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Wednesday, September 28, 2016
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Did the FDA Just Destroy Its Credibility?


Did the FDA Just Destroy Its Credibility?

One of the most interesting biotech stories of the last several years reached a climax this past week, and the outcome could ripple through the sector for a long time to come...More...
The failure of yet another Alzheimer's drug—Lundbeck's 5-HT6 receptor antagonist idalopirdine, spells bad news not only for patients, the company, and partner Otsuka, but also Axovant, which is developing a similar drug. (Pfizer shuttered its own 5-HT6 program earlier this year). Still, the month hasn't been without encouraging news on the Alzheimer's front, including some new early-stage data on Biogen's aducanumab and even some intriguing if extremely preliminary/uncontrolled/anecdotal/please don't take it very seriously data from Anavex Life Sciences.

Former Wall street darlings Juno Therapeutics and Bluebird Bio got some much-needed juice this month. For Juno, it was promising-if-early data for the JCAR-014 program in advanced non-Hodgkin's lymphoma. For Bluebird, it was an improved manufacturing process the company says will enhance transduction efficiency and the launch of a pivotal trial in beta thalassemia. -KT
Juno (JUNO) Surges as Small Cancer Study is Hailed a Success, Shows Promise for Other Drugs
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Investors Sigh With Relief as bluebird bio (BLUE) Improves Its Gene Therapy Process
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Another Good Day for Amgen (AMGN) as Repatha Phase III GLAGOV Trial Met Primary, Secondary Endpoints
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Genentech (RHHBY)'s Tecentriq Shows Positive Data in Phase III Trial, Has an Upcoming Action Date in October
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Lundbeck (LUN.CO)'s Phase III Data Crushes Hope for Alzheimer's Once Again
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More Bench To Clinic News
More big moves in the C-suite this month. Andrew Witty's successor at GlaxoSmithKline has been named: It is Emma Walmsley, who is currently head of the company's consumer healthcare division, perhaps signaling that the company will remain integrated rather than breaking into separate units. It's surprising to note, in 2016, that Walmsley will become the first female chief executive of a major global pharma company. Novo Nordisk president and chief executive officer, Lars Rebien Sorensen, will step down at the end of the year, to be replaced by current executive vice president and head of Corporate Development, Lars Fruergaard Jorgensen.

Another move spooked the market somewhat. Novartis is dissolving its Cell and Gene Therapies Unit, which not only means job shuffling and pink slips, but was regarded by some as a signal that the company has less confidence in some white-hot areas of research, including CAR-T therapies. However, it's not entirely clear what Novartis means by reincorporating some programs—including CART-T research—back into the core organization. Certainly the company has been active in dealmaking and R&D around immuno-oncology, so don't expect them to simply turn their back on this. -KT
Drumroll, Please...GlaxoSmithKline (GSK) Just Named This Woman Its New CEO
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Pfizer (PFE) Snags World-Renowned Scientist as CSO of Neuroscience Research
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Turn the Page: Sarepta (SRPT) Stock Pops on Rumors DMD Drug Naysayer Leaves the FDA
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Among Global Challenges, Novo Nordisk (NVO)'s CEO Steps Down, Executive Team is Shuffled
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Novartis (NVS) to Dissolve Cell and Gene Therapy Unit, Move Affects 400 Staffers
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More Career Track News
Third time's the charm: Bayer finally sweetened its offer enough to win approval from Monsanto, and a $66 billion M&A deal has been reached. It will create a dominant enough agochemical giant that the reaction of regulators remains a significant unknown; the companies will almost certainly have to sell off some assets to pass antitrust muster. Bayer will also likely shed the controversial Monsanto name.

Amgen has been quite active, too, announcing an immuno-oncology deal with Boehringer Ingelheim while also advancing the cardiac myosin activator Omecamtiv mecarbil into phase 3. That latter move extends a partnership with Cytokinetics formed all the way back in 2007. But despite moving slowly, Amgen likes what it sees in this program...and so does Seriver, which triggered an option on European rights to the drug. But nobody beats Allergan for having a busy month. It's deal with Tobira was just one of four acquisitions the company made in September (so far). -KT
How Sweet It is as Bayer (BAY) Finally Clinches Monsanto (MON) With $66B Deal
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Danaher (DHR) Coughs Up About $4B for Diagnostics Maker Cepheid (CPHD)
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Horizon Discovery And Fulcrum Therapeutics Form Collaboration For Novel CRISPR-Based Target Discovery In Genetic Diseases
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Massachusetts' Sunovion Swallows Up Cynapsus (CYNA) in $624M Deal, Gains Experimental Parkinson's Drug
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Continuing Its String of Deals, Allergan (AGN) Buys Bay Area's Tobira (TBRA) for $1.695B
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More Golden Handshakes News

Top Jobs
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IDEAYA Biosciences
Sr. Director, Immuno-oncology
Will be tasked with running a leading edge compliance program and will have broad oversight over the compliance aspects of Neos' operation. The CCO will be expected to Chair the Compliance Committee.

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VP, Translational Biology
You will develop and implement strategies for transitioning programs from the preclinical stage to clinical studies across all therapeutic areas in the portfolio.

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Alder BioPharma
VP, Scientific Computing
This newly created position will report to the CSO and will be responsible for developing innovative yet pragmatic data analysis solutions for collecting and analyzing biological data from our research efforts.

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MabPlex
Sr. Director/VP, Therapeutics Chemistry Development
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This month's least surprising financial news: Sarepta has taken advantage of its surging stock price by raising money! Duh! Since the company needs to do an expensive trial if it wants to establish that Exondys 51 actually works, this $300 million will come in handy. Meanwhile, CRISPR Therapeutics is looking to become the third pure-play public CRISPR company after Editas Medicine and Intellia. -KT
Facebook CEO Zuckerberg and Wife Chan Set Up New Bay Area Biohub With $3B Investment to Cure All Diseases
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Gene Editing Phenom CRISPR Files for $90M IPO
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AnTolRx Announces Series A Equity Funding From Pfizer (PFE), Juvenile Diabetes Research Foundation And Orion Equity Partners To Develop Targeted Nanoparticle Tolerance Therapeutics
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Sarepta (SRPT) Announces Pricing Of $300M Public Offering Of Common Stock
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Everybody's Talkin' About New Houston Biotech Startup Cellenkos
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More Money Talk News

Pfizer CEO Ian Read has gotten some unwelcome attention from the current White House, and it's little surprise that he doesn't like some of the proposals Hilary Clinton is making on drug pricing. But you have to wonder, what could he possibly think of the alternative?

Meanwhile, Sarepta has won a second victory regarding Exondys 51. A year ago, a patent interference concerning composition of matter claims for exon 51- and exon 53-skipping drugs was decided in favor of BioMarin Pharmaceuticals. Now the U.S. Patent Trial and Appeal Board has essentially reversed that finding, leaving Sarepta pretty much unencumbered in the U.S. (pending appeal from BioMarin). The picture is different in Europe, however, where a similar interference would prevent Sarepta from marketing Exondys. As it stands, Sarepta may have to pay BioMarin a royalty on any eventual European sales, but it's likely to be fairly modest. -KT
Pfizer (PFE) CEO Shakes Head at Clinton's Drug Pricing Plan
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Apobiologix Announces Victory Over Amgen (AMGN) In Biosimilar Patent Case
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After Sarepta (SRPT)'s Win, BioMarin (BMRN) Wants a Piece of the Action Too
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Sarepta (SRPT) Announces Favorable USPTO Decisions In Exon 51 And Exon 53 Composition Of Matter Patent Interference Cases Against BioMarin (BMRN)
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More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test
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More Legal Briefs News
One of the most anticipated decisions of the year is in: FDA has approved Sarepta's eteplirsen, now named Exondys 51, for Duchenne muscular dystrophy. The price tag of roughly $300,000 per year will be based on weight--the price tag rises and the boys who take the drug age. While some see the approval as the final nail in the coffin of FDA's credibility, this was on balance a good move (see Introduction), as well as the only new chemical entity approved over the past month. Meanwhile, anticipation over Clovis Oncology's PARP inhibitor rucaparib—and comments from Gilead Sciences that it is very very interested in this area—is driving this volatile stock higher once again after a huge drop last November. -KT
Victory at Last! Sarepta (SRPT) Stock Doubles as the FDA Finally Approves DMD Drug
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Clovis Oncology (CLVS) Stock Jumps as FDA Skips Review Panel for New Cancer Drug
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FDA Clears Amgen (AMGN) Copy of AbbVie (ABBV)'s Blockbuster Humira
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Another Celgene (CELG) Bet Pays Off as Agios (AGIO) Eyes Early Approval of Leukemia Drug
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Bay Area's Dynavax (DVAX) Plummeted After the FDA Cancels Advisory Meeting
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More Rockville Files News

Karl Thiel is an analyst for The Motley Fool and a longtime follower of the biotech industry. He lives in Austin, Texas.

You may contact Karl Thiel at news@biospace.com.

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