Biopharma Business

Approval

FDA approves BioMarin’s manufacturing facility in Cork, Ireland

    FDA approves BioMarin’s manufacturing facility in Cork, Ireland

The Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance (N-acetylgalactosamine 6-sulfatase (GALNS) used

Read Full Article

UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

    UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

The UK National Institute for Health and Care Excellence (NICE) has granted approval for Roche’s breast cancer drug Kadcyla for routine use within the NHS region. NICE has recommended Kadcyla

Read Full Article

Novo Nordisk wins European approval for Refixia

    Novo Nordisk wins European approval for Refixia

Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in the fourth quarter. The European Commission marketing authorisation comes one

Read Full Article

EC approves Johnson & Johnson’s $30bn acquisition of Actelion

    EC approves Johnson & Johnson’s $30bn acquisition of Actelion

The European Commission (EC) has approved Johnson & Johnson’s proposed $30bn acquisition of Actelion Pharmaceuticals, subject to conditions J&J signed an agreement in January this year to acquire Actelion, which develops

Read Full Article

Pfizer’s Meningococcal Group B vaccine, Trumenba, gets approval in Europe

    Pfizer’s Meningococcal Group B vaccine, Trumenba, gets approval in Europe

Pfizer has secured approval the European Commission (EC) for TRUMENBA (Meningococcal Group B Vaccine) for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years

Read Full Article

Aptar Pharma’s electronic lockout device approved by EMA

    Aptar Pharma’s electronic lockout device approved by EMA

The European Medicines Agency (EMA) has approved Aptar Pharma’s integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International. Aptar Pharma agreed to supply Takeda with its

Read Full Article

Brilique (ticagrelor) new formulation gains European approval

    Brilique (ticagrelor) new formulation gains European approval

The European Commission (EC) has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new method of treatment administration. This decision means that ticagrelor will become the

Read Full Article

EMA approves once-daily therapy for partial-onset epilepsy

    EMA approves once-daily therapy for partial-onset epilepsy

The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. It is already indicated in Europe as an

Read Full Article

Biogen Wins Full EC Approval for MS Drug Fampyra

    Biogen Wins Full EC Approval for MS Drug Fampyra

The EC granted full marketing approval for Biogen’s Fampyra® (prolonged-release fampridine) as a treatment to improve walking in people with multiple sclerosis (MS). Clearance in Europe was based on the

Read Full Article

The EMA Grants Priority to an Enzyme to Avoid Liver Transplant Rejection

    The EMA Grants Priority to an Enzyme to Avoid Liver Transplant Rejection

Hansa Medical has accessed the EMA’s priority medicines scheme to accelerate the development of a therapy that broadens the access to kidney transplants. Hansa Medical, based in Lund, Sweden, develops

Read Full Article

EMA’s CHMP backs Novartis’ Zykadia for first-line use in lung cancer

    EMA’s CHMP backs Novartis’ Zykadia for first-line use in lung cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis’ Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell

Read Full Article

Treatment for hyperkalaemia receives European marketing approval recommendation

    Treatment for hyperkalaemia receives European marketing approval recommendation

Veltassa (patiromer), developed by Relypsa, has received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the

Read Full Article

A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

    A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

Cinfa Biotech announced trial results for a biosimilar of Amgen’s Neulasta, a multi-billion blockbuster to treat chemotherapy-induced neutropenia. Cinfa Biotech is a Spanish company specialized in developing biosimilars. The biotech

Read Full Article

Abbott announces CE Mark and first use of the world’s first smartphone compatible insertable cardiac monitor

Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world’s first smartphone compatible ICM that will help physicians identify

Read Full Article

Intuitive Surgical gets CE mark for robot-assisted device

Intuitive Surgical has bagged a CE mark for the latest product in its da Vinci series of robot-assisted surgical systems. The regulatory nod clears Intuitive Surgical to start selling a

Read Full Article

Impax Launches Generic Version of Vytorin

Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. Food and Drug Administration (FDA) approval for a generic version of Vytorin (ezetimibe/simvastatin tablets), 10/10, 10/20, 10/40 and 10/80

Read Full Article

FDA Approves More Drugs, and Faster, than Europe, Study Says

Contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than European regulators did in recent years, new research shows. “It’s

Read Full Article

Novartis’ lung cancer drug combination receives EU approval

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The

Read Full Article

Pfizer’s Xeljanz Authorized for Marketing in the European Union

Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for the treatment of moderate to severe active rheumatoid arthritis (RA). Pfizer Inc. announced today that the European Commission (EC)

Read Full Article

EMA Recommends Approval of New Treatment for Brain Cancer

Apeiron Biologics has announced that the EMA’s CHMP has recommended the approval of APN311 for immunotherapy of high risk neuroblastoma. Apeiron Biologics is a Vienna-based biotech company developing immunological approaches

Read Full Article

A New Parkinson’s Drug from Italy just got FDA Approval!

Newron, an Italian biotech focused on CNS diseases, is on a roll. The latest win? FDA approval of its Parkinson’s drug, Xadago. Just in time for World Parkinson’s Day on

Read Full Article

Debiopharm’s triptorelin 6-month formulation receives EU approval

Debiopharm International, a Swiss-based company, part of Debiopharm Group, announced that triptorelin 6-month formulation (Decapeptyl and Pamorelin 22.5 mg) received approval for the treatment of central precocious puberty (CPP) in

Read Full Article

British Biotech’s Breast Cancer Drug gets FDA Approval for Novartis

Novartis has received FDA approval for Kisqali, a first-line treatment for breast cancer originally developed by the British biotech Astex

Read Full Article

Upcoming Events

  • November 12, 2018Compamed
  • November 13, 2018Foodpharmatech
  • April 21, 2019Labvolution
AEC v1.0.4

The Magazine

New Subscriber





Subscribe Here



Advertisements