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Checkmate brings in $22mm through Series C round
Oncology immunotherapy developer Checkmate Pharmaceuticals Inc. raised $22mm through what appears to be its Series C round. New investor Decheng Capital led and was joined by returning backers Sofinnova, venBio, and F-Prime. Funds will support continued development of lead TLR9 agonist CMP001, in Phase I for advanced melanoma and non-small cell lung cancer.
Strategic Transactions - December 14, 2018
Ra Pharmaceuticals nets $122.2mm in FOPO
Ra Pharmaceuticals Inc. netted $122.2mm in a follow-on public offering of 8.4mm common shares at $15.50. The company plans to use the proceeds to fund clinical development of lead drug zilucoplan, including for the Phase III program in generalized myasthenia gravis (gMG) and for other pipeline drugs. Zilucoplan is a complement C5 inhibitor drug administered via a daily subcutaneous dose. Last year the FDA approved Alexion's blockbuster Soliris for gMG.
Strategic Transactions - December 14, 2018
AC Immune partners with Lilly for Alzheimer's treatments in $1.9bn deal
Eli Lilly & Co. and AC Immune SA have joined forces in a new multi-year deal focused on tau aggregation inhibitors for Alzheimer’s disease and other neurodegenerative conditions.
Strategic Transactions - December 14, 2018
Series B lands $70mm for Akero
Just six months after its $65mm Series A financing, Akero Therapeutics Inc. has now raised $70mm through a Series B round led by Janus Henderson Investors, which was joined by other first-time backers Redmile Group, Boxer Capital of Tavistock Group, Cormorant Asset Management, BVF Partners, Rock Springs Capital, and LifeSci Venture Partners, and returning shareholders Apple Tree Partners, Atlas Venture, venBio Partners, and Versant Ventures. The company will use the proceeds to move its lead program AKR001 (licensed from Amgen in June) through Phase II trials for nonalcoholic steatohepatitis, to scale manufacturing, and expand its metabolic disease pipeline.
Strategic Transactions - December 14, 2018
Synthorx completes $140mm initial public offering
Synthorx Inc. (synthetic biology for protein therapeutics development) netted $140mm through its initial public offering of 13.7mm common shares (including the overallotment) at $11. The company originally planned to sell 9.1mm shares at a range of $10-12.
Strategic Transactions - December 14, 2018
EDGe Surgical gets $4.3mm in Series A
EDGe Surgical Inc. (devices for orthopedic surgery) raised $4.3mm in its Series A round to angels. According to the Form D, 20 investors participated and the financing consisted of principal and interest from notes that were converted into equity securities.
Strategic Transactions - Devices - December 14, 2018
OrthoPediatrics nets $43.8mm via FOPO
Implants developer OrthoPediatrics Corp. netted $43.8mm through a follow-on public offering of 1.7mm common shares (including full exercise of the overallotment) at $27 each. The company will use about $20mm of the proceeds to invest in implant and instrument sets for consignment to its customers, $3mm for R&D, and $3mm for sales and marketing activities.
Strategic Transactions - Devices - December 14, 2018
Bausch initiates stalking horse bid process for Synergy Pharma
Concurrent with filing for Chapter 11, Synergy Pharmaceuticals Inc. signed a definitive agreement under a court-supervised stalking horse bid process to sell substantially all its assets, including all rights to Trulance (plecanatide), to Bausch Health Companies Inc. for $200mm in cash
Strategic Transactions - December 14, 2018

WashU Researchers Plan Major Trial Of Non-Invasive Radiation Ablation For Ventricular Tachycardia
Physicians developing a promising technique for noninvasive cardiac radioablation for ventricular tachycardia are working with US FDA to develop a...
Medtech Insight - December 13, 2018
Device Servicing And Remanufacturing: US FDA, Stakeholders Try To Draw Distinction
US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to...
Medtech Insight - December 13, 2018
Good Progress Toward Notified Body Designations: But Is There A Threat?
The European Commission looks to be on track, and in some cases ahead of schedule, in steps toward the designation...
Medtech Insight - December 13, 2018
Into 2019: Intelligent Innovation's Role In The Shape Of Medtech Things To Come
Brexit, the "Implant Files" and the new EU regulations – however large they loom at present, they will in time...
Medtech Insight - December 13, 2018
AUDIO: Device Week, Dec. 14, 2018 – Physicians Offer Perspective On Diabetes Apps; Researchers Apply Cancer Radiation To Cardiac Arrhythmia
In this edition of Device Week, Medtech Insight’s weekly podcast, Marion Webb gives an overview of physicians’ perspective of digital...
Medtech Insight - December 13, 2018
QUOTED. Dec. 13, 2018. Quynh Hoang And Elaine Tseng.
FDA is considering publishing a list of devices 510(k)-cleared based on predicates over ten-years-old to encourage companies to adopt new...
Medtech Insight - December 13, 2018

Deal Watch: Millendo Completes Merger With OvaScience, With $85m In Bank For Two Mid-Stage Programs
OvaScience’s cash plus a $49.5m venture capital raise leave Millendo with more than enough to get two current programs to...
Scrip - December 13, 2018
After Imbruvica Passes Chemo-Free Tests, Shorter Duration Regimens Could Be Next Value-Adds
AbbVie/Pharmacyclics executives Danelle James and Mohamed Zaki, in an interview at ASH, discussed Imbruvica's worth in chemo-free settings and noted...
Scrip - December 13, 2018
Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus
US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a...
Scrip - December 13, 2018
Top 20 Pharma Ranks: As Some Move Up, Others Fall Down
Sanofi and Gilead moved down in the rankings of Scrip's top 100 pharmaceutical companies, based on 2017 pharma sales, while...
Scrip - December 13, 2018
Novo Nordisk CSO Outlines Obesity R&D Strategy, Calls Condition "Ticking Time Bomb"
Novo Nordisk' obesity pipeline consists of projects addressing both appetite reduction and energy expenditure, with GLP-1 semaglutide topping the list...
Scrip - December 13, 2018
Valbenazine's Consistent But Weak Effect In Tourette Dismays Neurocrine
In "very top-line" Phase IIb data, the magnitude of the treatment effect for valbenazine in children with Tourette syndrome was...
Scrip - December 13, 2018
Mylan Claims Victory On US Lantus Patents
Mylan has succeeded in convincing the PTAB to invalidate two of Sanofi’s US formulation patents for its Lantus (insulin glargine)...
Scrip - December 13, 2018
FDA Flags Up Repeat Issues At Pfizer's McPherson Plant in Kansas
Problems persist at Pfizer’s US manufacturing facility in McPherson, Kansas, after an FDA audit led the agency to issue a...
Scrip - December 13, 2018
Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups
Scrip's latest rankings of the top 100 revenue earners in the medical technology industry, published in Outlook 2019, show the groups...
Scrip - December 13, 2018
EU Court Cuts Perindopril Fines For Krka And Servier
A ruling by the EU’s General Court has confirmed that agreements between Servier and several generics firms over perindopril constituted...
Scrip - December 13, 2018
Novartis Pruned Pipeline Producing Attractive Respiratory And Neurology Fruits
Novartis executives highlighted their stars from its refined pipeline during the company’s first R&D day since Vas Narasimhan took the...
Scrip - December 13, 2018

US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination
Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter...
The Pink Sheet - December 13, 2018
Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus
US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a...
The Pink Sheet - December 13, 2018
EMA Clarifies Sponsor Role In Contracting For Investigator Sites
The European Medicines Agency has made it clear that all clinical trial-related medical activities are the responsibility of the investigator...
The Pink Sheet - December 13, 2018
UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality
The UK government has criticized Vertex for the company’s approach to pricing its cystic fibrosis drug Orkambi. In the meantime...
The Pink Sheet - December 13, 2018
Amended Credit Agreement Aids Lannett As It Commits To The US Generics Space 
Saddled with a mountain of debt and the loss of a lucrative distribution contract representing around a third of annual...
The Pink Sheet - December 13, 2018

Top 20 Pharma Ranks: As Some Move Up, Others Fall Down
Sanofi and Gilead moved down in the rankings of Scrip's top 100 pharmaceutical companies, based on 2017 pharma sales, while...
IN VIVO - December 13, 2018
Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups
In Vivo's latest rankings of the top 100 revenue earners in the medical technology industry show the groups leading the...
IN VIVO - December 13, 2018

Checkmate brings in $22mm through Series C round
Oncology immunotherapy developer Checkmate Pharmaceuticals Inc. raised $22mm through what appears to be its Series C round. New investor Decheng Capital led and was joined by returning backers Sofinnova, venBio, and F-Prime. Funds will support continued development of lead TLR9 agonist CMP001, in Phase I for advanced melanoma and non-small cell lung cancer.
Strategic Transactions - December 14, 2018
Ra Pharmaceuticals nets $122.2mm in FOPO
Ra Pharmaceuticals Inc. netted $122.2mm in a follow-on public offering of 8.4mm common shares at $15.50. The company plans to use the proceeds to fund clinical development of lead drug zilucoplan, including for the Phase III program in generalized myasthenia gravis (gMG) and for other pipeline drugs. Zilucoplan is a complement C5 inhibitor drug administered via a daily subcutaneous dose. Last year the FDA approved Alexion's blockbuster Soliris for gMG.
Strategic Transactions - December 14, 2018
AC Immune partners with Lilly for Alzheimer's treatments in $1.9bn deal
Eli Lilly & Co. and AC Immune SA have joined forces in a new multi-year deal focused on tau aggregation inhibitors for Alzheimer’s disease and other neurodegenerative conditions.
Strategic Transactions - December 14, 2018
Series B lands $70mm for Akero
Just six months after its $65mm Series A financing, Akero Therapeutics Inc. has now raised $70mm through a Series B round led by Janus Henderson Investors, which was joined by other first-time backers Redmile Group, Boxer Capital of Tavistock Group, Cormorant Asset Management, BVF Partners, Rock Springs Capital, and LifeSci Venture Partners, and returning shareholders Apple Tree Partners, Atlas Venture, venBio Partners, and Versant Ventures. The company will use the proceeds to move its lead program AKR001 (licensed from Amgen in June) through Phase II trials for nonalcoholic steatohepatitis, to scale manufacturing, and expand its metabolic disease pipeline.
Strategic Transactions - December 14, 2018
Synthorx completes $140mm initial public offering
Synthorx Inc. (synthetic biology for protein therapeutics development) netted $140mm through its initial public offering of 13.7mm common shares (including the overallotment) at $11. The company originally planned to sell 9.1mm shares at a range of $10-12.
Strategic Transactions - December 14, 2018
Bausch initiates stalking horse bid process for Synergy Pharma
Concurrent with filing for Chapter 11, Synergy Pharmaceuticals Inc. signed a definitive agreement under a court-supervised stalking horse bid process to sell substantially all its assets, including all rights to Trulance (plecanatide), to Bausch Health Companies Inc. for $200mm in cash
Strategic Transactions - December 14, 2018

Warnings Up As FDA Trims Its List Of Uninspected OTC Drug Manufacturers
Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety...
The Rose Sheet - December 13, 2018
Swiss Regulatory Change Takes Over 500 OTCs Out Of Pharmacy
Swiss medicines authority, Swissmedic, rules that hundreds of non-prescription medicines are safe to be purchased outside pharmacy, following the completion...
The Rose Sheet - December 13, 2018
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