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Torrent to acquire Unichem's branded business of India and Nepal
Torrent Pharmaceuticals has entered into a definitive binding agreement with Unichem to acquire its branded business of India and Nepal (India business) for a consideration of Rs3600 crores.
Production & Manufacturing > Manufacturing > News
Celonic acquires Glycotope’s bio-manufacturing plant in Germany
Celonic, a privately owned CDMO based in Basel, Switzerland, has completed the acquisition of Glycotope’s bio-manufacturing facility in Heidelberg, Germany.
Production & Manufacturing > Manufacturing > News
Trial finds blood plasma infusions could help treat Alzheimer’s
By PBR Staff Writer
A team of researchers in the US have found that regular infusions of blood plasma from young donors could well be a new treatment option for Alzheimer’s disease.
Contract Research & Services > Clinical Trials > News
Sanofi, Alnylam present positive complete results of patisiran from phase 3 study in hATTR amyloidosis patients with polyneuropathy
Sanofi Genzyme, and Alnylam Pharmaceuticals have reported positive complete results from the Apollo Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.
Contract Research & Services > Clinical Trials > News
Xenetic signs sublicense deal related to PolyXen technology with Baxalta
Xenetic Biosciences has entered into a Right to Sublicense Agreement with Baxalta, Baxalta, and Baxalta (collectively, with their affiliates, “Baxalta”), wholly-owned subsidiaries of Shire.
Contract Research & Services > Contract Services > News
Boehringer, Dicerna partner on RNAi treatment for NASH
By PBR Staff Writer
Boehringer Ingelheim and Dicerna Pharmaceuticals have partnered to develop treatments for chronic liver diseases including Nonalcoholic Steatohepatitis (NASH).
Drug Research > Drug Discovery & Development > News
GSK study shows COPD 'superiority' for Anoro Ellipta versus Stiolto Respimat
By PBR Staff Writer
GlaxoSmithKline’s (GSK) study showed that Anoro Ellipta is more effective than Stiolto Respimat in improving lung function in patients with chronic obstructive pulmonary disease (COPD).
Contract Research & Services > Clinical Trials > News
Novartis seeks FDA approval for second Kymriah indication
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
Production & Manufacturing > Process & Production > News
FDA advisory committees recommend approval of Indivior's RBP-6000 to treat opioid use disorder
Indivior has announced that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD).
Regulatory Affairs > News
AbbVie says Elagolix reduces pelvic pain in two phase 3 extension studies
By PBR Staff Writer
AbbVie said that its gonadotropin-releasing hormone (GnRH) antagonist elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse in two replicate Phase 3 extension studies.
Contract Research & Services > Clinical Trials > News
Amgen to buy Japanese joint venture
By PBR Staff Writer
Amgen has entered an agreement to acquire Kirin-Amgen, its joint venture (JV) with Japan-based Kirin Holdings for $780m.
Drug Research > Drug Discovery & Development > News
Aviragen Therapeutics and Vaxart sign merger deal
By PBR Staff Writer
Aviragen Therapeutics, which is engaged in the discovery and development of direct-acting antivirals to treat infections with limited therapeutic options, has signed a merger agreement with Vaxart, a clinical-stage company focused on developing oral recombinant vaccines.
Drug Research > Drug Discovery & Development > News
Voyager to gain global rights to VY-AADC program for advanced Parkinson’s disease
Voyager Therapeutics, a clinical-stage gene therapy company focused on developing treatments for severe neurological diseases, has announced an update to its VY-AADC program for advanced Parkinson’s disease.
Drug Research > Drug Discovery & Development > News
AstraZeneca’s Calquence secures FDA approval for mantle cell lymphoma
By PBR Staff Writer
AstraZeneca’s Calquence (acalabrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Regulatory Affairs > News
FDA approves new dosing for Xarelto to reduce risk of VTE
Janssen Pharmaceuticals reported that 10mg once-daily dose of Xarelto (rivaroxaban) has been approved by the US Food and Drug Administration (FDA) for reducing the continued risk for recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy.
Regulatory Affairs > News
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