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Inozyme Pharma secures $49m funding for rare disease therapies
Inozyme Pharma, which is developing novel medicines to treat rare diseases of calcification, affecting soft tissues and bone, has raised a $49m Series A financing.
Drug Research > Drug Discovery & Development > News
Arvinas, Genentech expand license agreement for Protac
Arvinas has expanded its ongoing license agreement with Genentech for the development of new therapeutics using its novel PROTAC technology.
Contract Research & Services > Contract Services > News
Ultragenyx’s Mepsevii secures FDA approval for Mucopolysaccharidosis VII
By PBR Staff Writer
Ultragenyx Pharmaceutical’s enzyme replacement therapy Mepsevii (vestronidase alfa) has secured approval from the US Food and Drug Administration (FDA) for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) in both children and adults.
Regulatory Affairs > News
AstraZeneca gets FDA nod for Fasenra to treat severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca, along with its wholly owned subsidiary MedImmune, has secured approval from the US Food and Drug Administration (FDA) for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.
Regulatory Affairs > News
Purdue Pharma to invest in oncology research and development
Purdue Pharma says that it has finalized major oncology related investments as part of its move to diversify its scientific research into areas of high unmet medical need.
Drug Research > Drug Discovery & Development > News
Cardinal to divest drug distribution business in China to Shanghai Pharma
By PBR Staff Writer
Cardinal Health, an Ohio-based health care services company has signed a deal to divest its drug distribution business in China to Shanghai Pharmaceuticals (Shanghai Pharma) for $557m.
Production & Manufacturing > Manufacturing > News
Bayer and Loxo Oncology to develop and commercialize two cancer therapies
Bayer has entered into an exclusive global collaboration with Loxo Oncology for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195.
News
Arcus Biosciences secures funding to advance clinical programs for AB928
Clinical-stage biotechnology company Arcus Biosciences has completed a $107m series C financing, bringing the total equity capital to around $227m.
Contract Research & Services > Clinical Trials > News
Sumitomo to buy 20% stake in Sawai America for $211m
By PBR Staff Writer
Sumitomo Corporation of Americas (SCOA) has agreed to acquire 20% interest in Sawai Pharmaceutical’s US subsidiary Sawai America (SAI) for around $211m.
Production & Manufacturing > Manufacturing > News
EMA grants PRIME designation for Mereo’s BPS-804 to treat osteogenesis imperfecta
Mereo BioPharma Group’s BPS-804 has been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of osteogenesis imperfecta (OI), or "brittle bone disease."
Production & Manufacturing > Process & Production > News
US FDA approves first drug with digital ingestion tracking system
By PBR Staff Writer
Otsuka Pharmaceutical has secured approval from the US Food and Drug Administration for its Abilify MyCite (aripiprazole tablets with sensor), an antipsychotic drug that has an embedded sensor to digitally track if patients have ingested their medication.
Regulatory Affairs > News
Sprycel approval expanded to include treatment of children with Ph+ CML in chronic phase
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Regulatory Affairs > News
Research indicates potential treatment for autism and intellectual disability
A University of Nebraska Medical Center researcher and his team at the Munroe-Meyer Institute (MMI) made a breakthrough in finding the mechanism and a possible therapeutic fix for autism and intellectual disability
Drug Research > Drug Discovery & Development > News
EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.
Production & Manufacturing > Process & Production > News
Pfizer to exit from Chinese generic drug JV with Hisun
By PBR Staff Writer
Pfizer will exit from Hisun-Pfizer Pharmaceuticals, its Chinese joint venture (JV) for generic drugs, by divesting 49% stake to Sapphire I (HK) Holdings for an undisclosed price.
Production & Manufacturing > Manufacturing > News
76-90 of 50849 results