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Novartis and Amgen secure FDA approval for migraine drug Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention. Regulatory Affairs > News
Biopharmaceutical firm Accent Therapeutics launches with $40m financing By PBR Staff Writer
Accent Therapeutics has been launched with $40m Series A financing for precision cancer treatments targeting RNA-modifying proteins.
Drug Research > Drug Discovery & Development > News Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).
News Pfizer’s Lyrica meets primary endpoint in phase 3 pediatric epilepsy trial Pfizer has reported positive top-line results from a phase 3 study, which assessed the use of Lyrica (pregabalin) oral solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.
Contract Research & Services > Clinical Trials > News
Novartis and Amgen secure FDA approval for migraine drug By PBR Staff Writer
Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.
Regulatory Affairs > News OptiBiotix Health signs manufacturing and supply deal in India with Akums OptiBiotix Health has entered into a five year agreement with Akums Drugs and Pharmaceuticals to exclusively manufacture and supply products featuring OptiBiotix's cholesterol and blood pressure reducing strain LPLDL in India.
Drug Research > Drug Delivery > News IDMC recommends to expand Tiziana’s phase 2a trial of Milciclib Tiziana Life Sciences announces that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

Aquestive settles Suboxone drug patent infringement case with Par Pharmaceuticals
Aquestive Therapeutics has reached a settlement agreement resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film with Par Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
Amryt, Aegerion sign expanded deal for Lojuxta capsules
Amryt has signed an agreement with Aegerion Pharmaceuticals to expand its exclusive licence agreement for Lojuxta (lomitapide) into Russia and the Commonwealth of Independent States (CIS), as well as the non-EU Balkan states.
Production & Manufacturing > Manufacturing > News

Drug Research

Biopharmaceutical firm Accent Therapeutics launches with $40m financing
By PBR Staff Writer
Accent Therapeutics has been launched with $40m Series A financing for precision cancer treatments targeting RNA-modifying proteins.
Drug Research > Drug Discovery & Development > News
OptiBiotix Health signs manufacturing and supply deal in India with Akums
OptiBiotix Health has entered into a five year agreement with Akums Drugs and Pharmaceuticals to exclusively manufacture and supply products featuring OptiBiotix's cholesterol and blood pressure reducing strain LPLDL in India.
Drug Research > Drug Delivery > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

Pfizer’s Lyrica meets primary endpoint in phase 3 pediatric epilepsy trial
Pfizer has reported positive top-line results from a phase 3 study, which assessed the use of Lyrica (pregabalin) oral solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.
Contract Research & Services > Clinical Trials > News
IDMC recommends to expand Tiziana’s phase 2a trial of Milciclib
Tiziana Life Sciences announces that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial.
Contract Research & Services > Clinical Trials > News

Automation

Horizon Discovery out-licenses cell line engineering technology to US firm
Horizon Discovery Group has entered into a non-exclusive out-licensing agreement with an undisclosed US-based immuno-oncology company (the Partner) for its technologies to support the development and manufacture of a biomanufacturing cell line for commercial use.
Automation > IT & Software > News
GE to provide biomanufacturing platform for Clover’s Chinese facility
By PBR Staff Writer
GE Healthcare will provide its biomanufacturing platform for Clover Biopharmaceuticals’ new production facility in China.
Automation > IT & Software > News

Regulatory Affairs

Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer
The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).
News
Novartis and Amgen secure FDA approval for migraine drug
By PBR Staff Writer
Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.
Regulatory Affairs > News



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