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Morphosys: Janssen updates on development of guselkumab

5:33am EDT

May 24 (Reuters) - MORPHOSYS AG ::ANNOUNCES THAT ITS LICENSEE JANSSEN REPORTED UPDATES ON DEVELOPMENT OF GUSELKUMAB.IN ADDITION, JANSSEN ANNOUNCED PLANS FOR THREE NEW PHASE 3 CLINICAL TRIALS WITH GUSELKUMAB.

Regeneus gets Japanese patent for Progenza stem cell technology

Tuesday, 23 May 2017 07:26pm EDT

May 24 (Reuters) - Regeneus Ltd :Announces Japanese patent office decision to grant key patent for Progenza stem cell technology.Progenza for treatment of osteoarthritis and other inflammatory conditions for human and animal applications.

Achagaon says FDA grants its antibiotic Plazomicin "breakthrough therapy" status

Tuesday, 23 May 2017 04:07pm EDT

May 23 (Reuters) - Achaogen Inc :Plazomicin granted fda breakthrough therapy designation.Co intends to include care trial data, along with data from epic trial, in an nda submission in second half of 2017.

U.S. FDA grants priority review status to Ultragenyx metabolic disorder drug

Tuesday, 23 May 2017 08:30am EDT

May 23 (Reuters) - Ultragenyx Pharmaceutical Inc -:Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorization application filed and accepted for review; FDA grants priority review status.Ultragenyx Pharmaceutical Inc - prescription drug user fee act (pdufa) goal date for a decision is november 16, 2017.Ultragenyx Pharmaceutical Inc - opinion from committee for medicinal products for human use (chmp) is expected in first half of 2018.

Human Metabolome Technologies wholly-owned unit receives approval of drug wholesale

Tuesday, 23 May 2017 05:21am EDT

May 23(Reuters) - Human Metabolome Technologies Inc <6090.T>:Says its wholly-owned unit, which is located in Yokohama, has received approval of drug wholesale on May 22.Says license number is 118120046.Says the period of validity from May 22 to May 21, 2023.

Zealand Pharma: positive Phase 2a results with microdoses of dasiglucagon

Tuesday, 23 May 2017 02:40am EDT

May 23 (Reuters) - ZEALAND PHARMA A/S :POSITIVE PHASE 2A RESULTS WITH MICRODOSES OF DASIGLUCAGON SUPPORT USE IN A DUAL-HORMONE ARTIFICIAL PANCREAS SYSTEM.DATA FROM THIS FIRST PHASE 2A TRIALS INDICATE THAT DASIGLUCAGON INCREASES BLOOD SUGAR LEVELS ACROSS ALL TESTED DOSE LEVELS.RESULTS FROM SECOND PHASE 2A TRIAL ON USE OF DASIGLUCAGON IN DUAL-HORMONE ARTIFICIAL PANCREAS SYSTEM, ILET(TM), ARE EXPECTED AT END OF JUNE 2017.

Herantis Pharma granted U.S. patent on therapeutic use of MANF

Tuesday, 23 May 2017 02:00am EDT

May 23 (Reuters) - HERANTIS PHARMA OYJ :REG-HERANTIS PHARMA GRANTED A U.S. PATENT ON THERAPEUTIC USE OF MANF.UNITED STATES PATENT AND TRADEMARK OFFICE ("USPTO") HAS ISSUED TO HERANTIS PHARMA PLC ("HERANTIS") A PATENT TITLED "NEUROTROPHIC FACTOR MANF AND USES THEREOF".

Regeneron, Sanofi RA drug wins FDA nod; co's price it at $39,000/patient/yr

Monday, 22 May 2017 05:45pm EDT

May 22 (Reuters) - Sanofi Sa :Regeneron and sanofi announce fda approval of kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients.Regeneron pharmaceuticals inc - in u.s., kevzara will be marketed by regeneron and sanofi genzyme, specialty care global business unit of sanofi.Regeneron pharmaceuticals, inc says in clinical trial program, sarilumab was statistically significant.Regeneron - final decision on marketing authorization application for kevzara in european union will be made by european commission in coming months.Regeneron pharmaceuticals inc - u.s. Wholesale acquisition cost of kevzara is $39,000/year for 200 mg and 150 mg doses.

Collplant Holdings Ltd signs a new, exclusive distributor agreement in Turkey

Monday, 22 May 2017 09:15am EDT

May 22 (Reuters) - Collplant Holdings Ltd : :Collplant Holdings Ltd - signed a new, exclusive distributor agreement in Turkey to market Vergenix FG, for treatment of chronic wounds.Collplant Holdings Ltd - market potential for treatment of chronic wounds in Turkey is estimated at in excess of 400,000 procedures annually.

Amgen submits Biologics License Application to the FDA for erenumab

Thursday, 18 May 2017 09:00am EDT

May 18 (Reuters) - Amgen Inc :Amgen submits biologics license application to the fda for erenumab.Amgen inc says bla includes data from pivotal studies in patients with episodic and chronic migraine.Amgen inc - announced submission of a biologics license application to u.s. Food and drug administration for erenumab to prevent migraine.

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