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Full FDA approval for Imbruvica in CLL

FDA granted full approval to Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and Johnson & Johnson (NYSE:JNJ) as first-line therapy for chronic lymphocytic leukemia (CLL) in patients with 17p deletion and to treat CLL in patients who have received at least one prior therapy. FDA granted accelerated approval to the drug for the latter indication in February. The full approvals -- which trigger $60 million in milestone payments to Pharmacyclics from J&J -- came over two months ahead of the Oct. 7 PDUFA date. Pharmacyclics said Imbruvica is the first drug approved specifically for the 17p deletion population, and estimated that 3-7% of de novo patients have 17p deletion at diagnosis and an additional 30-40% of patients may have acquired the deletion during the course of disease. The Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 is already available in the U.S. at a wholesale acquisition cost (WAC) of $8,200 for a 30-day supply. The median treatment duration was 8.6 months in the Phase III RESONATE (PCYC-1112-CA) trial. more >>


Reckitt Benckiser to spin out pharma business

Reckitt Benckiser Group plc (LSE:RB) disclosed in its 2Q14 earnings that it plans to spin out Reckitt Benckiser Pharmaceuticals Inc. -- its pharmaceutical business -- with a separate listing on the London Stock Exchange over the next 12 months. Last year, Reckitt said it was exploring strategic options for the business, which had 1H14 revenues of L344 million ($588.4 million) -- down 8% in constant currencies from 1H13. more >>

AcelRx plummets on Zalviso complete response

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell $4.44 (41%) to $6.39 on Monday after receiving a complete response letter from FDA for an NDA for Zalviso sufentanil sublingual tablet system to treat moderate to severe acute pain. According to the company, the agency requested additional information from AcelRx to "ensure proper use" of Zalviso, a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. more >>

Horizon falls on Duexis, Vimovo coverage concerns

Horizon Pharma Inc. (NASDAQ:HZNP) dropped $4.69 (34%) to $9.20 on Monday after disclosing that pharmacy benefit managers CVS Caremark Corp. (NYSE:CVS) and Express Scripts Holding Co. (NASDAQ:ESRX) notified the company that arthritis drugs Duexis ibuprofen/famotidine (HZT-501) and Vimovo naproxen/esomeprazole will be dropped from their formularies in August and added to their exclusions lists next year. Horizon, which reported 1Q14 U.S. sales of $34 million for Vimovo and $13.9 million for Duexis, estimates about 20-30% of Duexis and Vimovo prescriptions could be affected. The company reported total 1Q14 revenues of $92.2 million. more >>

AZ partners with Qiagen, Roche to develop plasma-based EGFR mutation tests

AstraZeneca plc (LSE:AZN; NYSE:AZN) announced a pair of deals on Monday to develop companion diagnostics that can detect non-small cell lung cancer (NSCLC) EGFR mutations directly from circulating tumor DNA in plasma samples. Under one deal, Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN) will develop a test that detects 21 EGFR mutations to identify patients that could benefit from AZ's NSCLC drug Iressa gefitinib, a small molecule EGFR tyrosine kinase inhibitor (TKI). The collaboration is an extension of an agreement the companies signed last year. more >>

EC approves Veloxis' Envarsus

The European Commission approved Envarsus tacrolimus from Veloxis Pharmaceuticals A/S (CSE:VELO) to prevent organ rejection in adult kidney and liver transplant patients. Veloxis said partner Chiesi Farmaceutici S.p.A. (Parma, Italy) plans to launch the product -- a once-daily tablet formulation of tacrolimus delivered with Veloxis' MeltDose technology -- in the EU late this year. Envarsus is also under FDA review to prevent organ rejection in kidney transplant patients, with an Oct. 30 PDUFA date. more >>

Boehringer, Zealand enter cardio-metabolic deal

Boehringer Ingelheim GmbH (Ingelheim, Germany) and Zealand Pharma A/S (CSE:ZEAL) partnered to discover and develop therapeutic peptide candidates against an undisclosed cardio-metabolic target from Zealand's preclinical portfolio. more >>

Hospira said to be mulling bid for Danone unit

Hospira Inc. (NYSE:HSP) declined to comment on media reports that the company is in talks to acquire the medical nutrition unit of food product conglomerate Danone (Euronext:BN) in a deal valued at about $5 billion. The deal, if completed, would allow Hospira to lower its tax rates by re-domiciling abroad while maintaining a U.S. headquarters. Danone's medical nutrition unit recorded 2013 sales of EUR 1.3 billion ($1.8 billion), and Hospira recorded adjusted net sales of $4.1 billion for the year. Danone, which could not be reached for comment, was up EUR 0.47 to EUR 55.53 on Monday. Hospira was up $0.12 to $51.84 on Monday. more >>


Emulate raises $12 million in series A

The Wyss Institute for Biologically Inspired Engineering at Harvard University spun out its organs-on-chips technology into newco Emulate Inc. (Cambridge, Mass.), which raised $12 million in a series A round led by NanoDimension. Cedars-Sinai Medical Center and Hansjorg Wyss, the founder of the Wyss Institute, also participated. more >>

PaxVax secures up to $62M, acquires typhoid vaccine

Vaccine company PaxVax Inc. (Redwood City, Calif.) secured up to $62 million comprising up to $50 million in debt from Pharmakon Advisors and $12 million in an extension of a series B round from undisclosed existing and new investors. PaxVax used part of the funds to acquire typhoid vaccine Vivotif from Johnson & Johnson (NYSE:JNJ) subsidiary Crucell N.V. and the vaccine's Swiss manufacturing facility. more >>

T2 amends IPO

Diagnostics company T2 Biosystems Inc. (Lexington, Mass.) amended its IPO on NASDAQ and now plans to sell 4 million shares at $15-$17. At the $16 midpoint, the company would raise $64 million and be valued at $288.4 million. Earlier this month, the company filed to raise up to $69 million. Goldman Sachs; Morgan Stanley; Leerink Partners; and Janney Montgomery Scott are underwriters. In May, T2 Biosystems submitted a 510(k) application to FDA for the company's T2Dx bench-top instrument and its T2Candida assay for use on T2Dx to identify five species of Candida from whole blood samples. T2Candida uses NanoDx magnetic biosensor technology to detect the sepsis-causing pathogens. more >>


QPI-1002 misses in graft function Phase II

The Quark Pharmaceuticals Inc. subsidiary of SBI Biotech Co. Ltd. (Tokyo, Japan) said a single IV dose of QPI-1002 missed the primary endpoint vs. placebo in the Phase II portion of the Phase I/II QRK.006B trial to prevent delayed graft function (DGF) after renal transplantation. Specifically, in 327 evaluable dialysis-dependent patients with end-stage kidney disease, QPI-1002 given 30 minutes after circulatory reperfusion did not lead to at least a 30% relative risk reduction of DGF -- defined as the need for dialysis within the first seven days post-transplant -- vs. placebo. DGF occurred in 30.9% of patients who received QPI-1002 vs. 36.4% for placebo (p=0.349). A post hoc analysis showed QPI-1002 led to an approximate 30% risk reduction of DGF relative to placebo in subgroups of patients who received kidney grafts from donors 35 years of age and older and 45 years of age and older. Data were presented at the World Transplant Conference in San Francisco. more >>

Targacept slides after hours on OAB setback

Targacept Inc. (NASDAQ:TRGT) slid $0.94 (24%) to $3.92 in early after-hours trading on Monday after the company said it was discontinuing development of dexmecamylamine (TC-5214). Targacept said after market close that top-line data from a Phase IIb trial of dexmecamylamine to treat overactive bladder (OAB) "were not compelling enough to justify the compound's continued development." The compound is an S-enantiomer of mecamylamine, a broad spectrum non-competitive nicotinic receptor antagonist. more >>




Partnering Afrezza

Its inhaled insulin approved, MannKind now must persuade any marketing partner to invest in answering a new host of questions.


Afrezza's journey

On the third try, MannKind's Afrezza finally won FDA approval, overcoming the high profile failure of Exubera as well as its own setbacks.


Still betting on Abeta?

Despite a Phase II miss in AD, AC Immune's hypothesis that it could dial out enough toxicity in crenezumab to enable a higher dose could get another shot.


Spero: Killing the quiet

Spero is targeting the MvfR virulence factor to combat persistent and drug resistant bacterial infections such as Pseudomonas.

amcure: Reimagining angiogenesis

amcure hopes targeting a tumor-specific co-receptor of tyrosine kinases will improve angiogenesis inhibition and block metastasis.


Putting FDA to biosimilars test

The first disclosed FDA biosimilar application is for a relatively simple molecule, but Sandoz coupled it to three regulatory challenges.


Staying the course with half a billion

Sofinnova sticking with strategy with $500M in second life sciences-only fund

Head of the class

Why Gilead shares didn't jump on 2Q14 Sovaldi sales

Gut reaction

Synlogic using $29.4M series A to fine-tune bacterial drug delivery

Analyst tracks

Biotech investor, banker and analyst personnel changes

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