FDA+ roundup: Republicans will be key for Rob Califf’s confirmation; Janet Woodcock and Margaret Hamburg talk FDA and the pandemic

December 8, 2021 02:02 PM EST

FDA+ roundup: Republicans will be key for Rob Califf's confirmation; Janet Woodcock and Margaret Hamburg talk FDA and the pandemic

Zachary Brennan

Senior Editor

President Biden’s nominee to be the next FDA commissioner officially has his Senate confirmation hearing set for next Tuesday. Rob Califf, who’s prepping for his second run as FDA commish, will be peppered with questions by senators ahead of an up or down vote that will likely go Califf’s way.

At least four Democrats, including Bernie Sanders and West Virginia’s Joe Manchin, have already said they won’t vote for Califf, as they did during Califf’s first confirmation (89-4 was the final vote on that one). While Califf’s industry ties and views on the pandemic will likely be the focus of the hearing, all eyes will be on the Republicans (given the tight R-D split in the Senate), and whether they’re willing to back a Biden nominee.

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Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

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August 13, 2022 06:00 AM EDT

Weekly

Historic drug pricing reforms pass; Pfizer acquires GBT; The long search for non-opioid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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August 12, 2022 09:19 AM EDT

R&D

Pharma

Gold for adults, silver for infants: Pfizer's Prevnar 2.0 headed to FDA months after Merck's green light

Kyle LaHucik

Associate Editor

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Experimental Drug Development Centre

Singapore

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

August 12, 2022 01:51 PM EDTUpdated 02:14 PM

Pharma

Law

Paving the way for Merck's buyout, Seagen loses arbitration dispute with Daiichi over ADC tech

Zachary Brennan

Senior Editor

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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August 12, 2022 12:47 PM EDTUpdated 02:10 PM

Pharma

FDA+

FDA approves second indication for AstraZeneca and Daiichi's Enhertu in less than a week

Aayushi Pratap

News Reporter

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Benjamin Oakes, Scribe Therapeutics CEO

August 12, 2022 07:46 AM EDTUpdated 01:01 PM

Cell/Gene Tx

CEO of Doudna spinout: Within five years, genome editors will have a 'really big impact' on patients' lives

Zachary Brennan

Senior Editor

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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Elcin Barker Ergun, Menarini Group CEO

August 11, 2022 09:32 AM EDTUpdated 01:57 PM

Pharma

FDA+

Amid Roche and Sanofi's oral SERD setbacks, Menarini gets speedy review at FDA

Kyle LaHucik

Associate Editor

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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CAI

Boston, MA, USA

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August 12, 2022 05:36 PM EDTUpdated August 13, 08:08 AM

Law

House passes historic drug pricing reforms, lining up decades-in-the-making win for Biden and Democrats

Zachary Brennan

Senior Editor

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

August 12, 2022 02:02 PM EDTUpdated 03:16 PM

Pharma

Law

Senate Finance chair continues his investigation into pharma taxes with requests for Amgen

Zachary Brennan

Senior Editor

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.