Biopharma Business

Tag "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

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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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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European Commission conditionally approves Roche’s cancer drug Alecensa

Roche’s oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were

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