Related articles

• Business

  Richterʼs Romanian subsidiary re-obtains license to operate

  

  Hungarian pharmaceutical company Gedeon Richter announced Wednesday that, with effect from September 18, the Romanian National Agency for Medicines and Medical Devices has once again granted a license to operate to Pharmafarm SA, Richter’s wholesale subsidiary in the country. 

   Thu, Sept. 20, 2018, 08:33

  • Richter
  • Pharmafarm
  • license
  • Romania
• Business

  Richter in deal to distribute fertility drug in EU-27

  

  Hungarian pharmaceutical firm Gedeon Richter said Tuesday it has signed a license and distribution agreement with U.K.-based L.D. Collins to commercialize the latterʼs assisted reproductive technology (ART) product Cyclogest in 27 EU countries, with the productʼs launch expected in early 2019.

   Wed, Sept. 19, 2018, 09:35

  • Richter
  • drug
  • EU
  • distribution
  • fertility
  • L.D. Collins
  • Cyclogest
• Business

  Richter, Mithra partner on commercialization of oral contraceptive Estelle

  

  Hungarian drugmaker Gedeon Richter on Wednesday said it is partnering with Mithra Pharmaceuticals to commercialize the Belgium companyʼs oral contraceptive Estelle in Europe and Russia, Hungarian news agency MTI reports

   Wed, Sept. 12, 2018, 10:00

  • Richter
  • Mithra
  • contraceptive
  • commercialization
• Business

  U.S. FDA seeks additional info on drug from Richter partner

  

  Pharmaceuticals firm Gedeon Richter says that the U.S. Food and Drug Administration (FDA) has requested additional information from its partner Allergan in response to the latterʼs New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of uterine fibroids. UPA is the active ingredient of Richterʼs drug Esmya.

   Wed, Aug. 22, 2018, 11:55

  • gedeon richter
  • allergan
  • fda
  • esmya
  • drug
  • uterine fibroids
• Business

  Drug maker Richterʼs earnings lifted in Q2

  

  Second-quarter net income of Hungarian drugmaker Gedeon Richter nearly tripled to HUF 24.3 billion from HUF 8.4 bln in the base period, boosted by financial gains, an earnings report released early today shows.

   Thu, Aug. 2, 2018, 07:51

  • richter
  • earnings
• Business

  Richter acquires fertility drug rights for U.S. market

  

  Gedeon Richter Plc. has announced the conclusion of a sale and purchase agreement with Swiss corporation Fertility Biotech AG to transfer intellectual property rights, relevant studies, related data and documents of the drug Bemfola for use in the United States.

   Tue, July 10, 2018, 18:03

  • richter
  • bemfola
  • rights
  • u.s.
  • fertility
  • biotech
• Business

  Romanian authorities suspend license of Richter wholesaler

  

  Hungarian drugmaker Gedeon Richter said on Thursday the Romanian National Agency for Medicines and Medical Devices (NAMMD) has suspended the operating license of its local wholesaler, Pharmafarm, for a breach of Good Distribution Practice.

   Fri, June 22, 2018, 08:30

  • richter
  • pharmafarm
  • romania
  • wholesale
  • license
• News

  New regulatory recommendations on Richterʼs Esmya

  

  Gedeon Richter Plc. announced Friday that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), as a conclusion of its review procedure related to Richterʼs drug Esmya, is recommending new measures to minimize the risk of rare but serious liver injury using Esmya for treatment of uterine fibroids.

   Tue, May 22, 2018, 10:00

  • esmya
  • richter
  • prac
  • ema
  • recommendation
• Business

  Richter financial loss weighs on earnings

  

  Hungarian drugmaker Gedeon Richterʼs first-quarter net income fell 30% year-on-year to HUF 14.5 billion, dragged down by financial losses even as margins improved, an earnings report published early Tuesday shows.

   Tue, May 8, 2018, 13:22

  • richter
  • earnings
  • loss
  • financial
• Business

  Richter, Allergan announce positive results for cariprazine

  

  Hungarian drugmaker Gedeon Richter and its Irish peer Allergan on Tuesday announced positive topline results in a Phase III clinical trial of cariprazine for treatment of bipolar I depression, according to a press release sent to the Budapest Business Journal.

   Tue, Apr. 3, 2018, 16:57

  • richter
  • clinical
  • drug
  • cariprazine
  • trial
  • bipolar