8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

February 13, 2020 04:53 PM EST

8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

Amber Tong

Editor

CAMELLIA-TIMI 61 was supposed to be the trial that would resolve the FDA’s concerns about Belviq as Eisa investigators showed that the weight loss drug didn’t increase incidences of cardiovascular events. Instead, it unearthed new issues that’s now led to its demise.

At regulators’ request, Eisai said it’s withdrawing both the original and extended release version of Belviq from the US market, where it earned a little more than $28 million from April to December 2019.

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Inside FDA HQ (File photo)

August 12, 2020 06:30 PM EDTUpdated 21 hours ago

Pharma

Regulatory

The FDA just approved the third Duchenne MD drug. And regulators still don’t know if any of them work

Max Gelman

Associate Editor

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Contract Manufacturers Must Embrace Digitization

Rachit Jain

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Franz-Werner Haas, CureVac CEO

August 14, 2020 06:32 AM EDTUpdated 08:41 AM

IPOs

UPDATED: On the heels of a snap $1B raise, CureVac outlines plans to seek emergency OK for their Covid-19 vaccine in a matter of months

John Carroll

Editor & Founder

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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August 14, 2020 10:37 AM EDT

R&D

Coronavirus

US government reportedly begins preparing for Covid-19 challenge trials. Are they ethical?

Max Gelman

Associate Editor

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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August 14, 2020 08:19 AM EDTUpdated 09:07 AM

Peer Review

Sanofi vet Katherine Bowdish named CEO of PIC Therapeutics; As the world Terns: Liver disease biotech makes executive changes

Alex Hoffman

Assistant Editor

Kathy Wong

Assistant Editor

→ PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

August 14, 2020 07:28 AM EDT

People

Pharma

Martin Shkreli continued to orchestrate anti-competitive schemes for Daraprim behind bars — FTC

Amber Tong

Editor

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

Trevor Martin (Mammoth)

August 14, 2020 10:26 AM EDTUpdated 12:40 PM

Deals

R&D

Eyeing in-vivo editing, Mammoth licenses Jennifer Doudna’s new CRISPR enzyme

Jason Mast

Associate Editor

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.

ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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Clockwise from left: Canaccord Genuity principal Michelle Gilson, Canaccord Genuity CSO Brian Mueller and BioMarin CSO Hank Fuchs (Canaccord Genuity webcast)

August 14, 2020 10:23 AM EDT

Bioregnum

Cell/Gene Tx

BioMarin CSO disses rivals for the hemophilia A gene therapy crown: Way behind, facing big recruitment challenges and at best a .6 on the gen-one scale

The leader in the race to a hemophilia A gene therapy does not like to be compared unfavorably to the competition. And when their top execs do the comparing, don’t look for any modesty — BioMarin, they say, owns the lead.

As Factor VIII expression wanes over time, quite a few analysts have raised questions about the kind of future BioMarin’s gene therapy — a supposed once-and-done treatment — faces if it stops working. But just 7 days away from their PDUFA date, with high odds of success, the top execs clearly feel that they are way out front, while promising their rivals will discover there’s a tough slog ahead trying to pursue trials where large numbers of patients are ineligible for new therapies.

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James Wilson, WuXi Global Forum at JPM20

August 13, 2020 09:13 AM EDTUpdated 10:44 AM

R&D

Regulatory

FDA puts up a red light for Passage Bio’s first gene therapy program, delaying a program from James Wilson's group at Penn

John Carroll

Editor & Founder

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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