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QUOTED. 20 August 2019. Suzanne Winter.
Medtronic and the nonprofit health plan Capital District Physicians' Health Plan Inc. (CDPHP) announced they'll be collaborating on an outcomes-based...
Medtech Insight - August 20, 2019

QUOTED. 20 August 2019. Suzanne Winter.
Medtronic and the nonprofit health plan Capital District Physicians' Health Plan Inc. (CDPHP) announced they'll be collaborating on an outcomes-based...
Medtech Insight - August 20, 2019

Sarepta Surprised By CRL For Exon 53-Skipping DMD Drug Golodirsen
The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and...
Scrip - August 19, 2019
Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL
Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said...
Scrip - August 19, 2019
Roche's New Chief Medical Officer Levi Garraway Brings Deep Cancer Genomics Expertise
CMO Sandra Horning will retire at the end of the year, to be succeeded by Lilly's former senior VP of...
Scrip - August 19, 2019
Generics Players Dominating New OTC Launches In Germany
An analysis by Sempora Consulting of the German OTC market in 2018 shows that generic products dominate new OTC product...
Scrip - August 19, 2019
Juvenescence Raises $100M To Advance Anti-Aging Programs
The financing, which brings the total raised by Juvenescence to $165m, comes as longevity R&D programs supported by the company...
Scrip - August 19, 2019
US Is Land Of Opportunity For Zealand
The Danish group is beefing up its operations across the Atlantic as it prepares filings for dasiglucagon and glepaglutide.
Scrip - August 19, 2019
Pipeline Watch: Phase III Results With Osimertinib, Ripretinib And Evinacumab
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - August 19, 2019
Sanders Maintains The Pressure On Teva, Mylan and Heritage
After urging the US DoJ to act against pharma companies alleged to have conspired in a price-fixing conspiracy, Bernie Sanders...
Scrip - August 19, 2019

Advances On the Biosimilar Litigation Battlefield
A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump...
Pink Sheet - August 19, 2019
Cures 2.0: Can Congress Recapture The Legislative Magic?
Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to...
Pink Sheet - August 19, 2019
Bladder Cancer: More Questions Than Answers With pCR Endpoint
Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems...
Pink Sheet - August 19, 2019
EMA And FDA Claim 'High Concordance' In Approval Decisions
Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in...
Pink Sheet - August 19, 2019
Industry Pact Aligns Canadian Prices To International Levels
An agreement between industry and authorities in effect from April last year is already having a major effect in ensuring...
Pink Sheet - August 19, 2019
Italy Unveils New Payment Model For Novartis’s CAR-T Kymriah
The Italian authorities have agreed a new kind of reimbursement model for Novartis's CAR-T therapy Kymriah that involves payment in...
Pink Sheet - August 19, 2019
Teligent Prepares For Injectables Filings With Strengthened Team
As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its...
Pink Sheet - August 19, 2019

European Companies Are Now Being ‘Properly Funded’
In the first half of 2019, life science companies raised $469m through series A rounds in Europe – a solid...
In Vivo - August 19, 2019

Newsoara licenses rights to Zenith's BET inhibitor ZEN3694
Zenith Epigenetics Corp. granted Newsoara BioPharma Co. Ltd. rights to develop, market, and distribute its BET inhibitor ZEN3694 in China, Hong Kong, Taiwan, and Macau.
Strategic Transactions - August 19, 2019
Neurodegenerative-focused start-up NeuroBo goes public through reverse merge with Gemphire
Gemphire Therapeutics Inc. (therapies for dyslipidemia and nonalcoholic fatty liver disease (NASH)) and private neurodegenerative disease start-up NeuroBo Pharmaceuticals Inc. agreed to an all-stock merger that will result in NeuroBo owning approximately 95.94% of the combined company, which will keep the NeuroBo name and business focus and take over Gemphire's NASDAQ listing with a new ticker symbol.
Strategic Transactions - August 19, 2019

Brands Target Men With Sonic Cleansing, 100% Vegan Skin Care; Personal-Care Launches In Brief
Launches announced in August include Clarisonic Mia Men, the brand’s first cleansing device specifically engineered for men’s thicker skin and...
HBW Insight - August 19, 2019
Study Takes Measure Of Supplement Size And Link To Swallowing Problems
FDA and CDC Analysis of the 20,791 adverse event reports for vitamins, minerals and supplements from 2006 through 2015 found...
HBW Insight - August 19, 2019
NRT Delivery Innovation Proposal In US Doesn't Deliver Expanded Indications
GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from he first...
HBW Insight - August 19, 2019
Stada ‘Continuously Evaluating’ OTC Deals As Sales Grow Double Digits
Stada tells HBW Insight it remains on the lookout for deals despite only last month closing the acquisition of a...
HBW Insight - August 19, 2019
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