Take­da clears fi­nal reg­u­la­to­ry hur­dle to com­plet­ing its $62B Shire deal. Now on­ly one ob­sta­cle re­mains

Take­da has just put the last reg­u­la­to­ry piece in place for its $62 bil­lion takeover of Shire. The Eu­ro­pean Com­mis­sion has pro­vid­ed its bless­ing for the deal, with one re­quire­ment. 

As ex­pect­ed, Take­da will have to di­vest SHP647 so it can re­tain its block­buster drug En­tyvio, where the Eu­ro­peans saw an over­lap. The oth­er reg­u­la­tors in­volved in the US and Japan have al­ready signed off.

Now there’s just one last ob­sta­cle to clear as CEO Christophe We­ber looks to vault past a group of dis­si­dent Japan­ese share­hold­ers and com­plete the jour­ney in­to the top ranks of in­dus­try play­ers.

The share­hold­er vote comes De­cem­ber 5, with a band of hold­outs — in­clud­ing mem­bers of the Take­da fam­i­ly — vow­ing to fight to the end. If the vote goes Web­ber’s way, the deal will close Jan­u­ary 8, right in the mid­dle of JP­Mor­gan.

Not­ed We­ber to­day:

We are an­oth­er step clos­er to cre­at­ing a glob­al, val­ues-based, R&D-dri­ven bio­phar­ma­ceu­ti­cal leader, and af­ter sev­er­al months of con­struc­tive di­a­logue, we are op­ti­mistic that our share­hold­ers rec­og­nize the sig­nif­i­cant long-term val­ue cre­ation po­ten­tial of this pow­er­ful com­bi­na­tion.


Im­age: Christophe We­ber, Take­da CEO Get­ty Im­ages

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.

Amir Nashat, World Medical Innovation Forum via Youtube

Bay­er bets up to $100M on ex­plor­ing new bio­mol­e­c­u­lar con­den­sate ter­rain with a biotech up­start

In the Indiana Jones warehouse of genomic oddities, the millions of units of so-called “junk DNA” that create nothing but play a hand in tons of things have grabbed most of the attention. But there are other arks and Templar crosses out there.

Among them: the code for intrinsically disordered regions. Floating like boundless clumps of boiling spaghetti throughout the cell, these regions first appeared in scientific sketches at the turn of the century before vanishing from most cell diagrams, such as those in a high school textbook. Most organelles were neatly bound in membranes. These loose molecules resisted characterization. Scientists largely ignored them.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

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%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

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.