Latest Pharma Insights
UroGen licenses zalifrelimab from Agenus
Agenus Inc. granted UroGen Pharma Ltd. exclusive rights to develop and commercialize zalifrelimab (AGEN1884) via intravesical delivery in combination with UroGen’s UGN201 for urinary tract cancers. UroGen’s rights are global, excluding Argentina, Brazil, Chile, Colombia, Peru, Venezuela.
Strategic Transactions - November 16, 2019
Agenus Inc. granted UroGen Pharma Ltd. exclusive rights to develop and commercialize zalifrelimab (AGEN1884) via intravesical delivery in combination with UroGen’s UGN201 for urinary tract cancers. UroGen’s rights are global, excluding Argentina, Brazil, Chile, Colombia, Peru, Venezuela.
Strategic Transactions - November 16, 2019
Initial public offering nets $55.8mm for Galera Therapeutics
Galera Therapeutics Inc. (developing dismutase mimetics for cancer and oral mucositis) netted $55.8mm through its initial public offering of $55.8mm common shares at $12. The company originally set a price range for its shares of $14-16.
Strategic Transactions - November 16, 2019
Galera Therapeutics Inc. (developing dismutase mimetics for cancer and oral mucositis) netted $55.8mm through its initial public offering of $55.8mm common shares at $12. The company originally set a price range for its shares of $14-16.
Strategic Transactions - November 16, 2019
Reata nets $428mm through public offering
Reata Pharmaceuticals Inc. netted $428mm through a public offering of 2.4mm Class A common shares at $183. Proceeds will support continued development and future commercialization of lead candidates bardoxolone (Phase III for chronic kidney disease caused by Alport syndrome) and omaveloxolone (Phase II for Friedreich's ataxia). Money will also be used to make payments due to AbbVie following Reata's reacquisition of all rights to bardoxolone and omaveloxolone earlier this year. (AbbVie had global rights (excluding US and Asia) to the candidate under a 2010 deal, which Reata terminated in October. It now owes AbbVie $330mm, primarily for the rights to bardoxolone.)
Strategic Transactions - November 16, 2019
Reata Pharmaceuticals Inc. netted $428mm through a public offering of 2.4mm Class A common shares at $183. Proceeds will support continued development and future commercialization of lead candidates bardoxolone (Phase III for chronic kidney disease caused by Alport syndrome) and omaveloxolone (Phase II for Friedreich's ataxia). Money will also be used to make payments due to AbbVie following Reata's reacquisition of all rights to bardoxolone and omaveloxolone earlier this year. (AbbVie had global rights (excluding US and Asia) to the candidate under a 2010 deal, which Reata terminated in October. It now owes AbbVie $330mm, primarily for the rights to bardoxolone.)
Strategic Transactions - November 16, 2019
ResTORbio Pins Hopes On Parkinson’s After Failed CSRI Study
Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic...
Scrip - November 15, 2019
Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic...
Scrip - November 15, 2019
Roche Paying $390m Up Front For Fibrosis-Fighting Promedior
The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that...
Scrip - November 15, 2019
The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that...
Scrip - November 15, 2019
NASH Companies Take The Stage At AASLD
NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s...
Scrip - November 15, 2019
NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s...
Scrip - November 15, 2019
Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review
Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory...
Scrip - November 15, 2019
Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory...
Scrip - November 15, 2019
BioMarin’s Momentum Grows With Twin Blockbuster Plans
The frontrunner in hemophilia A gene therapy has been hit by data doubts, but this and achondroplasia drug could deliver...
Scrip - November 15, 2019
The frontrunner in hemophilia A gene therapy has been hit by data doubts, but this and achondroplasia drug could deliver...
Scrip - November 15, 2019
Double Delight For Novartis At The CHMP
Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis...
Scrip - November 15, 2019
Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis...
Scrip - November 15, 2019
Apotex Is Blocked On Canadian Abiraterone
Apotex has failed to convince a Canadian federal court that a patent protecting Janssen’s Zytiga abiraterone brand until August 2027...
Scrip - November 15, 2019
Apotex has failed to convince a Canadian federal court that a patent protecting Janssen’s Zytiga abiraterone brand until August 2027...
Scrip - November 15, 2019
Women In High Places: Slow Progress In Pharma
With gender diversity only slowly increasing in biopharma c-suites, Scrip spoke to executives from five companies about the importance of...
Scrip - November 15, 2019
With gender diversity only slowly increasing in biopharma c-suites, Scrip spoke to executives from five companies about the importance of...
Scrip - November 15, 2019
Levorphanol Write-Down Dents Zydus in Q2 But Saroglitazar Expectations Build
As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes down investment by $37.5m causing Q2...
Scrip - November 15, 2019
As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes down investment by $37.5m causing Q2...
Scrip - November 15, 2019
The Factory Floor: Aurobindo Receives Another Form 483
Aurobindo has received further Form 483s from the FDA, while Biocon has received an EIR for its Bengaluru facility. The...
Scrip - November 15, 2019
Aurobindo has received further Form 483s from the FDA, while Biocon has received an EIR for its Bengaluru facility. The...
Scrip - November 15, 2019
Pharma Declares Wishlist As Brexit Heightens UK Election Stakes
The UK pharma industry association has underscored the sector’s importance while outlining its demands for the country’s policy around medicines...
Pink Sheet - November 15, 2019
The UK pharma industry association has underscored the sector’s importance while outlining its demands for the country’s policy around medicines...
Pink Sheet - November 15, 2019
Roche’s Polivy Among Seven New Drugs On Track For EU-Wide Approval
Seven drugs, including two orphans and two generics, are on track to receive pan-EU approval.
Pink Sheet - November 15, 2019
Seven drugs, including two orphans and two generics, are on track to receive pan-EU approval.
Pink Sheet - November 15, 2019
WHO Moves To Reduce Insulin Prices By Widening Supply
Including human insulin in the World Health Organization’s quality assurance scheme should lead to lower prices and wider availability in...
Pink Sheet - November 15, 2019
Including human insulin in the World Health Organization’s quality assurance scheme should lead to lower prices and wider availability in...
Pink Sheet - November 15, 2019
UK Price Shifts Do Not Always Follow Reimbursement
Price movements seen among recently-launched generics in the UK do not always reflect changes in reimbursement prices, according to the...
Pink Sheet - November 15, 2019
Price movements seen among recently-launched generics in the UK do not always reflect changes in reimbursement prices, according to the...
Pink Sheet - November 15, 2019
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Pink Sheet - November 15, 2019
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Pink Sheet - November 15, 2019
Sandoz Is Stalled On Swiss Pemetrexed
Sandoz’ unsuccessful attempts to show a lack of inventive step in a Swiss vitamin regimen patent leave Lilly’s Alimta pemetrexed...
Pink Sheet - November 15, 2019
Sandoz’ unsuccessful attempts to show a lack of inventive step in a Swiss vitamin regimen patent leave Lilly’s Alimta pemetrexed...
Pink Sheet - November 15, 2019
Pfenex Expects To Be Alone With Teriparatide
Pfenex believes it and commercial partner Alvogen could enjoy an extended period as the only direct competitor to Eli Lilly’s...
Pink Sheet - November 15, 2019
Pfenex believes it and commercial partner Alvogen could enjoy an extended period as the only direct competitor to Eli Lilly’s...
Pink Sheet - November 15, 2019
Mylan Reforms As It Prepares To Become Viatris
Mylan is pushing ahead with reforms that include wide-ranging product rationalization in the US, refocusing its commercial resources and cutting...
Pink Sheet - November 15, 2019
Mylan is pushing ahead with reforms that include wide-ranging product rationalization in the US, refocusing its commercial resources and cutting...
Pink Sheet - November 15, 2019
Celltrion Pushes ‘Biobetters’ Concept With Remsima SC
Celltrion head of clinical development Sang Joon Lee has set out the promise of ‘biobetters’ – biosimilars that improve upon...
Pink Sheet - November 15, 2019
Celltrion head of clinical development Sang Joon Lee has set out the promise of ‘biobetters’ – biosimilars that improve upon...
Pink Sheet - November 15, 2019
Indoco Grows By Over A Fifth
Indoco has reported 21% sales growth in its financial second quarter and is awaiting a string of ANDA approvals after...
Pink Sheet - November 15, 2019
Indoco has reported 21% sales growth in its financial second quarter and is awaiting a string of ANDA approvals after...
Pink Sheet - November 15, 2019
Market Access 2020: Understanding US Payer Expectations
Big pharma is facing a difficult US competitive landscape as its traditional customers realign to build their own redoubts of...
In Vivo - November 14, 2019
Big pharma is facing a difficult US competitive landscape as its traditional customers realign to build their own redoubts of...
In Vivo - November 14, 2019
Welcome To Alexion 2.0
In an exclusive interview, Alexion R&D head John Orloff takes In Vivo on a tour around the company’s rejuvenated pipeline...
In Vivo - November 14, 2019
In an exclusive interview, Alexion R&D head John Orloff takes In Vivo on a tour around the company’s rejuvenated pipeline...
In Vivo - November 14, 2019
Deals Shaping The Medical Industry, November 2019
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of...
In Vivo - November 14, 2019
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of...
In Vivo - November 14, 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 - November 14, 2019
As the US generics market continues to experience turbulence, the industry’s largest players are adopting a wide range of strategies...
In Vivo - November 14, 2019
FDA Expands Indication For Axonics’ Incontinence System; Medtronic Claims Patent Infringement
The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The...
Medtech Insight - November 15, 2019
The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The...
Medtech Insight - November 15, 2019
FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices
US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in...
Medtech Insight - November 15, 2019
US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in...
Medtech Insight - November 15, 2019
Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It
Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki...
Medtech Insight - November 15, 2019
Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki...
Medtech Insight - November 15, 2019
Nypro Experts: Adaptability And Agility Are More Critical Than Ever In Medtech
Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer...
Medtech Insight - November 15, 2019
Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer...
Medtech Insight - November 15, 2019
QUOTED. 15 November 2019. Krishna Rocha-Singh.
On-going scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at...
Medtech Insight - November 15, 2019
On-going scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at...
Medtech Insight - November 15, 2019
Health And Wellness Product Trademark Review 12 November, 2019
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the...
HBW Insight - November 15, 2019
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the...
HBW Insight - November 15, 2019
HBW Market News: CHPA Petitions For CBD Reg, PEW Urges Stronger Supplement Oversight
AHPA releases guidance for tea and infusion products on regulatory and liability implications as a result of increasing Prop 65...
HBW Insight - November 15, 2019
AHPA releases guidance for tea and infusion products on regulatory and liability implications as a result of increasing Prop 65...
HBW Insight - November 15, 2019
House Members Suggest Buying Some Supplements With Pre-Tax Savings
Eight GOP House members urge IRS to allow supplements labeled with approved health claims to be considered “medical expenses” eligible...
HBW Insight - November 15, 2019
Eight GOP House members urge IRS to allow supplements labeled with approved health claims to be considered “medical expenses” eligible...
HBW Insight - November 15, 2019
Direct Seller's CBD Supplement Recall Mandated, More Ranitidine, Tween Cosmetic Recalls
FDA's latest recalls records update includes Basic Reset CBD supplements and another 4,300 units of Tween Brands cosmetics containing colors...
HBW Insight - November 15, 2019
FDA's latest recalls records update includes Basic Reset CBD supplements and another 4,300 units of Tween Brands cosmetics containing colors...
HBW Insight - November 15, 2019
Neptune Wellness, IFF Partner To ‘Up The Game’ In Hemp/CBD Personal Care
Canadian extraction specialist Neptune, which has transitioned from marine-based oils for the nutrition market to focus on cannabis opportunities, says...
HBW Insight - November 15, 2019
Canadian extraction specialist Neptune, which has transitioned from marine-based oils for the nutrition market to focus on cannabis opportunities, says...
HBW Insight - November 15, 2019
Sanofi Strikes Deal To Develop Respiratory Health App
Sanofi Consumer Healthcare is working with digital health firm ResApp to develop a mobile application which consumers can use to...
HBW Insight - November 15, 2019
Sanofi Consumer Healthcare is working with digital health firm ResApp to develop a mobile application which consumers can use to...
HBW Insight - November 15, 2019
Germany’s Phoenix Connects Nordics With New Giant Logistics Center
Pan-European wholesaler and retailer Phoenix takes advantage of Nordics growth with new $88m logistics center in Denmark.
HBW Insight - November 15, 2019
Pan-European wholesaler and retailer Phoenix takes advantage of Nordics growth with new $88m logistics center in Denmark.
HBW Insight - November 15, 2019
UroGen licenses zalifrelimab from Agenus
Agenus Inc. granted UroGen Pharma Ltd. exclusive rights to develop and commercialize zalifrelimab (AGEN1884) via intravesical delivery in combination with UroGen’s UGN201 for urinary tract cancers. UroGen’s rights are global, excluding Argentina, Brazil, Chile, Colombia, Peru, Venezuela.
Strategic Transactions - November 16, 2019
Agenus Inc. granted UroGen Pharma Ltd. exclusive rights to develop and commercialize zalifrelimab (AGEN1884) via intravesical delivery in combination with UroGen’s UGN201 for urinary tract cancers. UroGen’s rights are global, excluding Argentina, Brazil, Chile, Colombia, Peru, Venezuela.
Strategic Transactions - November 16, 2019
Initial public offering nets $55.8mm for Galera Therapeutics
Galera Therapeutics Inc. (developing dismutase mimetics for cancer and oral mucositis) netted $55.8mm through its initial public offering of $55.8mm common shares at $12. The company originally set a price range for its shares of $14-16.
Strategic Transactions - November 16, 2019
Galera Therapeutics Inc. (developing dismutase mimetics for cancer and oral mucositis) netted $55.8mm through its initial public offering of $55.8mm common shares at $12. The company originally set a price range for its shares of $14-16.
Strategic Transactions - November 16, 2019
Reata nets $428mm through public offering
Reata Pharmaceuticals Inc. netted $428mm through a public offering of 2.4mm Class A common shares at $183. Proceeds will support continued development and future commercialization of lead candidates bardoxolone (Phase III for chronic kidney disease caused by Alport syndrome) and omaveloxolone (Phase II for Friedreich's ataxia). Money will also be used to make payments due to AbbVie following Reata's reacquisition of all rights to bardoxolone and omaveloxolone earlier this year. (AbbVie had global rights (excluding US and Asia) to the candidate under a 2010 deal, which Reata terminated in October. It now owes AbbVie $330mm, primarily for the rights to bardoxolone.)
Strategic Transactions - November 16, 2019
Reata Pharmaceuticals Inc. netted $428mm through a public offering of 2.4mm Class A common shares at $183. Proceeds will support continued development and future commercialization of lead candidates bardoxolone (Phase III for chronic kidney disease caused by Alport syndrome) and omaveloxolone (Phase II for Friedreich's ataxia). Money will also be used to make payments due to AbbVie following Reata's reacquisition of all rights to bardoxolone and omaveloxolone earlier this year. (AbbVie had global rights (excluding US and Asia) to the candidate under a 2010 deal, which Reata terminated in October. It now owes AbbVie $330mm, primarily for the rights to bardoxolone.)
Strategic Transactions - November 16, 2019
