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Wednesday, July 26, 2017
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Let's Get Rid Of Clinical Trials-Part 2


And So It Continues: Let's Get Rid Of Clinical Trials (Part 2)

Are overly burdensome regulations keeping great new medicines away from the public? No, probably not. Yet that's a widespread perception...More...
Vertex Pharmaceuticals has long been following a pathway toward treating an ever-increasing percentager of cystic fibrosis patients, and it seems to be combination therapies that are getting them closer to their goal. A cocktail of Kalydeco, tezacaftor, and one of several corrector drugs was able to significantly improve lung function in patients with F508del/Min disease—which is to say, one F508del mutation and one mutation resulting in minimal function of CFTR. The company will be advancing studies of four correctors—VX-440, VX-152, VX-659, and VX-445—as parts of combinations to treat this difficult form of CF . -KT
Vertex (VRTX) Gains $8B Overnight as Cystic Fibrosis Combo Drug Wows in Trials
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Kite Pharma (KITE) Touts Remissions Up to 56+ Months in Non-Hodgkin Lymphoma Patients on CAR T-Cell Therapy
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Patient Deaths Prompt the FDA to Suspend Three of Merck (MRK)'s Keytruda Trials
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Bristol-Myers (BMY)'s Opdivo Prevails in Phase III Melanoma Trial
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Investors Relieved as Seattle Genetics (SGEN) Pulls Out Win for Phase III Lymphoma Trial
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More Bench To Clinic News
Jacqueline Fouse's surprise "retirement" from Celgene, announced in February, was widely viewed as the fallout from a struggle between her and Mark Alles to replace Bob Hugin as CEO. When Alles came out on top in early 2016, Fouse may have started casting around for a new position. Now she's found it—as executive chairman of Dermavant Sciences. Founded by Vivek Ramaswamy, Dermavant is focused on dermatology, with a particular focus on buying up assets abandoned by other developers.

Meanwhile, AstraZeneca's Pascal Soriot created a lot of controversy—and some stock volatility—when a leak indicated that he would be leaving Astra to become the new head of Teva Pharmaceutical. Soriot remained mum for some time before finally indicating that he will not be leaving. Still, there will be plenty of questions when the company hosts a call on July 27. -KT
AstraZeneca (AZN) CEO Breaks Silence on Teva (TEVA) Rumors, Urges Staff to Remain Focused in Leaked Memo
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Gottlieb Lays Out Plans to Attract and Preserve Top Talent at the FDA
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'Retired' Celgene (CELG) Alum Lands Chairman Gig at Biotech Guru Ramaswamy's Dermavant
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GlaxoSmithKline (GSK) Poaches Another Top Exec—This Time From Pfizer (PFE)
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Effective Immediately: Advaxis (ADXS) CEO Resigns, Interim Leader Named
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More Career Track News
Celgene isn't shy about making bold bets, and it's paying China's BeiGene $263 million upfront for ex-Asia rights to its PD-1 inhibitor for solid tumors. Add in a $150 million equity investment and potential milestones, and the total could reach $1.4 billion. But the deal is bigger than that, with Celgene counting on BeiGene to expand its business within China. BeiGene is acquiring Celgene’s Chinese commercial operations, and is gaining exclusive licenses to commercialize Abraxane, Revlimid and Vidaza within the country. BeiGene also gets rights to Celgene’s C-122, in development for lymphoma and hepatocellular carcinoma. It certainly looks like a great deal for BeiGene, but Celgene may be taking a longer-term view toward finding a close partner with the manufacturing and commercial chops to help Celgene succeed China. -KT
Ablynx (ABLYF) Seals Nanobody R&D Deal Worth $2.8B With Drug Giant Sanofi (SNY)
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Sanofi (SNY) Finally Closes a Deal, Pays $750M for This Connecticut Biotech
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Bay Area's OncoMed (OMED) Tanks Some More as GlaxoSmithKline (GSK) Walks Away From R&D Pact
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Biotech Bestie Celgene (CELG) Takes Stake, Inks $1B+ Deal With BeiGene (BGNE)
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Japan's Konica Minolta (4902) Takes Out SoCal Diagnostics Firm Ambry Genetics in $1B Deal
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More Golden Handshakes News

Top Jobs
• Biotech Beach (San Diego, California)

Regulus
VP, Chemistry
The successful candidate will be senior member of the R&D Leadership Team and will provide proven drug hunting and leadership skills for the organization.

• Biotech Bay (Menlo Park, California)

MedCision
VP, R&D
Will serve on the company's leadership team, overseeing a growing family of novel process automation devices for cell therapy.

• BioCapital (Gaithersburg, Maryland)

AstraZeneca
Director-Immuno-Oncology Launch, GI
Will be responsible for the development and implementation of a strategic and operational plan that delivers a world class launch for our IO assets with a focus on upcoming registrational opportunities within GI.

• Genetown (Lexington, Massachusetts)

Curis
Associate Director/Director, Regulatory Affairs
The role will be essential to the registration and maintenance of the Curis pipeline across the U.S. and Internationally.

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E-Scape Bio landed a juicy $63 million Series A round on the strength of its work in neurodegenerative disease, particularly around the ApoE4 variant in Alzheimer's disease. Betting on Alzheimer's in perhaps the riskiest thing you can do in drug development, but E-Scape has the backing of OrbiMed, Novo Holding, Johnson & Johnson Innovation, Novartis Venture Fund and Osage University Partners, among others.

Evelo also has a big name behind its $50 million Series B round—notably Celgene and Google Ventures. These companies are interested in Evelo's focus on the human microbiome, not just in inflammatory and autoimmune disorders but also cancer. Evelo is chaired by biotech veteran Noubar Afeyan, CEO of Flagship Pioneering and founder of many biotechs, including Exact Sciences. -KT
Debt-Ridden Valeant (VRX) Dumps Another Asset in $190M Cash Deal
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Bay Area's E-Scape Bio Bursts Out of Stealth Mode With $63M to Tackle Alzheimer's
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Sources Reveal Tesaro (TSRO) is Unlikely to Find a Buyer
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Cash-Strapped Alder Biopharma (ALDR) Secures $160M in Stock Sale to Continue Operations
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Backed by Google (GOOG), Evelo Bags $50M and Names Some Industry Vets to the Team
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More Money Talk News

There's always a lot of political talk in Washington, but it isn't necessarily followed by any tangible action. But FDA Commissioner Scott Gottlieb just showed that he's willing to take concrete steps to lower barriers to new drug approval. The apparent beneficiary is Amicus Therapeutics. Last November, FDA told the company it would need a new clinical trial for its Fabry drug candidate, migalastat. Now the agency is reversing course, allowing Amicus to file for approval later this year. -KT
Teva (TEVA) Accuses Former Top Exec of Passing on Trade Secrets to Boyfriend—CEO of Rival Apotex
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Groundbreaking: Amicus (FOLD) Surges as the FDA Changes Its Tune on Fabry Disease Drug
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Alexion (ALXN) is Under Investigation by the HHS Office of Inspector General
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Court Papers Reveal AstraZeneca (AZN) CEO Was Livid Over Protege's Defection to GlaxoSmithKline (GSK)
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Omeros (OMER) Pursuing Legal Action Against Short Seller for Report That Caused Stock to Tank This Week
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More Legal Briefs News
There have been two new chemical entities approved since our last issue. J&J is hoping to take on mega-blockbuster Humira with Tremfya, just approved to treat plaque psoriasis. It appeared to outperform Humira in clinical trials, so blockbuster sales could be J&J's for the taking. Its Stelara racked up over $3 billion in sales last year for psoriasis, so J&J is building up a powerful franchise in this area. In late June, Portola won approval for Bevyxxa (don't ask me how to pronounce that), a novel anticoagulant aimed at long-term prophylaxis of deep vein thrombosis in hospitalized patients.

But perhaps the most exciting regulatory news of the month was an advisory committee's unanimous recommendation to approve Novartis' CTL019. This could become the first approved CAR-T therapy, and a potential game-changer for relapse or refractory B-cell acute lymphoblastic leukemia. -KT
FDA Green Lights Gilead (GILD)'s Vosevi, With a Black Box Warning Attached
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Puma Biotech (PBYI) Surges After the FDA Officially Approves Breast Cancer Drug
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FDA Gives Nod to J&J (JNJ)'s Potential Blockbuster Psoriasis Med
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FDA Panel Unanimously Endorses Novartis (NVS)'s CAR-T Leukemia Drug
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Bay Area's Portola (PTLA) Rockets as the FDA Approves First and Only Anticoagulant for Hospitals
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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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