Pacira receives European Commission approval for Exparel (bupivacaine liposome injectable suspension) for the treatment of post-surgical pain

18 November 2020 - Approval based on four pivotal studies showing Exparel reduced pain scores and opioid use following surgery. ...

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Omeros submits its biologics license application to U.S. FDA for narsoplimab in HSCT-TMA

18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...

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Knight Therapeutics announces filing of supplement to a new drug submission for Nerlynx (neratinib) to treat HER2-positive metastatic breast cancer

3 September 2020 - Knight Therapeutics Inc. announced filing of the supplement to a new drug submission (SNDS) of Nerlynx ...

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Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)

18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...

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NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis

18 November 2020 - UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the ...

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Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia

18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...

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FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease

18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...

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Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review

17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...

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Does remdesivir actually work against COVID-19?

17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...

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HLS Therapeutics announces Health Canada approval of Perseris for the treatment of schizophrenia

17 November 2020 - First once-monthly risperidone long-acting injectable used in the treatment of schizophrenia. ...

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Dupixent (dupilumab injection) now approved by Health Canada for patients with severe asthma

17 November 2020 - Only biologic approved in Canada to treat severe asthma with type 2 / eosinophilic phenotype, or oral ...

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ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention

17 November 2020 - ViiV Healthcare today announced that the US FDA has granted breakthrough therapy designation for long-acting, injectable cabotegravir ...

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Genentech files to block marketing of Centus' bevacizumab biosimilar

18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...

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FDA’s ongoing commitment to transparency for COVID-19 EUAs

17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...

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TRACON Pharmaceuticals announces submission for approval of envafolimab (KN035) with the NMPA in China by its corporate partners Alphamab Oncology and 3D Medicine

16 November 2020 - TRACON Pharmaceuticals today announced its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug ...

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