for ROS1+ advanced non-small cell lung cancer.

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January 27, 2021 10:11 AM EST

R&D

Pfizer's big blockbuster Xeljanz flunks its post-marketing safety study, renewing harsh questions for JAK class

Jason Mast

Editor

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Data Literacy: The Foundation for Modern Trial Execution

Kristin Mauri

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

January 28, 2021 08:26 AM ESTUpdated 09:14 AM

Deals

R&D

Top gene therapy deals, M&A pacts in 2020 highlight another big year in one of the hottest fields in biopharma

John Carroll

Editor & Founder

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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January 28, 2021 08:00 AM EST

R&D

Takeda earns win for its TKI inhibitor in tiny lung cancer group — but GI side effects could be an early red flag

Kyle Blankenship

Senior Editor

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Janet Woodcock (AP Images)

January 28, 2021 08:19 AM EST

People

Regulatory

Advocacy groups don't want Janet Woodcock to head the FDA, blasting ‘regulatory failures’ in opioid crisis

Amber Tong

Senior Editor

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Vas Narasimhan (AP Images)

January 28, 2021 06:37 AM ESTUpdated 07:01 AM

R&D

BeiGene's PD-1 scores PhIII win in esophageal cancer — a 'key indication' tapped by Novartis in $650M deal

Amber Tong

Senior Editor

Days after bringing BeiGene’s PD-1 into its portfolio, Novartis is adding a feather to its tislelizumab cap.

BeiGene reported that in the second-line setting, the checkpoint inhibitor extended overall survival for patients with esophageal squamous cell carcinoma, a key indication identified by Novartis. It was the primary endpoint in this Phase III trial.

“This is our fourth positive Phase 3 readout for tislelizumab and the first from our large Phase 3 program in gastrointestinal cancers that also include liver, stomach cancers as well as esophageal cancer,” BeiGene’s CMO in immuno-oncology, Yong Ben, said in a statement.

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January 27, 2021 07:02 AM ESTUpdated 11:05 AM

Coronavirus

Covid-19 roundup: EU and AstraZeneca trade blows over slowdowns; Unusual unions pop up to test antibodies, vaccines

Amber Tong

Senior Editor

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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January 28, 2021 08:00 AM EST

Deals

Dean Li kicks off Merck's post-Roger Perlmutter era by teaming with Artiva and its off-the-shelf CAR-NK tech

Max Gelman

Associate Editor

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.

January 28, 2021 07:22 AM ESTUpdated 08:24 AM

Coronavirus

Covid-19 roundup: Controversy around colchicine percolates after study failure; AstraZeneca's meeting with EU was 'constructive,' but didn't solve much

Amber Tong

Senior Editor

Nicole DeFeudis

Associate Editor

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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