Unum shares ricochet lower as premier drug slams into its second safety crisis, FDA slaps another hold on PhI

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July 2, 2019 05:27 PM EDTUpdated July 3, 06:26 AM

John Carroll

Unum shares ricochet lower as premier drug slams into its second safety crisis, FDA slaps another hold on PhI

Unum Therapeutics’ ailing shares $UMRX took a crippling hit after the market closed on Tuesday as executives revealed that the FDA had slapped a clinical hold on their premier Phase I drug after a patient in the safety cohort recently experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection as well as grade 4 respiratory distress.

And this wasn’t the first time Unum’s run into the same set of severe safety issues with this therapy.

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Communicating the value of precision medicine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

November 13, 2019 07:09 AM EST

John Carroll

Deals

R&D

Merck buys a fledgling neurodegenerative biotech spawned by an old GSK discovery alliance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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November 14, 2019 06:49 AM EST

Amber Tong

Venture

Investors could emerge from Neil Woodford debacle with £1B loss, internal analysis reveals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

ENDPOINTS CAREERS

Associate Medical Director/ Medical Director

Cold Genesys, Inc.

Irvine, CA

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November 13, 2019 09:09 AM ESTUpdated 09:34 AM

Natalie Grover

R&D

GSK's asthma biologic Nucala scores in rare blood disorder study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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November 11, 2019 06:00 AM ESTUpdated 18 hours ago

Endpoints Staff

People

R&D

Special report: Twenty extraordinary women in biopharma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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November 12, 2019 08:47 AM ESTUpdated 06:35 PM

John Carroll

R&D

FDA Vascepa review spotlights new safety signals, possible mineral oil spoiler as Amarin hunts a blockbuster approval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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November 12, 2019 07:15 AM ESTUpdated 07:35 AM

John Carroll

Cell/Gene Tx

R&D

FDA puts Solid Bio’s lead gene therapy program on hold — again — after another patient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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ENDPOINTS CAREERS

Director, Safety Assignment

Battelle Memorial Institute

Columbus, OH

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November 13, 2019 10:28 AM EST

Jason Mast

R&D

FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

November 13, 2019 08:43 AM EST

Jason Mast

R&D

Eli Lilly-backed biotech grabs $100M to dispatch antibody-oligonucleotide conjugates after muscular dystrophy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.

Unum shares ric­o­chet low­er as pre­mier drug slams in­to its sec­ond safe­ty cri­sis, FDA slaps an­oth­er hold on PhI

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Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Keep reading Endpoints with a free subscription

In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

Cold Genesys, Inc.

Irvine, CA

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

Keep reading Endpoints with a free subscription

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

Keep reading Endpoints with a free subscription

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

Keep reading Endpoints with a free subscription

FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Keep reading Endpoints with a free subscription

Battelle Memorial Institute

Columbus, OH

FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Unum shares ricochet lower as premier drug slams into its second safety crisis, FDA slaps another hold on PhI

Communicating the value of precision medicine

Merck buys a fledgling neurodegenerative biotech spawned by an old GSK discovery alliance. What’s up with that?

Investors could emerge from Neil Woodford debacle with £1B loss, internal analysis reveals

GSK's asthma biologic Nucala scores in rare blood disorder study

Special report: Twenty extraordinary women in biopharma R&D who worked their way to the top

FDA Vascepa review spotlights new safety signals, possible mineral oil spoiler as Amarin hunts a blockbuster approval

FDA puts Solid Bio’s lead gene therapy program on hold — again — after another patient is hurt by SGT-001

FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares

Eli Lilly-backed biotech grabs $100M to dispatch antibody-oligonucleotide conjugates after muscular dystrophy