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Fink Densford

Teva wins EU nod for Ajovy migraine prophylactic

April 2, 2019 By Fink Densford

Teva Pharmaceutical logo - updated

Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization in the European Union for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month. The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related […]

Filed Under: Featured, Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: Teva

Biolinq adds $5m to Series A

March 28, 2019 By Fink Densford

Biolinq

Biosensor developer Biolinq said today that it raised $4.8 million as an extension of its Series A financing round. The San Diego-based company said that the investment in its expanded, oversubscribed Series A round was led by the JDRF T1D Fund, Aphelion Capital and LifeSci Venture Partners. With the additional funding, Biolinq said it raised a […]

Filed Under: Business/Financial News, Diabetes, Wall Street Beat Tagged With: biolinq

Valeritas inks Israeli distro deal with Tritech Biomed

March 28, 2019 By Fink Densford

Valeritas V-Go device - updated

Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with Tritech Biomed to commercialize its V-Go wearable insulin delivery device, designed for patients with Type 2 diabetes, in Israel. Through the deal, the Bridgewater, N.J.-based company said that Tritech Biomed will have rights to promote, market and sell the V-Go system to diabetes clinics […]

Filed Under: Diabetes, Distribution, Drug-Device Combinations, Featured Tagged With: Valeritas Inc.

Cook Regentec launches ProFusion therapeutic infusion needle

March 27, 2019 By Fink Densford

Cook Medical - updated logo

Cook Medical‘s Regentec division said today that it launched the ProFusion therapeutic infusion needle designed for the intramuscular or subdermal infusion of therapeutic agents in the U.S. and Canada. The Indianapolis-based business said that the ProFusion Therapeutic Infusion Needle features multiple sideports arranged in a spiral to aid in the uniform delivery and dispersement of […]

Filed Under: Business/Financial News Tagged With: cook medical

DarioHealth, Glytec ink joint marketing deal

March 27, 2019 By Fink Densford

DarioHealth, Glytec

DarioHealth (NSDQ:DRIO) said today it inked a joint marketing agreement with Glytec through which DarioHealth’s smart glucose meter will be able to transmit information to Glytec’s Glucommander Outpatient software. Israel-based DarioHealth said that blood glucose data from its Dario Blood Glucose Monitoring System will now be imported into the Glucommander Outpatient for use in conjunction with […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: dariohealth, Glytec

PolarityTE reveals SEC investigation

March 20, 2019 By Fink Densford

PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws. The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an […]

Filed Under: Business/Financial News, Legal News, Regenerative Medicine Tagged With: polarityte

Clearside Biomedical shares down on Q4 miss

March 13, 2019 By Fink Densford

Clearside Biomedical logo - updated

Shares in Clearside Biomedical (NSDQ:CLSD) have fallen slightly today after the biopharmaceutical company posted fourth quarter 2018 earnings that missed expectations on Wall Street. The Alpharetta, Ga.-based company reported research and development costs of approximately $17.5 million with a total net loss of $21.6 million, or 68¢ per share, for the three months ended December 31, […]

Filed Under: Business/Financial News, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Clearside Biomedical

Senseonics shares dip on Q4 sales miss, lowered guidance

March 13, 2019 By Fink Densford

Senseonics - updated logo

Shares in Senseonics (NYSE:SENS) fell slightly today after the diabetes-focused device maker posted fourth quarter and full year 2018 earnings that beat loss-per-share consensus but missed sales expectations and lowered its guidance for the 2019 fiscal year. The Germantown, Md.-based company posted losses of $7.3 million, or 4¢ per share, on sales of $7.2 million for […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Senseonics

Livongo preps for $1B IPO

March 8, 2019 By Fink Densford

Livongo

Livongo Health is preparing for a $1 billion initial public offering this year, according to a new report from The Wall Street Journal. The IPO for the Mountain View, Calif.-based diabetes-focused digital health company is set to drop in the third quarter of this year, according to the report. Livongo tapped Morgan Stanley, Goldman Sachs […]

Filed Under: Business/Financial News, Featured, Initial Public Offering (IPO), Wall Street Beat

Novocure shares dip on Q4, 2018 earnings miss

February 28, 2019 By Fink Densford

Novocure

Shares in Novocure (NSDQ:NVCR) fell slightly today after the medical device maker missed expectations on Wall Street with its fourth quarter and full year 2018 earnings release. The St. Helier, Jersey-based company posted losses of $15.6 million, or 17¢ per share, on sales of $69.7 million for the three months ended December 31, seeing losses grow […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: NovoCure

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