Biosimilars At US FDA: Personnel Spending Losing Influence Over Program
Percentage of personnel spending as a proportion of biosimilar review costs dropped more than 17% over three-year period as equipment...
The Pink Sheet - August 19, 2018

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?
Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.
The Pink Sheet - August 19, 2018

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expanded And Constricted
The latest drug development news and highlights from our US FDA Performance Tracker. 
The Pink Sheet - August 19, 2018

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expand And Constrict
The latest drug development news and highlights from our US FDA Performance Tracker. 
The Pink Sheet - August 19, 2018

Regeneron's Less Frequent Eylea Dosing Makes Late Sprint Across FDA Finish Line
Regeneron's blockbuster AMD biologic Eylea improved its ability to compete with future longer-acting VEGF inhibitors with a label supporting every...
Scrip - August 17, 2018

Bristol's Opdivo Enjoys IO First-Mover Advantage In Small Cell Lung Cancer
In addition to Opdivo, three other PD-1/L1 inhibitors are in late-stage development for a high-unmet need disease, including Roche's Tecentriq...
Scrip - August 17, 2018

First In 10 Years, But Lenvima's First-Line Liver Label Could Be Challenged Soon
Eisai and Merck won the first US FDA approval in 10 years for a first-line hepatocellular carcinoma treatment with Lenvima...
Scrip - August 17, 2018

Biohaven Readies Glutamate Modulator BHV-0223 For Phase III In Anxiety
Glutamate modulators could play a role in a range of central nervous system disorders, including social anxiety, amyotrophic lateral sclerosis...
Scrip - August 17, 2018

Sun Hopes Cequa’s Nano Formulation Makes Big Impact
Sun’s now-approved higher concentration, quicker-acting formulation of cyclosporine A could offer competitive advantage in dry eye versus Allergan’s Restasis, but...
Scrip - August 17, 2018

Novo Nordisk Makes Long-Term Bet On GBM Technology With Ziylo Buy
Novo Nordisk has bought UK-based start-up Ziylo in hopes of accelerating development of glucose-responsive insulins, but admits any such products...
Scrip - August 17, 2018

Pharma Industry Braces For Tough Times In Turkey As Turkish Lira Fluctuates
In the recent crisis between Turkey and the US, the Turkish lira went down in value against major currencies, including...
Scrip - August 17, 2018

Pipeline Watch: Phase III Starts In ALS And Lupus
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - August 17, 2018

Biosimilars At US FDA: Personnel Spending Losing Influence Over Program
Percentage of personnel spending as a proportion of biosimilar review costs dropped more than 17% over three-year period as equipment...
The Pink Sheet - August 19, 2018

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?
Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.
The Pink Sheet - August 19, 2018

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expanded And Constricted
The latest drug development news and highlights from our US FDA Performance Tracker. 
The Pink Sheet - August 19, 2018

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expand And Constrict
The latest drug development news and highlights from our US FDA Performance Tracker. 
The Pink Sheet - August 19, 2018

TRD Societal Cost Can Sway US Payer On VNS Coverage Decision
LivaNova is counting on CMS paying more than lip service to the value-based agenda as it assesses coverage decisions for...
IN VIVO - August 15, 2018

OCD Indication Approved For Brainsway TMS Device
US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat...
Medtech Insight - August 17, 2018

Federal Court Sides With IRS In Medtronic Transfer Tax Dispute
The 8th Circuit Court of Appeals has sent a Medtronic transfer pricing tax dispute back to US Tax Court after...
Medtech Insight - August 17, 2018

Terumo Aneurysm Device Gets FDA Panel Date
US FDA's Neurological Device Panel is set to meet Sept. 27 to weigh the merits of a PMA submitted for...
Medtech Insight - August 17, 2018

Makers Of An Array Of Devices Can Now Report Malfunctions In Summaries To FDA. Did Your Product Make The Cut?
US FDA rolled out its Voluntary Malfunction Summary Reporting Program on Aug. 17, allowing device-makers and manufacturers of device-led combination...
Medtech Insight - August 17, 2018

Giant Turkish Medical Device Tender Postponed Again
A big tender for advanced imaging and patient monitoring devices originally had been scheduled by the Turkish Government for July...
Medtech Insight - August 17, 2018

QUOTED. Aug. 17, 2018. Ben Hwang.
Start-up firm Profusa recently completed a successful funding round to help commercialize its novel biosensor for peripheral artery disease. The...
Medtech Insight - August 17, 2018

Failed NDIs, FDA's Opioid Concerns Don't Stop Kratom Supplement Sales
Proponents say the herbal ingredient extracted from a plant in the coffee family and available in powders, capsules or pills...
The Rose Sheet - August 17, 2018

E.l.f. Cut Down To Size As US Distribution Gaps Shrink, Fans’ Eyes Wander
After recording boast-worthy sales increases of 20% and 18% in fiscal 2016 and 2017, respectively, e.l.f.’s growth is tapering off...
The Rose Sheet - August 17, 2018

Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop
While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity...
The Rose Sheet - August 17, 2018

Mustang Bio enters rare disease gene therapy space through partnership with St. Jude Children's
Mustang Bio Inc. penned a deal with St. Jude Children’s Research Hospital to develop a new ex vivo gene therapy for X-linked severe combined immunodeficiency (X-SCID), or bubble boy disease as it is commonly known.
Strategic Transactions - August 17, 2018

AbbVie, Tolero enter AML trial collaboration
In a clinical trial collaboration, Tolero Pharmaceuticals Inc. is investigating a therapy that combines its own alvocidib with AbbVie Inc.’s venetoclax for relapsed/refractory acute myeloid leukemia (AML).
Strategic Transactions - August 17, 2018

BioNTech, Pfizer ally in infectious disease vaccines
In a multi-year collaboration, BioNTech AG and Pfizer Inc. are teaming up in the development of mRNA-based vaccines for influenza.
Strategic Transactions - August 17, 2018

Laekna Therapeutics closes $18.5mm Series A round
Laekna Therapeutics Shanghai Co. Ltd. (developing both small-molecule and antibody-targeted drugs for cancer and liver diseases) raised $18.5mm through a Series A round led by OrbiMed Asia, with AnlongMed also participating. The 2016 start-up plans to use the funding to progress its pipeline. Laekna currently has three oncology candidates, including Phase II LAE001 (CFG920), an oral CYP17 inhibitor for prostate cancer, in-licensed from Novartis last year. It is also developing compounds for liver diseases, including NASH and hepatic cirrhosis.
Strategic Transactions - August 17, 2018

Shanghai start-up Laekna gains exclusive license to Novartis prostate cancer compound CFG920
Laekna Therapeutics Shanghai Co. Ltd. acquired exclusive global rights from Novartis Pharma AG to develop, manufacture, and commercialize its CFG920 (Laekna renamed LAE001) oral CYP17 inhibitor for prostate cancer.
Strategic Transactions - August 17, 2018

Laekna in-licenses two more oncology pipeline assets from Novartis
Shanghai biotech Laekna Therapeutics Shanghai Co. Ltd. licensed exclusive worldwide rights to oral pan-AKT kinase inhibitors UPB795 (uprosertib) and ASB183 (afuresertib) from Novartis Pharma AG.
Strategic Transactions - August 17, 2018