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US FDA Outlines Streamlined Development Path For Targeted Therapies
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic...
The Pink Sheet - December 16, 2017
US FDA Outlines Streamlined Development Path For Targeted Therapies
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic...
Scrip - December 16, 2017
A Bad Day For DTC
US Senate Health Committee’s final 2017 hearing on drug pricing focused on a National Academies report with almost three dozen...
The Pink Sheet - December 16, 2017
A Bad Day For DTC
US Senate Health Committee’s final 2017 hearing on drug pricing focused on a National Academies report with almost three dozen...
Scrip - December 16, 2017
Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
Scrip - December 16, 2017
Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
The Pink Sheet - December 16, 2017
Allakos brings in $100mm through Series B
Exactly five years after closing its $32mm Series A round, therapeutic antibody developer Allakos Inc. has raised $100mm in Series B funding. New Enterprise Associates led (and takes a board seat), and was joined by Redmile Group, Partner Fund Management, Rock Springs Capital, LifeSci Venture Partners, Samsara Capital, and a large unnamed institutional investor, in addition to returning backers Alta Partners, RiverVest Venture Partners, Roche Venture Fund, and 3x5 Partners. Funds will support Allakos' preclinical and clinical projects, including lead candidate AK002 which is in Phase I and II trials for eosinophilic gastritis, indolent systemic mastocytosis, urticaria, and severe allergic conjunctivitis.
Strategic Transactions - December 16, 2017
Kyn emerges from stealth mode with $49mm Series A round
Immuno-oncology start-up Kyn Therapeutics has emerged from stealth mode and raised $49mm in Series A funding from Atlas Venture and OrbiMed.
Strategic Transactions - December 16, 2017
Public ADS offering nets $217mm for argenx
Therapeutic antibody developer argenx SE (cancer and autoimmune diseases) netted $217mm through an upsized public offering of 4.44mm American Depositary Shares (representing 4.44mm ordinary shares) at $52. The company originally filed to sell 3.5mm ADSs. Funds will support a variety of corporate and development activities, including pre-registration work on ARGX113, an antibody fragment entering Phase III trials with potential in severe autoimmune diseases, including multiple sclerosis, immune thrombocytopenia, systemic lupus erythematosus, myasthenia gravis, and skin blistering diseases
Strategic Transactions - December 16, 2017
Proteostasis nets $37.6mm via FOPO
Proteostasis Therapeutics Inc. (mostly focused on developing cystic fibrosis therapies) netted $37.6mm in a follow-on offering of 8mm common shares priced at $5 each. The company will use some of the funds to advance its double and triple combination therapies in dose-range-finding and proof-of-concept studies; move its double combination therapy of PTI801 and PTI808 through the Phase I; and advance triple combination PTI801, PTI808, and PTI428 in a Phase I trial.
Strategic Transactions - December 16, 2017
Relay Therapeutics raises $63mm through Series B
Relay Therapeutics (drug discovery start-up) raised $63mm through its Series B round from lead investor BVF Partners, new buyers GV, Casdin Capital, EcoR1, and Section 32, along with returning backers Third Rock Ventures and Alexandria Venture Investments. BVF joins the company's board of directions. Relay, which was founded in 2016 and raised $57mm in a Series A round that year, is using its drug discovery tools to analyze protein motion, with an initial focus on cancer therapeutics.
Strategic Transactions - December 16, 2017
VistaGen nets $13.95mm through FOPO
VistaGen Therapeutics Inc. (neuro-focused stem cell therapies) netted $13.95mm through the public offering of 10mm shares at $1.50 together with five-year warrants to purchase 10mm common shares at $1.50. VistaGen will use the proceeds primarily to advance lead prodrug candidate AV101 (L-4-chlorokyurenine), an oral NMDA receptor antagonist expected to begin a Phase II adjunctive treatment study in major depressive disorder in Q1 2018. Because of its unique mechanism of action, the company believes AV101 may also have potential in multiple other CNS disorders; it has already shown to be safe and well-tolerated in two Phase I safety studies in neuropathic pain.
Strategic Transactions - December 16, 2017
Puma and Daiichi Sankyo enter trial collaboration
Daiichi Sankyo Co. Ltd. and Puma Biotechnology Inc. agreed to study the combination of two of their cancer therapies as a potential new treatment approach for HER2-mutated or HER2-positive solid cancers.
Strategic Transactions - December 16, 2017
King's College London licenses glycoimmune IP to Palleon
King’s College London granted Palleon Pharmaceuticals exclusive rights to a patent portfolio surrounding the development of glycoimmune checkpoint inhibitor therapeutics for cancer.
Strategic Transactions - December 16, 2017
Arrakis gets IP from UPenn relating to RNA-targeted small molecules
Arrakis Therapeutics Inc. in-licensed from the University of Pennsylvania exclusive rights to intellectual property surrounding small-molecule drug candidates that directly target RNA.
Strategic Transactions - December 16, 2017

US FDA Outlines Streamlined Development Path For Targeted Therapies
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic...
Scrip - December 16, 2017
A Bad Day For DTC
US Senate Health Committee’s final 2017 hearing on drug pricing focused on a National Academies report with almost three dozen...
Scrip - December 16, 2017
Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
Scrip - December 16, 2017

US FDA Outlines Streamlined Development Path For Targeted Therapies
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic...
The Pink Sheet - December 16, 2017
A Bad Day For DTC
US Senate Health Committee’s final 2017 hearing on drug pricing focused on a National Academies report with almost three dozen...
The Pink Sheet - December 16, 2017
Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
The Pink Sheet - December 16, 2017

Methodology: R&D Productivity Ranking
To evaluate the R&D productivity of the world’s 30 largest public pharmaceutical companies, as judged by total pharmaceutical sales, Catenion...
IN VIVO - December 13, 2017
Methodology: R&D Productivity Ranking
To evaluate the R&D productivity of the world’s 30 largest public pharmaceutical companies, as judged by total pharmaceutical sales, Catenion...
IN VIVO - December 13, 2017
Biopharma R&D Productivity And Growth 2017: Big Pharma Closes The Gap
Catenion updates its annual list of the year's top pharma R&D performers. R&D productivity declined for the first time since...
IN VIVO - December 13, 2017
Biopharma R&D Productivity And Growth 2017: Big Pharma Closes The Gap
Catenion updates its annual list of the year's top pharma R&D performers. R&D productivity declined for the first time since...
IN VIVO - December 13, 2017

A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path
510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed...
Medtech Insight - December 15, 2017
A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path
510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed...
Medtech Insight - December 15, 2017
European Commission Sorts Medtech Working Groups And Creates New One
The current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.
Medtech Insight - December 15, 2017
European Commission Sorts Medtech Working Groups And Creates New One
The current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.
Medtech Insight - December 15, 2017
Retroactive Device-Tax Suspension Won't Work, Industry Says, Pressing For Urgent Action
AdvaMed told Republican leaders of the House and Senate that they should rethink any plans to wait until next year...
Medtech Insight - December 15, 2017
Retroactive Device-Tax Suspension Won't Work, Industry Says, Pressing For Urgent Action
AdvaMed told Republican leaders of the House and Senate that they should rethink any plans to wait until next year...
Medtech Insight - December 15, 2017
Siemens Adds Infectious Disease Tests With Luxembourg's Fast-Track Diagnostics
Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics (FTD) the developer of diagnostics that can distinguish...
Medtech Insight - December 15, 2017
Siemens Adds Infectious Disease Tests With Luxembourg's Fast-Track Diagnostics
Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics (FTD) the developer of diagnostics that can distinguish...
Medtech Insight - December 15, 2017
Siemens Adds Infectious Disease Tests With Luxembourg's Fast-Track Diagnostics
Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics (FTD) the developer of diagnostics that can distinguish...
Medtech Insight - December 15, 2017
QUOTED. Dec 15, 2017. Jaap Laufer.
Emergo's Jaap Laufer says the oncoming Medical Device and IVD Regulations have serious flaws that could lead to the demise...
Medtech Insight - December 15, 2017
QUOTED. Dec 15, 2017. Jaap Laufer.
Emergo's Jaap Laufer says the oncoming Medical Device and IVD Regulations have serious flaws that could lead to the demise...
Medtech Insight - December 15, 2017

Opioid-Withdrawal 'Aids' Warrant Immediate FDA, FTC Action – CSPI
FDA and the Federal Trade Commission should bring immediate enforcement action against marketers of non-kratom dietary supplements promoted as opioid-withdrawal...
The Rose Sheet - December 15, 2017
Cosmetics Weekly Trademark Review Nov 14, 2017
Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3...
The Rose Sheet - December 15, 2017
Cosmetics Weekly Trademark Review Nov 14, 2017
Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3...
The Rose Sheet - December 15, 2017

Allakos brings in $100mm through Series B
Exactly five years after closing its $32mm Series A round, therapeutic antibody developer Allakos Inc. has raised $100mm in Series B funding. New Enterprise Associates led (and takes a board seat), and was joined by Redmile Group, Partner Fund Management, Rock Springs Capital, LifeSci Venture Partners, Samsara Capital, and a large unnamed institutional investor, in addition to returning backers Alta Partners, RiverVest Venture Partners, Roche Venture Fund, and 3x5 Partners. Funds will support Allakos' preclinical and clinical projects, including lead candidate AK002 which is in Phase I and II trials for eosinophilic gastritis, indolent systemic mastocytosis, urticaria, and severe allergic conjunctivitis.
Strategic Transactions - December 16, 2017
Kyn emerges from stealth mode with $49mm Series A round
Immuno-oncology start-up Kyn Therapeutics has emerged from stealth mode and raised $49mm in Series A funding from Atlas Venture and OrbiMed.
Strategic Transactions - December 16, 2017
Public ADS offering nets $217mm for argenx
Therapeutic antibody developer argenx SE (cancer and autoimmune diseases) netted $217mm through an upsized public offering of 4.44mm American Depositary Shares (representing 4.44mm ordinary shares) at $52. The company originally filed to sell 3.5mm ADSs. Funds will support a variety of corporate and development activities, including pre-registration work on ARGX113, an antibody fragment entering Phase III trials with potential in severe autoimmune diseases, including multiple sclerosis, immune thrombocytopenia, systemic lupus erythematosus, myasthenia gravis, and skin blistering diseases
Strategic Transactions - December 16, 2017
Proteostasis nets $37.6mm via FOPO
Proteostasis Therapeutics Inc. (mostly focused on developing cystic fibrosis therapies) netted $37.6mm in a follow-on offering of 8mm common shares priced at $5 each. The company will use some of the funds to advance its double and triple combination therapies in dose-range-finding and proof-of-concept studies; move its double combination therapy of PTI801 and PTI808 through the Phase I; and advance triple combination PTI801, PTI808, and PTI428 in a Phase I trial.
Strategic Transactions - December 16, 2017
Relay Therapeutics raises $63mm through Series B
Relay Therapeutics (drug discovery start-up) raised $63mm through its Series B round from lead investor BVF Partners, new buyers GV, Casdin Capital, EcoR1, and Section 32, along with returning backers Third Rock Ventures and Alexandria Venture Investments. BVF joins the company's board of directions. Relay, which was founded in 2016 and raised $57mm in a Series A round that year, is using its drug discovery tools to analyze protein motion, with an initial focus on cancer therapeutics.
Strategic Transactions - December 16, 2017
VistaGen nets $13.95mm through FOPO
VistaGen Therapeutics Inc. (neuro-focused stem cell therapies) netted $13.95mm through the public offering of 10mm shares at $1.50 together with five-year warrants to purchase 10mm common shares at $1.50. VistaGen will use the proceeds primarily to advance lead prodrug candidate AV101 (L-4-chlorokyurenine), an oral NMDA receptor antagonist expected to begin a Phase II adjunctive treatment study in major depressive disorder in Q1 2018. Because of its unique mechanism of action, the company believes AV101 may also have potential in multiple other CNS disorders; it has already shown to be safe and well-tolerated in two Phase I safety studies in neuropathic pain.
Strategic Transactions - December 16, 2017
Puma and Daiichi Sankyo enter trial collaboration
Daiichi Sankyo Co. Ltd. and Puma Biotechnology Inc. agreed to study the combination of two of their cancer therapies as a potential new treatment approach for HER2-mutated or HER2-positive solid cancers.
Strategic Transactions - December 16, 2017
King's College London licenses glycoimmune IP to Palleon
King’s College London granted Palleon Pharmaceuticals exclusive rights to a patent portfolio surrounding the development of glycoimmune checkpoint inhibitor therapeutics for cancer.
Strategic Transactions - December 16, 2017
Arrakis gets IP from UPenn relating to RNA-targeted small molecules
Arrakis Therapeutics Inc. in-licensed from the University of Pennsylvania exclusive rights to intellectual property surrounding small-molecule drug candidates that directly target RNA.
Strategic Transactions - December 16, 2017
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