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Wednesday, January 25, 2017
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Is Biotech "Getting Away With Murder?"

Well, here we are, just a few days into the Trump presidency, and the relationship between the life sciences industry and the Oval Office is uneasy at best. On January 11, in his first press conference since winning the election, Trump called the drug industry "disastrous," and said it was "getting away with murder...More...
It's early-stage stuff, but BioMarin continues to impress with its gene therapy program in hemophilia A. Of seven patients treated with BMN-270 at the highest dose, six have produced functionally normal levels of Factor VIII for an extended period. Fortress Biotech, or at least its stock, also got a nice boost. This came following a report on a single patient with glioblastoma treated with the company's CAR-T therapy. It's probably better to wait for more data before getting too excited.

Seattle Genetics, on the other hand, had to halt several trials of SGN-CD33A for acute myeloid leukemia after liver toxicity led to four deaths. It's not clear at this point if the drug is at fault, but this is particularly sensitive because SGN-CD33A is in a phase 3 trial for older AML patients and is also in development for myelodysplastic syndromes. Those trials are ongoing. -KT
BioMarin (BMRN) Release: Bay Area Biotech Solidifies Status as Top Dog in Hemophilia A Gene Therapy
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Phase III Flop for Pfizer (PFE)'s Drug Partner Opko Health (OPK)
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4 Fatal Deaths in Seattle Genetics (SGEN)' Early-Stage Trials of AML Drug
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Fortress Biotech (FBIO) Surged After Reporting Big Success With CAR-T Cancer Approach
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Investors Sigh With Relief as Biogen (BIIB)'s Alzheimer's Drug Delivers in Early-Stage Study
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Trump's various cabinet picks are undergoing vetting on Capitol Hill right now. Rep. Tom Price, Trump's pick for HHS Secretary, has already faced various questions about his approach toward repealing and replacing the Affordable Care Act. But that's been overshadowed by his financial dealings. Specifically, he's gotten a lot of heat over his significant investment in Australian biotech Innate Immunotherapeutics. As a "sophisticated investor," he received a sweetheart deal on share price—although he says he will now divest his shares. -KT
What Trump and His Potential Nominees Should Understand About the FDA
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485 Eli Lilly (LLY) Employees Will be Out of Work Beginning March 31
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Trump's HHS Nominee and His Ties With Two Massachusetts Biotech Firms
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Meet AstraZeneca PLC (AZN)'s New Head of Oncology
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Meet Biogen (BIIB)'s New CEO
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Takeda has gotten more aggressive in its partnering and M&A over the past few years, and it has just kicked things up another notch. Its $5.2 billion cash acquisition of Ariad builds out its oncology portfolio with two products. Ariad's Iclusig is approved for chronic myeloid leukemia and some acute lymphoblastic leukemia patients. Brigatinib is still in development, but could work in a subset of patients with non-small cell lung cancer.

And Ionis Pharmaceuticals is having a good month. Fresh from winning approval for Spinraza, the company entered into a large, multi-product cardiovascular deal with Novartis. The drugs are intended to treat elevated lipoprotein and patients with high triglycerides. -KT
Takeda (TKPYY) Swallows Up Struggling Ariad (ARIA) in $5.2B Deal
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SoCal's Ionis Pharma (IONS) Stock Jolted by $1.6B Cardio Drug Deal With This Big Pharma
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Massachusetts' CoLucid Pharma (CLCD) Surges on $960M Eli Lilly (LLY) Buyout Deal
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On a Roll: Kite Pharma (KITE) Bags $250M CAR-T Deal From Daiichi Sankyo, Forms Joint Venture With Fosun Pharma
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This German Biotech Just Inked a $1B+ Cancer Deal With Biotech Giant Amgen (AMGN)
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Aries Pharma
Vice President, Medical Affairs
Will have overall responsibility for Medical Device Reporting / Pharmacovigilance and the Scientific Affairs group.

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True North Therapeutics
Executive Director/VP, Clinical Operations
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Jounce Therapeutics made headlines when it scored a $2.25 billion deal with Celgene last year, just three years after being founded. Now it's making its way toward an IPO, expected to raise $76 million. The company is working in the crowded cancer immunotherapy space, but it is taking a slightly different tack from most rivals. Some of its strategies involve profiling the tumor microenvironment, and developing biomarkers to make treatments more specific while speeding development. In some cases it is seeking to activate B cells instead of T cells. -KT
Massachusetts Startup Neon Therapeutics Rakes in $70M for Personalized Cancer Vaccines
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Listen Up Researchers: Versant Ventures to Fund 2 Dozen Biotech Startups With $400M
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New Jersey's Braeburn Pharma Sets Terms for $150M IPO
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Chinese Upstart Ascletis Bags $100M in Series B Financing
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Cambridge-Based Jounce Files for $75M IPO
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We knew Martin Shkreli would be in the news this year because of his upcoming securities fraud trial. But he's jumped the gun—making recent headlines in two very different ways. One, for his creepy harassment of a reporter that resulted in the suspension of his Twitter account. Another was for the outcome of the Federal Trade Commission's suit against Mallicnkrodt.

Mallickrodt entered a $100 million settlement regarding charges that violated antitrust laws to protect its monopoly on adrenocorticotropic hormone (ACTH) drugs used to treat spasms. Interestingly, the investigation followed a lawsuit brought by none other than Shkreli. No irony there.

Meanwhile, the $2.54 billion judgment against Gilead Sciences in its dispute with Merck over hepatitis C drugs is the largest patent infringement award in U.S. history. -KT
Martin Shkreli's Complaint Leads to a $100M FTC Settlement for This Biotech
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Theranos Shuts Down Last Remaining Blood-Testing Lab After Another Failed Inspection
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Pfizer (PFE) CEO: What Trump Doesn't Understand About Pharma
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Trump Says Pharma Getting Away With Murder, Vows to Lower Drug Prices
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Gilead (GILD) Sinks, Will Pay Rival $2.54B for a Patent Dispute
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There were three novel drug approvals since our last issue (which went out early due to the holiday). That brings the total for 2016 to 22—nudging out 2010 by one approval. Still, we closed out the year with a bang. Spinraza, the antisense drug for spinal muscular atrophy developed by Biogen and Ionis Pharmaceuticals, promises to be a blockbuster treatment for a disease that had no prior treatment. Certainly the price—$750,000 for the first year and $375,000 a year thereafter—is likely to deliver a new round of sticker shock and further stoke the raging debate on high drug prices. -KT
New Spinraza Data Has Biogen (BIIB) Screaming 'It's Worth It!'
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Tesaro (TSRO) Craters as the FDA Denies Approval of Rolapitant IV
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FDA Approval of Aurobindo (AUROPHARMA.BO)'s Two Drugs Sends Stock Up
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Clovis (CLVS) Announces FDA Accelerated Approval Of RUBRACA (Rucaparib) For The Monotherapy Treatment Of Advanced Ovarian Cancer In Women With Deleterious Germline Or Somatic BRCA Mutations
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FDA Green Lights Pfizer (PFE)'s Eczema Drug Eucrisa
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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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