Better than CAR-T? Already prepping for a US launch, MorphoSys posts stellar DLBCL data to field against Novartis, Gilead

May 17, 2019 07:27 AM EDTUpdated May 21, 10:40 AM

John Carroll

Better than CAR-T? Already prepping for a US launch, MorphoSys posts stellar DLBCL data to field against Novartis, Gilead

Already beavering away at building a US commercial operation, MorphoSys $MOR is now bearing down on Novartis and Gilead with a potential CAR-T killer soon to be put into the hands of US regulators.

The German biotech says its final cut of the data on their CD19-targeting antibody tafasitamab — or MOR208 — combined with lenalidomide crossed the finish line in a group of patients suffering from treatment-resistant DLBCL, a common form of non-Hodgkin lymphoma.

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Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

September 20, 2019 10:31 AM EDTUpdated 01:58 PM

Jason Mast

Pharma

R&D

Genentech submits a big plan to expand its South San Francisco footprint

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City.

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

September 20, 2019 12:52 PM EDT

Amber Tong

Pharma

R&D

Here comes the oral GLP-1 drug for diabetes — but Novo Nordisk isn't disclosing Rybelsus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

September 20, 2019 07:11 AM EDT

Amber Tong

IPOs

As Nasdaq enrolls the final batch of 2019 IPOs, how have the numbers compared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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ENDPOINTS CAREERS

Manager, Compound Management

Recursion Pharaceuticals

Salt Lake City

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

September 20, 2019 11:14 AM EDT

Natalie Grover

R&D

Regulatory

Intrexon unit pushes back against claims its GM mosquitoes are making disease-friendly mutants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

September 20, 2019 11:04 AM EDT

Jason Mast

Pharma

Purdue threatens to walk away from settlement, asks to pay employees millions in bonuses

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

September 18, 2019 01:10 PM EDTUpdated September 19, 11:20 AM

Natalie Grover

Cell/Gene Tx

R&D

'Disconnect the bastards' — one biotech's plan to break cancer cells' unified defenses

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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September 18, 2019 09:57 AM EDTUpdated September 19, 05:39 PM

John Carroll

People

A favorite in Alexion’s C-suite is leaving, and some mighty surprised analysts aren’t the least bit happy about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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ENDPOINTS CAREERS

Senior Analyst - Science & Technology

Alexandria Real Estate Equities

Cambridge, Massachusetts, USA

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Scott Gottlieb, AP Images

September 17, 2019 08:59 AM EDTUpdated 09:14 AM

John Carroll

People

Scott Gottlieb is once again joining a team that enjoyed good times at the FDA under his high-energy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

September 16, 2019 03:59 PM EDT

John Carroll

Bioregnum

#UKBIO19: Join GSK’s Hal Barron and a group of top biotech execs for our 2nd annual biotech summit in London

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.