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136-150 of 49239 results
ChemDiv signs drug discovery collaboration deal with Cystic Fibrosis Foundation Therapeutics
ChemDiv has entered into a new drug discovery collaboration agreement with Cystic Fibrosis Foundation Therapeutics (CFFT).
Drug Research > Drug Discovery & Development > News
European Commission approves Imbruvica for first-line treatment of CLL patients
By PBR Staff Writer
The European Commission (EC) has approved Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
FDA approves Allergan's TEFLARO for pediatric patients
The U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.
Regulatory Affairs > News
Jazz Pharmaceuticals agrees to acquire Celator for $1.5bn
By PBR Staff Writer
Jazz Pharmaceuticals has agreed to acquire oncology-focused biopharmaceutical firm Celator Pharmaceuticals for about $1.5bn.
Drug Research > Drug Discovery & Development > News
Teva receives CRL from FDA in response to SD-809 NDA
The US Food and Drug Administration (FDA) has asked Teva Pharmaceutical Industries to examine blood levels of several metabolites in response to the company's new drug application (NDA) for SD-809 tablets to treat chorea associated Huntington disease (HD).
Regulatory Affairs > News
DCGI gives limited approval to market first Allogeneic cell therapy product in India
The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease.
Regulatory Affairs > News
Amgen receives positive CHMP opinion to extend indication of Kyprolis to treat relapsed multiple myeloma
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
Production & Manufacturing > Process & Production > News
European CHMP adopts positive opinion for Gilead’s Epclusa to treat all genotypes of chronic hepatitis C
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on Gilead Sciences' Marketing Authorization Application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
Drug Research > Drug Delivery > News
Genmab to receive $30m milestone payment from Janssen in Darzalex collaboration
By PBR Staff Writer
Danish biotechnology firm Genmab will receive $30m payment from Janssen Biotech under Darzalex (daratumumab) collaboration.
Contract Research & Services > Contract Services > News
Abivax starts second phase IIa trial of ABX464 in HIV/AIDS patients
By PBR Staff Writer
Abivax has enrolled first patient in second phase IIa trial of ABX464 drug candidate in HIV/AIDS patients.
Contract Research & Services > Clinical Trials > News
European Commission approves Samsung Bioepis’ Remicade biosimilar
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug.
Regulatory Affairs > News
TG Therapeutics enters into global collaboration to develop Jubilant's novel BET inhibitor program
TG Therapeutics unveiled that as part of a broader agreement with Indian biotechnology firm Jubilant Biosys, it has entered into a sub-license agreement with Checkpoint Therapeutics to develop and commercialize Jubilant's novel BET inhibitor program in the field of hematological malignancies.
Contract Research & Services > Contract Services > News
CHMP backs extended approval of Takeda Pharmaceutical's Adcetris
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of Takeda Pharmaceutical's ADCETRIS (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).
Drug Research > Drug Delivery > News
Kitov announces completion of manufacturing pivotal batches of KIT-302 for registration in US
Kitov Pharmaceuticals announced the completion of manufacturing by Dexcel Pharma of pivotal batches required for registration of KIT-302 with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News
Shire gets positive CHMP opinion in Europe for Revestive for paediatric patients with SBS
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Shire's Revestive (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS).
Drug Research > Drug Delivery > News
136-150 of 49239 results