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UniQure Aiming To Be First With Hemophilia B Gene Therapy
The company has come a long way since gene therapy flop Glybera, and claims best-in-class status for viral vector.
Scrip - December 6, 2019
Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation
Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution...
Scrip - December 6, 2019
Voluntary EU Joint Clinical Assessments ‘Risk Access To Medicines’
Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.
Pink Sheet - December 6, 2019
Krka Sets Out Strategy In Multiple Markets
Krka has revealed its new growth strategy for 2020-2024, including growing through joint ventures, partnerships and acquisitions and focusing on...
Scrip - December 6, 2019
Early Assets Excite At Novartis R&D Day
NIBR chief Jay Bradner tells Scrip that the Swiss major's focus is on developing first in class therapies rather than...
Scrip - December 6, 2019
Cadila Healthcare Merges Four Subsidiaries
India’s Cadila Healthcare, which has been suffering on the earnings front, is amalgamating four subsidiaries under its roof to reduce overheads from...
Scrip - December 6, 2019
Sun Fights US Charges Over Delays
Sun Pharmaceutical Industries is back before US courts as it contests US antitrust charges filed by plaintiffs over the delayed...
Scrip - December 6, 2019
GemVax's Novel Peptide For Alzheimer’s Set To Advance After Positive Phase II
GemVax unveils positive topline results for South Korean Phase II study of novel peptide drug targeting patients with moderate to...
Scrip - December 6, 2019
Venclose gets $27mm via Series C round
Venclose Inc. raised $27mm in its Series C financing round led by Ally Bridge Group.
Strategic Transactions - December 6, 2019
Kodiak sells Baker Bros. royalty on net sales of KSI301
Ophthalmic-focused Kodiak Sciences Inc. entered a royalty agreement with Baker Bros. Advisors involving Kodiak’s KSI301.
Strategic Transactions - December 6, 2019
Amgen, Hummingbird Bio team up in potential $1.2bn multi-target collaboration
Hummingbird Bioscience and Amgen Inc. are teaming up in a multi-target collaboration.
Strategic Transactions - December 6, 2019
Hummingbird Bio gets $19mm in Series B funding
Four-year-old Hummingbird Bioscience raised $19mm through its Series B financing led by Mirae Asset Venture Investment and GNTech Venture Capital, which were joined by returning shareholders Heritas Capital and Seeds Capital, and first-time backers Delian Capital, Mirae Asset Capital, DAValue-GiltEdge, HB Investment, Wooshin Venture Investment, and Kiwoom Investment-Shinhan Capital.
Strategic Transactions - December 6, 2019
Inventiva launches with assets from Abbott subsidiary
Inventiva Pharma has launched with assets from Laboratoires Fournier (part of Abbott’s Solvay). The assets include laboratories and equipment and a 230k molecule library.
Strategic Transactions - December 6, 2019
Kodiak Sciences nets $259.4mm via FOPO
Ophthalmic-focused Kodiak Sciences Inc. netted $295.4mm in a follow-on offering of 6mm common shares at $46 each. The company will use some of the funds to move its KSI301 towards the BLA filing in retinal vein occlusion and for sBLA submissions (expected in 2022) for wet age-related macular degeneration, diabetic macular edema (DME), and possibly diabetic retinopathy without DME. Additional funds will support development of additional pipeline candidates including KSI501 for DME and uveitis. Just one day prior to the offering, Kodiak sold Baker Bros. a capped 4.5% royalty on net sales of KSI301 in exchange for $225mm.
Strategic Transactions - December 6, 2019
QUOTED. 6 December 2019. Jon Speer.
Medical device regulations that were set in place by the US FDA in the 1990s are evolving with the emergence...
Medtech Insight - December 6, 2019

QUOTED. 6 December 2019. Jon Speer.
Medical device regulations that were set in place by the US FDA in the 1990s are evolving with the emergence...
Medtech Insight - December 6, 2019

UniQure Aiming To Be First With Hemophilia B Gene Therapy
The company has come a long way since gene therapy flop Glybera, and claims best-in-class status for viral vector.
Scrip - December 6, 2019
Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation
Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution...
Scrip - December 6, 2019
Krka Sets Out Strategy In Multiple Markets
Krka has revealed its new growth strategy for 2020-2024, including growing through joint ventures, partnerships and acquisitions and focusing on...
Scrip - December 6, 2019
Early Assets Excite At Novartis R&D Day
NIBR chief Jay Bradner tells Scrip that the Swiss major's focus is on developing first in class therapies rather than...
Scrip - December 6, 2019
Cadila Healthcare Merges Four Subsidiaries
India’s Cadila Healthcare, which has been suffering on the earnings front, is amalgamating four subsidiaries under its roof to reduce overheads from...
Scrip - December 6, 2019
Sun Fights US Charges Over Delays
Sun Pharmaceutical Industries is back before US courts as it contests US antitrust charges filed by plaintiffs over the delayed...
Scrip - December 6, 2019
GemVax's Novel Peptide For Alzheimer’s Set To Advance After Positive Phase II
GemVax unveils positive topline results for South Korean Phase II study of novel peptide drug targeting patients with moderate to...
Scrip - December 6, 2019

Voluntary EU Joint Clinical Assessments ‘Risk Access To Medicines’
Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.
Pink Sheet - December 6, 2019

US Generics Market Continues To Seek Stability
As the US generics market continues to experience turbulence, the industry’s largest players are adopting a wide range of strategies...
In Vivo - December 4, 2019
Could A Type 1 Diabetes Immunotherapy Be In Reach?
Promising data from the likes of Provention Bio and Diamyd Medical suggest that treatment for the autoimmune disorder type 1...
In Vivo - December 4, 2019

Kodiak sells Baker Bros. royalty on net sales of KSI301
Ophthalmic-focused Kodiak Sciences Inc. entered a royalty agreement with Baker Bros. Advisors involving Kodiak’s KSI301.
Strategic Transactions - December 6, 2019
Venclose gets $27mm via Series C round
Venclose Inc. raised $27mm in its Series C financing round led by Ally Bridge Group.
Strategic Transactions - December 6, 2019
Amgen, Hummingbird Bio team up in potential $1.2bn multi-target collaboration
Hummingbird Bioscience and Amgen Inc. are teaming up in a multi-target collaboration.
Strategic Transactions - December 6, 2019
Hummingbird Bio gets $19mm in Series B funding
Four-year-old Hummingbird Bioscience raised $19mm through its Series B financing led by Mirae Asset Venture Investment and GNTech Venture Capital, which were joined by returning shareholders Heritas Capital and Seeds Capital, and first-time backers Delian Capital, Mirae Asset Capital, DAValue-GiltEdge, HB Investment, Wooshin Venture Investment, and Kiwoom Investment-Shinhan Capital.
Strategic Transactions - December 6, 2019
Inventiva launches with assets from Abbott subsidiary
Inventiva Pharma has launched with assets from Laboratoires Fournier (part of Abbott’s Solvay). The assets include laboratories and equipment and a 230k molecule library.
Strategic Transactions - December 6, 2019
Kodiak Sciences nets $259.4mm via FOPO
Ophthalmic-focused Kodiak Sciences Inc. netted $295.4mm in a follow-on offering of 6mm common shares at $46 each. The company will use some of the funds to move its KSI301 towards the BLA filing in retinal vein occlusion and for sBLA submissions (expected in 2022) for wet age-related macular degeneration, diabetic macular edema (DME), and possibly diabetic retinopathy without DME. Additional funds will support development of additional pipeline candidates including KSI501 for DME and uveitis. Just one day prior to the offering, Kodiak sold Baker Bros. a capped 4.5% royalty on net sales of KSI301 in exchange for $225mm.
Strategic Transactions - December 6, 2019

HBW Executive Decisions: HELP Endorses Hahn, Industry Award For AHPA's McGuffin, CHPA, Herbalife Hires
CHPA adds Allgaier to head development, relations; Vetere joins Herbalife as VP, CIO; Hahn's FDA commissioner nomination clears HELP committee;...
HBW Insight - December 5, 2019
On CRN Challenge, Nexus Formulas Gets Lesson On Supporting Ad Claims For Supplements
So full of errors were the firm's online ads for its Plavinol supplement, the National Advertising Division noted support for...
HBW Insight - December 5, 2019
FDA’s Cannabidiol Crackdown: What Do Warning Letters Say About CBD In Cosmetics?
Cannabidiol (CBD) represents an intriguing opportunity for cosmetics, without the statutory obstacles faced by food and dietary supplement companies. Cosmetics...
HBW Insight - December 5, 2019
Bayer Hit With Fine For Ads Targeting Kids In Hungary
Bayer broke rules on advertising directly to children in promotions for its Supradyn supplement, according to Hungary's competition authority, which...
HBW Insight - December 5, 2019
Novartis Seeks 'Amicable' Resolution Of German Probiotics Dispute
Novartis is in discussion via its Hexal subsidiary with Germany's Association for Social Competition (VSW) over whether it must withdraw its Biosan...
HBW Insight - December 5, 2019
US House Cosmetics Hearing: Preemption, FDA Ingredient Review Could Be Regulatory Reform Snags
Federal preemption of state and local requirements that differ from federal mandates came up repeatedly at the House Energy &...
HBW Insight - December 5, 2019
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