Marketing authorization

Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces its Submission of a New Drug Application for TREAKISYM® Ready-To-Dilute Formulation

Retrieved on: 
Monday, October 7, 2019

Eagle Pharmaceuticals, Inc. (Eagle or the Company) (NASDAQ: EGRX) today announced that its marketing partner SymBio Pharmaceuticals Limited (SymBio) has submitted a New Drug Application (NDA) for TREAKISYM ready-to-dilute (RTD) liquid formulation in Japan.

Key Points: 
  • Eagle Pharmaceuticals, Inc. (Eagle or the Company) (NASDAQ: EGRX) today announced that its marketing partner SymBio Pharmaceuticals Limited (SymBio) has submitted a New Drug Application (NDA) for TREAKISYM ready-to-dilute (RTD) liquid formulation in Japan.
  • SymBio expects to launch the TREAKISYM RTD product in the first quarter of 2021, after obtaining marketing authorization.
  • In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and rapid infusion (RI) formulations of TREAKISYM in Japan.
  • According to SymBio, sales in Japan for TREAKISYM were $78 million in 2018 and $77 million through June 30, 2019.

European Commission Grants Marketing Authorisation to Simparica Trio™, a Once-Monthly Triple Combination Antiparasitic Medication for Dogs

Retrieved on: 
Friday, September 20, 2019

Zoetis Inc. (NYSE:ZTS) today announced that the European Commission has granted marketing authorisation for Simparica Trio (sarolaner/moxidectin/pyrantel) chewable tablets, a once-monthly triple combination antiparasitic medication for dogs with, or at risk from, mixed external and internal parasitic infestations.

Key Points: 
  • Zoetis Inc. (NYSE:ZTS) today announced that the European Commission has granted marketing authorisation for Simparica Trio (sarolaner/moxidectin/pyrantel) chewable tablets, a once-monthly triple combination antiparasitic medication for dogs with, or at risk from, mixed external and internal parasitic infestations.
  • The granting of the marketing authorisation follows a positive opinion adopted by the Committee for Medicinal Products for Veterinary Use on July 18, 2019.
  • We are excited to bring Simparica Trio to veterinarians in the European Union as a new, effective triple combination parasiticide for dogs, said Dr. Catherine Knupp, Executive Vice President and President, Research and Development at Zoetis.
  • The marketing authorization for Simparica Trio was based on the results of veterinary patient studies conducted in eight countries, involving more than 1900 dogs of various breeds.

MediWound to Report Second Quarter 2019 Financial Results and Host a Conference Call and Webcast on August 13

Retrieved on: 
Tuesday, August 6, 2019

To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.

Key Points: 
  • To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.
  • An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.
  • The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health.
  • MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid.

Portola Launches European Sales of Ondexxya® (Andexanet Alfa) with First Orders in Europe

Retrieved on: 
Tuesday, August 6, 2019

SOUTH SAN FRANCISCO, Calif., Aug. 6, 2019 /PRNewswire/ --Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) today announced the Company's first sales of Ondexxya (andexanet alfa) in Europe.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Aug. 6, 2019 /PRNewswire/ --Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) today announced the Company's first sales of Ondexxya (andexanet alfa) in Europe.
  • "We look forward to continuing discussions with individual reimbursement authorities and further expanding access to Ondexxya in Europe."
  • Ondexxya is now recognized in nine European medical society guidelines, including the European Stroke Organisation.
  • The European Commission (EC) granted conditional Marketing Authorization for Ondexxya in Europe in April 2019.

Aimmune Therapeutics to Host Conference Call and Webcast to Discuss Second Quarter 2019 Financial Results and Recent Operational Highlights

Retrieved on: 
Thursday, August 1, 2019

ET to discuss its financial results for the quarter ended June 30, 2019, and recent operational highlights.

Key Points: 
  • ET to discuss its financial results for the quarter ended June 30, 2019, and recent operational highlights.
  • To access the live call by phone, dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and enter the passcode 1564807.
  • To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at www.aimmune.com .
  • In June 2019, Aimmune submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for AR101.

BioMarin Plans Regulatory Submissions for Marketing Authorization of Valoctocogene Roxaparvovec to Treat Severe Hemophilia A in 4Q 2019 in both U.S. and Europe

Retrieved on: 
Monday, July 8, 2019

Both submissions are expected to represent the first time a gene therapy product for any type of hemophilia will be reviewed for marketing authorization by health authorities.

Key Points: 
  • Both submissions are expected to represent the first time a gene therapy product for any type of hemophilia will be reviewed for marketing authorization by health authorities.
  • Valoctocogene roxaparvovec is one of the first therapies to go through the new PRIME initiative.
  • "We applaud the FDA's efforts to incorporate the patient voice in the regulatory review process.
  • Completion of this portion of the study is not required for initial marketing authorizations of valoctocogene roxaparvovec.

Registration of Animal Feed Additives in the EU Seminar: Roles of the EU Commission, the EURL, EFSA and Member States - London, United Kingdom - June 5-6, 2019

Retrieved on: 
Tuesday, May 21, 2019

DUBLIN, May 21, 2019 /PRNewswire/ -- The "Registration of Animal Feed Additives in the EU" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 21, 2019 /PRNewswire/ -- The "Registration of Animal Feed Additives in the EU" conference has been added to ResearchAndMarkets.com's offering.
  • This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
  • Presentations will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different types of feed additives.
  • Key areas covered and course objectives:
    Roles of the EU Commission, the EURL, EFSA and Member States
    Data required - product characterisation safety, quality and efficacy
    Interacting with the EU Commission, Member States and EFSA

Soligenix and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for SGX942

Retrieved on: 
Tuesday, April 9, 2019

An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for any new medicinal product in Europe.

Key Points: 
  • An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for any new medicinal product in Europe.
  • Oral mucositis remains an extremely debilitating side effect of cancer treatment and is particularly severe and prevalent in HNC patients.
  • Soligenix looks forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as quickly as possible."
  • It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.

Diamond Pharma Services Supports Akcea Therapeutics in Gaining EU Regulatory Approval for WAYLIVRA Treatment for Familial Chylomicronaemia Syndrome (FCS)

Retrieved on: 
Monday, March 25, 2019

Headquartered in Boston, MA, Akcea is a development and commercialisation company focused on bringing transformative medicines to patients with serious and rare diseases.

Key Points: 
  • Headquartered in Boston, MA, Akcea is a development and commercialisation company focused on bringing transformative medicines to patients with serious and rare diseases.
  • Since 2016, Diamond provided full and comprehensive EU Regulatory support for WAYLIVRA to Akcea, leading up to and through the Conditional Approval.
  • Akcea Therapeutics Ltd obtained a positive CHMP opinion for WAYLIVRA on 28th February 2019, which was also Rare Disease Day .
  • Maureen Graham, Managing Director, Regulatory, Diamond Pharma Services, said: The Conditional Marketing Authorisation for WAYLIVRA is a major achievement for Akcea, and Diamond were grateful for the opportunity to assist with the European Regulatory support.

Advicenne Announces Submission of European Marketing Authorization Application (MAA) for ADV7103 as Treatment for Distal Renal Tubular Acidosis (dRTA)

Retrieved on: 
Tuesday, March 12, 2019

Advicenne (Paris:ADVIC) (Euronext: ADVIC FR0013296746), specializing in the development of adult and pediatric therapeutic products for the treatment of orphan renal and neurological diseases, announces today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate, ADV7103, as a treatment for distal renal tubular acidosis (dRTA).

Key Points: 
  • Advicenne (Paris:ADVIC) (Euronext: ADVIC FR0013296746), specializing in the development of adult and pediatric therapeutic products for the treatment of orphan renal and neurological diseases, announces today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate, ADV7103, as a treatment for distal renal tubular acidosis (dRTA).
  • The application comes after positive results in a pivotal Phase III clinical trial (B21CS) and its twenty-four-month extension study (B22CS).
  • This European marketing authorization application represents a major step in Advicennes growth, observes Caroline Roussel, Advicenne Co-Founder and Director of Operations, one made possible by the outstanding work of our teams.
  • The French pharmaceutical companys lead product, ADV7103, has achieved positive results in Europe in a pivotal Phase III study of distal Renal Tubular Acidosis (dRTA) in children and adults, leading to its recent submission for European marketing authorization.