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Delcath readies for reverse stock split
Delcath Systems (NSDQ:DCTH) said today that it inked a deal to extinguish its 2016 convertible notes with the unnamed holder of the majority of the notes. But the agreement is contingent upon the...
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Synlogic finalizes Mirna Therapeutics merger
Synlogic said today that it finished its merger with Mirna Therapeutics after the deal won approval from Mirna’s stockholders last week. The merged company, which will trade on the Nasdaq market under...
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BioDelivery Sciences president, CEO Sirgo to retire | Personnel Moves – Aug...
BioDelivery Sciences (NSDQ:BDSI) said last week that its president & CEO, Mark Sirgo, plans to retire at the end of this year. Sirgo has held the corner office at the Raleigh, N.C.-based company...
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Sorrento seeks FDA nod for lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) said today that its subsidiary Scilex Pharmaceuticals resubmitted the new drug application for its lidocaine patch, ZTlido, to the FDA. The San Diego, Calif.-based...
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MedGenome raises $30m for biomarker discovery program
Genomics research and diagnostics company MedGenome said today that it closed a $30 million Series C round led by Sequoia India and Sofina. Zodius Capital, the co-founder & former CEO of Infosys,...
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Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s...
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Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion...
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Express Scripts, other PBMs named in lawsuit over pricey EpiPens
Express Scripts (NSDQ:ESRX) and other pharmacy benefit managers have been accused of giving Mylan‘s (NSDQ:MYL) EpiPens favorable placement on drug formularies in exchange for kickbacks, according to a...
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Investors sue Teva over $41B Actavis deal
Teva Pharmaceuticals (NYSE:TEVA) and a handful of current and former executives were hit with a lawsuit yesterday alleging that the drugmaker hid the negative fallout linked to its $40.5 billion...
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Fresenius closes Merck biosimilar biz purchase
Fresenius Kabi said today that it closed its acquisition of Merck KGaA’s biosimilars unit. The company paid €156 million at closing ($185.7 million USD) and could pay up to €500 million ($595.2 million...
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Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN)...
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Diabetes orgs send insulin, glucose meters to Texas
Thousands of people in Texas have been displaced from their homes after Hurricane Harvey landed there last week, leaving many without life-saving medication and supplies. People with diabetes are...
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Sanofi wins tentative FDA nod for Admelog insulin lispro injection
Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection. The decision is based on physicochemical, non-clinical and clinical similarity...
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Novartis CEO departs, leaving corner office to Harvard doc
Novartis‘ (NYSE:NVS) chief executive Joseph Jimenez is slated to leave his post next February, the drugmaker reported over the weekend. The CEO’s surprise departure leaves the corner office to Dr....
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Enteris BioPharma launches endometriosis trial with oral peptide delivery tech
Enteris BioPharma, a 24-person biotech based in Boonton, N.J., last month launched a trial of its oral leuprolide endometriosis therapy, Ovarest. Ovarest is the company’s most advanced internal...
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Bioventus wins FDA nod for knee osteoarthritis pain injection
Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis. When a person develops osteoarthritis in...
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Bellerophon Therapeutics touts Ph2 COPD trial of inhaled nitric oxide
Bellerophon Therapeutics (NSDQ:BLPH) touted data today from a Phase II trial of pulsed, inhaled nitric oxide in patients with pulmonary hypertension associated with chronic obstructive pulmonary...
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Nordisk settles DOJ’s Victoza marketing suit for $59m
Novo Nordisk (NYSE:NVO) said yesterday afternoon that it inked a $58.7 million deal with the U.S. Dept. of Justice to settle an investigation into the company’s marketing practices for Victoza – its...
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Biotech, pharma chime in over Trump’s move to halt immigration program
On Tuesday, biotech and pharmaceutical companies urged president Donald Trump to reconsider his decision to end former president Barack Obama’s policy protecting undocumented immigrants who arrived in...
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Pulmatrix licenses inhaled COPD drug to Vectura
Pulmatrix (NSDQ:PULM) said today that it licensed its inhaled COPD drug to Vectura. The PUR0200 compound combines tiotropium bromide and Pulmatrix’s iSperse drug-delivery technology. Vectura plans to...
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