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Teva Barred From Agreeing ‘No-Authorized Generics’ Deals Under Reverse-Payment FTC Settlement
Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the...
Scrip - February 20, 2019
FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four
FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and...
The Pink Sheet - February 20, 2019
Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers
In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10...
Scrip - February 20, 2019
Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes
Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more...
Scrip - February 20, 2019
Teva’s Schultz Sets Sights On The Horizon While Continuing To Face Headwinds
Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex...
Scrip - February 20, 2019
Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration
Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids...
Scrip - February 20, 2019
French Patients To Get Pre-Approval Access To Bayer’s Vitravki
Patients in France are to receive Bayer’s Vitravki through an early access scheme pending the product's EU-wide marketing authorization.
The Pink Sheet - February 20, 2019
Germany Could Introduce Biosimilar Substitution By Pharmacists In Three Years
A German bill aims to cut spending on biologics, but new revisions mean that measures on biosimilar substitution are likely...
The Pink Sheet - February 20, 2019
Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know
In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to...
Scrip - February 20, 2019
Mithra Produces First Commercial Myring Batch For Europe
Mithra has produced its first commercial batch of Myring (ethinylestradiol/etonogestrel) for the European market at its CDMO facility in Belgium...
Scrip - February 20, 2019
Reckitt ‘Not Happy’ With Consumer Health Growth In 2018, Following European And Infant Nutrition Woes
RB's Health business failed to keep pace with market growth in 2018, with the firm admitting its mindset in Europe...
The Rose Sheet - February 20, 2019
Wellness Research Round-up: Vit C, Mango Leaf And L-Theanine For Sports and Aged Garlic For Blood Pressure
Monthly summary of wellness-related research. In this edition: studies on the benefits of vitamin C, l-theanine and mangiferin for sports...
The Rose Sheet - February 20, 2019
Pfenex One Step Closer To Teriparatide As FDA Accepts NDA
Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after...
Scrip - February 20, 2019
Deal-Making Fires Up To Unlock Checkpoint Inhibitors’ Full Potential
Merck & Co.’s Keytruda is already elbowing its way into the top ten best-selling drugs. But it, and its expanding...
Scrip - February 20, 2019
Biopharma Quarterly Dealmaking Statistics, Q4 2018
At $10.9bn, biopharma financing was at its lowest quarter of the year. GSK’s $5.1bn acquisition of oncology player Tesaro led...
Scrip - February 20, 2019
Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording
Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes...
Medtech Insight - February 20, 2019
Stealth BioTherapeutics nets $72.5mm via IPO
Stealth BioTherapeutics Corp. (developing therapies for diseases involving mitochondrial dysfunction) netted $72.5mm through the initial public offering of 6.5mm American Depositary Shares (each ADS represents 12 ordinary shares) at $12 each.
Strategic Transactions - February 20, 2019
Neurogene launches with $68.5mm Series A round
Rare neurological disease-focused gene therapy start-up Neurogene Inc. launched with a $68.5mm Series A round from investors including Samsara BioCapital, EcorR1 Capital, Cormorant Asset Management, Redmile Group, and an undisclosed healthcare investment fund.
Strategic Transactions - February 20, 2019
Vor Biopharma raises $42mm in Series A round
Vor Biopharma Inc. (immuno-oncology) raised $42mm through its Series A round. RA Capital Management and 5AM Ventures co-led and were joined by Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research, and Osage University Partners, and founding investor PureTech Health. Vor is developing oncology immunotherapies based on its engineered hematopoietic stem cell technology, and will use the Series A proceeds to advance its lead acute myeloid leukemia candidate closer to clinical trials.
Strategic Transactions - February 20, 2019
Initial public offering nets $70mm for TCR2 Therapeutics
Immuno-oncology firm TCR2 Therapeutics Inc. netted $70mm through its initial public offering of 5mm common shares at $15, the mid-point of the company’s $14-16 intended range.
Strategic Transactions - February 20, 2019
Almirall options European rights to Dermira's lebrikizumab for up to $1.4bn
Almirall SA acquired an option to license exclusive European development and commercialization rights to Dermira Inc.'s interleukin 13 (IL-13) antagonist lebrikizumab for atopic dermatitis and potential indications in other diseases involving the IL-13 pathway.
Strategic Transactions - February 20, 2019
Xeris nets $55.3mm via FOPO
In its first financing since going public last year, drug delivery firm Xeris Pharmaceuticals Inc. netted $55.3mm through a follow-on public offering of 5.88mm common shares at $10 each. The company will use some of the proceeds to fund commercial activities for its Gvoke HypoPen, which delivers ready-to-use glucagon via an auto-injector to treat hypoglycemia; Phase III trials of the glucagon HypoPen for Europe in post-bariatric hypoglycemia and congenital hyperinsulinism; Phase II trials in hypoglycemia-associated autonomic failure and exercise-induced hypoglycemia; and preclinical and clinical studies for ready-to-use diazepam and pramlintide-insulin.
Strategic Transactions - February 20, 2019
Spectrum divests seven marketed oncology products to US Aurobindo division Acrotech
Spectrum Pharmaceuticals Inc. divested seven marketed blood cancer therapeutics to Acrotech Biopharma LLC, a division of Aurobindo Pharma USA Inc.
Strategic Transactions - February 20, 2019
QUOTED. Feb. 20, 2019. Karl Vahey.
When a device-maker is trying to figure out what went wrong with a troublesome product, launching a failure investigation is...
Medtech Insight - February 20, 2019

Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording
Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes...
Medtech Insight - February 20, 2019
QUOTED. Feb. 20, 2019. Karl Vahey.
When a device-maker is trying to figure out what went wrong with a troublesome product, launching a failure investigation is...
Medtech Insight - February 20, 2019

Teva Barred From Agreeing ‘No-Authorized Generics’ Deals Under Reverse-Payment FTC Settlement
Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the...
Scrip - February 20, 2019
Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers
In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10...
Scrip - February 20, 2019
Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes
Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more...
Scrip - February 20, 2019
Teva’s Schultz Sets Sights On The Horizon While Continuing To Face Headwinds
Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex...
Scrip - February 20, 2019
Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration
Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids...
Scrip - February 20, 2019
Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know
In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to...
Scrip - February 20, 2019
Mithra Produces First Commercial Myring Batch For Europe
Mithra has produced its first commercial batch of Myring (ethinylestradiol/etonogestrel) for the European market at its CDMO facility in Belgium...
Scrip - February 20, 2019
Pfenex One Step Closer To Teriparatide As FDA Accepts NDA
Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after...
Scrip - February 20, 2019
Deal-Making Fires Up To Unlock Checkpoint Inhibitors’ Full Potential
Merck & Co.’s Keytruda is already elbowing its way into the top ten best-selling drugs. But it, and its expanding...
Scrip - February 20, 2019
Biopharma Quarterly Dealmaking Statistics, Q4 2018
At $10.9bn, biopharma financing was at its lowest quarter of the year. GSK’s $5.1bn acquisition of oncology player Tesaro led...
Scrip - February 20, 2019

FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four
FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and...
The Pink Sheet - February 20, 2019
French Patients To Get Pre-Approval Access To Bayer’s Vitravki
Patients in France are to receive Bayer’s Vitravki through an early access scheme pending the product's EU-wide marketing authorization.
The Pink Sheet - February 20, 2019
Germany Could Introduce Biosimilar Substitution By Pharmacists In Three Years
A German bill aims to cut spending on biologics, but new revisions mean that measures on biosimilar substitution are likely...
The Pink Sheet - February 20, 2019

Execs On The Move, Feb 2019
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
IN VIVO - February 18, 2019
Science Matters: Merck Joins Crowded NASH Race As Several Data Readouts Loom
No NASH treatments are on the market yet, but Phase III data readouts are emerging, mid-stage drugs are demonstrating their...
IN VIVO - February 18, 2019
Hitting Refresh: Aduro CEO On Company Cuts, Pipeline Programs And Alliances
Aduro Biotech announced a “strategic reset” in January 2019 that will see the Californian company center around two core pipeline...
IN VIVO - February 18, 2019

Stealth BioTherapeutics nets $72.5mm via IPO
Stealth BioTherapeutics Corp. (developing therapies for diseases involving mitochondrial dysfunction) netted $72.5mm through the initial public offering of 6.5mm American Depositary Shares (each ADS represents 12 ordinary shares) at $12 each.
Strategic Transactions - February 20, 2019
Neurogene launches with $68.5mm Series A round
Rare neurological disease-focused gene therapy start-up Neurogene Inc. launched with a $68.5mm Series A round from investors including Samsara BioCapital, EcorR1 Capital, Cormorant Asset Management, Redmile Group, and an undisclosed healthcare investment fund.
Strategic Transactions - February 20, 2019
Vor Biopharma raises $42mm in Series A round
Vor Biopharma Inc. (immuno-oncology) raised $42mm through its Series A round. RA Capital Management and 5AM Ventures co-led and were joined by Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research, and Osage University Partners, and founding investor PureTech Health. Vor is developing oncology immunotherapies based on its engineered hematopoietic stem cell technology, and will use the Series A proceeds to advance its lead acute myeloid leukemia candidate closer to clinical trials.
Strategic Transactions - February 20, 2019
Initial public offering nets $70mm for TCR2 Therapeutics
Immuno-oncology firm TCR2 Therapeutics Inc. netted $70mm through its initial public offering of 5mm common shares at $15, the mid-point of the company’s $14-16 intended range.
Strategic Transactions - February 20, 2019
Almirall options European rights to Dermira's lebrikizumab for up to $1.4bn
Almirall SA acquired an option to license exclusive European development and commercialization rights to Dermira Inc.'s interleukin 13 (IL-13) antagonist lebrikizumab for atopic dermatitis and potential indications in other diseases involving the IL-13 pathway.
Strategic Transactions - February 20, 2019
Xeris nets $55.3mm via FOPO
In its first financing since going public last year, drug delivery firm Xeris Pharmaceuticals Inc. netted $55.3mm through a follow-on public offering of 5.88mm common shares at $10 each. The company will use some of the proceeds to fund commercial activities for its Gvoke HypoPen, which delivers ready-to-use glucagon via an auto-injector to treat hypoglycemia; Phase III trials of the glucagon HypoPen for Europe in post-bariatric hypoglycemia and congenital hyperinsulinism; Phase II trials in hypoglycemia-associated autonomic failure and exercise-induced hypoglycemia; and preclinical and clinical studies for ready-to-use diazepam and pramlintide-insulin.
Strategic Transactions - February 20, 2019
Spectrum divests seven marketed oncology products to US Aurobindo division Acrotech
Spectrum Pharmaceuticals Inc. divested seven marketed blood cancer therapeutics to Acrotech Biopharma LLC, a division of Aurobindo Pharma USA Inc.
Strategic Transactions - February 20, 2019

Reckitt ‘Not Happy’ With Consumer Health Growth In 2018, Following European And Infant Nutrition Woes
RB's Health business failed to keep pace with market growth in 2018, with the firm admitting its mindset in Europe...
The Rose Sheet - February 20, 2019
Wellness Research Round-up: Vit C, Mango Leaf And L-Theanine For Sports and Aged Garlic For Blood Pressure
Monthly summary of wellness-related research. In this edition: studies on the benefits of vitamin C, l-theanine and mangiferin for sports...
The Rose Sheet - February 20, 2019
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