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Roche acquires DNA sequencing technology company Stratos Genomics

Roche acquires DNA sequencing technology company Stratos Genomics

Roche acquisition of Stratos Genomics : Swiss pharma giant Roche has acquired US-based early-stage DNA sequencing technology company Stratos Genomics for an undisclosed price. The transaction is expected to help Roche advance the development of its nanopore sequencer through the access to Sequencing by Expansion (SBX), Stratos Genomics’ unique chemistry. Roche said that once developed, […]

Cipla gets FDA’s final approval for generic version of Migranal with CGT designation

Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation. The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for […]

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Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19. According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction […]

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Coronavirus vaccine trial results : Moderna mRNA-1273 shows early promise

Moderna said that mRNA-1273, its novel coronavirus vaccine candidate, has delivered positive interim data in a phase 1 clinical trial by eliciting neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts. The early-stage clinical trial in humans was led by the US National Institute of Allergy […]

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Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib. The decision from the FDA marks Qinlock as the first drug approved in […]

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FDA rejects Blueprint’s NDA for AYVAKIT for treatment of fourth-line GIST

Blueprint Medicines said that the US Food and Drug Administration (FDA) has rejected its new drug application (NDA) for AYVAKIT (avapritinib) for the treatment of fourth-line gastrointestinal stromal tumor (GIST). The US precision therapy company received a complete response letter (CRL) from the FDA in this connection. Blueprint Medicines was seeking FDA approval for avapritinib […]

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Sorrento Therapeutics says STI-1499 fully inhibited SARS-CoV-2 virus

Sorrento Therapeutics said that STI-1499, its anti-SARS-CoV-2 antibody, showed 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. The US biotech company will look to create an antibody cocktail product that will work as a protective shield against SARS-CoV-2 coronavirus infection and stay effective even […]

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AbbVie acquisition of Allergan gets antitrust clearance from US FTC

AbbVie acquisition of Allergan update : US biopharma company AbbVie has secured clearance from the US Federal Trade Commission (FTC) for its previously announced $63 billion acquisition of Botox developer Allergan. According to AbbVie, the approval from the FTC satisfies all the necessary antitrust clearances required for the closing of the cash cum stock deal […]

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Alexion Pharmaceuticals to acquire Portola Pharmaceuticals for $1.4bn

Alexion acquisition of Portola : Alexion Pharmaceuticals has agreed to acquire Portola Pharmaceuticals, a commercial-stage biopharma company focused on life-threatening blood-related disorders, for $1.41 billion. Portola Pharmaceuticals developed Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], which is marketed as Ondexxya in Europe. The drug is the first and only approved Factor Xa inhibitor reversal agent, and […]

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Italy’s Menarini to acquire US biopharma company Stemline Therapeutics

Menarini acquisition of Stemline : Menarini Group, an Italian pharma and diagnostics company, has agreed to acquire US biopharma company Stemline Therapeutics in a deal worth up to $677 million. Stemline Therapeutics is engaged in the development and commercialization of novel oncology therapeutics. Its acquisition enables Menarini Group to establish its footprint in the US […]

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